(55 days)
The Biopro devices are intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which presents themselves as either a painful, instable thumb or a thumb with limited range of motion.
The Biopro Modular Thumb prosthesis has been designed for dysfunction associated with advanced degenerative or rheumatoid arthritis of the thumb carpo-metacarpal joint. The implant is modular and is made available in 3 combinations a neutral a +2mm and +4mm length of 4 head dimensions (12mm-15mm in one millimeter increments) and 4 stem sizes (7.5mm, 8.5mm, 10.0mm and 11.0mm). The tri-flanged and partially porecoated stem provides an immobile press-fitted fixation within the medullary canal. The varus angle of the implant assures the implant remains in contact with the trapezium throughout range of motion, reducing the risk for dislocation. The stem is anatomically configured in the sagital plane to fit the curvature of the metacarpal canal. The head is slightly medialized and is at a 15-20 degree varus angle. The head articulates against the trapezium after a spherical concavity is burred into the trapezium to match the radius of the head.
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the BioPro Modular Thumb Implant, focusing on its substantial equivalence to a predicate device.
The document does not contain any information about acceptance criteria or specific studies (beyond the comparison to a predicate device) to demonstrate performance against such criteria. It primarily describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence for regulatory approval.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.