The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:

· First metatarsal osteotomies for hallux valgus correction such as:

Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
· Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
· Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
· Flatfoot Osteotomies
· Lateral Column Lengthening (Evans Osteotomy)
· Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
Mid / Flatfoot Fusions
· LisFranc Arthrodesis and/or Stabilization
· 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
· Intercuneiform Fusions
· Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion
· Medial Column Fusion
· Arthrodesis of the first metatarsophalangeal joint (MTP)

Device Description

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, and H- shaped plates and 2.5mm diameter screws in lengths ranging from 10-28mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

The provided documents are a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria, sample sizes, and ground truth establishment in the way an AI/ML device would.

Therefore, the specific information requested about acceptance criteria, study design parameters (sample sizes for test and training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance), and ground truth types are not applicable to this 510(k) submission for the TMC Plating System.

The provided text describes performance testing focused on mechanical properties to demonstrate substantial equivalence to predicate devices. Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Mechanical testing, including static and dynamic 4 point bend testing and static torsional and pullout testing have been performed per ASTM F382 and ASTM F543 on the subject TMC Plating System and the results have shown them to be substantially equivalent to the predicate devices."

This indicates that the acceptance criterion was "substantially equivalent to the predicate devices" based on the results of the specified ASTM tests. The specific numerical performance values are not provided in this summary.

Acceptance Criterion	Reported Device Performance
Substantially equivalent to predicate devices based on mechanical testing per ASTM F382 and ASTM F543.	Results shown to be substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable to a mechanical testing study for a 510(k) submission. No patient data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the established engineering standards (ASTM F382 and ASTM F543) and the measured physical properties of the materials and designs.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary: The provided document is for a traditional medical device (bone plating system) seeking 510(k) clearance based on substantial equivalence. The "study" referenced is mechanical performance testing, not a clinical study involving patients or an AI/ML algorithm. Therefore, many of the requested details, which are typical for AI/ML device evaluations, are not present or not relevant here.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2015

Treace Medical Concepts, Incorporated % Ms. Kimberly Strohkirch Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K143717

Trade/Device Name: Treace Medical Concepts (TMC) Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 2, 2015 Received: March 3, 2015

Dear Ms. Strohkirch:

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 (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. 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.

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

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Page 2 - Ms. Kimberly Strohkirch

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K143717

Device Name

Treace Medical Concepts (TMC) Plating System

Indications for Use (Describe)

· First metatarsal osteotomies for hallux valgus correction such as:

Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
· Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
· Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
· Flatfoot Osteotomies
· Lateral Column Lengthening (Evans Osteotomy)
· Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
Mid / Flatfoot Fusions
· LisFranc Arthrodesis and/or Stabilization
· 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
· Intercuneiform Fusions
· Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion
· Medial Column Fusion
· Arthrodesis of the first metatarsophalangeal joint (MTP)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

ATTACHMENT 2-1

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510(k) Summary

Treace Medical Concepts (TMC) Plating System February 27, 2015

Company:	Treace Medical Concepts, Inc.3107 Sawgrass Village CirclePonte Vedra Beach, FL 32082
Primary Contact:	Kimberly StrohkirchPhone: (901) 361-2037Fax: 904.834.7169Strohkirch@memphisregulatory.com
Company/Secondary Contact:	Joe Ferguson, Chief Operating OfficerPhone: 904.373.5840 Ext. 303Fax: 904.834.7169jferguson@treace.net
Trade Name:	Treace Medical Concepts (TMC) Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 (Single/Multiple Component Metallic BoneFixation Appliances and Accessories)21 CFR 888.3040 (Smooth or Threaded Metallic Bone FixationFastener)
Panel:	87- Orthopedic
Product Code:	HRS	HWC

Device Description:

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Indications for Use:

The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:

First metatarsal osteotomies for hallux valgus correction such as: ●
- · Opening base wedge osteotomy
- Closing base wedge osteotomy
- · Crescentic osteotomy
- Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)
First metatarsal fracture fixation
Arthrodesis of the first metatarsalcuneiform ioint (Lapidus Fusion)
Flatfoot Osteotomies
- · Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
Mid / Flatfoot Fusions ●
- · LisFranc Arthrodesis and/or Stabilization
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

Substantial Equivalence:

The subject TMC Plating System components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA:

DePuy (Biomet): ALPS Small Fragment Plating System- K081546
Wright Medical Technology. Inc.: Ortholoc™ 3Di Foot Reconstruction Midfoot/Flatfoot . System- K121651
Wright Medical Technology, Inc.: Ortholoc™ 3Di Hallux System- K120359
Wright Medical Technology, Inc.: Ortholoc™ ORTHOLOC® 2.0/2.4 Plate & ● ORTHOLOC® 2 .0/2 .4 Screw- K090692

As indicated above, there are insignificant differences between the subject and predicate devices. The subject device includes all of the same indications as the predicates. The 2.5mm locking screws fall within the size range of those previously cleared by the predicates. Additionally, the subject 4-hole and 5-hole straight plates fall within the lengths of the previously cleared devices. differing only slightly in width and thickness. The subject H-plate is similar in design to the

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WMT Ortholoc™ U plate in design, with added "arms" for additional stabilization and fixation. The subject L-plate is similar to the previously cleared L-plates, differing in degree at which the "L-arm" protrudes. The subject L-plate forms a 90 degree angle, while the predicate device angles are slightly larger.

Performance Testing:

Mechanical testing, including static and dynamic 4 point bend testing and static torsional and pullout testing have been performed per ASTM F382 and ASTM F543 on the subject TMC Plating System and the results have shown them to be 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.