(581 days)
The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software, Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.
GALIX GBI - 3S - LP Digital Holter Recorder
The provided document is a 510(k) clearance letter from the FDA to Galix Biomedical Instrumentation, Inc. for their GALIX GBI-3S-LP device. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, specific performance studies, sample sizes, or ground truth establishment for the device's analytical capabilities.
Therefore, I cannot provide the requested information as it is not present in the given text. The letter only states that the device is "substantially equivalent" to marketed predicate devices and outlines general regulatory compliance requirements. It does not include the detailed technical study information that would be necessary to answer the questions you've posed.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).