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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.

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