(63 days)
- Rheumatoid arthritis
-
- Traumatic arthritis
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- Osteoarthritis
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- Post Fracture deformation or bone loss
Not Found
I am sorry, but based on the provided document, I cannot fulfill your request for details about acceptance criteria, device performance, and study information. The document is a 510(k) clearance letter from the FDA for a device called "Modular Thumb Implant."
This letter confirms that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. However, this type of document does not typically contain detailed information about acceptance criteria, specific device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process focuses on demonstrating substantial equivalence, not necessarily on presenting exhaustive clinical trial data with specific performance metrics and acceptance criteria in the way you've outlined for AI/ML device studies.
The document only provides:
- Device Name: Modular Thumb Implant
- Regulation Number and Name: 21 CFR 888.3770, Wrist joint carpal trapezium polymer prosthesis
- Indications for Use: Rheumatoid arthritis, Traumatic arthritis, Osteoarthritis, Post Fracture deformation or bone loss.
- Product Code: KYI
To find the information you're looking for, you would generally need to refer to the actual 510(k) submission summary, sometimes publicly available on the FDA website, or directly to the manufacturer's technical documentation or publications if such studies were conducted and published.
§ 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.