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ANSHA (QHRV1) is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rase by electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.

ANSHA -QHRV1 has the same intended use as the legally marketed predicate device systems. The ANSHA -QHRV1 is intended for non-invasive measurement of pulse waveform by photoelectric plethysmography and heart rate by electrocardiograph. The device is for use in outpatient departments of hospitals, healthcare clinics and physician practices.

The provided text is a 510(k) summary and an FDA clearance letter for a medical device called "ANSHA - QHRV1". It describes the device's intended use and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, specific performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

The document states: "The functions are substantially equivalent to the predicate. In addition the device has undergone performance testing and meets the same safety and performance standards as the predicate." However, it does not elaborate on what these performance standards are, what the test results were, or how the testing was conducted.

Therefore, I cannot provide the requested table and study details as the information is not present in the provided text.

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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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