(34 days)
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").
Not Found
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to fulfill the request regarding acceptance criteria and study descriptions.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on the regulatory clearance for the device, stating its indications for use and confirming its substantial equivalence to a predicate device. It briefly mentions that the device "Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method," but it does not provide performance metrics, study details, or acceptance criteria.
§ 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).