(23 days)
The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems' ECLIPSE Version 3.0 software for MS-DOS®.
J.una™ can be used only in conjunction with Stellate Systems' HARMONIE™ software package.
Luna™ may be used for sleep recordings (polysomnography) in research or clinical cuvironments for:
- · Digital rooording of high-level output signals (such as EBO, respiratory and oximety signals) from the Digital recording of might-level cations (society costs of amplifiers, by means of a personal computer (PC) and PC-based data acquisition board.
- · Selection of recorded signal sections for on-sereen review, annotation and marking of sleep stages.
- · Manual event-marking and annotation of polygraphic signal sections.
- · Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximelry signals.
- · Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency, and simple statistical measures of marked events.)
The software is not intended to replace conventional devices or methods used for sloup monitoring in critical care or intra-operative scilings.
The software requires competent user input, and its output must be reviewed and interpreted by trained The sollware requires or neurologists who will excruise professional judgment in using this information.
The software does not make any judgment of normality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.
Prescription Use
(Per 21 CFR 801.109)
Not Found
I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Luna." This document primarily focuses on the regulatory clearance process and does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details on how ground truth was established for test sets.
- Information on the number or qualifications of experts, or adjudication methods for test sets.
- Details about multi-reader multi-case (MRMC) studies or standalone performance studies.
- Sample sizes for training sets or how ground truth was established for training sets.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. However, it does not provide the underlying study data that would demonstrate specific performance metrics against defined acceptance criteria.
The "Indications For Use" section describes what the software can be used for (e.g., digital recording, selection of signal sections, manual and computer-assisted event marking and analysis), but not specific performance metrics or studies.
§ 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).