(174 days)
The S-Wire is intended to perform as temporary fixation and stabilization unit of bone fractures and as guidance at insertion of implants into the skeletal system.
The S-Wire is composed of wires manufactured from stainless steel per ASTM F138 and nitinol per ASTM F2063. The wires are available in lengths of 150-550mm and diameters of .7-1.6mm. The S-wire is available with the following tip styles: Diamond Smooth, Diamond Threaded, Round Smooth, Round Threaded, Trocar Smooth, Trocar Threaded, and Diamond Suture Passer.
This is a 510(k) premarket notification for a medical device called "S-Wire." The document does not contain information about an AI/ML device or a study involving acceptance criteria for such a device.
The provided text describes a traditional medical device (fixation pins/wires) and its substantial equivalence to a predicate device based on material, design, and intended use. Therefore, I cannot extract the requested information about acceptance criteria or studies related to AI/ML device performance.
Here's why the requested information cannot be provided from this document:
- No AI/ML Device: The S-Wire is a physical orthopedic device made of stainless steel and nitinol. It is not an AI/ML software or system.
- No Performance Study as Described: The 510(k) submission establishes substantial equivalence to a predicate device. This typically involves demonstrating similar design, materials, manufacturing, intended use, and performance characteristics (often through bench testing or literature review), not complex clinical trials or detailed performance metrics against acceptance criteria in the way AI/ML algorithms are evaluated.
- Lack of Specific Data: There is no mention of sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training sets, or how ground truth for training sets was established, as these are not relevant to the type of device and submission described.
§ 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.