(30 days)
eVISION® Data Management Software (eVISION) is an optional accessory for use with Nonin's Model 7600 Regional Oximeter System. It is intended for use by healthcare professionals when 1) transferring data from the Model 7600 to a computer in order to maintain individual records of regional oximetry data, 2) reviewing data according to userselected parameters, and 3) generating reports.
eVISION® Data Management Software (eVISION) is an optional accessory for use with the Model 7600 Regional Oximeter System to display and summarize downloaded patient regional oxygen saturation (rSO2) data on a personal computer. Data can be displayed as data graphs and/or statistics for review and interpretation by a clinician. Data is obtained from the Model 7600 via Bluetooth® connection provided by the host computer on which eVISION is installed. The software also allows regional oximetry data and patient information to be saved in a "library" for future retrieval and analysis. The clinicain using eVISION software is solely responsible for selecting the analysis criteria used to calculate summary statistics included in the reports. eVISION® software is an adjunct system requiring clinician interpretation of results; it does not suggest a course of treatment or generate a diagnosis.
The provided text does not contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications for the eVision Data Management Software. The document is primarily a 510(k) summary for a software device, focusing on its substantial equivalence to a predicate device and its intended use.
The relevant sections state:
- "Functional and Safety Testing: The Risk Management process is used to assess the safety of the device; no new risks were identified with the modification to the eVISION Data Management Software. Software Verification and Validation was completed to verify the performance, functionality, and features of eVISION."
This statement indicates that software verification and validation were performed to confirm performance and functionality, but it does not specify the acceptance criteria used or the results against those criteria. It also doesn't describe a study in the sense of clinical performance or diagnostic accuracy.
Therefore, the requested information cannot be extracted from the given text.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).