Document information
This Instructions for Use document applies only to the MIV TMJ software version identified below. The user should verify the installed software version before use.
| Device | MIV TMJ System |
|---|---|
| Manufacturer | MIV P.S.A. |
| IFU version | [rev. XX] |
| Software version | [X.X.X] |
| Issue date | [DD.MM.YYYY] |
| Document ID | MIVTMJ-TF-II.2 |
Device description
MIV TMJ is desktop medical software designed to process CBCT imaging datasets in DICOM format and support qualified healthcare professionals in the assessment of selected anatomical and spatial parameters of the temporomandibular joints.
The system uses image-processing and AI/ML algorithms to identify predefined anatomical structures and landmarks, calculate selected parameters and present the results in a structured analysis environment.
Important
MIV TMJ is a decision-support tool. It does not provide an autonomous diagnosis and does not replace clinical examination, professional knowledge or independent clinical judgement.
Intended purpose
MIV TMJ is intended to support qualified healthcare professionals in the assessment of selected parameters of the temporomandibular joints based on CBCT DICOM imaging data.
The software supports structured review of selected anatomical landmarks, reference planes, measurements and bilateral relationships of the right and left temporomandibular joints.
All automatically generated outputs must be reviewed and verified by a qualified user before being interpreted in the clinical context.
Intended users
MIV TMJ is intended exclusively for qualified healthcare professionals with appropriate knowledge of craniofacial anatomy, CBCT imaging and assessment of the temporomandibular joint.
- Dentists
- Orthodontists
- Prosthodontists
- Oral and maxillofacial surgeons
- Other appropriately trained healthcare professionals within the defined intended purpose
Professional use only
MIV TMJ is not intended for use by patients, consumers or other lay persons.
Patient population
MIV TMJ may be used for patients for whom a CBCT examination containing the required temporomandibular joint structures has been obtained on the basis of an independent clinical indication.
The software does not determine whether CBCT imaging should be performed and must not be used as the basis for exposing a patient to ionising radiation.
System capabilities
- Import of CBCT DICOM imaging datasets
- 3D visualization of selected anatomical structures
- Automatic identification of selected anatomical landmarks
- Segmentation of selected anatomical structures
- Definition of selected reference planes and axes
- Calculation of selected TMJ measurements
- Analysis of selected radiological joint-space parameters
- Comparison of selected right and left TMJ parameters
- Manual review and correction of automatically generated outputs
- Structured presentation and reporting of results
CBCT input requirements
The input dataset must contain CBCT imaging data in a supported DICOM format and include the anatomical structures required for the selected analysis.
Before starting the analysis, verify:
- correct DICOM import;
- appropriate field of view (FOV);
- visibility of required anatomical structures;
- adequate image quality and spatial resolution;
- patient positioning;
- absence of artefacts significantly affecting interpretation;
- correct orientation and geometry of the reconstructed volume.
WARNING – Limitations related to field of view and CBCT input quality
MIV TMJ analyses anatomical structures visible in the supplied CBCT examination. The software does not independently determine whether the CBCT examination was acquired correctly or whether the available field of view is sufficient for reliable completion of all analyses and measurements.
Before starting the analysis, the qualified user should verify image quality, field of view (FOV), patient positioning and complete visibility of the anatomical structures required for the intended analysis.
Particular attention should be paid when the anatomical structure of interest, including the temporomandibular joint, is located close to the boundary of the acquired imaging volume. Such structures may be partially truncated, incomplete or insufficiently represented for stable automated segmentation, anatomical landmark localisation or measurement geometry.
A CBCT examination may appear visually acceptable for specialist review while still containing insufficient information for reliable automated analysis.
Automatically generated segmentations, anatomical landmarks, reference planes and measurements shall be verified by the qualified user before use in clinical assessment.
If the required anatomical structures are not fully visible, or if there is any doubt regarding image quality or completeness of the input data, the automatically generated results should not be used as the sole basis for clinical decision-making.
CBCT data quality warning
If possible abnormalities in the input data are detected, patient positioning, field of view or visibility of the required anatomical structures may be insufficient for reliable analysis.
Generated results may be incomplete or inaccurate. A qualified user must verify the quality and clinical suitability of the CBCT examination before continuing.
The presence or absence of a warning does not constitute confirmation that the CBCT examination is clinically adequate or correctly acquired. Final assessment of the quality, completeness and suitability of the imaging data remains the responsibility of the qualified user.
Hardware and use environment
MIV TMJ is intended for operation on a compatible desktop or laptop computer in a professional healthcare environment.
The computer must meet the minimum hardware and operating-system requirements specified for the installed MIV TMJ software version.
Performance
Processing time depends on the size and resolution of the CBCT dataset, the hardware configuration and the available computational resources. The user should allow the analysis to complete before reviewing the generated results.
Typical analysis workflow
Import CBCT
Load the appropriate CBCT DICOM dataset.
Verify input data
Check image quality, FOV, positioning and visibility of required anatomy.
Automatic processing
The software processes the CBCT dataset and generates selected anatomical landmarks and structures.
Review AI outputs
Verify automatically generated landmarks, segmentation and anatomical references.
Review measurements
Assess calculated parameters and bilateral comparison of the joints.
Clinical interpretation
Interpret the information together with the examination, symptoms, medical history and other relevant clinical data.
AI-generated outputs
MIV TMJ uses automated image-analysis components, including models supporting segmentation of selected structures and identification of predefined anatomical landmarks.
