(245 days)
The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in:
- the replay, analysis, display, editing and report generation of ambulatory ECG data
- . the assessment of cardiac disturbance and myocardial ischemia
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "GALIX WinTer ECG Holter Analyzer." It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or specific study details such as sample sizes, expert qualifications, or ground truth establishment.
The document states the intended use of the device: "the replay, analysis, display, editing and report generation of ambulatory ECG data" and "the assessment of cardiac disturbance and myocardial ischemia." However, it does not specify performance metrics or the studies conducted to demonstrate these.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the information given. This type of information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).