(84 days)
The CORE® FM System is intended to measure blood pressure in all blood vessels, including the coronary and peripheral arteries during diagnostic and/or interventional procedures.
The CORE FM System should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.
The CORE FM System provides the capability to make Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®) measurements. The system consists of a bedrail or cart mounted PC Console, a patient interface module (OPIM) for connecting the pressure measurement guide wire to the PC Console, and one or more Hemo Converter Box (HCB) modules for transmitting the aortic pressure and ECG signals form the hemodynamic monitoring system to the PC Console.
The provided text is a 510(k) summary for the Volcano CORE® FM Physiological Measurement System, which is a device intended to measure blood pressure, specifically Fractional Flow Reserve (FFR) and Instant Wave-Free Ratio™ (iFR®).
It does not include the detailed information, such as acceptance criteria table, sample sizes, expert qualifications, or details about comparative effectiveness studies, that would be present in a clinical performance study. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through various performance testing categories, but these categories generally refer to non-clinical tests (e.g., electrical safety, software verification, packaging validation, simulated use/usability) rather than a clinical study establishing the device's diagnostic performance against a ground truth.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested, as the document does not contain that level of detail regarding clinical validation.
The closest relevant statement is: "The results of the performance data demonstrate equivalence to the predicate device." However, this does not detail specific clinical acceptance criteria or a clinical study design.
If the request is to complete the table and answer the questions based only on the provided text, the answer would mostly be "Information not provided in release.
Let's break down why each specific point cannot be addressed from the given text:
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A table of acceptance criteria and the reported device performance:
- Information not provided: The document lists general categories of performance testing (EMC, Reliability, Electrical Safety, Design Verification, Software Verification, Packaging Validation, Simulated Use/Usability Validation) and states "The results of the performance data demonstrate equivalence to the predicate device." It does not provide specific numerical acceptance criteria (e.g., accuracy +/- X mmHg, sensitivity/specificity thresholds) or the reported numerical performance data.
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Sample sizes used for the test set and the data provenance:
- Information not provided: No clinical sample sizes are mentioned. The testing described is primarily non-clinical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Information not provided: This information would be relevant for a clinical study comparing device measurements to a "ground truth" established by experts. Since no such clinical study is detailed, this is not applicable.
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Adjudication method for the test set:
- Information not provided: Not applicable as no clinical test set adjudication is described.
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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:
- Information not provided: The device is a "Physiological Measurement System" for blood pressure, FFR, and iFR, not an AI-assisted diagnostic imaging system that would typically involve human readers. Therefore, an MRMC study is not relevant to the described device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not provided: The device is a measurement system. Its performance is inherent in its readings. The document states "The CORE FM takes the software code base for blood pressure measurement (FFR and iFR) from the software currently implemented on the CORE Mobile system," implying that the performance is based on the established accuracy of this measurement. However, specific standalone performance metrics (e.g., accuracy against a gold standard in a patient cohort) are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information not provided: Not detailed. For physiological measurements like FFR/iFR, the ground truth would typically be invasive pressure measurements. However, the document does not elaborate on how this was established or used in verification specific to the new device, beyond stating software code base inheritance.
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The sample size for the training set:
- Information not provided: This would be relevant for a machine learning model, but the description points to a software update based on an existing system, not necessarily a new machine learning model requiring a defined training set.
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How the ground truth for the training set was established:
- Information not provided: See point 8.
Conclusion:
The provided document, a 510(k) summary, serves the purpose of demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include a detailed clinical performance study with the specific elements requested (acceptance criteria table, sample sizes, expert involvement, MRMC studies, ground truth methodology for clinical data) that would typically be found in a paper describing the clinical validation of a novel diagnostic or AI-powered device. The "Performance Data" section lists high-level categories of testing, largely non-clinical, leading to the conclusion of "equivalence to the predicate device."
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).