(84 days)
The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.
Not Found
The provided text is a 510(k) Summary for a medical device called "FiberStitch™ Implant". This document details the device's classification, indications for use, and a comparison to predicate devices, including nonclinical testing performed to support its safety and effectiveness.
However, the 510(k) Summary does not contain information about a study proving the device meets specific acceptance criteria based on AI performance, human reader improvement with AI assistance, or standalone algorithm performance. The testing discussed is biomechanical tensile strength testing and cadaveric evaluation to assess the device's usability and functionality for its intended surgical uses.
Therefore, I cannot provide a response filling in the requested table and study details as they pertain to AI/algorithm performance. The document focuses on the physical and functional characteristics of a surgical implant, not a diagnostic or AI-driven medical 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.