(466 days)
The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.
Examples include:
- rigid or semi-rigid hammertoe deformity .
- revision of failed arthroplasty or arthrodesis .
- 2nd toe shortening .
The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:
- . Fixed or semi-fixed hammer toe
- Revision of failed arthrodesis or arthroplasty ●
- . Shortening due to length excess of the second toe
This interphalangeal implant configuration will be offered in two different sizes.
The provided text describes the Newdeal® Interphalangeal implant and its substantial equivalence to other devices. It focuses on the regulatory submission (510(k) summary) for this medical device. As such, the information required to populate the table (acceptance criteria and device performance based on a study of AI/algorithm performance) and subsequent questions about AI/algorithm-related studies are not present in the document. This document is a regulatory submission for a physical medical implant, not an AI or algorithm-based device.
Therefore, I cannot provide the requested information.
Here's why:
- Acceptance Criteria & Device Performance: The document mentions "Static and Fatigue Bending tests were performed comparing the mechanical properties" but does not detail specific quantitative acceptance criteria or the reported device performance against those criteria. It only states that the results "helped to support substantial equivalence."
- AI/Algorithm Related Questions (2-7): The entire submission is for a physical orthopedic implant. It does not involve an AI or algorithm. Therefore, there are no test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types related to AI.
- Training Set (8-9): Similarly, the concept of a "training set" and establishing ground truth for it is irrelevant for a physical mechanical implant.
§ 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.