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The AptiVue™ E series software is intended to be used 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.

OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data.

The provided document (K232386) describes the premarket notification for the "ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6". This submission primarily focuses on the addition of cloud connectivity features (remote software updates and telemetry data transmission) to an existing device (predicate device K183320).

Crucially, the document explicitly states that "No clinical testing is provided in this pre-market notification" (page 4). Therefore, the information requested regarding acceptance criteria and study proving device performance (including sample sizes, expert involvement, ground truth, MRMC studies, and standalone performance) cannot be extracted from this document, as such studies were not performed or reported for this particular submission.

The document focuses on demonstrating substantial equivalence based on the updated software's functional similarity and verification and validation (V&V) testing.

Here's what can be inferred from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the non-clinical testing performed:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

The remaining requested information (2-9) pertains to clinical studies and performance evaluation of an AI/ML algorithm against a ground truth, which is explicitly stated as not included in this submission.

Here's a breakdown of why the other points cannot be answered:

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/ML performance was used. The V&V testing would have involved engineering and software test cases, not patient data in the context of an AI performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for AI/ML performance was established or reviewed for this submission.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. The submission is about adding cloud connectivity, not about AI-assisted interpretation or improvement of human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission concerns software and hardware systems for imaging, FFR, and RFR; the "AptiVue™ Imaging Software" is part of the system, but the document does not indicate a distinct AI/ML algorithm for standalone diagnostic performance beyond what the predicate device already provided. The predicate's capabilities (OCT, FFR, RFR) involve algorithms, but this submission does not describe a new or modified AI/ML algorithm requiring standalone clinical validation.
7. The type of ground truth used: Not applicable, as no clinical ground truth assessment (e.g., pathology, outcomes data) was reported for this submission. The "ground truth" for the V&V of the new features would be the expected functional behavior according to design specifications.
8. The sample size for the training set: Not applicable, as no machine learning model training was described or modified for this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily address an update to existing software with new cloud-based functionalities. It clearly states that "No clinical testing is provided." Therefore, the detailed questions about acceptance criteria for AI/ML performance, clinical test sets, experts, and ground truth are not relevant to the information contained within this specific document.

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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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