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The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software.

The provided text is a 510(k) premarket notification summary from the FDA for a device called "Meditech ABPM-04 Ambulatory Blood Pressure Monitor." This document confirms the device's substantial equivalence to a legally marketed predicate device, but it does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA has determined that the Meditech ABPM-04 is as safe and effective as a similar device already on the market. However, the details of the studies conducted to demonstrate this substantial equivalence, including acceptance criteria and performance data, are typically found in a separate FDA review memo or the manufacturer's 510(k) submission, not in this clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or provide a table of performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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: This device is an ambulatory blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device measures blood pressure using an oscillometric method, which is an algorithm, but the document does not detail a standalone performance study.
7. The type of ground truth used: Not explicitly stated, though for blood pressure monitors, ground truth typically involves a reference method like invasive arterial pressure measurement or a highly accurate clinical standard.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain this information, one would need to access the full 510(k) submission (if it's publicly available) or the FDA's internal review memorandum for K051149.

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