Search Results

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.

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.

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.

Ask a specific question about this device

The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph 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 BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.

The BRM2 Brain Monitor is a two-channel EEG device, consisting of skin electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole. All components other than the skin electrodes and Sensor Lead are the same as described in 510(k) K030489 for the BRM2 Brain Monitor.

Changes to the BRM2 Brain Monitor consist of using the Neonatal Sensor Set for the EEG skin electrodes, which has two signal electrode pairs and a reference electrode all pre-wired to a single connector. The Sensor Lead has been modified to add a compatible connector for the Neonatal Sensor Set. Products used for skin preparation at the EEG electrode application sites have been made available in a convenience kit.

Here's a breakdown of the acceptance criteria and the study that indicates the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (BRM2 Brain Monitor) seeking substantial equivalence. As such, the level of detail regarding acceptance criteria, study methodologies, and exact performance metrics is often less comprehensive than what would be found in a full scientific publication or clinical trial report. The information is focused on demonstrating equivalence to predicate devices, rather than establishing de novo performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical testing of the Neonatal Sensor Set.
• Data Provenance: The document does not specify the country of origin for the clinical testing data. It mentions "Clinical testing was carried out," implying it was a prospective study, but doesn't explicitly state "retrospective" or "prospective."

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

• This information is not provided in the document. The clinical test was to demonstrate the effective duration of use for the Neonatal Sensor Set, implying observation of electrode function and patency rather than a diagnostic accuracy study requiring expert adjudication of ground truth for EEG interpretation.

4. Adjudication Method for the Test Set

• This information is not provided as the nature of the clinical test described (electrode duration of use) does not typically involve an adjudication method in the way a diagnostic accuracy study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and clinical testing focused on the device's technical performance and electrode efficacy, not a comparison of human reader performance with and without AI assistance. The device itself is an electroencephalograph, a signal acquisition device, not an AI-powered diagnostic interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Not applicable / No. This device is an electroencephalograph, which is a hardware device for measuring and recording brain activity. It does not contain an AI algorithm for standalone performance evaluation that would be distinct from human interpretation. The "performance" being evaluated relates to the quality of the signal acquisition and the durability of the electrodes.

7. The Type of Ground Truth Used

• For the electrical safety, biocompatibility, and shelf-life testing, the "ground truth" is adherence to established international and national standards (e.g., IEC 60601-1, UL 2601-1, AAMI EC12).
• For the clinical testing of the Neonatal Sensor Set's effective duration of use, the "ground truth" would likely be direct observation of electrode integrity, signal quality over time, and possibly absence of adverse skin reactions (though not explicitly detailed beyond "acceptable performance"). It relies on objective measurements and clinical assessment, not expert consensus on diagnostic interpretation.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware system for signal acquisition. It does not use a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and regulatory standards.

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

• Not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Brainz Instruments Ltd BRM2 Brain Monitor is an Electroencephalograph 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 BRM2 Brain Monitor is intended to monitor the state of the brain by acquisition of electroencephalogram (EEG) signals, in the intensive care unit, operating room, and for clinical research.

The BRM2 Brain Monitor is a two-channel BBG device, consisting of Skin Electrodes, Sensor Lead, Acquisition Unit, Isolation Unit, Serial and Power Cables, Monitor, and Roll-Pole. The Acquisition Unit is an EBG head stage, providing filtering, amplification and digitization of EEG signals. The Acquisition and Lolation Units provide electrical isolation of the equipment from the patient and protection of the equipment from defibrillator discharges. The Monitor provides processing, display and storage of EEG signals. User operation of the BRM2 Brain Monitor is via the Monitor graphical user interface (GUI) and touch-sensitive screen. The main display formats are Spectral Edge, Integrated Amplitude, and EEG Wavoform. Various time and amplitude display scale options, timeaveraged display traces and numeric values, and event marking features are available. EEG signal processing includes data checking for environment, and electrode contact quality problems, with continuous signal quality monitoring for the user. Data file transfer to removable media, and printing of summary report data features are included. A telescoping-pole mounting system supports the Monitor, providing tilt- and heightadjustment options. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with casters that include foot-operated brake levers.

The provided text is a 510(k) summary for the BRM2 Brain Monitor. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it explicitly states that "No clinical testing was necessary to demonstrate substantial equivalence for this product." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

As a result, I cannot provide the requested information regarding acceptance criteria and performance data, sample sizes, ground truth establishment, or clinical study specifics (MRMC, standalone performance, etc.) because these details are not present in the provided document.

The document focuses on non-clinical testing for safety and performance against international standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1, IEC 60601-2-26).

Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance:

Note: The document states "The BRM2 Brain Monitor meets the requirements..." for the listed standards, implying successful performance against these criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical test set was used. Non-clinical testing typically involves a single device or a small number of devices for validation. The country of origin of testing data is not specified, but the applicant is from New Zealand.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set was used to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used.

5. 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 applicable. The device is an electroencephalograph, not an AI-assisted diagnostic tool, and no clinical comparative effectiveness study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an EEG monitor, not an algorithm being tested for standalone performance in a clinical context. Its performance was assessed through non-clinical engineering and safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the specifications and requirements defined by the various international and national safety and performance standards (IEC, UL).

8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device undergoing a training phase with a dataset.

9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.

Ask a specific question about this device