(117 days)
Clever TD-3026 Digital Wrist Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" - 7.75".
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This document is a 510(k) clearance letter from the FDA for a medical device, the Clever TD-3026 Digital Wrist Blood Pressure Monitor. It grants permission to market the device based on its substantial equivalence to a legally marketed predicate device.
*Crucially, this document does not contain information about acceptance criteria or specific study data proving the device meets those criteria, nor does it address any AI/algorithm performance.
The letter confirms the device's classification, intended use, and regulatory compliance. It does not include details on product-specific performance studies, sample sizes, ground truth establishment, or expert involvement as would be required to answer your detailed questions. Such information would typically be found in the 510(k) submission summary or other supporting documents, which are not provided here.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter.
- Sample size used for the test set and the data provenance: This information is not present in the provided FDA letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided FDA letter.
- Adjudication method for the test set: This information is not present in the provided FDA letter.
- 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 a blood pressure monitor, not an AI-assisted diagnostic imaging tool, so an MRMC study related to human readers and AI assistance is not applicable. Moreover, this information is not present in the provided FDA letter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical medical instrument, not a standalone algorithm. Performance relates to its accuracy in measuring blood pressure against known standards. This information is not present in the provided FDA letter.
- The type of ground truth used: This information is not present in the provided FDA letter.
- The sample size for the training set: This information is not present in the provided FDA letter.
- How the ground truth for the training set was established: This information is not present in the provided FDA letter.
To obtain the information you're seeking regarding acceptance criteria and performance study details, you would need to consult the full 510(k) submission for K073445, which is typically available through the FDA's website or upon request.
§ 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).