(89 days)
The BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.
This two-channel digital Biofeedback/EEG device uses industry-accepted standard Windows - based PC as control and display console. The device consists of the following:
- a) BrainMaster™ 2E Hardware Module
- BrainMaster™ BMT (basic educational/research SW) b)
- BrainMaster™ PT (clinical SW) c)
The System uses commercially available standard EEG electrodes and pastes such as 9 mm gold disks with 10 - 20 paste.
This 510(k) summary for the BrainMaster™ 2E device indicates that clinical studies were not performed to establish substantial equivalence. Instead, the submission relies on non-clinical tests (electrical, mechanical, and environmental) and comparison to predicate devices, asserting that differences do not affect functionality or safety/effectiveness.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable based on the provided document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with corresponding device performance metrics in relation to clinical efficacy for relaxation training. Instead, the acceptance criteria are implicitly tied to meeting regulatory standards for electrical, mechanical, and environmental safety, as demonstrated by non-clinical testing, and maintaining substantial equivalence to predicate devices in terms of technical specifications.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (electrical isolation) and FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. | "BrainMaster™ 2E tested product met all relevant requirements of the aforementioned test." "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards." |
| Mechanical Performance | Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards." (Implied to cover mechanical aspects alongside electrical) |
| Environmental Performance | Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards." (Implied to cover environmental aspects) |
| **Electromagnetic | ||
| Compatibility** | Compliance with DCRND Reviewer's Guideline, November 1993 for Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing. | "All testing met required parameters." |
| Functional Equivalence | Substantial equivalence in intended use, method of operation, material, and design to predicate devices (Lexicor NRS-2D / Stoelting AT 62 EEG). | "The BrainMaster™ 2E device is substantially equivalent in intended use, design, material and technology as the Lexicor NRS-2D/Stoelting AT 62 EEG devices. All devices use EEG Signals, measure EEG and process it to produce frequency band energy. Differences do not affect functionality of the device..." |
2. Sample size used for the test set and the data provenance
Clinical tests were "Not Applicable." Therefore, there was no test set of patient data used to directly evaluate the device's performance in achieving relaxation via alpha EEG biofeedback. The testing focused on device safety and technical specifications, not clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set was used and no clinical ground truth was established for the device's primary intended use. The "ground truth" implicitly referred to here is compliance with technical standards as assessed by a contract testing laboratory.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring expert adjudication 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. This device is an EEG biofeedback system, not an AI-assisted diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's technical specifications and electrical/mechanical performance. The device's performance in these non-clinical aspects was tested in a standalone manner by a contract laboratory. The "performance" in this context refers to its ability to meet electrical isolation, EMI/EMC, and basic functional specifications, which it reportedly did.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was compliance with established industry standards (e.g., IEC 60601-1) and FDA guidance documents for medical device safety and performance. This is a technical standard ground truth, not a clinical one based on patient data or expert consensus on clinical outcomes.
8. The sample size for the training set
Not applicable. The device relies on fundamental EEG principles and digital signal processing, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for a machine learning model.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.