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The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the perior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

The Tigereye ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Tigereye ST CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox.

The provided text is a 510(k) summary for the Tigereye ST CTO-Crossing Catheter. It focuses on demonstrating substantial equivalence to a predicate device (Tigereye CTO-Crossing Catheter K201330) based on similarities in indications for use, technological characteristics, and performance data from bench and biocompatibility testing.

However, the document does not contain information regarding a study involving AI/algorithm performance, human reader studies (MRMC), or details about acceptance criteria for such a study, sample sizes for test/training sets, expert adjudication, or ground truth establishment for an AI device.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text. The device described is a medical instrument (catheter with OCT imaging), not an AI/algorithm-based diagnostic or assistive device that would typically undergo the type of performance evaluation criteria you are asking about (e.g., acceptance criteria for diagnostic accuracy, standalone algorithm performance, or human-in-the-loop improvement with AI).

The "Software Verification and Validation Testing" section mentions that the software of the Lightbox component has not been changed since a previous clearance (K212468) and is considered "moderate" level of concern, but this does not imply AI-driven diagnostic or assistive capabilities requiring the kind of study details you've requested.

In summary, the provided document is a 510(k) for a physical medical device and does not contain information about an AI/algorithm study.

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