(217 days)
No
The summary describes image processing for segmentation and creating patient-specific devices, but there is no mention of AI or ML algorithms being used for these processes or any other function of the device.
Yes
The device produces physical outputs like implants, surgical guides, anatomical models, and dental splints, which are used directly in surgical procedures for bone fixation, reconstruction, and guiding surgery, indicating a direct therapeutic effect or support in treatment.
No
The device is described as a software system and image segmentation system used for surgical planning, designing patient-specific surgical instruments and implants, and simulating treatment options. Its output is data files for manufacturing physical outputs, not a diagnosis of a patient's condition.
No
The device description explicitly states that the solution is comprised of both software (Surgeon Review Tool) and physical components (surgical instruments and implants). The performance studies also include testing for physical aspects like cleaning, sterilization, biocompatibility, magnetic compatibility, and mechanical testing of the implant.
Based on the provided information, the tmCMF Solution is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- tmCMF Solution's Function: The tmCMF Solution processes medical images (CT scans) to create digital models and physical outputs (anatomical models, surgical guides, dental splints, and implants). Its purpose is to aid in surgical planning and execution, not to analyze biological specimens for diagnostic purposes.
The device falls under the category of medical devices used for surgical planning, guidance, and implantation, which are distinct from IVDs.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZJ, LLZ
Device Description
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT-based system
Anatomical Site
maxillofacial, midface, and mandibular surgery, maxillofacial skeleton, midface, mandible, and chin, Mandible, Midface (including orbital floor, medial & lateral orbital walls)
Indicated Patient Age Range
adolescents (greater than 12 to 21 years of age) and adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 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 the tmCMF Solution and substantial equivalence with the predicate device. The testing aligns with the test strategy and performance metrics used by the predicate.
Key results:
- Performance verification: Testing demonstrated that the surgical guide and implants meets the predetermined acceptance criteria.
- Locking screw compatibility verification: Testing demonstrated that the implant compatibility with locking screw design meets the predetermined acceptance criteria
- Ti device manufacturing accuracy verification: Testing demonstrated that the manufacturing of titanium device meets the predetermined accuracy acceptance criteria.
- Torque through resistance verification: Testing demonstrated that the implant resistance of screw torquing through meets predetermined acceptance criteria.
- Hardware verification inspection and analysis: Testing demonstrated that instruments' implementation is compliant with the predetermined acceptance criteria.
- Surgical case report verification: Testing demonstrated that the surgical case reports are compliant with predetermined acceptance criteria.
- System validation: Testing demonstrated that the system has met user needs and is compliant with predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K063790, K210731, K213684, K080331, K050608, K083388
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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 302 |
| Knoxville, 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 302 |
| Knoxville, 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 device
K231520) | Comment on Substantial
Equivalence |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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
surgical treatment options. | 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 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. | The subject device is a solution that
includes software and 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
indications for use for the software
and patient-specific instrumentation. |
| | tmCMF Solution
(subject device) | tmCMF Solution
(Primary predicate device
K231520) | Comment on Substantial
Equivalence |
| Data Inputs | Images from medical scanners | Images from medical scanners | The subject device is an update to
the primary predicate device
K231520, with no change in inputs
from the predicate device. The data
inputs are substantially equivalent. |
| Data Outputs | Output for dental splints, surgical
guides, anatomical models, and
implants | Output for dental splints, surgical
guides, and anatomical models | The subject device outputs for
polyamide (PA) surgical guides and
anatomical models are identical to
the primary predicate device
K231520.
The subject device introduces two
additional outputs for Ti surgical
guides and implants which are
equivalent to the secondary
predicate devices K173039 and
K170272.
Subject device and primary
predicate device outputs for dental
splints are identical with the
exception that the subject device
introduces an optional titanium (Ti)
palatal insert for dental splints, which
is equivalent to the reference device
K210731. |
| | tmCMF Solution
(subject device) | tmCMF Solution
(Primary predicate device
K231520) | Comment on Substantial
Equivalence |
| Physical
Outputs | Dental splints, PA surgical guides, Ti
surgical guides, anatomical models,
implants, and patient-specific case
reports | Dental splints, surgical guides,
anatomical models, and patient-
specific case reports | The subject device's physical
outputs for surgical guides (PA), and
anatomical models are identical to
the primary predicate device
K231520. |
| | | | The subject device includes two
additional physical outputs for
surgical guides (titanium) and
implants, which are equivalent to the
secondary predicate devices
K173039 and K170272. |
| | | | The subject device and primary
predicate device K231520 physical
outputs for dental splints are
identical with the exception that the
subject device introduces an
optional palatal insert (titanium) for
dental splints, which is equivalent to
the reference device K210731. |
| Sterilization | Steam sterilization for both terminal
and reprocessing.
Sterility assurance level of 1x10-6 | Steam sterilization.
Sterility assurance level of 1x10-6 | The subject device sterilization
method for both end sterilization and
terminal sterilization are equivalent
to the predicate device. |
| Packaging | Non-Sterile
Sterile | Non-Sterile | The subject device offers the same
identical non-sterile packaging as
the predicate device.
The subject device adds sterile
packaging which was not present in
the primary predicate device. |
| | tmCMF Solution
(subject device) | tmCMF Solution
(Primary predicate device
K231520) | Comment on Substantial
Equivalence |
| Patient
Contact | Surgical guides: Surface Contacting -
Tissue / Bone Limited ( 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.
| Performance
verification | Testing demonstrated that the surgical guide and
implants meets the predetermined acceptance criteria. |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Locking screw
compatibility
verification | Testing demonstrated that the implant compatibility with
locking screw design meets the predetermined
acceptance criteria |
| Ti device
manufacturing
accuracy verification | Testing demonstrated that the manufacturing of
titanium device meets the predetermined accuracy
acceptance criteria. |
| Torque through
resistance verification | Testing demonstrated that the implant resistance of
screw torquing through meets predetermined
acceptance criteria. |
| Hardware verification
inspection and analysis | Testing demonstrated that instruments' implementation
is compliant with the predetermined acceptance criteria. |
| Surgical case report
verification | Testing demonstrated that the surgical case reports are
compliant with predetermined acceptance criteria. |
| System validation | Testing demonstrated that the system has met user
needs and is compliant with predetermined acceptance
criteria. |
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.