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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.

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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.

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