LogoFDA 510(k) Search
K Number
K963631
Device Name
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
Manufacturer
OMEGA RESULTS
Date Cleared
1997-04-02

(203 days)

Product Code
OLZ
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is indicated for use under the supervision of a Physician. This product is indicated for use in the computer aided scoring of sleep study recordings.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) FDA clearance letter for a medical device called "Sleep Study Analysis (SSA) Version 96.10". This document indicates that the device has been found substantially equivalent to a predicate device, meaning it doesn't require a full PMA (Premarket Approval) application. However, it does not contain a detailed study description with acceptance criteria, reported performance, sample sizes, or ground truth establishment methods for the device itself.

The document mainly focuses on the regulatory aspects of the clearance, such as:

  • Trade/Device Name: Sleep Study Analysis (SSA) Version 96.10
  • Regulation Number/Name: 21 CFR 882.1400 / Electroencephalograph
  • Regulatory Class: II
  • Product Code: OLZ
  • Intended Use: Computer-aided scoring of sleep study recordings for the adult population with suspected sleep disorders, assisting a trained clinician in reviewing polysomnographic recordings to identify sleep stage events. It explicitly states it is "in no way intended to replace a human clinician."
  • Physiological Parameters: Electroencephalogram, Electromyogram, Electrocardiogram, Respiratory Effort, Respiratory Air Flow, Pulse Oximetry.
  • Environment of Use: Hospital sleep laboratory or free-standing sleep laboratory.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because that data is not present in the provided text.

The document is a clearance letter, not a study report. To obtain the specific study details, one would typically need to refer to the 510(k) submission document itself, which would contain the technical data and performance 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).