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The Tigereye System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior 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 System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.

The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox 3 Imaging Console (referred to as "Lightbox 3" or "L300").

The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.

The Tigereye 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 CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox 3 imaging console.

The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.

The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.

The Tigereye catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

This Traditional 510(k) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.

Here's a breakdown of the acceptance criteria and study information for the Tigereye CTO-Crossing Catheter, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary for a medical device (Tigereye CTO-Crossing Catheter) seeking clearance for a software and console update, not a device proving its initial efficacy or diagnostic performance. Therefore, many of the typical acceptance criteria related to diagnostic accuracy, sensitivity, specificity, and expert adjudication are not present in this document.

The focus of this submission is to demonstrate that the updated device (Tigereye System with Lightbox 3 imaging console) remains substantially equivalent to its predicate device (Tigereye System cleared under K201330) and that the changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a software/console update and not an initial efficacy study, the "acceptance criteria" are primarily related to meeting performance standards for the modified components and showing equivalence to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of an efficacy study. This submission is for a software/console upgrade of an already cleared device. The performance data for the mechanical and electrical components likely involved a small number of test units (e.g., a few consoles and catheters) for engineering verification and validation.
• Data Provenance: Not explicitly stated as real-world patient data. The tests described are primarily bench testing, electrical safety, EMC, and software testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. This submission does not involve clinical studies or expert consensus for diagnostic ground truth. The "ground truth" for the engineering performance tests would be established by validated test methods, reference standards, and specifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no expert adjudication for a test set in this 510(k) 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

• MRMC Study: No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This device is an imaging-assisted crossing catheter, not an AI-driven diagnostic system that assists human readers in interpreting images.

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

• Standalone Performance: Not applicable. The device is an imaging system providing real-time OCT images to a clinician during a procedure. It is inherently a human-in-the-loop device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical, electrical, and software performance tests, the "ground truth" is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1). For example, "OCT image accuracy" would be compared against a known, accurate reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development of a machine learning or AI model, thus there is no "training set." The software updates are likely traditional software enhancements and bug fixes, verified and validated through standard software engineering practices.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model described here.

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The Tigereye System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior 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 system is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox HS Imaging Console (referred to as "Lightbox"). The Tigereye 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 CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox. The software of the Lightbox has been updated to version 4.6.0, which builds on version 4.4.0 that was reviewed and cleared under K182341.

The provided text does not describe a study involving an AI/Machine Learning device. Instead, it is a 510(k) summary for the Tigereye CTO-Crossing Catheter, a medical device used for crossing chronic total occlusions in peripheral vasculature. The device utilizes Optical Coherence Tomography (OCT) for imaging and orientation, but this is a physical imaging technology, not an AI/ML algorithm.

Therefore, many of the requested elements, such as acceptance criteria for AI performance (e.g., sensitivity, specificity), ground truth establishment for AI models, sample sizes for training/test sets for AI, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Ocelot PIXL CTO-Crossing Catheter) and a reference device (Pantheris SV Catheter) through:

• Comparison of Technological Characteristics: Highlighting similarities in intended use, imaging modality (OCT), safety standards, materials, and operational characteristics.
• Performance Data: This section details engineering and biocompatibility tests, not clinical or AI performance. These include:
  • Biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, etc.)
  • Electrical safety and electromagnetic compatibility (EMC)
  • Software verification and validation (for the Lightbox component, which houses the control software, not an AI for image analysis)
  • Mechanical testing (e.g., catheter length, flow rate, tip rotation, force to cross occlusion, torque, tensile strength).

The conclusion states that the data "raises no new questions of safety and effectiveness and that the Tigereye catheter is substantially equivalent to the predicate device."

In summary, based on the provided text, it's impossible to fill out the requested table or answer most of the questions, as they pertain to the evaluation of an AI/Machine Learning device, which the Tigereye CTO-Crossing Catheter is not.

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