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INTENDED USE
The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

INDICATIONS FOR USE
The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.
Procedure: Rotator cuff repair, Achilles Repair
Joint: Shoulder, Ankle

The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.

The provided text describes a 510(k) premarket notification for a medical device called the "CuffLink Implant System Biocomposite". The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily focuses on comparing the new device to existing ones in terms of intended use, technological characteristics, and safety and effectiveness, rather than establishing acceptance criteria for an AI algorithm or presenting a detailed study proving its performance against such criteria.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The document is for a physical medical implant (suture anchor system) and focuses on demonstrating substantial equivalence through comparison to predicate devices and general performance testing (e.g., biocompatibility, packaging, sterilization).

Specifically, the following detailed information is not available in the provided text:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm): The document lists "performance data" which refers to general engineering and biological testing of the physical implant, not algorithmic performance metrics.
• Sample size used for the test set and data provenance (for an AI/ML algorithm): No mention of test datasets for an algorithm.
• Number of experts used to establish ground truth and qualifications: Not applicable, as there's no AI algorithm being evaluated for diagnostic accuracy.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document's "Performance Data" section states: "Testing has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits. Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity." This refers to standard engineering and biological tests for a physical implant, not the kind of AI/ML performance evaluation you've asked about.

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