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K Number
K021986
Device Name
BRAINET
Manufacturer
NICOLET BIOMEDICAL, INC.
Date Cleared
2002-08-23

(66 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
K780045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

Device Description

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Nicolet BraiNet device. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be extracted from the provided text:

  • A table of acceptance criteria and the reported device performance: This information is not present. The document concludes that the "intended use and technology...is substantially equivalent to the predicate device" and that "No new questions of safety or effectiveness are raised," but it does not provide specific performance metrics or acceptance criteria.
  • Sample size used for the test set and the data provenance: Not mentioned.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  • Adjudication method for the test set: Not mentioned.
  • If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This type of study is typically for evaluating AI-assisted diagnostic tools, which the BraiNet (an electrode cap) is not.
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Similarly, this is not relevant for the type of device.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
  • The sample size for the training set: Not mentioned.
  • How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on:

  • Description of the Device: BraiNet, an electrode cap for EEG electrode placement.
  • Intended Use: Supports EEG electrode placement.
  • Technological Characteristics: Made from elastic and Velcro commercial garment grade materials.
  • Predicate Device: Electro-Cap (K780045).
  • Conclusion: Substantial equivalence to the predicate device.

§ 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).