(49 days)
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The Gryphon P BR Anchor is an absorbable suture anchor manufactured of "Biocryl Rapide" material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The suture option is provided without needles. The Gryphon P BR Anchor is provided as size 3.0 mm.
The provided text is a 510(k) Summary for the DePuy Mitek Gryphon P BR Anchor, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving performance against specific acceptance criteria for a novel device through clinical studies. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth establishment.
Specifically, the document states:
- Substantial Equivalence: "The Gryphon P BR Anchor is substantially equivalent to the Gryphon BR Anchor (K073412, January 17, 2008)."
- Safety and Performance: "Based on the Indications for Use, technological characteristics and safety and performance testing, the Gryphon P BR Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act."
- Validation Testing: The submission includes "the results of validation testing (performance testing) for the device modification." However, detailed results or specific acceptance criteria are not provided in this summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets, as this information is not present in the provided 510(k) summary.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and performance through non-clinical testing, rather than extensive clinical efficacy trials against pre-defined acceptance criteria like those typically seen for novel devices that require PMAs or more comprehensive studies.
§ 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.