Search Results

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 and pediatric patients aged > 12 years. 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 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
• 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-Cubiod (CC) Fusion
• Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, curved and Python plates and associated screws. 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) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961).
All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Plating System." It is a submission to the FDA seeking clearance to market a device that is demonstrably "substantially equivalent" to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence through a clarification of 'indications for use' and states that 'performance testing was not required.' This implies that the device is a modification or re-statement of an existing cleared device, rather than an entirely new device requiring extensive new performance validation studies.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for de novo device approvals or for devices requiring complex performance validation (e.g., AI/ML-based diagnostic devices), is not present in this document.

Here's an analysis based on the provided text:

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

Not applicable/Provided. The document states: "Performance testing was not required to support the clarification of the indications statement." The basis for clearance is "substantial equivalence" to predicate devices, not performance against specific acceptance criteria developed for a new device study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance studies with test sets were conducted or reported in this document, as "Performance testing was not required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set was performed or reported.

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

Not applicable. No test set adjudication was performed or reported.

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 device is a metallic bone fixation system, not an AI/ML-based diagnostic or assistive technology. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. No specific ground truth was established for performance testing as no such testing was required. The "ground truth" for this submission is effectively the established safety and effectiveness of the multiple predicate devices to which the TMC Plating System is demonstrated to be substantially equivalent.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the document's approach to "proving" the device meets acceptance criteria:

The "acceptance criteria" in this context are not quantitative performance metrics from a new study, but rather the qualitative assessment of "substantial equivalence" to existing, legally marketed devices.

The "study that proves the device meets the acceptance criteria" in this case is a comparison to predicate devices and a risk analysis, as stated:

• "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 reconstruction of small bones of the feet, identical to the predicate devices."
• "Indications for use have been clarified and were found through a risk analysis including literature review to be equivalent to the predicate device."
• "Thus, it can be concluded that the subject changes to the Indications for Use do not raise new questions about safety and effectiveness."
• "The Treace Medical Concepts (TMC) Screw Fixation System has identical design and construction to the predicate devices. A risk analysis found that the Indications for Use statement remain substantially equivalent to those of the system in previous clearances. Therefore, it can be concluded that the subject device is as safe, as effective, and performs as safely and effectively as the predicate device."

In essence, the "proof" is the argument that the refined indications for use and the device's design and materials are so similar to previously cleared devices that no new performance testing is necessary to establish its safety and effectiveness.

Ask a specific question about this device