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K Number
K982053
Device Name
EEG ELECTRODES MODEL 445 SERIES
Manufacturer
CLASS A ENT.
Date Cleared
1999-04-20

(313 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

EEG Electrodes Model "445 Series" will be used to record the surface EEG potentials of the brain.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for EEG Electrodes Model "445 Series". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document typically does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, and while they include performance data, the public letter does not detail the specific acceptance criteria, study methodologies, or outcomes in the granular way you've asked for.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This is not present.
  2. Sample sizes used for the test set and data provenance: This is not present.
  3. Number of experts used to establish ground truth and their qualifications: This is not present.
  4. Adjudication method: This is not present.
  5. MRMC comparative effectiveness study details (effect size): This is not present.
  6. Standalone performance study details: This is not present.
  7. Type of ground truth used: This is not present.
  8. Training set sample size: This is not present.
  9. How ground truth for the training set was established: This is not present.

The document only states the device name ("EEG Electrodes Model "445 Series"") and its intended use ("to record the surface EEG potentials of the brain"). It also confirms the regulatory class (II) and product code (GXY).

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).