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 a curved PYTHON™ plate to accommodate the tarso-metatarsal (TMT) joint, which is an indication of the TMC Plating System. The plate is available in both right and left configurations and is used with compatible 2.5 mm diameter screws in lengths ranging from 10-28 mm. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

The provided document is a 510(k) summary for the Treace Medical Concepts (TMC) Plating System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as typically understood for AI/ML or diagnostic device performance evaluation.

Here's why and what information is available:

Device Type: The TMC Plating System is a metallic bone fixation appliance, not an AI/ML or diagnostic device. Its clearance relies on demonstrating that its mechanical performance is equivalent to an already cleared device, not on diagnostic accuracy metrics.
Regulatory Pathway: A 510(k) submission generally requires demonstration of substantial equivalence through design comparisons, material testing, and mechanical performance testing, rather than clinical efficacy trials that would generate acceptance criteria and detailed performance statistics like sensitivity, specificity, or ROC AUC.

However, I can interpret some of the information in the context of "acceptance criteria" as applied to mechanical testing and "study" as referring to the mechanical testing performed:

1. Table of "Acceptance Criteria" and Reported Device Performance (as interpreted for a mechanical device):

Acceptance Criteria (Proxy)	Reported Device Performance
Mechanical Performance: • Dynamic 4-point bending strength equivalent to the predicate device per ASTM F382.	The results of the dynamic 4-point bend testing confirmed the subject PYTHON™ plate to be substantially equivalent to the predicate devices of the TMC Plating System.
Material Equivalence: • Implants manufactured from medical grade titanium alloy (Ti6Al4V-ELI).	All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI), identical to the predicate device.
Design/Dimension Equivalence: • Design and dimensions are identical to the predicate device.	The subject PYTHON™ plate is identical to the predicate device with respect to indications for use, design, dimension, and materials.
Indications for Use Equivalence: • Indications for use are the same as the predicate device.	The subject device includes all of the same indications as the predicates.

Study That Proves Device Meets "Acceptance Criteria":

The "study" referenced is mechanical testing, specifically dynamic 4-point bend testing performed according to ASTM F382.

Regarding the other requested information, it is not present in the document because it pertains to AI/ML or diagnostic performance studies, which were not conducted for this type of device submission:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was mechanical testing, not a clinical study on a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical equivalence is established through engineering specifications and comparison to a predicate device's known mechanical properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No human reader involvement or AI assistance for implantable hardware.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" for substantial equivalence is based on:
- Mechanical equivalence to the predicate device (as determined by ASTM F382 testing).
- Material equivalence (both devices use medical grade titanium alloy Ti6Al4V-ELI).
- Design and dimensional equivalence to the predicate device.
The sample size for the training set: Not applicable. There is no training set for a mechanical device.
How the ground truth for the training set was established: Not applicable.

In summary, the document describes a 510(k) submission for a bone plating system, where "acceptance criteria" are demonstrated through engineering specification comparison and mechanical testing to an already cleared predicate device, rather than through clinical performance metrics and expert-derived ground truth as would be relevant for AI/ML or diagnostic devices.

Summary

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

January 7, 2016

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

Re: K153531 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: December 8, 2015 Received: December 9, 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 (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

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forth in the quality systems (QS) 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" (21 CFR 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153531

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)

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510(k) Summary

Treace Medical Concepts (TMC) Plating System December 8, 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:	HRSHWC

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 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)

Substantial Equivalence:

The subject PYTHON™ plate of the TMC Plating System components is identical to the predicate device with respect to indications for use, design, dimension, and materials to the following device, previously cleared by the FDA:

Treace Medical Concepts (TMC) Plating System (K143717) ●
As indicated above, there are insignificant differences between the subject and predicate devices. The PYTHONTM plate does not present a new worst-case to the TMC plating system. The subject device includes all of the same indications as the predicates. Thus, the subject PYTHON™ plate is substantially equivalent to the predicate TMC Plating System.

Performance Testing:

Mechanical testing, includes dynamic 4-point bend testing has been performed per ASTM F382 on the subject PYTHON™ plate of the TMC Plating System and the results have confirmed them to be substantially equivalent to the predicate devices of the TMC Plating System.

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.