(77 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 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:
| Acceptance Criteria (from non-clinical testing) | Reported Device Performance (from non-clinical testing) |
|---|---|
| Meets requirements of IEC 60601-1 General Safety | Device meets these requirements |
| Meets requirements of IEC 60601-1-2 EMC International Standards | Device meets these requirements |
| Meets relevant USA deviations of UL 2601-1 Standard for General Safety | Device meets these requirements |
| Meets particular requirements of IEC 60601-2-26 Standard for Electroencephalographs | Device meets these requirements |
| Mechanical Safety | Carried out |
| Electrical Safety | Carried out |
| Thermal Safety | Carried out |
| Environmental Conditions | Carried out |
| Electromagnetic Compatibility | Carried out |
| Functional Verification | Carried out |
| Performance | Carried out |
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.
§ 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).