(417 days)
The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture.
The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements.
The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.
This document describes the Osteotec Silicone Finger Implant, a joint replacement implant. However, the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other statistical measures often associated with AI/ML medical devices.
The document is a 510(k) premarket notification for a medical device and focuses on establishing substantial equivalence to legally marketed predicate devices, primarily based on material, design, and intended use. The testing discussed ("dynamic mechanical properties," "static mechanical properties," "drop testing," "shelf life," and "instrument tray validation") pertains to the physical and functional characteristics of the implant and its packaging, not to the performance of an AI/ML system.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and a study proving device performance as described in your prompt, because this information is not present in the provided text.
§ 888.3230 Finger joint polymer constrained prosthesis.
(a)
Identification. A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.(b)
Classification. Class II.