(14 days)
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
| Acceptance Criteria Category | Specific Criteria / Standards Met | Reported Device Performance/Conclusion |
|---|---|---|
| Electrical Safety | IEC 60601-1 (general safety international standard) | Device (BRM2 Brain Monitor and Neonatal Sensor Set) meets the requirements. |
| UL 2601-1 (relevant USA deviations for general safety) | Device meets the requirements. | |
| IEC 60601-2-26 (particular requirements for electroencephalographs) | Device meets the requirements. | |
| Biocompatibility | (Not explicitly named, but implied for device components) | Non-clinical testing to cover biocompatibility was carried out. (Conclusion: meets design and performance requirements) |
| Product Shelf Life | (Not explicitly named) | Non-clinical testing to cover product shelf life was carried out. (Conclusion: meets design and performance requirements) |
| Electrode Performance | AAMI EC12 (standard for disposable ECG electrodes) | Neonatal Sensor Set meets the requirements. |
| FDA / IEC requirements for safety of electrode lead wires | Neonatal Sensor Set meets the requirements. | |
| Clinical Effectiveness | Acceptable performance of electrodes in general use and over the 24-hour maximum recommended usage period for the Neonatal Sensor Set. | "Clinical testing was carried out to demonstrate the effective duration of use for the Neonatal Sensor Set. This established acceptable performance in general use of the electrodes and in particular over the 24-hour maximum recommended usage period." |
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.
§ 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).