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510(k) Data Aggregation
(130 days)
The traCMF 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 rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to the maxillofacial and mandibular bone in mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.
The TechMah CMF (tmCMF) Solution is a family of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software, and maxillofacial and mandibular surqical instruments (surgical quides, anatomical models, and dental splints). The surqical instruments are patient-specific devices and are designed utilizing CT and dental scan patient image data.
Surgical guides are patient-specific devices or templates that are based on preoperative software planning and are 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 of bone for plate fixation screws and the position of the osteotomy marking slots. Surgical guides are available for treatment (maxilla and mandible) and harvesting (fibula, iliac crest, and scapula). Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit.
Anatomical models are patient-specific models that are based on pre-operative anatomy and surgical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing preoperative, intra-operative, and post-operative anatomical models as guidance. Anatomical models are available for treatment (maxilla and mandible), and harvesting (fibula, iliac crest, and scapula) anatomy. Anatomical models can be used to check quide fit.
Dental splints are patient-specific devices or templates that are based on preoperative software surgical planning and are designed to fit a specific patient. Dental splints are available as single splint desired occlusions or combined splint-in-splint option. 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.
The Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs. The SRT software is accessed through a web interface from a surgeon's device.
The tmCMF Solution's acceptance criteria and the study proving it meets these criteria are detailed below.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cleaning | Testing was performed to validate the end-user cleaning protocol of the subject device per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and AAMI TIR 30. (Passed) |
| Sterilization | Testing was performed to validate the end-user sterilization protocol of the subject device per ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST79. (Passed) |
| Biocompatibility | Biocompatibility assessment per the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and biocompatibility testing per ISO 10993-1:2018 for its contact classification was conducted. (Ensured biocompatibility) |
| Software Verification and Validation | Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304:2006/A1:2015, and relevant FDA guidance documents. (Passed) |
| Usability | Usability was validated in accordance with IEC 62366-1:2020. (Validated) |
| Benchtop Performance - Hardware Performance Verification | Testing demonstrated that the surgical guide and dental splint meets the predetermined acceptance criteria. (Passed) |
| Benchtop Performance - Cadaveric Benchtop Performance Testing | Comparison of pre-operative surgical plan to post-operative CT measurements. Results passed the predetermined acceptance criteria, indicating substantial equivalence. (Passed) |
| Benchtop Performance - Hardware Integrity Test Verification | Testing demonstrated that the instruments meet the predetermined acceptance criteria. (Passed) |
| Benchtop Performance - Hardware Verification Inspection and Analysis | Testing demonstrated that instruments' implementation is compliant with the acceptance criteria. (Compliant) |
| Surgical Case Verification | Testing demonstrated that the surgical case reports are compliant with acceptance criteria. (Compliant) |
| System Validation | Testing demonstrated that the system has met user needs and is compliant with acceptance criteria. (Compliant) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Cadaveric Benchtop Performance Testing" as part of the benchtop performance evaluation. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. It only states that a comparison of pre-operative surgical plan to post-operative CT measurements was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions that the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs," implying surgeon involvement in the process but not specifically for ground truth establishment for a test set in the regulatory submission context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (such as 2+1 or 3+1) used for establishing ground truth or evaluating the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The tmCMF Solution is described as a software system for image segmentation, surgical planning, and the production of physical outputs, with the Surgeon Review Tool (SRT) facilitating surgeon review and approval, but not explicitly as an AI assistance tool for human readers in a diagnostic setting that would typically involve a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the document describes the tmCMF Solution as a "software system and image segmentation system," it also highlights the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs" and "Physician Interaction with Planning and Physician Model / Guide Approval." This indicates that the device is intended for human-in-the-loop performance, with the surgeon involved in the review and approval process. A standalone algorithm-only performance is not explicitly described as a primary evaluation method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Cadaveric Benchtop Performance Testing," the ground truth was established by "Comparison of pre-operative surgical plan to post-operative CT measurements." This suggests that the ground truth for accuracy was based on direct measurement from CT scans after the surgical plan was implemented on cadavers, rather than expert consensus, pathology, or long-term outcomes data.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for the training set of the tmCMF Solution's "software system and image segmentation system."
9. How the ground truth for the training set was established
The document does not disclose how the ground truth for the training set was established.
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