(172 days)
The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use.
The provided text is a 510(k) summary for the Arthrex AlloSync™ PushLock® Suture Anchor, a medical device used for soft tissue fixation to bone. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does not contain information related to a study involving artificial intelligence (AI) or machine learning (ML) models. Specifically, it does not discuss the following:
- Acceptance criteria for an AI/ML model's performance.
- A test set for an AI/ML model.
- Ground truth establishment by experts for an AI/ML model.
- Adjudication methods for an AI/ML model's test set.
- Multi-Reader Multi-Case (MRMC) studies for AI assistance.
- Standalone performance of an AI algorithm.
- Training set for an AI/ML model or how its ground truth was established.
Instead, the performance data discussed in this document relates to the mechanical and biological testing of the physical suture anchor device, comparing its strength, biocompatibility, and pyrogenicity to existing predicate devices.
Therefore, I cannot provide the requested table and study details as the input document does not contain information about an AI/ML device or its performance evaluation.
§ 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.