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K Number
K100126
Device Name
STELLATE GRIDVIEW
Manufacturer
EXCEL-TECH LTD. (XLTEK)
Date Cleared
2010-12-03

(318 days)

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

The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.

Device Description

The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.

AI/ML Overview

I'm sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "Stellate Gridview" (later referred to as "GridView Software") and it primarily focuses on the substantial equivalence determination.

Specifically, the text doesn't include:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes for test sets, data provenance, or training sets.
  • Information about the number or qualifications of experts, or how ground truth was established for either test or training sets.
  • Adjudication methods.
  • Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or details about standalone algorithm performance studies.
  • The type of ground truth used (e.g., pathology, outcomes data).

The document states the indications for use of the GridView software, which is "for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed." However, it does not provide study details demonstrating how well the device performs these functions against specific 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).