(29 days)
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.
The provided text is an FDA 510(k) clearance letter for the Ascension Silicone MCP and Ascension Silicone PIP devices. This document focuses on the regulatory clearance of a physical medical device (finger joint prostheses) based on a special 510(k) for adding "MR Safe" labeling.
The information you've requested (acceptance criteria and study details for an AI/software device) is not present in this document. The document explicitly states:
- "Non-clinical performance data is not required to support the addition of MR Safe labeling to the subject devices."
- The determination of "MR Safe" was established through a "scientific rationale that addressed information about the electrical conductivity and magnetic properties of the device material per the FDA guidance document 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'"
Therefore, I cannot provide the requested details because the device in question is not an AI/software medical device that underwent the type of performance study you're asking about.
§ 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.