(159 days)
Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of the thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Following an old Bennet fracture.
The Avanta Orthopaedics Trapezium Implant is a device intended to be implanted in metacarpal bone of the thumb with resection of the trapezium bone of the wrist. It is made of molded silicone elastomer. The device is intended to be used in the treatment of thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.
The provided text is a 510(k) summary for the Avanta Orthopaedics Trapezium Implant. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in such studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study proving the device meets acceptance criteria. The document is a regulatory submission for substantial equivalence, not a clinical study report.
The FDA's finding of "substantial equivalence" in this context means the device is considered as safe and effective as a legally marketed predicate device, based on comparison, not necessarily based on a new performance study proving specific acceptance criteria.
§ 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.