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The ILUMIEN OPTIS with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.

The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core.

The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the Ilumien Optis System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

This document describes the ILUMIEN OPTIS system with the Dragonfly OPTIS Imaging Catheter, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested. Therefore, much of the specific information requested cannot be extracted directly from this document.

However, based on the provided text, I can infer and summarize what is available regarding performance testing and regulatory compliance.

Here's a breakdown of the information and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task or specific measurement tolerances) and corresponding reported device performance values. The performance testing section primarily lists compliance with general safety and electromagnetic compatibility standards, along with successful software verification/validation and design verification/validation through bench and pre-clinical animal testing. It concludes that the device is "safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device," but no quantitative performance metrics against specific acceptance thresholds are provided.

Therefore, this section cannot be completed as requested based on the input document.

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

• Test Set Description: The document mentions "bench testing and pre-clinical animal testing" as part of design verification and validation.
• Sample Size: The sample size for these tests is not specified in the document.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "pre-clinical animal testing," indicating it's not human data. It's a "prospective" study in the sense that these tests were conducted to demonstrate performance for regulatory submission, but not a prospective clinical trial on human subjects.

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

This information is not provided in the document. For animal testing, ground truth might be established by other imaging modalities or histological analysis performed by veterinary pathologists, but the document does not elaborate.

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

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• AI assistance: The document describes an "Ultrasonic pulsed echo imaging system" and an "Imaging Catheter" for Optical Coherence Tomography (OCT) and Fractional Flow Reserve (FFR) measurements. While these are advanced technologies, the document does not indicate that the device involves AI (Artificial Intelligence) or machine learning components that would assist human readers in image interpretation or diagnosis.
• MRMC study: A comparative effectiveness study with human readers (with vs. without AI assistance) is not mentioned in the document.

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

The device is an imaging system (ILUMIEN OPTIS) and a catheter (Dragonfly OPTIS) that generates OCT images and FFR measurements for physician use. It's an "algorithm only" in the sense that the system calculates FFR and constructs OCT images without human intervention in that specific process, but the overall purpose is to provide information for a human physician's judgment. The document does not discuss a "standalone" performance evaluation of the algorithms for diagnostic accuracy independent of human interpretation in a clinical context.

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

For the "pre-clinical animal testing," it's likely that invasive measures, histological analysis, or other validated imaging modalities would form the ground truth, but the document does not specify the type of ground truth used.

8. The sample size for the training set:

The document does not mention or describe a training set. This is typical for medical device submissions focused on substantial equivalence where the device performs a measurement or creates an image, rather than making a diagnostic prediction based on learned patterns from a large dataset. The "software verification and validation" indicates software testing, but not a "training set" in the machine learning sense.

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

Since a training set is not mentioned, this information is not applicable/provided.

Summary of available information regarding performance:

The document primarily states that the ILUMIEN OPTIS and Dragonfly OPTIS Imaging Catheter have undergone:

• Electrical safety testing: Compliance with UL Standard No 60601-1, IEC 60601-1-2, EN 60601-1-2, IEC 60825-1, 21 CFR 1040.10, and CFR 47 FCC Part 15 Subpart B.
• Software verification and validation: Conducted according to FDA regulations, standards, and guidance, concluding that the software met requirements.
• Design verification and validation: Included "bench testing and pre-clinical animal testing" in compliance with internal design control procedures. The results led to the conclusion that the device is "safe and effective and is substantially equivalent to the predicate ILUMIEN OPTIS device."

Conclusion:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed results of a new clinical performance study with specific acceptance criteria and outcome metrics for diagnostic accuracy, sensitivity, or specificity. The performance testing described is primarily related to safety, software functionality, and engineering design validation, concluding with an overall statement of safety, effectiveness, and substantial equivalence. Specific quantitative performance against predefined acceptance criteria for clinical use or AI diagnostic capabilities is not detailed in this document.

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