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The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction. restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/ evaluating virtual surgical treatment options.

TechMah CMF (tmCMF) Solution is a family of personalized product solutions for Reconstructive, Orthognathic, Trauma, and Augmentation procedures in the mandible and midface (including orbital floor, medial and lateral orbital walls). The solution is comprised of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments (surgical guides, anatomical models, and dental splints) and implants. The surgical instruments and implants are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking/drilling of bone for plate fixation screws and the position of the osteotomy marking/cutting slots. Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Surgical guides can be used with either tmCMF Solution patient-specific implants or compatible off-the-shelf DePuy Synthes implants.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surqical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing pre-operative, intra-operative, and post-operative anatomical models as quidance. Anatomical models can be used to check quide fit and facilitate the pre-bending of a non-patient-specific off-the-shelf plate.

Dental splints are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth.

Implants are patient-specific devices that are based on pre-operative software planning designed to fit a specific patient. These implants are integral components for CMF (craniomaxillofacial) procedures, facilitating bone repositioning, fixation, reconstruction, and the restoration of bone defects. They are designed according to the pre-operative surgical plan to ensure continuity in regions where bone is absent and to provide structural integrity to the maxillofacial skeletal components, midface, mandible, and chin. This could include stabilizing fractured or intraoperatively cut bone, fixating harvested graft segments, or augmenting bone defects. Implants can be used in conjunction with surgical guides and anatomical models to assist with anatomical positioning and fit.

The Surgeon Review Tool (SRT) software is used by surgeons for the review of surgical plans, surgical instruments, and implant designs. The SRT software is accessed through a web interface.

tmCMF Solution supports the following maxillofacial, midface (including orbital floor, lateral and medial orbital wall), and mandibular surgical procedures:

• . Reconstructive
• Orthognathic
• Trauma
• Augmentation ●

The provided text describes the tmCMF Solution device and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or the study details proving the device meets those criteria, particularly for performance metrics like accuracy, sensitivity, or specificity for the software components.

The "Benchtop Performance" section mentions that "Testing demonstrated that the tmCMF Solution and substantial equivalence with the predicate device" and lists several "Performance verification" items, but these are high-level statements rather than detailed acceptance criteria and reported performance values. For example, "Testing demonstrated that the surgical guide and implants meets the predetermined acceptance criteria" indicates that acceptance criteria exist but doesn't provide them or the specific performance results.

Therefore, I cannot fulfill all parts of your request with the given input. I will extract the information that is present and indicate where information is missing.

Here's a summary of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided with specific numerical acceptance criteria or reported performance values in the document. The document generally states that "Testing demonstrated that... meets the predetermined acceptance criteria" for various aspects.

Note: The document only states that the device "meets" or is "compliant" with predetermined acceptance criteria, without providing the specific quantitative or qualitative criteria themselves, nor the specific performance values (e.g., accuracy percentages, error margins).

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "testing" but does not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective) of data used for performance validation.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. The document focuses on the device's technical specifications and substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly present a standalone performance study with specific metrics (e.g., accuracy, sensitivity, specificity) for the imaging or segmentation algorithms. It mentions tmCMF Solution is "a software system and image segmentation system," and that "Software Verification and Validation Testing was conducted," but focuses on compliance with software standards (IEC 62304) and general system functionality rather than detailed standalone performance metrics against ground truth for clinical tasks.

7. Type of Ground Truth Used

The specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the software's performance assessment is not explicitly stated in the document. It generally refers to "predetermined acceptance criteria" for various verification items.

8. Sample Size for the Training Set

This information is not provided in the document.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

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