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The OPTIS™ Software with 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 Dragonfly™ DUO or Dragonfly ™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The 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 OPTIS™ Software 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 Metallic Stent Optimization SW E.4 is an OCT system software that allows update of the current software version of ILUMIEN OPTIS (K150878), OPTIS Mobile System (K152120) and OPTIS Integrated OCT Systems (K151286) on the field for the Stent Optimization Tool features. The Metallic Stent Optimization SW E.4 is also compatible with flush catheters compatible with the above mentioned OCT systems (Dragonfly OPTIS and Dragonfly DUO catheters).

The OCT system software is used to control the OCT imaging engine in order to acquire OCT images, it is used to make measurements based on acquired OCT images, it is used to maintain a database of OCT images and data, and it is used to review previously acquired OCT images and data.

The OCT System software is also used to control the Aortic (AO) and PressureWire (PW) USB receivers to collect and store pressure waveform data for computing Fractional Flow Reserve (FFR). Similar to the OCT images, the FFR waveforms are stored in the database and are available for later review.

The OPTIS™ Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. The software also contains Intel JPEG Library, Microsoft MPEG-4 Video Codec, Microsoft Video 1 codec, AMD FirePro V4900 Display Adapter Driver, Intel 82579LM/82583V Gigabit Ethernet Controller Driver, Microsoft Foundation Class Library, Active Template Library, Microsoft Standard C++ Library, LEADTOOLS Medical Imaging Suite SDK, Microsoft SQL Server Express 2008 Service Pack 2 (SP2), Open Inventor Library, Haru PDF Library, IDEA Video Driver, iWRAP Bluetooth Stack and Intel Integrated Performance Primitives commercial off the shelf (COTS) software.

The E.4 software introduces the following new features:

• . 3D Flythrough, 3D Bifurcation (Bifurcation Visualization)- Enhance assessment of ostium geometry with optimized 3D views
• Cross Frame Angio (Stent Roadmap) Display stent roadmap with . OCT/angiography coregistrations
• Stent Display (Quantification of Stent Strut Apposition, Metallic Stent . Visualization) and 3D Display Options (Guide Wire Detection, Side Branch Detection) - Provide intra-procedural guidance by automatic detection and 3D visualization of BMS struts, side branches, and guidewires

The provided text (K160878) describes the OPTIS™ Metallic Stent Optimization E.4 SW, an upgrade to Lightlab Imaging's OCT system software. It details the device's enhanced features, indications for use, and a general statement about performance testing, but it does not include a detailed study proving the device meets specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions 2 through 9 regarding a specific study's details like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information.

The document only states the following regarding performance:

• Performance Testing: "The OPTIS™ Metallic Stent Optimization E.4 SW has been developed and tested in compliance with IEC 62304: 2006 and DICOM Standard: 2015b. Software verification and validation was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and validation was also performed in compliance with internal design control procedures. The results of this testing conclude the OPTIS™ Metallic Stent Optimization E.4 SW is determined to be safe and effective and is substantially equivalent to the predicate OPTIS Mobile System software."

This is a general statement of compliance and outcome, not a detailed report of a study with specific acceptance criteria and measured numerical performance.

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The OPTISTM Mobile System with DragonflyTM DUO or DragonflyTM OPTISTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The DragonflyTM DUO or Dragonfly™ OPTISTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or DragonflyTM OPTISTM 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 OPTISTM Mobile System 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 OPTIS Mobile System is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the OPTIS Mobile 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 OPTIS Mobile System is comprised of the following main components:

• . A rapidly scanning laser engine
• A host computer with embedded application software ●
• A drive-motor and optical coupler (DOC) which connects to the imaging catheter ●
• A mobile console with monitors, keyboard and mouse housing laser engine and host computer, and connected to the DOC.
• An imaging catheter
• An optional Tableside Controller (TSC) ●
• o Video interfaces for interaction with the boom monitor and angiography system

The function of the Tableside Controller (TSC) is to provide tableside system control to the Physician. The TSC communicates with the console via wireless configuration or an optional wired configuration.

The OPTIS Mobile System can perform both OCT and FFR procedures, and is compatible with Dragonfly OPTIS, DUO and JP catheters and the PressureWire Aeris. The OPTIS Mobile system provides the ability to incorporate the angiography images into the GUI, which allows users to visualize the position of OCT image data on angiography images, tightening the linkage between anatomical assessment with OCT and subsequent therapeutic actions.

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study would typically describe for a new AI/ML device. The document is an FDA 510(k) clearance letter and summary for the LightLab Imaging, Inc. OPTIS™ Mobile System, which is an ultrasonic pulsed echo imaging system, not an AI/ML device in the context of typical AI study requirements.

The performance testing mentioned is primarily related to:

• Electrical Safety and EMC: Compliance with standards like IEC 60601-1, IEC 60601-1-2.
• Software Verification and Validation: Compliance with IEC 62304 and FDA regulations.
• Laser Safety: Compliance with IEC 60825-1 and 21 CFR 1040.10.
• Usability Engineering: Compliance with IEC 62366 and IEC 60601-1-6.
• OCT Parameter and Hardware Testing: This is mentioned as part of design verification and validation, but specific acceptance criteria and results are not detailed.

The document asserts that "The results of this testing conclude the software has met these requirements" and "The results of this testing concludes the OPTIS Mobile System is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device." However, no specific performance metrics, sample sizes for test sets, ground truth methodology, or details of comparative effectiveness studies (like MRMC) are provided in the context of diagnostic accuracy, which would be typical for an AI/ML device.

Therefore, I cannot populate the requested table and answer many of the questions because the provided text does not contain this information. The device is cleared based on substantial equivalence to predicate devices, and the performance testing described is focused on safety, electromagnetic compatibility, software V&V, and basic system functionality, rather than detailed diagnostic accuracy metrics for an AI/ML algorithm.

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