(65 days)
The Smith & Nephew, Inc. FOOTPRINT Ultra PK Suture Anchor, SL is intended for use in the fixation of soft tissue to bone for the following indications:
Shoulder
Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or capsulolabral reconstruction
Foot and Ankle
Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair
Knee
Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, SL consists of four assembled components; a non-absorbable suture anchor, a suture anchor insertion device, a stay suture, and a suture threader. The FOOTPRINT Ultra PK Suture Anchor is not preloaded with suture, but rather preassembled to an insertion device and held in place with a stay suture. The anchor accommodates up to four (4) strands of ULTRABRAID #2 suture.
The provided document is a 510(k) Premarket Notification for a medical device (suture anchor). It describes the device, its intended use, and states that it has met performance specifications. However, the document does not describe a study involving an AI/Machine Learning algorithm or a human-in-the-loop study as would be relevant for the acceptance criteria and study design questions posed.
Therefore, I cannot provide the requested information from the given text. The text only mentions "Mechanical insertion test data demonstrates the device has met the performance specifications" without detailing those specifications or the methodology of the mechanical tests.
To answer your request, the input text would need to describe an AI/ML device, its performance metrics (acceptance criteria), and the details of a clinical or technical study conducted to prove it meets those criteria, including details about data, ground truth, and expert involvement.
§ 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.