(108 days)
The Vitascore software is a computer program, intended to be used as an aid for the diagnosis of sleep and respiratory disorders.
The Vitascore software is intended to be used for analysis (semi-automatic and manual rescoring), display (similar to the use of a traditional paper based polygraph), redisplay (retrieve), summarize, to generate User defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders.
Vitascore is to be used under supervision of a physician.
Vitascore is a software program to
- score respiratory events
- score sleep stages and arousal
- indicate markers as for lights off/on
- produce customizable statistical reports.
Vitascore acts on
- long-term recordings that include all physiological signals that are required for clinical PolySomnoGraphy according to established standards for subsequent
- diagnosis of sleep- and sleep-related disorders.
Vitascore includes
- a workflow concept to handle the processing of sleep recordings
- optionally: automatic pre-scoring of respiratory events and sleep and arousal and EEG frequency analysis. This pre-analysis yields particular summary trend curves that facilitate the manual re-scoring.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a specific study. The document is a 510(k) summary for a software called Vitascore, which describes its intended use, classification, and substantial equivalence to a predicate device. It also includes the FDA's clearance letter. There is no information detailing a performance study with the metrics you requested.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).