(43 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.
The intended for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
The provided document is a 510(k) cleared letter for a Non-invasive Blood Pressure Measurement System (HL168W Touch Screen). This type of document typically focuses on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, or ground truth establishment as would be found in a clinical study report or a more comprehensive technical document.
Therefore, many of the requested details cannot be extracted from this letter.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantified acceptance criteria or reported device performance metrics in a table format. The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against specific, pre-defined acceptance criteria within the clearance letter itself.
2. Sample sized used for the test set and the data provenance:
Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in this document.
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:
Not applicable. This is a non-invasive blood pressure monitor, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone device intended for direct human use. The performance is the device's measurement.
7. The type of ground truth used:
Not explicitly stated in this document. For a non-invasive blood pressure monitor, the "ground truth" would typically involve comparison to an invasive blood pressure measurement or another validated reference method, but the details are not provided here.
8. The sample size for the training set:
Not applicable or not specified. This is a conventional medical device, not an AI/ML algorithm that undergoes a "training" process in the same sense.
9. How the ground truth for the training set was established:
Not applicable or not specified.
§ 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).