(26 days)
The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.
ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.
The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.
The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.
The IntraSight System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).
The provided text is a 510(k) summary for the Volcano IntraSight System, which is an imaging and pressure measurement system used in coronary and peripheral vasculature. The document clarifies that the IntraSight System is a modification of an already marketed device (Volcano s5i/CORE and CORE Mobile Precision Guided Therapy Systems, K173860). The focus of the 510(k) summary is to demonstrate substantial equivalence to the predicate device due to these modifications, not to establish the initial performance of a novel device.
Therefore, the summary primarily describes verification and validation activities conducted to ensure the modified device meets its specifications and remains substantially equivalent to the predicate, rather than presenting a standalone study with specific acceptance criteria and performance metrics for an AI/algorithm-driven device in the way a new diagnostic or prognostic AI algorithm would be evaluated.
Based on the provided information, I can answer some of your questions, but many cannot be answered because the document does not contain the details of a comparative effectiveness study or a standalone algorithm performance study with specific clinical acceptance criteria and results. It primarily mentions engineering and software verification activities.
Here's an attempt to answer based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance or reported device performance in the context of an AI/algorithm-driven diagnostic or prognostic task. The "Performance Data" section lists types of engineering and software verification tests performed (e.g., EMC, Electrical Safety, Environmental, Design Verification, Software Verification and Validation, Packaging Validation, Simulated Use/Usability Validation, Image Validation). These are not clinical acceptance criteria with specific performance metrics (like sensitivity, specificity, or AUC) as you would find for an AI study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document lists "Image Validation" as a type of performance data, but it does not specify the sample size, data provenance, or whether it was a test set for an algorithm. Given the nature of a 510(k) for modifications to an existing device, "Image Validation" likely refers to ensuring image quality equivalence or non-inferiority compared to the predicate, rather than a clinical study of an AI algorithm on a specific test set.
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)
This information is not provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the provided text. The document describes modifications to an existing imaging system (IntraSight System) and seeks substantial equivalence, not the clinical effect of an AI component on human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not mentioned. The IntraSight System itself is a device that includes hardware and software for imaging and pressure measurement, intended for use by clinicians, not a standalone AI algorithm being evaluated for accuracy independent of human interaction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. There is no mention of ground truth in the context of an AI algorithm evaluation.
8. The sample size for the training set
This information is not provided. The document does not describe the development or training of an AI algorithm in the context you are asking about. The "Software Verification and Validation" mentioned refers to the standard software development lifecycle for the device's operating system and features.
9. How the ground truth for the training set was established
This information is not provided.
In summary: The provided 510(k) summary is for a device system (IntraSight System) that underwent modifications, including updated hardware and software platforms. The "Performance Data" listed primarily pertains to engineering and software verification and validation activities to ensure the modified device remains substantially equivalent to its predicate. It does not present a clinical study evaluating the performance of an AI-driven diagnostic or prognostic algorithm with specific acceptance criteria, test sets, ground truth establishment, or human reader studies. Therefore, most of your questions, which are tailored to the evaluation of an AI algorithm's clinical performance, cannot be answered from this document.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).