Search Results

Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.

Three Meditec models are oscillometric systems intended for measurement of blood pressure and heart rate in a home care environment. Three models has a built-in pump for automatic inflation. Three Models include a constant air regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure and heart rate, and a memory function. Three models utilize a pressure measurement algorithm designed to detect, process, and store pressure readings. The pressure measurement range is 20 to 285 mmHg maintained within limits of 2 of 3 mmHg/sec to optimize measurement accuracy. Three models are powered by four AA-size batteries and are equipped with a circuit that will automatically cut off power after about 3 minutes of non-use to conserve battery charge.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document states "clinical studies" were conducted but does not specify the sample size of subjects used for the test set.
   • The document does not specify the country of origin of the data.
   • The document does not specify if the study was retrospective or prospective. However, typically, clinical validation studies for medical devices are prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide this information. The study was a clinical validation against a standard, not necessarily involving expert interpretation of data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not provide this information.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The device is a "Fuzzy Automatic Blood Pressure Monitor" and the studies focused on its standalone accuracy against a standard, not on human-AI interaction or improvement.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation was done. The studies assessed the "measurement performance of the Meditec systems" (the devices themselves) against the ANSI/AAMI Standard SP10-1992, which is a standard for automated blood pressure devices. This inherently evaluates the algorithm's performance without human intervention in the measurement process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for blood pressure measurement accuracy was established by compliance with the ANSI/AAMI Standard SP10-1992. This standard defines reference methods for blood pressure measurement (e.g., auscultatory method with trained observers) against which automated devices are compared. The document does not go into the specifics of how the "true" blood pressure was determined during the clinical studies, but it would align with the established reference methods of SP10.

7. The sample size for the training set:

   • The document does not specify a training set size. This device is a blood pressure monitor, and while it uses a "Fuzzy" algorithm, the primary validation is against established measurement standards, not necessarily through traditional machine learning training/testing paradigms with labeled patient data in the way an AI diagnostic tool would. It's more about hardware and algorithm calibration.

8. How the ground truth for the training set was established:

   • Given the nature of the device and the standards it follows, the concept of a "training set" ground truth in the typical machine learning sense is not explicitly presented or relevant here. The device's "fuzzy" algorithm would likely have been developed and calibrated internally using a variety of blood pressure patterns, but the document does not detail this process or how the ground truth for such internal development was established. The focus of the regulatory submission is on the validation against a known standard.

Ask a specific question about this device