(76 days)
HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems' RHYTHM and MONITOR software. The software remains consistent with its original design objectives:
- to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology.
- to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards.
- to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities.
- to complement the conventional continuous EEG recording, not replace it.
The software does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative cettings. In no way is the software or its function represented as being in and of itself divenestic
HARMONIE and Sensa EEG Software
The provided text is an FDA 510(k) clearance letter for the "Harmonie and Sensa EEG Software." It details the device's classification, regulation, and general controls, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the device's performance was not evaluated against specific acceptance criteria in a standalone study, but rather its equivalence to existing predicate devices was established.
Therefore, I cannot provide the requested information based solely on the text provided. The document focuses on regulatory clearance based on substantial equivalence, not on the results of a detailed performance study with acceptance criteria.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).