(70 days)
The Smith & Nephew TWINFIX FT PK suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Bankhart Repair, SLAP lesion repairs, Capsular Shift or capsulolabral Reconstructions, Acromioclavicular separation repairs, Deltoid Repairs, Rotator Cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instablility repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions), Elbow (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: medial collateral ligament, lateral collateral ligament, posterior oblique ligament, Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis)
Preloaded 5.5/6.5 mm suture anchor manufactured from PEEK (polyaryletherkeone) incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.
The provided document is a 510(k) summary for the TWINFIX FT PK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data. The document does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies for AI devices.
Instead, the document describes a traditional medical device (suture anchor) and its regulatory approval process, which relies on bench testing and comparison to existing similar devices.
Therefore, I cannot extract the requested information from the provided text because it is not an AI/ML device and the document does not discuss those evaluation metrics.
§ 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.