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The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

The GFS Ultimate devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture. The GFS Ultimate devices are provided sterile.

The provided text is a 510(k) Substantial Equivalence Determination for the GFS Ultimate device. This type of document is for medical device regulation and focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically contain information about AI-based CADe/CADx systems or studies with acceptance criteria as commonly understood in that context.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not present in the given document.

The document does include "Summary Performance Data" which states:

Summary Performance Data:

• The GFS Ultimate were evaluated and testing was conducted on the worst case configurations.
• Devices were assembled per the DFU and placed in a test fixture.
• Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions.
• Results were compared with test data for the predicate device and demonstrated substantial equivalency.

However, this summary does not provide specific acceptance criteria or quantitative performance metrics for the GFS Ultimate, nor does it detail the study design, sample sizes, or ground truth establishment that would be relevant for an AI-powered diagnostic/CADe device. Instead, it confirms that mechanical testing was performed and the results supported substantial equivalence to the predicate device.

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