The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

Device Description

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, and H- shaped , and Python 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.

The purpose of this special 510(k) submission is to expand the size ranges offered for the plates and screws, as well as add a curved plate option.

All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Plating System. However, this submission focuses on expanding the size ranges of existing plates and screws and adding a curved plate option. The core of the testing described is mechanical performance testing of these physical devices, not an AI/algorithm-based medical device.

Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as described in the provided document.

Here's a breakdown of what can be extracted or inferred from the text regarding acceptance criteria and device performance for this specific submission:

1. A table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" are implied to be that the new components perform at least as well as, or better than, the predicate devices, and that they meet relevant ASTM standards for bone fixation devices.

Acceptance Criteria (Implied)	Reported Device Performance
Meets or exceeds mechanical performance of predicate devices	"The results have shown the larger plates and screws to be substantially equivalent to the previously cleared devices."
Complies with ASTM F382 (4-point bend testing for metallic bone plates)	"Mechanical testing, including static and dynamic 4-point bend testing... have been performed per ASTM F382"
Complies with ASTM F543 (Static and torsional pullout testing for metallic bone screws)	"...static torsional and pullout testing have been performed per... ASTM F543 on the subject plates and screws."
No new worst-case scenario introduced by new sizes/shapes	"Thus, the addition of these plates and screws does not present a new worst case."
Biocompatibility (material)	"All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136" (implies biocompatibility suitability)

Regarding the other points, they are largely not applicable due to the nature of the device:

2. Sample sized used for the test set and the data provenance:

Not applicable in the context of clinical data/AI validation. For mechanical testing, the "sample size" would refer to the number of physical plates/screws tested. This detail is not provided in the summary. The data provenance would be laboratory testing.

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 devices is established through adherence to engineering standards and direct physical measurements, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This refers to clinical image interpretation or diagnosis consensus, which is not relevant to mechanical device testing.

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 a study design for evaluating AI systems in assisted reading scenarios, not for mechanical implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This describes AI performance, not mechanical device performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For mechanical devices, the "ground truth" is adherence to established mechanical properties and engineering standards. This is determined by validated test methods (e.g., ASTM F382, ASTM F543) and physical measurements of strength, fatigue, pullout force, etc.

8. The sample size for the training set:

Not applicable. There is no "training set" in the AI sense for a mechanical device.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for a mechanical device.

In summary, the provided document details a 510(k) submission for a physical medical device (bone plating system) where the primary "study" is mechanical performance testing to ensure the new component sizes and shapes are substantially equivalent to existing cleared devices based on relevant ASTM standards. The document does not describe the validation of an AI/algorithm-based device.

Summary

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October 30, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President Memphis Regulatory Consulting, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119

Re: K192504

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: September 28, 2019 Received: September 30, 2019

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

Shumaya Ali, M.P.H. 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

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Indications for Use

510(k) Number (if known)

K192504

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-Cubiod (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)

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K192504 510(k) Summary

Treace Medical Concepts (TMC) Plating System October 30, 2019

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 OsbeckVP, Quality Assurance & Regulatory AffairsTreace Medical Concepts, LLCPhone: 904.373.5940 Ext. 1304rosbeck@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 and HWC

Device Description:

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, and H- shaped , and Python plates and 2.5mm diameter screws in lengths ranging from

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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.

The purpose of this special 510(k) submission is to expand the size ranges offered for the plates and screws, as well as add a curved plate option.

All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

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. The system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion
Medial Column Fusion
Arthrodesis of the first metatarsophalangeal joint (MTP)

Substantial Equivalence:

The subject TMC Plating System is substantially equivalent to the predicate Treace Medical Concepts (TMC) Plating System (K183321, S.E. 01/25/2019; K153531, S.E. 01/07/2016; K143717, S.E. 03/19/2015).

The subject TMC Plating System is manufactured from titanium (Ti-6Al-4V-ELI) and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and

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reconstruction of small bones of the feet, identical to the predicate devices. Indications for use have not changed and are, thus, identical to the predicate device. The subject TMC Plating System also shares similar geometry, and construction with the predicate devices.

Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

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 plates and screws. The results have shown the larger plates and screws to be substantially equivalent to the previously cleared devices. Thus, the addition of these plates and screws does not present a new worst case.

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.