(422 days)
The EngagementHealth Kiosk is intended to be used by the general public as a non-invasive multi-functional unit which measures a person's weight, blood pressure and heart rate. The kiosk is not intended to be a diagnostic device and does not perform any diagnoses. Rather, the kiosk provides the user with weight and systolic/diastolic blood pressure to be used as supplemental data when consulting a professional physician. The EngagementHealth Kiosk is intended to be fully unattended and placed within public or corporate environments. The user can choose to send the data to the EngagementHealth web portal for later data visualization.
The EngagementHealth Kiosk is a device which provides a method for identifying a person's systolic and diastolic blood pressure, pulse rate, weight and displays the results onto the touch screen LCD computer screen. The individual using the device is seated during the entire operation of the device for accurate blood pressure readings.
The provided text describes the 510(k) premarket notification for the EngagementHealth Kiosk, which is a non-invasive multi-functional unit intended to measure a person's weight, blood pressure, and heart rate. It explicitly states that clinical testing was not required and that non-clinical tests found the device in compliance with recognized safety standards. The device's software was validated according to FDA guidance.
Therefore, the study that would typically prove a device meets acceptance criteria was not conducted for this specific submission to the extent of a clinical trial with human subjects for efficacy. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, and compliance with recognized safety standards through non-clinical testing and software validation.
Given the information provided:
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A table of acceptance criteria and the reported device performance
- No specific acceptance criteria (e.g., accuracy percentages for blood pressure readings against a gold standard) are provided in the document.
- No reported device performance metrics against such criteria are presented because clinical testing for efficacy was not performed. The document states "The EngagementHealth Kiosk has been tested and found to be in compliance with recognized safety standards." This refers to non-clinical safety, not performance against clinical accuracy benchmarks.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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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 device is a measurement kiosk, not an AI-powered diagnostic aide for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a standalone system for measurement. However, performance was established through non-clinical safety standards compliance and software validation, not through clinical accuracy trials.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For proving compliance, the ground truth was "recognized safety standards" and FDA guidance for software validation. There is no mention of clinical ground truth (e.g., invasive blood pressure measurements for comparison).
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The sample size for the training set
- Not applicable. As a measurement device validated through compliance with safety standards and software validation, there is no "training set" in the context of a machine learning algorithm.
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How the ground truth for the training set was established
- Not applicable.
In summary, the 510(k) submission for the EngagementHealth Kiosk relies on substantial equivalence to predicate devices and adherence to non-clinical safety and software validation standards, rather than clinical performance data from a specific study involving human subjects and their measurements against a "gold standard."
§ 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).