(30 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel and measurements will be announced in English (optional). The intended use of this over-the counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor HL168ET
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to answer the questions about acceptance criteria, study design, and ground truth establishment.
Specifically, the document only confirms that the device, "HL168ET Full Automatic (NIBP) Blood Pressure Monitor," is substantially equivalent to legally marketed predicate devices. It states its indications for use (measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method for age 16 and above) but does not provide any performance data or details of a study.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is a blood pressure monitor, not an AI software for medical image analysis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and generally not applicable to a standalone blood pressure monitor.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned. For a blood pressure monitor, ground truth would typically come from an established reference method (e.g., auscultation with a sphygmomanometer following specific protocols).
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
To obtain this information, one would need to refer to the actual 510(k) submission document (K043437) itself, which would include the performance testing data and 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).