(424 days)
Auxilock GFS Mini, GFS II Large, GFS Ultimate Mini and GFS Ultimate Large are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Auxilock GFS Mini, GFS II Large & GFS Ultimate are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6Al-4V ELI, grade 5 as per ASTM F136 and also includes an UHMWPE polyblend suture component as per ASTM F2848-17. These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.
I am sorry, but the provided text does not contain detailed information about acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) Premarket Notification for a medical device (Auxilock Graft Fixation System) and primarily focuses on establishing substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical bench testing.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance. While a comparison table between the subject and predicate devices is present, it focuses on general parameters like product code, regulation number, and material standards, rather than specific performance metrics with acceptance thresholds.
- Sample size used for a test set, data provenance, or details about patient data.
- Information about experts used to establish ground truth, their qualifications, or adjudication methods.
- Any mention of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone algorithm performance or human-in-the-loop performance details, as this is not an AI/ML medical device.
- The type of ground truth used (e.g., pathology, outcomes data) for clinical validation, as clinical studies involving such ground truth are not detailed.
- Training set sample size or how ground truth for a training set was established.
The document primarily states that "Bench tests were conducted to verify that the subject device met all design specifications" and that "The results of this testing indicate that the Auxilock Graft Fixation System is equivalent to a predicate device." The "performance tests" mentioned are "Tensile Static and Pull out following cyclic loading test." However, the specific acceptance criteria for these tests (e.g., minimum tensile strength, maximum pull-out force) and the detailed results showing the device met these criteria are not provided in this summary.
§ 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.