(76 days)
Devices (K-Wires and Steinmann Pins) are intended to be used as:
- · Guide wires for osteosynthesis implants
- · Accessories for external fixation (Steinmann Pins)
- · Implants according to principles of fracture management
The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.
This document is a 510(k) clearance letter for the "SMV Scientific K-Wire and Pins." It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML device. The device described here is a physical medical device (K-wires and Steinmann pins), and its clearance is based on substantial equivalence to a predicate device, not on a performance study with acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states:
"Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."
This indicates that the clearance was based on engineering analysis and comparison to a predicate device, not on a performance study that would generate the kind of data requested (acceptance criteria, reported device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.).
§ 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.