(64 days)
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.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).