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The Infinity-Lock™ Button System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption and as an adjunct in external and intramedullary fixation systems involving plates.

The Infinity-Lock™ Button System is indicated for patients with acromioclavicular separations resulting from disruption to the coracoclavicular ligaments.

The Infinity-Lock™ Button System comprises a permanent implantable 240 mm Tube-Tape and titanium alloy Button together with a disposable cannulated drill bit and guidewire. A coracoid passer, such as the Xiros CCHook, is also required.

This document is a 510(k) Premarket Notification from the FDA regarding the "Infinity-Lock™ Button System," a medical device for bone fixation. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria via a study on its diagnostic performance, as would be the case for an AI/ML medical device.

Therefore, the requested information for acceptance criteria and a study proving the device meets them (especially points 2-9 related to test sets, experts, ground truth, and training sets for an AI/ML device) is not applicable to this submission. This document describes a traditional medical device (implantable system) and its performance is evaluated through mechanical testing against a predicate device.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The document describes performance testing, but not in the framework of diagnostic performance or AI model validation. Instead, it focuses on the equivalence of mechanical properties.

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

Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is a series of pre-clinical mechanical and biological compatibility tests comparing the new device to a legally marketed predicate device.

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

• Sample Size: Not specified in the provided text. It merely states "The Infinity-Lock™ Button System when tested against the AC TightRope™ Repair Kit Titanium (K052776)..." without detailing the number of units tested.
• Data Provenance: The tests are pre-clinical (laboratory/bench testing) of the physical device components. Data provenance would be from the manufacturer's internal testing facilities, likely in the United Kingdom based on the submitter's address. It is not "retrospective or prospective" in the sense of patient data.

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

• Not Applicable. This is a mechanical device, not a diagnostic AI. "Ground truth" would be established by validated testing methods and equipment, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. This is not a human-in-the-loop diagnostic study.

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 device is an implant, not a diagnostic imaging AI.

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

• Not Applicable. This is a mechanical implant, not an algorithm. The "standalone performance" is its intrinsic mechanical properties.

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

• Engineering/Material Standards: The ground truth for mechanical testing is established by recognized engineering standards and validated test equipment measuring physical properties (e.g., tensile strength, fatigue resistance). For pyrogenicity, it's a biochemical assay standard.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set."

In summary, this 510(k) submission successfully demonstrates "substantial equivalence" for a physical medical device by comparing its mechanical and biological safety properties to a predicate device, rather than through complex clinical or AI performance studies involving human readers and ground truth data.

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