(81 days)
The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.
The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.
This document describes a 510(k) premarket notification for the Treace Medical Concepts (TMC) Compression Implant System, a metallic bone fixation appliance. The information herein pertains to an administrative change to the trade name of the product and its substantial equivalence to predicate devices, rather than an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, study methodologies for AI/ML devices, and ground truth establishment (such as those involving expert consensus, MRMC studies, or training/test set sample sizes for AI) is not applicable or cannot be extracted from the provided text.
However, I can extract information related to the device's performance testing and its comparison to a predicate device, which serves as the basis for its substantial equivalence claim.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device must meet the requirements of ASTM F564 for Bone Metallic Staples. | The testing demonstrated that the subject device met all acceptance criteria per ASTM F564. |
2. Sample Size & Data Provenance
The document does not specify a "sample size used for the test set" in the context of an AI/ML model or a clinical study with patients. The performance testing mentioned is mechanical testing. Therefore, the concept of data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was conducted on the device itself.
3. Number of Experts and Qualifications
Not applicable. The performance testing described is mechanical testing of the implant, not a study requiring human expert evaluation (e.g., radiologists interpreting images).
4. Adjudication Method
Not applicable. This is not a study requiring adjudication of human readings or AI outputs.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device whose performance is being compared to human readers.
6. Standalone Performance
The document states, "The testing demonstrated that the subject device met all acceptance criteria" per ASTM F564. This implies a standalone evaluation of the device's mechanical properties against a predefined standard. However, this is for a physical implant, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is the mechanical performance standards defined by ASTM F564 for Bone Metallic Staples. The device's performance was compared directly to these established engineering standards.
8. Sample Size for Training Set
Not applicable. This is not an AI/ML device.
9. How Ground Truth for Training Set was Established
Not applicable. This is not an AI/ML device.
Summary of Device and Evidence:
The Treace Medical Concepts (TMC) Compression Implant System is a metallic bone fixation appliance. Its clearance is based on demonstrating substantial equivalence to predicate devices (Z-Medical Z-Staple and Wright Medical FuseForce™ Flex Dynamic Compression System). The primary evidence for this equivalence, specifically regarding performance, is the mechanical testing of the device against the ASTM F564 standard for Bone Metallic Staples. The manufacturer states that the device successfully met all acceptance criteria defined by this standard, indicating similar mechanical properties and safety/effectiveness as the predicate device.
§ 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.