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The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as:
Shoulder: Bankart repair, SLAP lesion repair, Rotator cuff repair, Capsular shift repair, Biceps tenodesis, Acromio-clavicular separation
Elbow: Biceps tendon reattachment
Foot & Ankle: Achilles tendon repair/reconstruction, Lateral stabilization, Medial stabilization
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Joint capsule closure to anterior proximal tibia, Posterior oblique ligament or joint capsule to tibia repair, Extra capsular reconstruction/ITB tenodesis, Patellar ligament and tendon avulsion repairs
The Stryker XCEL Anchor is intended for single-use only.

The Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with nonabsorbable, braided polyester surgical suture, and pre-assembled on a disposable inserter. Stryker instrumentation, drill and soft-tissue guide/drill guide, will be used to install the Stryker XCEL Anchor. The Stryker XCEL Anchor System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO 10993 and G95-1.

The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the Stryker XCEL Anchor System. This document does not contain the kind of detailed information requested about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML performance (e.g., sample sizes for test/training sets, expert consensus, MRMC studies).

Instead, it describes a medical device (Stryker XCEL Anchor System) for securing soft tissue to bone and states its substantial equivalence to a predicate device (Mitek Panalok 3.5mm Absorbable Anchor System). The safety and effectiveness are established by demonstrating this substantial equivalence, not through a performance study against specific acceptance criteria as you've outlined for AI/ML devices.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Name and Classification: Stryker XCEL Anchor System, Class II, Smooth or Threaded Metallic Bone Fixation Fasteners.
• Predicate Device: Mitek Panalok 3.5mm Absorbable Anchor System.
• Intended Use: Securing soft tissue to bone.
• Device Description: Poly L-lactic acid (PLLA) anchor with non-absorbable, braided polyester surgical suture, pre-assembled on a disposable inserter.
• Substantial Equivalence: Claimed based on intended use, safety, efficacy, and performance compared to the predicate device.
• Sterilization and Biocompatibility: Information provided (Ethylene oxide, ISO 10993).
• Indications for Use: Specific surgical procedures (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair).

There is no mention of:

• Acceptance criteria in the form of performance metrics (like sensitivity, specificity, F-score, etc.).
• A specific "study" with test sets, training sets, ground truth establishment, expert readers, or AI/ML components.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

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