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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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