(331 days)
ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.
ARTELON STT Spacer is a woven one-piece, L-shaped implant made of ARTELON, a polycaprolactone based polyurethaneurea.
This submission is for a medical device (Artelon STT Spacer), not an AI/ML powered device. Therefore most of the requested information regarding AI/ML powered devices, such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable.
Here's a breakdown of the relevant information provided:
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Table of acceptance criteria and reported device performance: Not explicitly stated in the provided text in the format of acceptance criteria and reported performance. The document states, "A collection of tests have been successfully completed. The results from the performance testing demonstrate that ARTELON STT Spacer provides appropriate assurance of safety and effectiveness." However, specific quantitative or qualitative acceptance criteria and their corresponding results are not detailed.
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Sample size used for the test set and the data provenance: Not applicable. This is a medical device approval summary, not a study report for an algorithm. The testing described is likely mechanical and biocompatibility testing of the physical implant, not a test set for an algorithm.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation does not apply here.
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Adjudication method: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a medical device (implant) and not a reader-dependent diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used: Not applicable in the context of an AI/ML algorithm. For the device, safety and effectiveness would be established through mechanical testing, biocompatibility studies, and potentially clinical trials (though not detailed here for this 510(k) summary).
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
Additional Information from the document:
- Device Name: Artelon® STT Spacer
- Intended Use: "ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis."
- Comparison to Predicate Devices: The submission states that the Artelon STT Spacer is substantially equivalent to:
- K040070 Artelon® CMC Spacer (Artimplant AB)
- Swanson Trapezium Implant (Dow Corning Wright - a pre-amendment device)
- Basis for Equivalence: The Artelon STT Spacer is made of the same material (ARTELON) and has the same basic design as the Artelon CMC Spacer. It also serves a similar function (space-filling for osteoarthritis) to the Swanson Trapezium Implant.
- Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, and therefore presents no new concerns of safety and effectiveness.
§ 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.