(102 days)
The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2) deployment instrumentation, and 3) bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves multiple functions: 1) shifting of the PEEK Body and 2) applying tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint (PIPJ).
The provided text describes a medical device, the ProxiFuse Hammer Toe Device, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices through performance testing. However, it does not describe a study involving an AI/Machine Learning device or its acceptance criteria.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML-based medical devices. Since the ProxiFuse Hammer Toe Device is a physical implant and not an AI/ML device, these details are not present in the provided documentation.
Therefore, I cannot provide the requested information. The document details bench testing for a physical implant, not a study for an AI/ML device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.