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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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