(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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 2, 2023
TechMah CMF Lyndsay Bowers VP Quality 2240 Sutherland Ave. Suite 2 Knoxville, Tennessee 37919
Re: K231520
Trade/Device Name: tmCMF Solution Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: September 11, 2023 Received: September 11, 2023
Dear Lyndsay Bowers:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231520
Device Name tmCMF Solution
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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510(k) SUMMARY
K231520
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
Date Prepared: October 2, 2023
I. CONTACT DETAILS
| Applicant Name: | TechMah CMF |
|---|---|
| Applicant Contact Telephone: | +1.865.200.4376 |
| Applicant Contact: | Dr. Mohamed Mahfouz |
| Applicant Contact Email: | mmahfouz@tmcmf.com |
| Applicant Address: | 2240 Sutherland Avenue, Suite 2Knoxville, TN 37919 United States |
| Correspondent Name: | TechMah CMF |
|---|---|
| Correspondent Contact Telephone: | +1.410.258.2770 |
| Correspondent Contact: | Mrs. Lyndsay Bowers |
| Correspondent Contact Email: | lbowers@tmcmf.com |
| Correspondent Address: | 2240 Sutherland Avenue, Suite 2Knoxville, TN 37919 United States |
II. DEVICE NAME
| Device Trade Name: | tmCMF Solution |
|---|---|
| Device Common Name: | Surgical Guide and Surgical Planning Software |
| Classification Name: | Bone Cutting Instrument And Accessories |
| Regulation Number: | 21 CFR §872.4120 |
| Product Code: | DZJ |
| Subsequent Product Code: | LLZ |
III. LEGALLY MARKETED PREDICATE DEVICES
| Predicate Number: | K192282 |
|---|---|
| Predicate Trade Name: | MedCAD AccuPlan System |
| Product Code: | DZJ |
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IV. LEGALLY MARKETED REFERENCE DEVICES
| Predicate Number: | K103136 |
|---|---|
| Predicate Trade Name: | SurgiCase mandible/maxillofacial guides |
| Product Code: | JEY |
| Predicate Number: | K170419 |
| Predicate Trade Name: | SurgiCase Viewer |
| Product Code: | LLZ |
| Predicate Number: | K210347 |
| Predicate Trade Name: | VSP System |
| Product Code: | DZJ, LLZ |
| Predicate Number: | K120956 |
| Predicate Trade Name: | VSP System |
| Product Code: | DZJ, LLZ |
V. DEVICE DESCRIPTION SUMMARY
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
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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.
VI. INTENDED USE/INDICATIONS FOR USE
The tmCMF Solution is intended for use as a software system and image seqmentation 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 be used for the maxillofacial and mandibular bone in maxillofacial and mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.
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VII. SUBSTANTIAL EQUIVALENCE COMPARISON
| tmCMF Solution(Subject device) | MedCAD® AccuPlan® System(Predicate device) K192282 | SurgiCase Viewer(K170419) Reference Device | SurgiCasemandible/maxillofacial guides(K103136) Reference Device | VSP System(Reference device)K210347 | |
|---|---|---|---|---|---|
| Indication for Use | The tmCMF Solution isintended for use as a softwaresystem and imagesegmentation system for thetransfer of imaging informationfrom a medical scanner suchas a CT-based system. Theinput data file is processed bythe tmCMF Solution, and theresult is an output data file thatmay then be provided asdigital models or used as inputto a rapid prototyping portionof the system that producesphysical outputs includinganatomical models, surgicalguides, and dental splints foruse in maxillofacial andmandibular surgery. Thesurgical guides and dentalsplints are intended to be usedfor the maxillofacial andmandibular bone inmaxillofacial and mandibularsurgery. The tmCMF Solutionis also intended as apreoperative software tool forsimulating/evaluating surgicaltreatment options. | The MedCAD® AccuPlan®System is intended for use as asoftware system and imagesegmentation system for thetransfer of imaging informationfrom a medical scanner such asa CT based system. The inputdata file is processed