(156 days)
The Electronic Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32 cm.
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The provided text is an FDA 510(k) clearance letter for an Electronic Blood Pressure Monitor. It confirms the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document does not include any performance data, clinical trial results, or technical specifications that would outline acceptance criteria or how the device's performance was validated.
Therefore, I cannot extract the information requested for the following points:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The provided text only states that the device is an "Electronic Blood Pressure Monitor" intended for "non-invasive blood measurement of arterial blood pressure values in adults" and that it measures "diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the upper arm." The cuff circumference is limited to 22-32 cm.
To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification submitted with the 510(k) application, which typically contains the performance data and validation methodology.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).