(406 days)
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system has been tested to a variety of performance standards. The PhysioGlove ES Model I consists of an electronics data acquisition unit and software that runs on a medical grade PC. The PhysioGlove ES Model I uses a standard, FDA-cleared, 10-electrode ECG cable to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG. The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage. Users may also vary ECG acquisition parameters.
There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) summary and an FDA clearance letter for the PHYSIOGLOVE ES MODEL I. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
The information provided only describes the device, its intended use, and states that "The system has been tested to a variety of performance standards." However, it does not detail what those standards are, the results of the tests, or any specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or other study-related details based on the given text.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).