by theMedCAD® AccuPlan® Systemand the result is an output datafile that may then be provided asdigital models or used as input toa rapid prototyping portion of thesystem that produces physicaloutputs including anatomicalmodels, surgical guides, anddental splints for use inmaxillofacial surgery. Thesurgical guides and dentalsplints are intended to be usedfor the maxillofacial bone inmaxillofacial surgery. TheMedCAD® AccuPlan® System isalso intended as a preoperativesoftware tool for simulating /evaluating surgical treatmentoptions. | SurgiCase Viewer is intendedto be used as a softwareinterface to assist invisualization andcommunication of treatmentoptions. | SurgiCase Guides are intended tobe used as surgical tools totransfer a pre-operative plan to thesurgery. The devices are intendedto guide the marking of boneand/or guide surgical instrumentsin mandibular and maxillofacialsurgical procedures | The VSP® System isintended for use as asoftware system andimage segmentationsystem for the transfer ofimaging information from amedical scanner such as aCT based system.The input data file isprocessed by the VSP®System and the result is anoutput data file that maythen be provided as digitalmodels or used as input toa rapid prototyping portionof the system thatproduces physical outputsincluding anatomicalmodels, templates, andsurgical guides for use inmaxillofacial surgery. |
| Preoperativesoftware | Yes | Yes | Yes | Yes | Image transformation into3D models, ComputerAided Design, Surgicalplanning / simulation |
| Additivemanufacturing ofsplint, guides, andmodels | Yes | Yes | Unknown | Yes | 3D Printing to producephysical output devices |
| Data Inputs | Images from medical scanners | Images from medical scanners | Images from medicalscanners | Images from medical scanners | DICOM file from MedicalScanner (CT, CBCT),patient contoured andstandard implant .STL files;input fromPhysician |
| tmCMF Solution(Subject device) | MedCAD® AccuPlan® System(Predicate device) K192282 | SurgiCase Viewer(K170419) Reference Device | SurgiCasemandible/maxillofacial guides(K103136) Reference Device | VSP System(Reference device)K210347 | |
| Data Outputs | Output for dental splints,surgical guides, andanatomical models | Output for dental splints, surgicalguides, and anatomical models | Approved plans and designs | Output for dental splints, surgicalguides, and anatomical models | Output for dental splints,surgical guides, andanatomical models |
| Physical Outputs | Dental splints, surgical guide,anatomical models, andpatient-specific case reports | Dental splints, surgical guide,anatomical models, and patient-specific case reports | Unknown | Dental splints, surgical guide, | Dental splints, surgicalguide,anatomical models |
| Sterilization | Device is provided non-sterileand is steam sterilized by theend-user | Device is provided non-sterileand is steam sterilized by theend-user | Unknown | Device is provided non-sterile andis steam sterilized by the end-user | Steam sterilization |
| ManufacturingMethod | Additive Manufacturing | Additive Manufacturing | Unknown | Additive Manufacturing | Additive Manufacturing |
| Web Interface | Yes | Unknown | Yes | No | Unknown |
| 2D Image DisplayAxialSagittalCoronal | Yes | Yes | Yes | Yes | Yes |
| 3D Visualization | Yes | Yes | Yes | Yes | Yes |
| InstallationRequired | No | Unknown | No | Yes | Unknown |
| PhysicianInteraction withPlanning andPhysician Model /Guide Approval | Yes | Yes | Yes | Yes | Yes |
| Single Use | Yes | Yes | NA | Yes | Yes |
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VIII. INDICATIONS FOR USE COMPARISON
The tmCMF Solution has equivalent indication for use as its predicate device. The primary indication is to utilize pre-operative imaging data to perform surgical case planning and create patient-specific instrumentation to transfer the pre-operative plan on the patient in the operating room.
Differences
- . The predicate specifically refers to maxillofacial surgery, whereas the subject device covers both maxillofacial and mandibular surgeries, which is equivalent to the reference device (K103136).
