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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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The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriative immobilization, throughout the healing period.

The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton.

The provided document is a 510(k) premarket notification from the FDA to CONMED Corporation regarding their CuffLink Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document. The document focuses on showing the new device is as safe and effective as a previously approved one, often through non-clinical testing.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed reported performance data for the CuffLink Implant System in the way one would expect for a clinical study evaluating diagnostic accuracy or a specific functional outcome. It states that "Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device."

It lists categories of completed test data:

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for any of the performance testing categories. It also does not mention clinical test sets or data provenance (e.g., country of origin, retrospective/prospective) because the submission focuses on non-clinical performance and a comparison to a predicate device for substantial equivalence, not a clinical outcomes study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of submission relies on engineering and laboratory testing for device performance characteristics, not expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for reattaching soft tissue to bone (suture anchors), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests mentioned (biocompatibility, pyrogenicity, shelf-life, etc.), the "ground truth" would be established by validated test methods and industry standards (e.g., ISO standards for biocompatibility, specific microbial limits for pyrogenicity). No clinical or expert consensus ground truth is described in this document.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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