(90 days)
The ILUMIEN OPTIS with Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ 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 Drivemotor and Optical Controller (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 provided text describes a 510(k) summary for the LightLab Imaging, Inc. ILUMIEN OPTIS system, stating its intended use, technological characteristics, and performance testing. However, it does not contain detailed acceptance criteria, specific performance metrics, or study results in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (C7 XR™ Imaging System) by highlighting upgrades in performance (engine A-scan rate, frame rate, pullback speeds, pullback length, pullback time, display option, automated lumen measurement) and compliance with various safety and regulatory standards (UL, IEC, EN, DICOM, CFR, FCC).
Therefore, I cannot fulfill all parts of your request with the information provided.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot create: The document lists general performance upgrades (e.g., increased A-scan rate, frame rate), but it does not provide specific quantitative acceptance criteria or corresponding reported device performance values for these metrics. It states "Design verification and validation was also performed on the ILUMIEN OPTIS in compliance with internal design control procedures which included bench testing. This testing included physical, mechanical, and optical characteristics testing. The system hardware was evaluated for range, speed, and rotation accuracy and durability. Optical testing was conducted and included scan range and rate, resolution, and sensitivity." However, the actual criteria and results are not presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot provide: The document mentions "bench testing" for design verification and validation but does not specify sample sizes for any test sets, data provenance, or whether the testing was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot provide: The document refers to "software verification and validation" and "design verification and validation" (bench testing), but it does not mention the use of experts to establish ground truth for any test set, nor does it specify their number or qualifications. This type of expert assessment generally applies to clinical studies, which are not detailed here for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide: There is no mention of adjudication methods as no human expert review or clinical trial results establishing ground truth are detailed.
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:
- Cannot provide: The document does not describe any MRMC studies or any studies evaluating human reader improvement with AI assistance. The device is an imaging system (ILUMIEN OPTIS) and does not appear to involve AI assistance for human interpretation in the way your question implies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot provide: While software verification and validation were performed, the document does not detail specific algorithm-only performance studies or their results. It's an imaging device, and its "performance" largely relates to its hardware, software functionality, and physical/optical characteristics rather than a diagnostic algorithm's standalone accuracy against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot provide: The document only mentions "bench testing" and "software verification and validation." The nature of the ground truth (e.g., physical specifications, simulated data) for these tests is not explicitly defined in terms of clinical or pathological outcomes.
8. The sample size for the training set:
- Cannot provide: There is no mention of a "training set" as the context is not about a machine learning algorithm being trained.
9. How the ground truth for the training set was established:
- Cannot provide: (See point 8).
In summary, the provided text is a regulatory submission summary focused on demonstrating substantial equivalence and compliance with general safety and performance standards for a medical device upgrade. It does not contain the detailed study information regarding specific acceptance criteria, performance metrics, and validation methodologies that your request asks for.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.