(146 days)
The S Health is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-on devices for effective health management. The user also can share the data via sharing functions (Email and SMS).
The S Health is application software for mobile device. This mobile application helps users to care their personal health better by recording and displaying information such as comfort level(temperature and humidity), step count (pedometer), how much user exercises (calories burnt), the food user may consume (calories intake), weight, blood glucose level, and blood pressure in an effective and user friendly interface.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "S Health" device:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the "S Health" device does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes two types of performance evaluations:
- Data Accuracy Transmission: This involved testing the accuracy of data transmission for each meter (blood pressure, blood glucose, weight) and memory data rollover.
- Lay User Performance/Satisfaction: This assessed how easy the S Health application was to use for lay users and their overall satisfaction.
Based on the text, here's a representation of the acceptance criteria (inferred from the study results) and the reported device performance.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accurate transmission of measurement values, data, and time | "Test results show that all the measurement values, data, and time properly downloaded from the meters to the software." |
| Proper functioning of memory data rollover | "Memory data rollover also functioned properly where the new measurement values replaced the oldest glucose values." |
| High level of ease of use for lay users | "Overall, they rated the S Health at 100% for overall program as easy or somewhat easy. There were no users that rated the software program as somewhat difficult or difficult." |
| High level of satisfaction among lay users with the S Health and its manual | "100% of them also responded that they are satisfied with the S Health and its manual." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of lay users who participated in the human factors/usability study. It only states "a study intended to assess lay users' performance."
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be prospective, as it involved conducting a study to assess user performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the "lay user performance" study. The ground truth for this study appears to be the users' self-reported ease of use and satisfaction.
- For the data transmission accuracy tests, the "ground truth" would implicitly be the readings on the meters themselves, verified against the data received by the software. No specific number of experts or their qualifications are mentioned for this bench testing.
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Adjudication method for the test set:
- Not applicable for the described tests. The data transmission accuracy was a direct comparison, and the user performance was based on self-reported ratings.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The S Health is a data management application and not an AI-powered diagnostic tool requiring such a study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "bench testing to demonstrate data accuracy transmission for each meter" could be considered a standalone performance evaluation of the application's ability to receive and display data correctly, without human interpretation of the data itself. However, the application's intended use is to help users review and monitor vital signs, implying a human-in-the-loop for the monitoring aspect.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For data accuracy transmission: The ground truth was the direct measurements from the connected medical devices (blood pressure monitor, blood glucose meter, weight scale).
- For lay user performance: The ground truth was the users' self-reported ratings of ease of use and satisfaction.
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The sample size for the training set:
- The document does not describe any machine learning or AI components that would require a separate training set. The S Health is described as a "mobile application" that records and displays information.
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How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is mentioned.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).