(435 days)
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
WasherCap™ Fixation System is an implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery.
WasherCap™ Fixation System consists of three components: a Cap, a Screw and a Washer. The Cap and the Washer are manufactured from polyetheretherketone (PEEK) as per ASTM F-2026. The Screw is made of titanium alloy as per ASTM F136.
The WasherCap™ Fixation System is provided sterile and individually packaged and, it is available in a variety of sizes and should be implanted following the surgical procedure.
The provided text describes the WasherCap™ Fixation System, a medical device intended for fixation of soft tissue grafts during ACL reconstruction. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML-driven medical device.
The document appears to be an FDA 510(k) clearance letter and summary for a physical medical device (WasherCap™ Fixation System), not an AI/ML diagnostic or assistive device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to the content provided.
Specifically, the document states:
- "No clinical studies were conducted." This directly indicates that there aren't clinical performance metrics to discuss.
- "Performance Data" section lists "DESIGN VALIDATION" and "PERFORMANCE TESTING" (Cyclic and load-to-failure properties), and "PYROGENICITY" tests. These are mechanical and biological safety tests for a physical implant, not performance metrics for an AI/ML algorithm.
Therefore, I cannot provide the requested information based on the given input. The prompt's questions are designed for AI/ML device evaluations, and the provided document pertains to a traditional physical 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.