The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples:
· Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
Transverse osteotomy
• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
First metatarsal fracture fixation
· 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
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion

Device Description

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated. locking, and non-locking screws ranging in lengths from 10-32mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot.
The purpose of this traditional 510(k) submission is to introduce additional plate and screw options within the Treace Medical Concepts (TMC) Plating System.
All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel AI/ML devices.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/ML context, nor details about a study designed to prove the device meets such criteria. Specifically:

No acceptance criteria table or reported device performance for an AI/ML system: The document describes a metallic bone fixation system, not an AI/ML diagnostic tool. Its "performance" is evaluated through mechanical bench testing, not clinical metrics like sensitivity, specificity, or AUC.
No sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These are all concepts relevant to the validation of AI/ML systems, which are not applicable to the mechanical plating system described.
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design used to assess the impact of AI assistance on human reader performance, which is not applicable here.
No standalone (algorithm-only) performance: Again, this relates to AI/ML systems.
No type of ground truth (expert consensus, pathology, outcomes data): Ground truth in this context typically refers to a definitive diagnosis or determination for an AI system's output. For a physical plating system, "ground truth" would be related to its mechanical properties meeting specifications.
No training set sample size or ground truth establishment for a training set: These concepts are specific to the development and training of AI/ML models.

The "Performance Testing" section states:

"Mechanical testing including static and dynamic 4-point bend testing and static torsion, driving torque, removal torque, and axial pullout based on ASTM F382 and ASTM F543 were performed. Further, engineering analysis of the worst-case cross-sections and geometries on the subject and predicate devices were evaluated. The mechanical testing, cross-sectional, and geometrical analysis demonstrated the subject devices to be substantially equivalent to the predicate devices."

This indicates that the "study" proving the device meets requirements was a series of mechanical tests and engineering analyses to demonstrate substantial equivalence to existing predicate devices. This is distinctly different from the type of performance evaluation required for AI/ML-based medical devices.

In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and validation study in the manner requested. It is a traditional 510(k) summary for a mechanical orthopedic implant.

Summary

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January 5, 2023

Image /page/0/Picture/1 description: The image shows 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Treace Medical Concepts Inc. Melissa Coloroso Principal Regulatory Affairs Specialist 203 Fort Wade Road, Suite 150 Ponte Vedra, Florida 32081

Re: K221181

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: April 22, 2022 Received: April 25, 2022

Dear Melissa Coloroso:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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,

Shumaya Ali -S

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) K221181

Device Name

Treace Medical Concepts (TMC) Plating System

Indications for Use (Describe)

· Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin)
Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis

First metatarsal fracture fixation
· 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
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion

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)

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510(k) Summary Treace Medical Concepts (TMC) Plating System April 21, 2022

Company:	Treace Medical Concepts, Inc.100 Palmetto Park PlacePonte Vedra, FL 32081
EstablishmentRegistration:	3011623994
Primary Contact:	Melissa Coloroso, Principal Regulatory Affairs SpecialistPhone: 303-641-8592Fax: 904-834-7169Email: mcoloroso@treace.net
Secondary Contact:	Kristina Hall, Director, Regulatory AffairsPhone: 904-373-5904 ext. 1321Fax: 904-834-7169Email: khall@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 bone fixationappliance and accessories and accessories) (primary)21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener
Panel:	87- Orthopedic
Product Code(s):	HRS, HWC

Predicate Device(s):

Primary Predicate:

K220136 Treace Medical Concepts (TMC) Plating System .
Additional Predicates:
K181872 CrossRoads Extremity Systems, LLC. MIS Bunion System .
o K101962, OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating System

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Device Description:

The purpose of this traditional 510(k) submission is to introduce additional plate and screw options within the Treace Medical Concepts (TMC) Plating System.

All implantable components are manufactured from implant 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 the feet. The system can be used in both and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples:

· Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:
- · Opening base wedge osteotomy
- · Closing base wedge osteotomy
- · Crescentic osteotomy
- Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)
- Transverse osteotomy

First metatarsal fracture fixation
· 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
- Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion

Substantial Equivalence:

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

Primary Predicate:

Treace Medical Concepts (TMC) Plating System, K220136 .

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Additional Predicates:

CrossRoads Extremity Systems LLC., MIS Bunion System, K181872 ●
OrthoHelix Surgical Designs Inc., Mini MaxLock Extreme Plating System, K101962 o

The subject TMC Plating System is manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and is intended to be used in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet, identical to the primary predicate device. The subject TMC Plating System shares similar materials, geometry, construction, and overall design 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:

Mechanical testing including static and dynamic 4-point bend testing and static torsion, driving torque, removal torque, and axial pullout based on ASTM F382 and ASTM F543 were performed. Further, engineering analysis of the worst-case cross-sections and geometries on the subject and predicate devices were evaluated. The mechanical testing, cross-sectional, and geometrical analysis demonstrated the subject devices to be substantially equivalent to the predicate devices.

Conclusion:

The Treace Medical Concepts (TMC) Plating System has similar intended use, overall design, materials, and mechanical properties to that of the predicate devices. Therefore, it can be concluded that the subject device is at least as safe and effective and are 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.