TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the "TMC Compression Implant System," primarily focuses on establishing substantial equivalence to previously cleared predicate devices for a physical medical device (bone fixation implants). It does not describe a study involving an AI or software-based device that would require the detailed acceptance criteria and performance study information typically requested for AI/ML-based medical devices.

Therefore, I cannot extract the information required to answer your prompt, such as:

A table of acceptance criteria and reported device performance: This document does not present performance data in this format for AI/ML metrics (e.g., sensitivity, specificity, AUC). It discusses mechanical testing for the implants.
Sample size for the test set and data provenance: Not applicable in the context of an AI/ML study.
Number of experts used to establish ground truth and their qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable for AI/ML ground truth; it refers to mechanical testing standards for implants.
Sample size for the training set: Not applicable.
How ground truth for the training set was established: Not applicable.

The document states the following regarding performance testing for the physical device:

Acceptance Criteria Mentioned (Implicit for Mechanical Testing): "The analysis demonstrated that the subject devices met all acceptance criteria..." This refers to mechanical performance criteria outlined in the standards, specifically:
- ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples for dynamic fatigue strength (four-point bending test, Annex A1)
- ASTM F564-17 for pull-out strength (Annex A2)
- ASTM F543-17 for the added screw options.
Reported Device Performance: The document only states that the devices met these acceptance criteria, rather than providing specific numerical performance results. It concludes that the devices are "substantially equivalent" to predicate devices based on these tests and other factors (materials, design, intended use).
Study Type: Mechanical testing.
Ground Truth: The "ground truth" in this context is the performance standard established by ASTM (American Society for Testing and Materials) for metallic bone staples and screws.
Sample Size: The document does not specify the number of implants tested, but rather refers to meeting the requirements of the ASTM standards.

In summary, this document describes a traditional medical device submission for physical implants, not an AI/ML-driven device. The elements you're asking for are specific to the validation of AI/ML algorithms and are not present in this regulatory submission for the TMC Compression Implant System.

Summary

{0}------------------------------------------------

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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

September 6, 2024

Treace Medical Concepts Brittany Grochala Sr. Regulatory Affairs Specialist II 100 Palmetto Park Place Ponte Vedra, Florida 32081

Re: K242415

Trade/Device Name: TMC Compression Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: August 14, 2024 Received: August 15, 2024

Dear Brittany Grochala:

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 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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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.

{2}------------------------------------------------

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,

Christopher Ferreira -S

Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242415

Device Name

TMC Compression Implant System

Indications for Use (Describe)

The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

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}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Treace Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letters 'AC'. Below the company name is the tagline 'A Step Ahead in Foot and Ankle Surgery' in red. The logo is simple and modern, and the tagline is clear and concise.

TMC Compression Implant System Special 510(k) Premarket Notification

510(k) Summary Treace Medical Concepts (TMC) Compression Implant System August 14th, 2024

Company:	Treace Medical Concepts, Inc.100 Palmetto Park PlacePonte Vedra, FL 32081
Establishment Registration:	3011623994
Primary Contact:	Brittany Grochala, Senior Regulatory Affairs Specialist IIPhone: 515-865-0494Fax: 904-834-7169Email: bgrochala@treace.net
Secondary Contact:	Kristina Hall, Sr. Director, Regulatory AffairsPhone: 904-373-5940 ext. 1321Fax: 904-834-7169Email: khall@treace.net
Trade Name:	Treace Medical Concepts (TMC) Compression ImplantSystem
Common Name:	Primary: Staple, fixation, boneSubsequent: Screw, fixation, bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030
Panel:	87- Orthopedic
Product Code(s):	Primary: JDRSubsequent: HWC

Predicate Device(s):

. Primary Predicate: TMC Compression Implant System (K232387, S.E. 08/28/2023)
Additional Predicate: TMC Plating System (K240173, S.E. 02/22/2024) ●
. Additional Predicate: Restore Bunion Correction System (K131061, S.E. 08/28/2013)

Device Description:

{5}------------------------------------------------

K242415

TMC Compression Implant System Special 510(k) Premarket Notification

The changes described within this submission do not impact reprocessing, sterility, shelf-life, and biocompatibility considerations in comparison to the predicate device. The software, cybersecurity, EMC, and wireless technology sections are not applicable to the subject device.

The added locking bone screw options to the TMC Compression Implant System were previously cleared under the TMC Plating System.

Indications for Use:

The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

Substantial Equivalence:

The subject TMC Compression Implant System is substantially equivalent to the following predicate devices:

Primary Predicate: TMC Compression Implant System (K232387, S.E. 08/28/2023) ●
. Additional Predicate: TMC Plating System (K240173, S.E. 02/22/2024)
Additional Predicate: Restore Bunion Correction System (K131061, S.E. 08/28/2013) .

The subject compression implants are intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle, identical or similar to the predicate devices. Additionally, the subject compression implants are manufactured using wrought titanium alloy Ti-6Al-4V-ELI per ASTM F136 and Type II anodized identical to the primary and TMC Plating System additional predicate devices.

The subject device modifications includes the introduction of additional four (4) tine staples and associated instrumentation for implantation to the TMC Compression Implant System. These added compression implants have the capability to accept TMC locking screws for further fixation. Additional modifications include updates to the bridge geometry, tine profile, and tine locations (4 tine staple only). The 2x1 staple design remains unchanged.

The subject devices share similar materials, geometry, construction, packaging, overall design, and performance with the predicate devices. Thus, it can be concluded that the subject devices do not raise new questions about safety and effectiveness and are substantially equivalent to the predicate devices.

Performance Testing:

A mechanical analysis per ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples was used to evaluate the dynamic fatigue strength of the subject staples using a four-point bending test (Annex A1) and pull-out strength (Annex A2) to the previously tested primary predicate devices. The analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the primary predicate devices. The added screw options to the TMC Compression Implant System were previously evaluated per ASTM F543-17.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Treace Medical Concepts, Inc. The logo is in gray, except for a red swoosh above the letters 'AC'. Below the company name is the tagline 'A Step Ahead in Foot and Ankle Surgery' in red. The logo is simple and modern.

TMC Compression Implant System Special 510(k) Premarket Notification

K242415 Page 3 of 3

Conclusion:

The subject TMC Compression Implant System has similar intended use, overall design, materials, and mechanical properties to that of the predicate devices. Moreover, there is no change in the intended use as compared to the predicate TMC Compression Implant System. Therefore, it can be concluded that the subject device is at least as safe and effective and substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.