(217 days)
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.
| Performance Verification Item | Acceptance Criteria (Not explicitly detailed) | Reported Device Performance (Not explicitly detailed) |
|---|---|---|
| Performance verification | Predetermined acceptance criteria | Device meets criteria |
| Locking screw compatibility verification | Predetermined acceptance criteria | Device meets criteria |
| Ti device manufacturing accuracy verification | Predetermined accuracy acceptance criteria | Device meets criteria |
| Torque through resistance verification | Predetermined acceptance criteria | Device meets criteria |
| Hardware verification inspection and analysis | Predetermined acceptance criteria | Device is compliant with criteria |
| Surgical case report verification | Predetermined acceptance criteria | Reports are compliant with criteria |
| System validation | Predetermined acceptance criteria | System has met user needs and is compliant |
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2024
TechMah CMF Lyndsay Bowers VP Quality 2099 Thunderhead Road, Suite 302 Knoxville, Tennessee 37922
Re: K233874
Trade/Device Name: tmCMF Solution Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZJ, LLZ Dated: June 21, 2024 Received: June 21, 2024
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.
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"
{1}------------------------------------------------
(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 OS 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).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
{2}------------------------------------------------
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
tmCMF Solution
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K233874 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
Date Prepared: July 8, 2024
I. CONTACT DETAILS
| Applicant Name: | TechMah CMF, LLC |
|---|---|
| Applicant Contact Telephone: | +1.865.200.4376 |
| Applicant Contact: | Dr. Mohamed Mahfouz |
| Applicant Contact Email: | mmahfouz@tmcmf.com |
| Applicant Address: | 2099 Thunderhead Rd, Suite 302Knoxville, TN 37922 United States |
| Correspondent Name: | TechMah CMF, LLC |
| Correspondent Contact Telephone: | +1.410.258.2770 |
| Correspondent Contact: | Mrs. Lyndsay Bowers |
| Correspondent Contact Email: | lbowers@tmcmf.com |
| Correspondent Address: | 2099 Thunderhead Rd, Suite 302Knoxville, TN 37922 United States |
II. DEVICE NAME
| Device Trade Name: | tmCMF Solution |
|---|---|
| Regulation Name: | Dental |
| Classification Name: | Plate, Bone |
| Regulation Number: | 21 CFR §872.4120 |
| Product Code: | JEY |
| Subsequent Product Code: | DZJ, LLZ |
III. LEGALLY MARKETED PREDICATE DEVICES
| Predicate Number: | K231520 |
|---|---|
| Predicate Trade Name: | tmCMF Solution |
| Product Code: | DZJ & LLZ |
| Use: | Primary Predicate |
| Predicate Number: | K173039 |
| Predicate Trade Name: | TruMatch CMF Titanium 3D Printed Implant |
| Product Code: | JEY |
| Use: | Secondary Predicate |
| Predicate Number: | K170272 |
| Predicate Trade Name: | TruMatch CMF Titanium 3D Printed Implant System |
| Product Code: | JEY |
| Use: | Secondary Predicate |
| IV. LEGALLY MARKETED REFERENCE DEVICES | |
| Predicate Number: | K063790 |
| Predicate Trade Name:SYSTEM | SYNTHES MATRIXMANDIBLE PLATE AND SCREW |
| Product Code: | JEY |
| Predicate Number: | K210731 |
| Predicate Trade Name: | KLS Martin Individual Patient Solutions |
| Product Code: | JEY |
| Predicate Number: | K213684 |
| Predicate Trade Name: | SurgiCase Viewer |
| Product Code: | LLZ |
| Predicate Number: | K080331 |
| Predicate Trade Name: | Synthes Craniofacial Plate and Screw System |
| Product Code: | JEY |
| Predicate Number: | K050608 |
| Predicate Trade Name: | Synthes (USA) Craniofacial Plate and Screw System |
| Product Code: | JEY |
| Predicate Number: | K083388 |
| Predicate Trade Name: | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM |
| Product Code: | JEY |
{5}------------------------------------------------
{6}------------------------------------------------
V. DEVICE DESCRIPTION SUMMARY
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.
