(58 days)
The InfinityTM Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral ligament.
The CONMED Infinity™ Fixation System is a family of metal buttons and nonabsorbable Hi-Fi suture for suspensory fixation of tendon to bone used in ligament reconstruction procedures. The Infinity™ Fixation System is provided individually packaged, single-use, sterile. The anchor, suture, and disposable driver are EO Sterilized.
This is a 510(k) summary for a medical device called the "Infinity™ Fixation System," which is intended for soft tissue to bone fixation in ligament reconstruction procedures. The document does not describe acceptance criteria in the way you've outlined for an AI/ML device. Instead, it details performance testing for a traditional medical device (a mechanical fixation system).
Therefore, I cannot provide the specific information you requested in bullet points 1 through 9 because the provided text does not contain information related to AI/ML device acceptance criteria or studies involving AI/ML components.
The document focuses on demonstrating substantial equivalence to a predicate device ("ConMed Linvatec XO Button") for a mechanical device through:
- Device Description and Intended Use: Comparing the Infinity™ Fixation System to the predicate device.
- Technological Characteristics: Highlighting similarities in how the devices work (e.g., providing suspension fixation, pre-attached sutures).
- Performance Data: Listing various types of engineering and biological tests conducted (e.g., Ultimate Fixation Strength, Biocompatibility, Sterilization, Shelf-life) to show the device performs as intended and is safe and effective. These are standard tests for orthopedic fixation devices, not AI/ML performance metrics.
To reiterate, there is no mention of:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample sizes for test sets related to AI/ML, data provenance, or explicit ground truth establishment methods for an AI/ML model.
- Expert involvement for establishing AI/ML ground truth or adjudication methods.
- MRMC studies or standalone AI/ML performance.
- Training set details for an AI/ML model.
§ 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.