The models operate as fixed inference models during normal use. Patient examinations do not automatically retrain or modify the model.
Mandatory user verification
Automatically generated landmarks, segmentations, reference planes and measurements may be incorrect. The user must review their anatomical correctness before using the generated information in further assessment.
If an automatically generated result is inconsistent with the CBCT image or cannot be reliably verified, the result must not be relied upon.
Automated analysis depends on the information actually represented in the source CBCT dataset. A structure located near the scan boundary may be only partially represented even when the examination appears visually acceptable for specialist review. This may affect segmentation, landmark localisation, reference geometry and derived measurements.
Measurements and radiological joint space
MIV TMJ calculates selected distances, angles and spatial parameters on the basis of the CBCT dataset and verified anatomical references.
Radiological joint space
Radiological joint-space measurements describe selected distances between the bony surface of the mandibular condyle and bony structures of the articular fossa in defined directions.
Depending on the implemented analysis, these may include selected anterior, superior, posterior, medial and lateral measurements.
Interpretation limitation
Radiological joint space is an imaging measurement of bony spatial relationships. It does not directly visualise the articular disc or other soft tissues.
Its interpretation may also be affected by the mandibular position at the time of image acquisition.
Warnings and limitations
- Do not use an automatically generated result without verifying it against the source CBCT data.
- Do not use MIV TMJ as the sole basis for diagnosis or therapeutic decisions.
- Do not assume that bilateral symmetry indicates normal anatomy or normal function.
- A static CBCT examination does not by itself provide a complete assessment of TMJ function.
- CBCT primarily provides information about mineralised structures. Soft-tissue assessment may require other diagnostic methods.
- Image artefacts, incomplete FOV, incorrect patient positioning, unusual anatomy or structures located near the boundary of the scan may reduce the reliability of automated outputs.
- The software does not independently confirm that the examination was correctly acquired or that the FOV is sufficient for every intended analysis.
- A CBCT examination may appear visually acceptable for specialist review while still containing insufficient information for reliable automated analysis.
- The absence of an input-quality warning does not confirm that the examination is clinically adequate or complete.
- Zooming or enlarging an image does not increase the underlying information or spatial resolution of the original CBCT acquisition.
- Results must always be interpreted together with relevant clinical information.
Examinations with a limited field of view
A limited FOV does not automatically make a CBCT examination unsuitable for assessment of the TMJ.
If the required TMJ structures are fully visible and sufficiently represented, the examination may allow assessment of their visible bony anatomy.
Scan-boundary limitation
Particular attention is required when the temporomandibular joint or another structure required for the analysis is located at or close to the boundary of the acquired volume. The structure may be partially truncated, incomplete or insufficiently represented for stable automated segmentation, landmark localisation or measurement geometry.
The examination may still be visually interpretable by a specialist, but this does not guarantee that it contains sufficient data for reliable automated analysis. The qualified user must verify completeness of the required anatomy before relying on automatically generated results.
Topographical limitation
If the field of view does not allow the user to verify the relationship of the mandible to the maxilla or the patient's occlusal position during acquisition, anatomical structures may still be assessed, but interpretation of their topographical relationships must be limited accordingly.
Patient data and cybersecurity
Users must process patient data in accordance with applicable data-protection requirements and the policies of their healthcare organisation.
- Use individual user credentials.
- Do not share passwords.
- Use supported versions of the software.
- Install security and software updates provided by MIV P.S.A.
- Protect the workstation against unauthorised physical and remote access.
- Do not modify application files, AI models or software dependencies.
Updates and version control
MIV TMJ software versions are released through a controlled software release process.
Users should only use versions supported by MIV P.S.A. and should ensure that the IFU corresponds to the installed software version.
AI model versions
Changes to an AI model, its preprocessing, postprocessing or execution environment are subject to controlled verification and validation before release.
Troubleshooting
| Situation | Recommended action |
|---|---|
| DICOM dataset cannot be imported | Verify file integrity, DICOM compatibility and completeness of the imaging dataset. |
| CBCT quality warning displayed | Review positioning, FOV, image quality, artefacts and visibility of the required structures. Cancel the analysis if the data are not clinically suitable. |
| TMJ or required anatomy is close to the scan boundary | Verify that the structure is fully represented in the acquired volume. If it is partially truncated, incomplete or insufficiently visible, do not rely on the automated analysis as the sole basis for clinical decision-making. |
| No warning is displayed, but image quality or FOV is questionable | Do not interpret the absence of a warning as confirmation of scan adequacy. Independently verify image quality, FOV and visibility of the required anatomy. |
| Automatic landmark is incorrectly positioned | Verify the landmark against the CBCT image and correct it manually if the function is available. Do not accept an incorrect result. |
| Segmentation appears anatomically incorrect | Do not rely on measurements derived from the incorrect segmentation. Review the source image and repeat or discontinue the analysis. |
| Processing does not complete | Do not interpret incomplete outputs. Restart the workflow according to the application instructions or contact support. |
| Unexpected or implausible measurement | Verify the source image, landmark positions, segmentation and reference planes before interpreting the measurement. |
Manufacturer and support
MIV P.S.A.
Ignacego Mościckiego 1
24-110 Puławy
Poland
E-mail: info@mivtmj.com
Website: mivtmj.com
Current online IFU: mivtmj.com/ifu/
User manual: mivtmj.com/manual/
A paper or electronic copy of the current Instructions for Use may be requested from MIV P.S.A. using the contact details above.