{7}------------------------------------------------
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 ●
VI. INTENDED USE/INDICATIONS FOR USE
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.
{8}------------------------------------------------
VII. SUBSTANTIAL EQUIVALENCE COMPARISON
Comparison of the Subject Device to the Primary Predicate Device
| tmCMF Solution(subject device) | tmCMF Solution(Primary predicate deviceK231520) | Comment on SubstantialEquivalence | |
|---|---|---|---|
| Indication for Use | The tmCMF Solution is intended foruse as a software system and imagesegmentation system for the transferof imaging information from a medicalscanner such as a CT-based system.The input data file is processed by thetmCMF Solution, and the result is anoutput data file that may then beprovided as digital models or used asinput to a manufacturing portion of thesystem that produces physicaloutputs, including anatomical models,surgical guides, dental splints, andimplants for use in maxillofacial,midface, and mandibular surgery.Implants are intended for bone fixationand reconstruction, restoration ofbone defects, and intended to providecontinuity in regions where the bone ismissing and/or to augment the boneby means of an onlay device in themaxillofacial skeleton, midface,mandible, and chin in adolescents(greater than 12 to 21 years of age)and adults. The tmCMF Solution isalso intended as a preoperativesoftware tool for simulating/evaluatingsurgical treatment options. | The tmCMF Solution is intended foruse as a software system and imagesegmentation system for the transferof imaging information from a medicalscanner such as a CT-based system.The input data file is processed by thetmCMF Solution, and the result is anoutput data file that may then beprovided as digital models or used asinput to a rapid prototyping portion of thesystem that produces physicaloutputs including anatomical models,surgical guides, and dental splints foruse in maxillofacial and mandibularsurgery. The surgical guides anddental splints are intended to be usedfor the maxillofacial and mandibularbone in maxillofacial and mandibularsurgery. The tmCMF Solution is alsointended as a preoperative softwaretool for simulating/ evaluating surgicaltreatment options. | The subject device is a solution thatincludes software and patient-specific instruments (anatomicalmodels, surgical guides, splints),and patient-specific implants. Thesubject device is an update to itsprimary predicate device (K231520)to include patient-specific implants.The subject device and the primarypredicate device share identicalindications for use for the softwareand patient-specific instrumentation. |
| tmCMF Solution(subject device) | tmCMF Solution(Primary predicate deviceK231520) | Comment on SubstantialEquivalence | |
| Data Inputs | Images from medical scanners | Images from medical scanners | The subject device is an update tothe primary predicate deviceK231520, with no change in inputsfrom the predicate device. The datainputs are substantially equivalent. |
| Data Outputs | Output for dental splints, surgicalguides, anatomical models, andimplants | Output for dental splints, surgicalguides, and anatomical models | The subject device outputs forpolyamide (PA) surgical guides andanatomical models are identical tothe primary predicate deviceK231520.The subject device introduces twoadditional outputs for Ti surgicalguides and implants which areequivalent to the secondarypredicate devices K173039 andK170272.Subject device and primarypredicate device outputs for dentalsplints are identical with theexception that the subject deviceintroduces an optional titanium (Ti)palatal insert for dental splints, whichis equivalent to the reference deviceK210731. |
| tmCMF Solution(subject device) | tmCMF Solution(Primary predicate deviceK231520) | Comment on SubstantialEquivalence | |
| PhysicalOutputs | Dental splints, PA surgical guides, Tisurgical guides, anatomical models,implants, and patient-specific casereports | Dental splints, surgical guides,anatomical models, and patient-specific case reports | The subject device's physicaloutputs for surgical guides (PA), andanatomical models are identical tothe primary predicate deviceK231520. |
