(59 days)
Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.
The provided document is a 510(k) premarket notification for a medical device called Acu-Sinch Knotless Mini. It describes the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI/ML devices. Instead, the acceptance criteria are framed in terms of substantial equivalence to a predicate device (Arthrex CMC Mini Tightrope). The key performance criteria evaluated through non-clinical testing are static and dynamic fatigue, and MRI compatibility.
| Acceptance Criteria Category | Specific Criteria/Goal | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device performs statistically equivalent to the predicate device in static and dynamic fatigue testing. | Acu-Sinch Knotless Mini performed as well as, or better than the predicate device. (This indicates it met or exceeded the performance of the predicate in these tests). |
| MRI Compatibility | Device meets safety requirements for image artifact, magnetically induced displacement force, radio frequency induced heating, and magnetically induced torque in the Magnetic Resonance Environment, per relevant ASTM standards. | Tests conducted in accordance with ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213 were performed. The document states these tests were conducted, implying compliance with the standards, but does not state specific numerical results or explicitly say "passed" for each. However, the overall conclusion that the device is "safe and effective for the indication" implies these tests were successful. |
| Biocompatibility | Endotoxin levels meet requirement of |
§ 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.