(67 days)
The DePuy NeuFlex PIP Finger Prosthesis is indicated for cementless replacement of the proximal interphalangeal (PIP) joints of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
The DePuy NeuFlex PIP Finger Prosthesis is a flexible, one-piece silicone implant designed to be implanted across the PIP joint. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed. This angle is the most obvious difference between the DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.
The provided text describes a 510(k) summary for the DePuy NeuFlex PIP Finger Prosthesis. It discusses the device's information, indications for use, and substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
The document only states: "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards." This suggests that the device's performance was compared to existing standards, but the specific details of those standards or any performance data are not included.
§ 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.