(106 days)
The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.
The Apollo Knotless Suture Anchors are made from PEEK (Zeniva ZA-500 and Zeniva ZA-600) per ASTM F2026. The Anchors are provided loaded on individual inserters with and without integrated sutures made of ultra-high molecular weight polyethylene (UHMWPE), sterile, for single use only.
This document is a 510(k) Summary for the Maruho Medical Apollo Knotless Suture Anchor. It details the device, its intended use, and a comparison to predicate devices, but it does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI/machine learning device.
Instead, this document describes a medical device (a suture anchor) and its substantial equivalence to previously cleared predicate devices. The "performance testing" mentioned is related to the physical characteristics of the suture anchor (e.g., pullout strength, fatigue) and material biocompatibility, not diagnostic performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/ML-driven device.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because this document is not about an AI/ML-enabled medical device or a diagnostic tool with performance metrics typically associated with such criteria.
The information provided is about a physical implantable medical device and its mechanical/physical performance.
§ 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.