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 previously cleared Treace Medical Concepts, Inc (TMC) Plating System includes the PYTHON® plate. The PYTHON® Plate is a curved plate available in both left and right configurations. The plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "PYTHON Plate Trial Instruments." This submission focuses on the substantial equivalence of trial instruments to an already cleared plating system. Crucially, the document does not contain information about studies proving the device meets acceptance criteria related to AI/software performance, diagnostic accuracy, or human reader improvement.

The "Performance Testing" section explicitly states: "Engineering analysis has confirmed the subject instruments to be substantially equivalent to the predicate PYTHON® Plates." This indicates the evaluation was likely based on mechanical properties, material safety, and design equivalence, typical for surgical instruments, rather than performance metrics related to diagnostic algorithms or AI assistance.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: No such criteria or performance data for an AI/software device are present.
Sample sizes used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic ground truth establishment process described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable; this device is a surgical instrument, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to the regulatory clearance of surgical trial instruments, not an AI-powered diagnostic device. Therefore, the requested information regarding AI acceptance criteria and performance studies is not available in this text.

Summary

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Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President MRC|X, LLC. 203 Fort Wade Rd., Suite 150 Ponte Vedra, Florida 32081

March 19, 2018

Re: K173930

Trade/Device Name: PYTHON Plate Trial Instruments Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: February 19, 2018 Received: February 20, 2018

Dear Dawn Norman:

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 forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Dawn Norman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -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

510(k) Number (if known) K173930

Device Name

PYTHON Plate Trial Instruments

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) X 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.

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510(k) Summary

PYTHON® Plate Trial Instruments December 22, 2017

Company:	Treace Medical Concepts, Inc.203 Fort Wade Rd., Suite 150Ponte Vedra, FL 32081
Primary Contact:	Dawn NormanExecutive Vice President, MRC X, LLCPhone: 618.604.3064dawn.norman@mrc-x.com
Company/SecondaryContact:	Rachel OsbeckSr. Director, Quality AssuranceTreace Medical Concepts, LLCPhone: 904.373.5940 Ext. 1304rosbeck@treace.net
Trade Name:	PYTHON Plate Trial Instruments
Common Name:	Plate, Fixation, Bone
Classification:	Class II
Regulation Number:	21 CFR 888.3030 (Single/Multiple Component Metallic BoneFixation Appliances and Accessories)
Panel:	87- Orthopedic
Product Code:	HRS

Device Description:

This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.

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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 Trial Instrument components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following device, previously cleared by the FDA:

Treace Medical Concepts, Inc (TMC) Plating System- PYTHON® Plate (K153531) ●
The intended use and indications for use, material and overall geometry for the predicate device is identical to those of the subject device. As the subject device is a trial instrument, and is not intended for implantation, it has additional attached drill guides that can be used to replace the modular drill guides which were cleared with the predicate implant. These drill guides allow bone preparation to be performed through the trial instrument and do not raise new questions about safety and effectiveness.

Performance Testing:

Engineering analysis has confirmed the subject instruments to be substantially equivalent to the predicate PYTHON® Plates.

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.