| The subject device includes twoadditional physical outputs forsurgical guides (titanium) andimplants, which are equivalent to thesecondary predicate devicesK173039 and K170272. | |||
| The subject device and primarypredicate device K231520 physicaloutputs for dental splints areidentical with the exception that thesubject device introduces anoptional palatal insert (titanium) fordental splints, which is equivalent tothe reference device K210731. | |||
| Sterilization | Steam sterilization for both terminaland reprocessing.Sterility assurance level of 1x10-6 | Steam sterilization.Sterility assurance level of 1x10-6 | The subject device sterilizationmethod for both end sterilization andterminal sterilization are equivalentto the predicate device. |
| Packaging | Non-SterileSterile | Non-Sterile | The subject device offers the sameidentical non-sterile packaging asthe predicate device.The subject device adds sterilepackaging which was not present inthe primary predicate device. |
| tmCMF Solution(subject device) | tmCMF Solution(Primary predicate deviceK231520) | Comment on SubstantialEquivalence | |
| PatientContact | Surgical guides: Surface Contacting -Tissue / Bone Limited (< 24 hours)Dental splints: Surface Contacting -Mucosal Membrane Prolonged (< 30days) | Surgical guides: Surface Contacting- Tissue / Bone Limited (< 24 hours)Dental splints: Surface Contacting -Mucosal Membrane Prolonged (< 30days) | The subject device surgical guides'and dental splints' patient contactingsurfaces and duration are identicalto the primary predicate deviceK231520. |
| Implants: Tissue/Bone contacts forLong-term implantation, as directed byHCP | The subject device differs from thepredicate device in that it offersimplants with long-term tissue/boneimplantation as directed by HCP. | ||
| AnatomicAreas of Use | Mandible, Midface (including orbit) | Mandible, Midface | The subject device and primarypredicate device contact areas aremandible and midface. The subjectdevice adds support for orbit whichis part of the midface. |
| PatientPopulation | Adolescents (12 to 21 years) andadults | Adolescents (12 to 21 years) andadults | The target patient population forboth subject and primary predicatedevice is identical. |
| WebInterface | Yes | Yes | The subject device is an update tothe primary predicate deviceK231520, it utilizes the sameidentical web interface. |
| 2D ImageDisplayAxialSagittalCoronal | Yes | Yes | Both the subject device and theprimary predicate device K231520display 2D images and aresubstantially equivalent. |
| 3DVisualization | Yes | Yes | The subject and the primarypredicate device K231520 have 3Dvisualization and are substantiallyequivalent. |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
510(k) Summary
| TechMah CMF LLC |
|---|
| tmCMF Solution(subject device) | tmCMF Solution(Primary predicate deviceK231520) | Comment on SubstantialEquivalence | |
|---|---|---|---|
| Preoperative software | Yes | Yes | The subject device is an update tothe primary predicate deviceK231520. The subject device usespre-operative software in the samemanner as the primary predicatedevice and is substantiallyequivalent. |
| Installation Required | No | No | The subject and primary predicatedevice K231520 do not requireinstallation and are substantiallyequivalent. |
| Physician Interaction with Planning and Design Review | Yes | Yes | The physician can interact withplanning and hardware designs forboth the subject device and theprimary predicate device K231520;thus, they are substantiallyequivalent. |
| Single-Use | Yes | Yes | The subject and the primarypredicate device K231520 aresingle-use and are substantiallyequivalent |
| Implant Visualization | Yes | No | The subject device is an update tothe primary predicate deviceK231520, with an added ability tovisualize implants on CT images.This functionality is equivalent to thereference device K213684. |
{13}------------------------------------------------
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
|---|---|---|---|---|
