(23 days)
Use of the TIE-IN™ Trapezium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with:
- Localized pain and palpable crepitation during circumduction movement with axial . compression of involved thumb ("grind test")
- Decreased motion, decreased pinch and decreased 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 TIE-INTM Trapezium is for single use.
The design features of the TIE-IN™ Trapezium are summarized below:
- Manufactured from silicone elastomer, identical to the Swanson Trapczium Implant .
- Offered in 3 sizes .
- Sides of the implant have an hour glass shape that can be used to wrap a tendon around . and stabilize the implant
- Round peg for insertion into the canal of the ulna .
The provided text is a 510(k) summary for the TIE-IN™ Trapezium, a medical device. It does not describe a study to prove acceptance criteria in the way a clinical trial for diagnostic AI would. Instead, it demonstrates "substantial equivalence" to a predicate device, which is a different regulatory pathway.
Therefore, the requested information elements related to AI algorithm studies (sample sizes, expert adjudication, MRMC studies, standalone performance, training data) are not applicable to this document.
Here's an analysis based on the information provided:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This document describes the regulatory submission for a medical device (TIE-IN™ Trapezium) under the 510(k) pathway, which establishes substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a clinical study as would be done for an AI diagnostic device.
The "acceptance criteria" in this context are the regulatory requirements for establishing substantial equivalence, primarily demonstrating similar intended use, materials, and design features to a legally marketed predicate device, with safety and effectiveness adequately supported by the provided information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Substantial Equivalence for a medical implant) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Identical to predicate device. | "The indications for use... of the TIE-IN™ Trapezium are identical to the Swanson Trapezium Implant." |
| Material: Identical or highly similar to predicate device. | "Manufactured from silicone elastomer, identical to the Swanson Trapezium Implant." |
| Design Features: Similar to predicate device, with differences not raising new questions of safety/effectiveness. | "many design features of the TIE-IN™ Trapezium are equivalent to the Swanson Trapezium Implant." Specific features mentioned: 3 sizes, hourglass shape for tendon wrapping, round peg. |
| Safety and Effectiveness: Adequately supported by substantial equivalence information, materials information, and analysis data. | "The safety and effectiveness of the TIE-IN™ Trapezium are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for a physical medical implant, not an AI diagnostic device requiring a test set of data. The "test" for substantial equivalence is a comparison against the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI diagnostic device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a 510(k) submission of this type, the "ground truth" for demonstrating safety and effectiveness is largely based on the established safety and effectiveness of the predicate device (Swanson Trapezium Implant) and the material properties of the silicone elastomer, which is identical to the predicate. The submission relies on the long-standing clinical use and regulatory clearance of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.