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The TMC Implant Fixation 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 pediatric (aged > 12-21) and adult (aged 22 and over) patients. 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

The TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments requiring adjudication.

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:

• No. This is a medical device for bone fixation, not an AI diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

• No. This is a physical implant system, not a software algorithm.

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

• For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

• Static 4-point bend testing
• Dynamic 4-point bend testing
• Axial pullout testing

These tests were conducted in accordance with established standards:

• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
• Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

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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

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.

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