| Indication forUse | The tmCMF Solution isintended for use as asoftware system and imagesegmentation system forthe transfer of imaginginformation from a medicalscanner such as a CT-based system. The inputdata file is processed bythe tmCMF Solution, andthe result is an output datafile that may then beprovided as digital modelsor used as input to amanufacturing portion ofthe system that producesphysical outputs, includinganatomical models,surgical guides, dentalsplints, and implants foruse in maxillofacial,midface, and mandibularsurgery. Implants areintended for bone fixationand reconstruction,restoration of bonedefects, and intended toprovide continuity inregions where the boneis missing and/or to | The TruMatch CMFTitanium 3D Printedlmplant is a patient specificimplant and is intendedfor bone fixation andreconstruction,restoration of bonedefects and intended toprovide continuity inregions where the boneis missing and/or toaugment the bone bymeans of an onlay devicein the maxillofacialskeleton, midface andchin. | The TruMatch CMFTitanium 3D PrintedImplant System isintended for bonerepositioning, fixationand reconstruction of themaxillofacial skeleton,midface, mandible andchin in adolescents(greater than 12 to 21years of age) and adults.Specific indications for use:• Orthognathicsurgery• Reconstructivemandible andmaxillofacial surgery• mandible andmaxillofacial traumasurgery | The subject device is asolution that includessoftware and patient-specific instruments(anatomical models,surgical guides, dentalsplints) and patient-specificimplants. Both secondarypredicate devices'indication for use is asubset of the subjectdevice as both are Tiimplants and surgicalguides hardware with nosoftware or plasticinstruments.The subject device and thesecondary predicate device(K173039) have anequivalent indication foruse: bone fixation,reconstruction, and boneaugmentation/enhancement in the mandible, midface,and chin.The subject device and thesecondary predicate device(K170272) have equivalentindication for use includingtarget patient population. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| augment the bone bymeans of an onlay devicein the maxillofacialskeleton, midface,mandible, and chin inadolescents (greater than12 to 21 years of age) andadults. The tmCMFSolution is also intended asa preoperative softwaretool forsimulating/evaluating virtualsurgical treatment options. | ||||
| Intended Use | Bone fixation andreconstruction, restorationof bone defects, andintended to providecontinuity in regions wherethe bone is missing and/orto augment the bone bymeans of an onlay devicein the maxillofacialskeleton, midface,mandible, and chin | Bone fixation andreconstruction, restorationof bone defects andintended to providecontinuity in regions wherethe bone is missing and/orto augment the bone bymeans of an onlay devicein the maxillofacialskeleton, midface, and chin | Bone repositioning, fixation,and reconstruction of themaxillofacial skeleton,midface, mandible, andchin | The subject and secondarypredicate device (K173039)have the same intendeduse: bone fixation,reconstruction, and boneaugmentation/enhancement in themandible, midface, andchin.The subject andsecondary predicatedevices (K170272) havethe same intended use:bone fixation andreconstruction in themandible, midface, andchin. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| IntendedAnatomicalRegions | Mandible, Midface(including orbital floor,medial & lateral orbitalwalls) | Mandible, Midface(including orbital floor,medial & lateral orbitalwalls) | Mandible, Midface(including orbital floor,medial & lateral orbitalwalls) | The subject and secondarypredicate devices(K173039, K170272) areused in the sameanatomical regions. |
| PatientPopulation | Adolescents (12 to 21years) and adults | Adolescents (12 to 21years) and adults | Adolescents (12 to 21years) and adults | The target patientpopulation for both subjectand secondary predicatedevices are identical. |
| Sterilization | Steam Sterilization for bothterminal and reprocessing.Sterility assurance level of1x10-6 | Steam SterilizationSterility assurance level of1x10-6 | Steam sterilizationSterility assurance level of1x10-6 | The subject devicesterilization method isequivalent to the secondarypredicate devices(K173039, K170272).Sterilization effectiveness isdemonstrated by testingand analysis. |
