(41 days)
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.
This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft for anchor insertion. This product is sterilized product and single use only.
Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.
The provided text is a 510(k) premarket notification for a medical device called "Suture Wing." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving that the device meets specific acceptance criteria based on a study involving AI or human readers.
Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of AI performance, human reader studies, and ground truth establishment) is NOT present in the provided document.
The document details non-clinical bench tests to verify design specifications and compliance with various standards related to materials, mechanical performance, sterilization, shelf-life, packaging, bacterial endotoxin, and pyrogenicity. It explicitly states: "Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
It describes the comparison to a predicate device and a reference device, indicating similarities and minor differences in material (needle presence, which is addressed by the reference device) and product size, with the safety of these differences evaluated through bench testing.
In summary, this document is a regulatory submission for a physical medical device (Suture Wing) establishing substantial equivalence based on bench testing and comparison to predicates, not a study evaluating AI or human reader performance.
§ 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.