(212 days)
Shoulder - rotator cuff repair
Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
The provided text describes a 510(k) submission for a medical device (Li Medical RotorBlade™) and an FDA clearance letter. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria and a study to prove the device meets these criteria in the context of an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.
The "Performance Data" section merely states: "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek anchors." This is a general statement of equivalence for the physical device, not an AI/ML performance metric.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.