(65 days)
The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.
The Crius PEEK Suture Anchor System is a soft-tissue to bone fixation device, provided preloaded on a disposable inserter. Crius PEEK Suture Anchor System includes four types Thread-Fix Anchor, Thread-Fix Ultra Anchor,Helicoil Anchor and Pile Anchor.The device is available in varying profile diameters. The system consists of a suture anchor, suture(except for Pile Anchor ), and insertion handle and insertion shaft) and is a sterile,single use device. The anchor body is manufactured from Polyetheretherketone(PEEK).The suture is made from ultra high molecular weight polyethylene(UHMWPE) available in white and blue/white colors. The blue dye used in the suture is Chromium-cobalt-aluminum oxide in accordance with 21 CFR 73.1015 regulations. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture. The insertion shaft is made from 304 stainless steel compliant with ISO 7153-1 and 630 stainless steel compliant with ISO 16061. The surgical instruments are provided non-sterile and shall be sterilized by the end user.
The provided document is a 510(k) premarket notification for a medical device called the "Crius PEEK Suture Anchor System." This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about the performance or acceptance criteria of an AI/ML device.
Therefore, I cannot provide a detailed answer to your request. The document describes a traditional medical device (suture anchors) and its physical and mechanical performance testing, not the performance of an AI/ML system.
However, I can extract the information that is present about the traditional device's performance testing:
Performance Data for Crius PEEK Suture Anchor System (Traditional Medical Device)
The performance data included in the document relates to mechanical testing of the suture anchors, not an AI/ML model.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "Acceptance criteria were based on similar sized predicate suture anchor devices and the results of the performance testing showed the subject device to have substantially equivalent performance compared to the predicate device."
Specific numerical acceptance criteria are not provided in this summary.
| Test Type | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|
| Insertion Force Testing | Based on similar sized predicate suture anchor devices. | Showed substantially equivalent performance compared to the predicate device. |
| Insertion Torque Testing | Based on similar sized predicate suture anchor devices. | Showed substantially equivalent performance compared to the predicate device. |
| Torsional Strength Testing | Based on similar sized predicate suture anchor devices. | Showed substantially equivalent performance compared to the predicate device. |
| Pullout Strength Testing | Based on similar sized predicate suture anchor devices. | Showed substantially equivalent performance compared to the predicate device. |
| Fatigue Strength Testing | Based on similar sized predicate suture anchor devices. | Showed substantially equivalent performance compared to the predicate device. |
| Pyrogen Limit |
§ 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.