| Packaging | Non-SterileSterile | Non-Sterile | Non-Sterile | Subject device offers bothsterile and non-sterilepackaging, whereas thesecondary predicatedevices offer non-sterilepackaging. Packagingintegrity and stability isdemonstrated by testingand analysis. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| PatientContact | Ti surgical guides: SurfaceContacting - Tissue / BoneLimited (< 24 hours)Implants: Tissue/Bonecontacts for Long-termimplantation, as directed byHCP | Ti surgical guides: SurfaceContacting - Tissue / BoneLimited (< 24 hours)Implants: Tissue/Bonecontacts for Long-termimplantation, as directed byHCP | Ti surgical guides: SurfaceContacting - Tissue / BoneLimited (< 24 hours)Implants: Tissue/Bonecontacts for Long-termimplantation, as directed byHCP | The subject and secondarypredicate devices(K173039, K170727) haveequivalent patient contacttissue types and duration. |
| Single-Use | Yes | Yes | Yes | The subject device andsecondary predicatedevices are single-use andare substantiallyequivalent. |
| Ti SurgicalGuides Use | Cutting/Drilling | Cutting/Drilling | Cutting/Drilling | The subject and thesecondary predicatedevices (K173039,K170272) have the sameuse for cutting and drillingof bone. |
| Implantsmade patient-specific | Yes | Yes | Yes | Implants for the subject andsecondary predicatedevices (K173039,K170727) are madepatient-specific,manufactured from patientCT scan data. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| Devicecompatibility | Mandible:DePuy SynthesMatrixMANDIBLEMidface, orbital:DePuy SynthesMatrixMIDFACEOrthognathicDePuy SynthesMatrixORTHOGNATHIC | Mandible:DePuy SynthesMatrixMANDIBLEMidface, orbital:DePuy SynthesMatrixMIDFACE | Mandible:DePuy SynthesMatrixMANDIBLEMidface, orbital:DePuy SynthesMatrixMIDFACEOrthognathicDePuy SynthesMatrixORTHOGNATHIC | The subject device and thesecondary predicatedevices (K173039,K170272) have equivalentdevice compatibility. |
| Screw Style | LockingNon-Locking | Non-Locking | Non-Locking | The subject device and thesecondary predicate device(K173039, K170272) offernon-locking screws.The subject device and thereference device K063790offer locking screws. |
| Anodization | Yes | Yes | Yes | The subject device isequivalent to bothsecondary predicatedevices (K173039,K170272) in offeringanodization. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| PlatesDimensionalRanges | Reconstruction (Midface)• Length: 20-294 mm• Width: 4.0 mmReconstruction(Mandibular)• Length: 20-294 mm• Width: 4.0-7.5 mmOrthognathic• 20 mm maximumadvancement• Maxillaryo Width: 2.4 – 4.0 mm• Mandibularo Single strut width:4.5 – 8.0 mmo Double strut width:2.7 – 4.5 mm (eachstrut)• Genioplastyo Width: 2.4 – 4.0 mmOrbital• Length: 5.5 – 4 mm | N/A | Reconstruction (Midface)• Length: 20-294 mm• Width: 4.0 mmReconstruction(Mandibular)• Length: 20-294 mm• Width: 4.0 mmOrthognathic• 20 mm maximumadvancement• Maxillaryo Width: 2.4 – 4.0 mm• Mandibularo Single strut width:4.5 – 8.0 mmo Double strut width:2.7 – 4.5 mm (eachstrut)• Genioplastyo Width: 2.4 – 4.0 mmOrbital• Length: 5.5 – 4 mm | The subject and thesecondary predicate deviceK170272 have equivalentranges of plate length andwidth with the exceptionthat the subject deviceoffers a wider mandiblereconstruction plate that iswithin the range ofreference device K063790. |
| ProfileImplantsRange ofLengths | Reconstruction (Midface,Mandibular)• 10 – 294 mm | Reconstruction (Midface,Mandibular)• 10 – 294 mm | N/A | The subject device and thesecondary predicate deviceK173039 have equivalentranges of implant length. |
| tmCMF Solution(Subject device) | TruMatch CMF Titanium3D Printed ImplantSystem (K173039) | TruMatch CMF Titanium3D Printed ImplantSystem (K170272) | Comment on SubstantialEquivalence | |
| PlateThickness | Mandible reconstruction• 1.0 – 3.0 mmMidface reconstruction• 0.5 – 1.5 mmMaxillary orthognathic• 0.8 – 1.5 mmMandibular orthognathic• 1.0 – 1.5 mmGenioplasty• 0.8 – 1.5 mm | N/A | Mandible reconstruction• 1.5 – 3.0 mmMidface reconstruction• 0.8 – 1.5 mmOrbital• 0.8 – 1.2 mmMaxillary orthognathic• 0.8 – 1.5 mmMandibular orthognathic• 1.0 – 1.5 mmGenioplasty• 0.8 – 1.5 mm | The subject and secondarypredicate device K170272have equivalent rangeswith differences in thelower bound of selecteddevices. The lower boundof the reconstruction/trauma plate for themandible and the midfaceare equivalent to referencedevices K063790 andK050608, respectively. Themechanical equivalent isdemonstrated by testingand analysis. |
