(119 days)
The Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions 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. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
The Next Generation Fully Threaded PEEK Suture Anchor is manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5mm and 5.5mm sizes. The screw-in anchor is pre-assembled onto a stainless steel inserter and pre-loaded with up to three strands of suture.
The provided text is a 510(k) Summary for a medical device called the "Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor." It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for performance studies involving AI or diagnostic accuracy.
Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The performance data mentioned is related to insertion and fixation properties of the suture anchor, which are biomechanical characteristics, not diagnostic accuracy.
Therefore, I cannot populate your requested table and information points as they pertain to clinical or diagnostic performance studies. The document states:
"The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent to the predicate TWINFIX AB 5.0 suture anchor, cleared via 510(k) K011299. The testing demonstrates that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy."
This indicates that the "study" was likely a series of mechanical tests to compare the new anchor's physical performance (e.g., pull-out strength, insertion torque) to that of the predicate device. The acceptance criteria would have been that these properties are comparable or equivalent to the predicate. The document doesn't provide the detailed numerical results, specific acceptance thresholds, or the methodology of these mechanical tests.
The questions you've asked (about sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are highly relevant for AI/diagnostic device performance studies, but they are not applicable to the type of 510(k) submission for a surgical implant like a suture anchor, which relies on demonstrating biomechanical equivalence rather than diagnostic accuracy.
§ 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.