(112 days)
The Modified 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 Modified 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 Modified DePuy NeuFlex PIP Finger Prosthesis and other commercially available silicone finger joint prostheses, which have an unflexed, neutral angle of 0°.
The provided text is a 510(k) summary for a medical device (DePuy NeuFlex PIP Finger Prosthesis). It describes the device, its indications for use, and its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, or MRMC studies.
Therefore, I cannot populate the table or answer the specific questions requested based on the given input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
§ 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.