LogoFDA 510(k) Search
K Number
K071449
Device Name
BRM3 BRAIN MONITOR
Manufacturer
BRAINZ INSTRUMENTS LTD.
Date Cleared
2007-09-14

(113 days)

Product Code
OMA,OLT,OMC
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
K030489,K033010,K983229
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Brainz Instruments Ltd BRM3 Brain Monitor is an electroencephalograph or EEG system, as per 21 CFR §882.1400: 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.

  • The BRM3 Brain Monitor is intended for use to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in clinical environments such as the intensive care unit, and for clinical research.
  • The BRM3 Brain Monitor is intended for use only with neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 24 to 46 weeks.
  • The BRM3 Brain Monitor does not provide any diagnostic conclusion about the patient's condition.
Device Description

The BRM3 Brain Monitor is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient's brain by placing two or more electrodes on the head.

The BRM3 Brain Monitor system consists of a Neonatal Sensor Set (EEG skin electrodes) or Sensor Adaptor Set (electrode adaptor), Data Acquisition Unit (EEG head stage), Data Cable, Monitor, Power Supply Unit, and Roll-Pole. These components have equivalent configuration and functions to those described in 510(k) K030489 and K033010 for the BRM2 Brain Monitor.

Changes to the BRM3 Brain Monitor consist of a new touch-screen panel PC (Monitor), new EEG head stage (Data Acquisition Unit) and new mobile mounting hardware (Roll-Pole). New software features include display of a further EEG channel, display of an aEEG parameter, and improved signal quality indication and file reviewing capacity. User instructions have been updated accordingly.

AI/ML Overview

The provided text is a 510(k) summary for the BRM3 Brain Monitor, and it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in terms of analytical performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristic summaries, non-clinical testing, and a declaration that clinical testing was not required for the modifications.

Here's an analysis based on the document, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission does not specify quantitative acceptance criteria for device performance (e.g., signal-to-noise ratio limits, frequency response ranges, accuracy of aEEG parameter against a gold standard) for the BRM3, nor does it report specific performance values against such criteria.

Instead, the document states:

  • "Non-clinical testing of the BRM3 Brain Monitor has been carried out to cover the changes to the system. These include performance testing of the new EEG head stage electronics module, full software verification procedures for updated device functionality, comparative results of the aEEG parameter implementation, and third-party testing of the entire system for compliance to IEC 60601 standards for electromagnetic compatibility, electrical safety, particular requirements for electroencephalographs, and US national requirements."
  • "This established correct functionality of the BRM3 Brain Monitor system according to requirements, and is equivalent to the predicate devices."
  • "The testing carried out for the BRM3 Brain Monitor indicates that it meets design and performance functional requirements."
  • "The software verification demonstrates that the modified device features are effective, and the hardware / electronics configuration functions equivalently to the predicate devices."

This indicates that the "acceptance criteria" were primarily related to meeting functional requirements, regulatory standards (IEC 60601), and demonstrating equivalence to predicate devices, rather than specific performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided in the context of typical clinical performance studies. The "test set" in this case refers to hardware components and software functionalities during non-clinical testing. The document does not describe a clinical test set of patient data, nor its provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. The document details non-clinical testing focused on hardware, software, and regulatory compliance, not on evaluating diagnostic accuracy against expert-established ground truth from medical images or signals.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. The testing described here is non-clinical.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described. The device is an electroencephalograph, not an AI-assisted diagnostic tool that would typically involve human reader performance comparison with and without AI assistance. The submission explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the modifications involved in the BRM3 Brain Monitor."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm is not described. The BRM3 Brain Monitor is described as an EEG system that acquires and displays signals, with an aEEG parameter implementation. While the "aEEG parameter implementation" was subject to "comparative results" during non-clinical testing, the details of this comparison (e.g., against a known gold standard or simulated data) are not provided, nor is it presented as an "algorithm only" performance study in the typical sense of AI.

7. Type of Ground Truth Used

For the described non-clinical testing, the "ground truth" would likely be engineering specifications, regulatory standards (e.g., IEC 60601), and the performance characteristics of the predicate devices. The document states that "technical equivalence has been established to ensure accuracy of the aEEG parameter implementation" and "the hardware / electronics configuration functions equivalently to the predicate devices." Implied ground truth for the aEEG parameter would be its accurate calculation according to established methods, possibly verified against simulated signals or the known performance of the predicate device's aEEG.

8. Sample Size for the Training Set

This information is not applicable/not provided. The BRM3 Brain Monitor is a medical device, not an AI algorithm that undergoes machine learning training on a "training set" of data in the common sense. The "software verification procedures" mentioned would involve testing the implemented code, not training a model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

Summary of the Study (as described in the document):

The "study" to prove the BRM3 Brain Monitor meets acceptance criteria was primarily a non-clinical engineering and regulatory compliance assessment.

  • Objective: To demonstrate substantial equivalence of the BRM3 Brain Monitor to predicate devices (K030489, K033010, K983229) after modifications to the touch-screen panel PC, EEG head stage, mobile mounting hardware, and software (new EEG channel display, aEEG parameter display, improved signal quality indication, file reviewing).
  • Methods:
    • Performance testing of the new EEG head stage electronics module.
    • Full software verification procedures for updated device functionality.
    • Comparative results of the aEEG parameter implementation (details of this comparison are not provided, but it likely involved comparison against established methods or predicate device output).
    • Third-party testing for compliance to IEC 60601 standards (electromagnetic compatibility, electrical safety, particular requirements for electroencephalographs) and US national requirements.
  • Results/Conclusion:
    • "Established correct functionality of the BRM3 Brain Monitor system according to requirements, and is equivalent to the predicate devices."
    • "Testing carried out... indicates that it meets design and performance functional requirements."
    • "Software verification demonstrates that the modified device features are effective, and the hardware / electronics configuration functions equivalently to the predicate devices."
    • "Clinical testing was not required."

Essentially, the device approval was based on demonstrating that the changes made did not negatively impact the device's fundamental function, safety, and effectiveness, and that it continued to perform equivalently to previously cleared devices while complying with relevant safety standards.

§ 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).