- . The predicate device does not include graft harvesting surgical guides, whereas the subject does. However, the predicate device (K120956) used by the current predicate (K192282) also included harvesting surgical guides, which is equivalent to the reference device (K210347)
- . The predicate device has a limited contact for the splint whereas the subject device has a prolonged contact for splints to allow for post-op usage of up to 30 days. However, the predicate device (K120956) used by the current predicate (K192282) also has a prolonged contact for splints to allow for postop usage of up to 30 days, which is equivalent to the reference device (K210347).
IX. TECHNOLOGICAL COMPARISON (WITH PREDICATE DEVICE)
Similarities to Predicate
The tmCMF Solution has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicates including input case data, manipulation, and surgical planning. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate. The system has similar technological characteristics including:
- System inputs: images from medical scanners (ex: CT), dental models, and/or . implant files (.STL)
- . System outputs: physical and/ or digital outputs such as patient-specific anatomical models, guides, and splints
- Materials: biocompatible polymers
- Sterility assurance level of 1x10-6 ●
The intended use of the subject device and the predicate both provide tools and accessories (software for image manipulation, anatomical models, splints, and guides) for use in reconstructive surgery. Additionally, both the subject and the predicate device are intended to be used by trained personnel with active support
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from the surgeon.
Differences to Predicate
- The predicate specifically refers to maxillofacial surgery, whereas the subject ● device covers both maxillofacial and mandibular surgeries.
- . The predicate device does not include graft harvesting surgical quides, whereas the subject does. However, the predicate device (K120956) used by the current predicate (K192282) also included harvesting surgical guides.
- The predicate device has a limited contact for the splint whereas the subject device has a prolonged contact for splints to allow for post-op usage of up to 30 days. However, the predicate device (K120956) used by the current predicate (K192282) also has a prolonged contact for splints to allow for postop usage of up to 30 days.
X. TECHNOLOGICAL COMPARISON (WITH REFERENCE DEVICES)
Reference device K170419:
-
The reference device served as a technologically equivalent device for the ● Surgeon Review Tool (SRT).
Reference device K103136: -
. This reference device was used to establish performance equivalence data.
Reference devices K210347 and K120956: -
The reference devices served as the basis for establishing equivalence on physical product features and offerings, product material compositions and their manufacturing processes. The reference devices encompass anatomical models, surgical guides, and dental splints, with the subject device utilizing similar product features and identical materials to ensure a state of equivalence.
The addition of the reference device comparison presents another substantially equivalent device with identical physical outputs, materials, and manufacturing processes.
XI. NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY
The following performance data were provided in support of the substantial equivalence determination.
Cleaning
Testing was performed to validate the end-user cleaning protocol of the subject
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device per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and AAMI TIR 30.
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.
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 to ensure the biocompatibility of the materials and manufacturing process used in the tmCMF surgical instruments.
Software Verification and Validation
Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304:2006/A1:2015. The following FDA quidance documents were also followed: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Device Software Functions.
Usability
Usability was validated in accordance with IEC 62366-1:2020.
Benchtop Performance
Benchtop performance testing was performed to demonstrate the performance of the tmCMF Solution and substantial equivalence with the predicate device. The testing aligns with the test strategy and performance metrics used by the predicate.
| Hardware PerformanceVerification | Testing demonstrated that the surgical guide anddental splint meets the predetermined acceptancecriteria. |
|---|---|
| Cadaveric BenchtopPerformance Testing | Comparison of pre-operative surgical plan to post-operative CT measurements. Results passed thepredetermined acceptance criteria, indicatingsubstantial equivalence. |
| Hardware Integrity testVerification | Testing demonstrated that the instruments meet thepredetermined acceptance criteria. |
| Hardware VerificationInspection and Analysis | Testing demonstrated that instruments' implementationis compliant with the acceptance criteria. |
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| Surgical Case Verification | Testing demonstrated that the surgical case reportsare compliant with acceptance criteria. |
|---|---|
| System Validation | Testing demonstrated that the system has met userneeds and is compliant with acceptance criteria. |
XII. CONCLUSION
The tmCMF Solution has the same intended use as the predicate device and similar technological characteristics as the predicate and reference devices. Therefore, the subject device is substantially equivalent.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.