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The QHRV 1 -- Health Assessment System is intended for (HRV) I leart Rate Variability Measurements in response to a series of paced respiration, standardized and controlled exercises. These measurements and analysis are not intended as clinical diagnosis but only to substantiate appropriate patient health assessment procedures.

QHRV 1 - Health Assessment System

{"1. A table of acceptance criteria and the reported device performance": "The provided text doesn't contain a table of acceptance criteria and reported device performance. It mainly focuses on the 510(k) summary and the FDA's substantial equivalence determination for the QHRV 1 - Health Assessment System.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This information is not provided in the given text.",
"3. 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)": "This information is not provided in the given text.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This information is not provided in the given text.",
"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": "This information is not provided in the given text.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This information is not provided in the given text. The device is described as an "HRV Analysis System" and its intended use is for "Heart Rate Variability Measurements," suggesting it's a measurement and analysis tool, but not explicitly stating if its performance was evaluated standalone against a ground truth.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "This information is not provided in the given text.",
"8. The sample size for the training set": "This information is not provided in the given text.",
"9. How the ground truth for the training set was established": "This information is not provided in the given text."}

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