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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

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