| ProfileImplantsThickness | Mandible reconstruction• 0.8 – 13 mmMidface reconstruction• 0.8 – 13 mmOrbital• 0.4 – 1.5 mm | Mandible reconstruction• 1.2 – 10 mmMidface reconstruction• 0.8 – 10 mmOrbital• 0.4 – 1.5 mm | N/A | The subject and secondarypredicate device K173039have equivalent rangeswith difference in lowerbound of the mandiblereconstruction/traumaprofile implant is equivalentto the mechanical strengthof the plate in referencedevice K063790.Mechanical equivalence isdemonstrated by testingand analysis. |
{14}------------------------------------------------
{15}------------------------------------------------
{16}------------------------------------------------
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
{20}------------------------------------------------
VIII. INDICATIONS FOR USE COMPARISON
The subject device is a solution that includes software, patient-specific instruments (anatomical models, surgical guides, splints), and patient-specific implants.
The subject device is an update to its primary predicate device (K231520) to include patient-specific implants. The subject device and the primary predicate device share identical indication for use for the software and patient-specific instrumentation.
The subject device and the secondary predicate device (K173039) have an equivalent indication for use: bone fixation, reconstruction, and bone augmentation/enhancement in the mandible, midface, and chin.
The subject device and the secondary predicate device (K170272) have equivalent indication for use including target patient population. The subject device indication for use is equivalent to the combination of the primary predicate device and the secondary predicate devices.
IX. TECHNOLOGICAL COMPARISON (WITH PREDICATE DEVICES)
SIMILARITIES TO PREDICATE DEVICES
- . The subject device is an update to the primary predicate device to add patientspecific implants to the indication. The tmCMF Solution has an equivalent indication for use as its primary predicate device K231520. The primary indication is to utilize pre-operative imaging data to perform surgical case planning and create patient-specific hardware. tmCMF implant indication for use is equivalent to that of the secondary predicate devices K173039 and K170272.
- . The subject device software and primary predicate device software have equivalent technical characteristics. The subject device software is an update to the primary predicate device software to include new features. Those new features do not impact the features cleared under the primary predicate device.
- The subject device uses the same patient-specific tools and process flow as the primary predicate device K231520.
- . The subject device has equivalent software to the primary predicate device K231520.
- The subject device has equivalent mechanical performance to the secondary ● predicate devices K173039 and K170272.
- The surgical guides, anatomical models, and dental splints are identical for the . subject and primary predicate device.
- The newly introduced titanium alloy (Ti) surgical guides in the subject device share the same functional design as the polyamide (PA) surgical quides in the primary predicate device, with the only difference being the adaptation of the
{21}------------------------------------------------
thickness of the quide and assets to facilitate manufacturing using titanium allov.
- The newly introduced Ti palatal insert in the subject device shares the same functional design as the acrylic palatal insert in the primary predicate device, with the only difference being the adaptation of the thickness of the palatal insert to facilitate manufacturing using titanium alloy.
- . The implant shapes are identical between the subject and secondary predicate devices (K170272 and K173039).
- The subject and secondary predicate devices are anodized for device ● identification using color (K170272 and K173039).
- The subject device and predicate devices (K231520, K170272, and K173039) . are sterilized using steam sterilization with a sterility assurance level of 1x10-6.
- The subject and secondary predicate devices (K170272 and K173039) are ● compatible with identical screws.
- Subject and secondary predicate devices (K170272 and K173039) offer . titanium-based surgical quides to transfer pre-operative plan in surgery.
