(28 days)
The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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 soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The proposed device is a bioabsorbable push-in (press fit) suture anchor that is preloaded on a disposable inserter device with one or two non-absorbable. braided, polyethylene sutures. The proposed device is manufactured from 100% Poly L-lactic Acid with colorant D&C violet #2. The polymer is inert and noncollagenous through the absorption process. The device dimensions are 2.9mm diameter and 10.75mm in length.
The provided text is a 510(k) summary for a medical device (ConMed Linvatec Presto™ Suture Anchor) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot provide the requested information as it is not present in the given text.
The document primarily focuses on:
- Device Identification: Trade name, common name, classification, product code, and regulation.
- Predicate Devices: Listing previously cleared devices for substantial equivalence comparison.
- Device Description: Material, dimensions, and general mechanism.
- Intended Use/Indications: Explaining what the device is for.
- Substantial Equivalence Claim: Stating that the new device is substantially equivalent to predicate devices.
- FDA Clearance Letter: Confirming the FDA's acceptance of the 510(k) submission.
In summary, none of the requested information regarding acceptance criteria or the specific studies to prove device performance are available in the provided text.
§ 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.