(88 days)
The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:
Hip
• Acetabular labrum repair/reconstruction
Shoulder
- Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- · Rotator cuff tear repairs
The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.
The provided text is a 510(k) Summary for the MICRORAPTOR Knotless Suture Anchor, a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-based study.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Summary Performance Data" section mentions that the device met "performance specifications for insertion strength and pullout strength" and "met performance specifications for cyclic loading based on the predicate." However, it does not explicitly state what those specifications (acceptance criteria) were or provide numeric results of the testing. It implies that these were mechanical engineering tests, not studies involving human readers or AI.
This document is for a physical medical device (suture anchor), not software or an AI device. The questions in the prompt are more relevant to AI/software device submissions, particularly those involving image analysis or diagnostic support.
§ 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.