(314 days)
The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.
The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.
The provided text describes a 510(k) premarket notification for BrainScope's ZOOM-100DC, an Electroencephalograph (EEG). The document focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes. Therefore, much of the requested information regarding study design, sample sizes, expert adjudication, and ground truth establishment is not present in the provided text.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance targets for diagnostic accuracy or clinical utility. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and intended use. The "performance" assessment is based on this comparison.
| Characteristic | Predicate Devices (e.g., Nicólet Bravo, Crystal-EEG, BRM3, I-2000) (Range/Example) | ZOOM-100DC | Assessment/Comparison |
|---|---|---|---|
| Intended Use | Measure and record electrical activity of patient's brain, monitor state by acquisition/display of EEG signals and calculation of qEEG parameters (specifics vary slightly by predicate, e.g., BRM3 for neonates) | Measure and record electrical activity of patient's brain, monitor state by acquisition/display of EEG signals and calculation of standard qEEG parameters. | Equivalent: The intended use is directly comparable and within the scope of the predicates. |
| Modalities | EEG (some predicates also include EP, EMG, CSA) | EEG | Equivalent: ZOOM-100DC offers EEG, consistent with the core modality of the predicates. |
| Channels | 8, 16, 3, 2 channel arrays; 10/20 array capable | 10/20 Array (8 single-ended channels, 5 differential concurrently) | Equivalent: Supports standard EEG channel configurations. |
| Real Time EEG Display | Yes | Yes | Equivalent |
| Real Time EEG Bandwidth | 0.5 - 500 Hz (example from Bravo) | 0.5 - 4000 Hz available | Equivalent or Superior: Offers a broader available range, exceeding some predicates. |
| Processed EEG Bandwidth | 0.5 - 500 Hz (example from Bravo) | 0.5 - 45 Hz, 50Hz | Comparable: Falls within the typical range for processed EEG. |
| Amplifier CMRR | ≥ 110 dB (Nicolet Bravo) | ≥ 100 dB | Comparable: Meets a high standard, though slightly lower than one predicate. |
| Amplifier Input Impedance | > 100 Meg Ohms (Nicolet Bravo) | ≥ 10 Meg Ohms | Comparable: Meets a standard for EEG amplifiers, though lower than one predicate. |
| Electrode Impedance Test | Yes | Yes | Equivalent |
| EEG Derived Measures | Yes - Derived from FFT* (Nicolet Bravo) | Yes - Derived from FFT* | Equivalent: Offers similar qEEG parameters. |
The conclusion states that "Performance data demonstrate that the device performs equivalently to the predicate devices." This equivalence, rather than a specific numerical acceptance criterion, is the basis for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on a test set, sample size, or data provenance from a clinical study for the ZOOM-100DC. The submission relies on a comparison of technical specifications and intended use against existing predicate devices, not on new clinical performance data from a specific study.
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)
This information is not provided as there is no mention of a clinical study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a clinical study involving a test set that required adjudication.
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
This information is not provided. The ZOOM-100DC is an electroencephalograph, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study for comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided. The device is an EEG recording and display system, not an algorithm that operates standalone for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there is no mention of a clinical study that required establishing 'ground truth' for diagnostic outputs. The device measures and records EEG signals and calculates qEEG parameters; its "performance" is assessed by its ability to perform these functions reliably and comparably to predicate devices.
8. The sample size for the training set
This information is not provided. As the submission is for an EEG device and not a machine learning algorithm requiring a "training set," this concept is not applicable in the context of this document.
9. How the ground truth for the training set was established
This information is not provided. See 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).