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K Number
K090277
Device Name
NATUS SLEEPWORKS, MODEL 104017
Manufacturer
EXCEL-TECH LTD. (XLTEK)
Date Cleared
2011-04-19

(804 days)

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

The Sleepworks software works in conjunction with Connex, Trex or Netlink amplifiers intended for polysomnography studies. The software allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders.

The Sleepworks allows:

  • Automated analysis of physiological signals that is intended for use only in adults. .
  • An optional Audio / visual alert for user defined threshold on calibrated DC input. . These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
  • Sleep report templates are provided which summarize recorded and scored sleep . data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

SleepWorks software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners. in research and clinical environments.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary from the FDA for the Natus SleepWorks device. It states the device's indications for use and classification but does not contain any information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot extract the requested information from this document.

To answer your request, I would need a document that includes:

  1. Details of specific performance metrics (e.g., sensitivity, specificity, accuracy for event detection)
  2. Defined acceptance criteria for those metrics.
  3. A description of the clinical or performance study conducted to evaluate the device against those criteria, including details on sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods.

§ 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).