(59 days)
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Argo Knotless™ SP Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.
The Argo Knotless™ SP Anchor is a soft tissue to bone fixation device that consists of a titanium tip with an eyelet to thread suture through, and a threaded anchor body, manufactured of PEEK material. The anchor design includes a 1.0mm UHMWPE Hi-Fi™ retention ribbon which secures the titanium tip to the delivery system and to the retention suture cleat.
The provided text is a 510(k) Pre-market Notification for the Argo Knotless™ SP Anchor, a medical device used to reattach soft tissue to bone. It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML model.
The document focuses on demonstrating substantial equivalence of a physical medical device (suture anchor) to a previously cleared predicate device, through comparisons of manufacturing materials, intended use, and various performance tests. These tests are physical and mechanical in nature, not related to the performance of an AI/ML algorithm.
Thus, I cannot provide:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance for an AI/ML device.
- Number of experts used to establish ground truth and their qualifications for an AI/ML device.
- Adjudication method for an AI/ML device.
- MRMC study details or effect size for an AI/ML device.
- Standalone performance details for an AI/ML device.
- Type of ground truth used for an AI/ML device.
- Sample size for the training set for an AI/ML device.
- How ground truth for the training set was established for an AI/ML device.
§ 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.