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IHealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring.

lHealth cloud is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. IHealth cloud accepts data both electronically as well as from manually input. IHealth cloud is a medical device data system that displays and analyzes data received from iHealth home monitoring devices as well as manually input data. iHealth home monitoring devices include the apps and the device, such as KD-931, KD-936, KD-972 and Scale HS3 and HS5, AG-631, AG-632, AM3, PO3 and iHealth MyVitals.

The provided text is a 510(k) summary for the iHealth Cloud, a patient vital signs monitor viewing station. This document is primarily for regulatory approval and does not contain the details of a study with acceptance criteria and device performance as requested.

The document states:

• "The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software."

This is a general statement about software validation, not a specific performance study with acceptance criteria and quantitative results. It implies that internal testing was conducted to ensure the software functions as designed, but it does not provide the detailed information requested regarding:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: Not mentioned. The device is a viewing station, not primarily an algorithm performing diagnostic tasks.
7. Type of ground truth used: Not provided.
8. Sample size for the training set: Not applicable for a viewing station device in this context.
9. How the ground truth for the training set was established: Not applicable.

Therefore,Based on the provided text, the answering cannot be completed. The document describes a "Patient Vital Signs Monitor Viewing Station" which is a medical device data system, not a device that itself generates diagnostic results or uses AI in a way that would require the typical performance studies you are asking about (like sensitivity, specificity, etc., against a ground truth). The statement about "software validation results" is a general claim of compliance, not a detailed study report.

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