DIFFERENCES TO PREDICATE DEVICES
The subject device is an update to the primary predicate device K231520. Below is the summary of the differences.
- Software updates: ●
- Support for plan review of the following procedures: o
- I Augmentation
- . Orbital
- Trauma
- Patient-Specific Implant Review O
- Various enhancements O
- Support for plan review of the following procedures: o
- Surgical Guides: ●
- Expand surgical guides' offerings to include an option for manufacturing O guides from titanium alloy (Ti-6Al-4V).
- Update to Point of Care cleaning and sterilization instructions for non-sterile o quides.
- Dental Splints:
{22}------------------------------------------------
- Expand dental splints offering to include an option for manufacturing palatal O inserts from titanium alloy (Ti-6Al-4V).
- Update to Point of Care cleaning and sterilization instructions for non-sterile O dental splints.
- Implants ●
- Offering patient-specific implants that include both plates and 3D profile o implants to support the following procedures: orthognathic, reconstruction, augmentation, and trauma for both mandible and midface (including orbital) anatomical.
- o The subject device for the mandible region is compatible with both locking screws in K063790 system, while the secondary predicate devices (K170272 and K173039) are compatible with the non-locking screws only.
- The subject device is manufactured with titanium alloy, whereas the O secondary predicate devices (K170272 and K173039) are manufactured with commercial grade pure titanium. Subject device offers sterile and nonsterile packaging for hardware devices (surgical guides, implants, anatomical models, and dental splints); whereas the predicate devices (K231520, K170272, and K173039) offer only non-sterile packaging.
X. 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 device per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and AAMI TIR 30.
Sterilization & Shelf-life
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. Terminal sterilization, shelf life and shipping validations were performed according to ISO 11607-1, ISO 11607-2, ASTM D4169-22, and ASTM F1980-21.
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
{23}------------------------------------------------
biocompatibility of the materials and manufacturing process used in the tmCMF surgical instruments and implants.
The biocompatibility evaluation was conducted on the subject device on the following endpoints per its contact classification.
- . ISO 10993-5. "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity"
- ISO 10993-10, "Biological evaluation of medical devices Part 10: Tests for . skin sensitization"
- ISO 10993-11, "Biological evaluation of medical devices Part 11: Tests for . systemic toxicity"
- ISO 10993-23, "Biological evaluation of medical devices Part 10: Tests for . irritation"
- ISO 10993-17, "Biological evaluation of medical devices Part 17: . Toxicological risk assessment of medical device constituents"
- . ISO 10993-18, "Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process"
- . USP <151> Pyrogen Test (USP Rabbit Test)
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 guidance 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.
Maqnetic compatibility
Magnetic compatibility was conducted in accordance with ASTM F2182, ASTM F2052, and ASTM F2213.
Mechanical testing
Mechanical testing was performed to validate the mechanical integrity of the implant per ASTM F382-17.
Benchtop Performance
Benchtop performance testing was performed to demonstrate the performance of
{24}------------------------------------------------
the tmCMF Solution and substantial equivalence with the predicate device. The testing aligns with the test strategy and performance metrics used by the predicate.
| Performanceverification | Testing demonstrated that the surgical guide andimplants meets the predetermined acceptance criteria. |
|---|---|
| Locking screwcompatibilityverification | Testing demonstrated that the implant compatibility withlocking screw design meets the predeterminedacceptance criteria |
| Ti devicemanufacturingaccuracy verification | Testing demonstrated that the manufacturing oftitanium device meets the predetermined accuracyacceptance criteria. |
| Torque throughresistance verification | Testing demonstrated that the implant resistance ofscrew torquing through meets predeterminedacceptance criteria. |
| Hardware verificationinspection and analysis | Testing demonstrated that instruments' implementationis compliant with the predetermined acceptance criteria. |
| Surgical case reportverification | Testing demonstrated that the surgical case reports arecompliant with predetermined acceptance criteria. |
| System validation | Testing demonstrated that the system has met userneeds and is compliant with predetermined acceptancecriteria. |
XI. 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.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.