Search Results

The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, and metatarsophalangeal joint instability.

The Treace Medical Concepts (TMC) Hammertoe Fixation System is for the fixation of osteotomies and reconstruction of the lesser toes. The cannulated implant is made of PEEK (Polyetheretherketone) according to ASTM F2026 and is available in different sizes. The implants are delivered sterile packaged and for single use only.

The Implantable K-wire is made from stainless steel according to ASTM F138 and available in different sizes. The k-wire is delivered sterile packaged and for single use only.

All implantable components are provided sterile by gamma irradiation.

The provided text describes a 510(k) premarket notification for a medical device called the Treace Medical Concepts (TMC) Hammertoe Fixation System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria is not directly applicable in the context of this 510(k) summary.

Instead, the submission focuses on performance testing to demonstrate that the new device is as safe and effective as the predicate devices. The "acceptance criteria" here implicitly refer to the mechanical properties required to be substantially equivalent to the predicate devices and conform to relevant ASTM standards.

Here's an attempt to structure the information based on your request, understanding that it's framed for a different type of submission (e.g., a de novo or PMA where new clinical data might be generated):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The performance testing for substantial equivalence typically involves a predetermined number of physical units subjected to mechanical tests, as per the ASTM standards referenced. This is not a patient-based "test set" in the sense of clinical data.
• Data Provenance: The data provenance is from the mechanical testing performed by the manufacturer, Treace Medical Concepts, Inc. This is not clinical data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: For a 510(k) submission based on mechanical testing for substantial equivalence, "ground truth" established by human experts in the clinical diagnostic sense is not involved. The "ground truth" for mechanical performance is defined by the relevant ASTM standards and the performance characteristics of the predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable: There is no clinical "test set" in need of adjudication. Mechanical testing results are compared against predefined criteria and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study is designed to assess the impact of a device on human reader performance, typically in the context of imaging or diagnostics. This is a surgical fixation device, and the submission is based on mechanical equivalence, not clinical diagnostic performance.

6. Standalone (Algorithm Only) Performance Study

• No: This is a physical medical device (implants and K-wires), not an algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• Mechanical Standards and Predicate Device Performance: The "ground truth" for this submission is adherence to established ASTM mechanical testing standards (e.g., F382-17, F543-17) and demonstrating performance comparable to the legally marketed predicate devices (In2Bones SAS, Duafit® interphalangeal implant (K132912) and Wright Medical Technology Inc., PRO-TOE® Hammertoe Fixation System (K140148)).

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of a 510(k) submission for a physical device. This terminology relates to machine learning models, which are not involved here.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set or machine learning involved, this question is not relevant.

Ask a specific question about this device