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The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragong Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar 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 Dragonfly OpStar 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 internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues 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 Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the OPTIS System software to construct an Optical Coherence Tomography (OCT) image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dragonfly OpStar™ Imaging Catheter.

Important Note: The provided document is an FDA 510(k) clearance letter and summary. It focuses on demonstrating substantial equivalence to a predicate device, not on detailed clinical or standalone performance studies against specific acceptance criteria for a novel AI/software component. The "device" in this context refers to the physical imaging catheter, not an AI or software algorithm that provides diagnostic interpretations. Therefore, many of the requested items (like AI performance, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not present in this type of submission.

Let's break down what information is available and what is not for the "device" (the catheter itself).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and reported performance for the Dragonfly OpStar™ Imaging Catheter in the way one would for an AI diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device (K192019). The "performance" assessment is qualitative, focusing on meeting design specifications and not raising new safety or effectiveness concerns.

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test set. The testing performed was "Design verification and validation bench tests." These typically involve testing individual catheter units, components, and system functionalities.
• Data Provenance: Not applicable in the context of clinical data for a diagnostic algorithm. The tests were "bench tests," meaning they were conducted in a laboratory or simulated environment, not on human patients or derived from patient data.

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

This information is not applicable to this submission. The device is an imaging catheter that produces images, not an AI algorithm that interprets them to make a diagnosis requiring expert ground truth for validation. The "ground truth" for bench testing would be engineering specifications and measurements (e.g., catheter diameter, image resolution, material strength).

4. Adjudication Method for the Test Set

This is not applicable. Since there's no diagnostic interpretation requiring expert consensus, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing is provided in this pre-market notification." This type of study would be relevant for evaluating AI-assisted interpretation, which is not the subject of this 510(k) (it's for the physical catheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This question is relevant for AI algorithms. The device's "performance" described relates to its physical and functional capabilities as an imaging tool, not its interpretive accuracy.

7. The Type of Ground Truth Used

The ground truth for the "Design verification and validation bench tests" would be engineering specifications and measurements. For example, if a test was to verify the catheter's diameter, the ground truth would be the specified diameter in the design documents, and the test would confirm that measured catheters fall within acceptable tolerances of that specification.

8. The Sample Size for the Training Set

This information is not applicable. This question is for AI/machine learning algorithms. The Dragonfly OpStar™ Imaging Catheter is a physical medical device.

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

This information is not applicable. As above, this pertains to AI/machine learning training, which is not described for this device.

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The Dragonfly OpStar™ imaging catheter with OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar 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 AptiVue™ E-series software is intended for use only with compatible OPTIS™ imaging systems. The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The Dragonfly OpStar™ 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 internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues 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 Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the 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.
The AptiVue™ Software version E.5.1 controls the Optical Coherence Tomography (OCT) imaging engine to collect and store pressure wave form data for computing, Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) during procedures and to provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure).

The prompt asks for acceptance criteria and study details for a medical device. However, the provided text is a 510(k) summary for the Dragonfly OpStar™ Imaging Catheter and AptiVue™ Software version E.5.1. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results to prove device performance against those criteria.

Therefore, the requested information, specifically a table of acceptance criteria, device performance, details of test and training sets, ground truth establishment, expert qualifications, and MRMC study effect sizes, is not available in the provided text.

The document primarily states:

• Non-Clinical Testing: "Design verification and validation was performed on the Dragonfly OPSTAR Imaging Catheter as compared to the predicate Dragonfly OPTIS Imaging catheter in compliance with internal design control procedures, which included bench testing and pre-clinical animal testing. The testing involved head-to-head comparison between the proposed and predicate devices for modifications to technological characteristics. The results of this testing conclude the Dragonfly OPSTAR Imaging Catheter is substantially equivalent to the Dragonfly OPTIS Imaging Catheter."
• Software Verification: "Verification and Validation testing was completed for the AptiVue software version E.5.1 to demonstrate safety and effectiveness and ensure that the subject device performs as intended. Software design verification concludes these modifications do not raise different questions of safety or effectiveness."
• Clinical Testing: "No clinical testing is provided in this pre-market notification."

In summary, the provided text does not contain the detailed study information sought to answer the prompt.

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