(118 days)
The Extremity Medical Trapezium Prosthesis is indicated for use in degenerative or posttraumatic (e.g. following an old Bennett fracture) disabilities of the thumb basal joint with:
- Localized pain and palpable crepitation at the base of the thumb on the "grind test" (circumduction with axial compression of the thumb)
- Decreased motion, pinch, and grip strength
- X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium-second metacarpal joints, singly or in combination.
- Associated unstable, stiff, or painful distal joints of thumb or swan neck deformity
The EXTREMITY MEDICAL Trapezium Prosthesis
The provided text is a 510(k) summary for the EXTREMITY MEDICAL Trapezium Prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not present in this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The core "acceptance criteria" for K092548 is demonstrating substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
- Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, functional outcomes) are reported for the EXTREMITY MEDICAL Trapezium Prosthesis itself. The study's "performance" is its argument for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This document is a regulatory submission for substantial equivalence, not a clinical study reporting on patient outcomes with a specific test set.
- Data Provenance: Not applicable for a test set of the device itself. The data provenance for the predicate devices would be from their original studies or regulatory submissions, which are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" in the context of clinical performance evaluation described here, nor is there a ground truth established by experts for performance data of this specific device.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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 implant, not an AI diagnostic tool. MRMC studies and "human readers improve with AI" are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical implant, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device aims to demonstrate it is substantially equivalent to these already-approved devices, rather than establishing de novo safety and effectiveness through clinical trials with a primary ground truth (like pathology or outcomes data for a novel treatment).
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an algorithm being developed.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of what the document does provide regarding the "study" for acceptance:
- Study Type: This is a predator-based 510(k) submission, not a clinical or performance study of the subject device. The "study" here refers to the process of comparing the new device against legally marketed predicate devices.
- Acceptance Criteria (Implicit for 510k): The device is "accepted" (cleared for market) if it is found to be "substantially equivalent" to legally marketed predicate devices. This means it must have:
- The same intended use as the predicate device.
- The same technological characteristics as the predicate device; OR
- Different technological characteristics from the predicate device that do not raise different questions of safety and effectiveness; AND
- The information submitted to FDA, including appropriate scientific data, demonstrates that the device is as safe and effective as the legally marketed device.
- Device Performance (as presented): The document states: "The EXTREMITY MEDICAL Trapezium Prosthesis is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." No specific performance data (e.g., clinical outcomes, wear rates, complication rates) for the EXTREMITY MEDICAL Trapezium Prosthesis are presented. Performance is inferred from equivalence to the predicates.
- Predicate Devices Used for Comparison:
- Wright Medical, Metallic CMC Spherical Implant K960534
- Wright Medical, Orthosphere Ceramic Spherical Implant, K030319
- Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490
- Wright Medical, Swanson Titanium Carpal Lunate Implant, K864491
- Wright Medical, TIE-IN Trapezium, K033529
- Wright Medical, Trapezium Implant, K781756
- Ascension Orthopedics, PyroSphere, K042690
- Ascension Orthopedics, PyroCarbon Lunate, K080997
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.