(243 days)
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Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages.
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Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers:
- -Amplitude Integrated EEG (aEEG),
- -Peak Envelope,
- -Envelope Asymmetry,
- -Spectrogram,
- -Band Power.
- -Power Ratio,
- -Spectral Entropy,
- -Burst Suppression Ratio,
- -Inter-burst Interval, and
- -Bursts-per-Minute.
These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis.
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The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.
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Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.
Cadwell Bolt is a software-only device for use with EEG data. The Cadwell Bolt receives EEG data as an input and uses this input to calculate and display the following quantitative measures of electroencephalographic data:
(1) amplitude integrated EEG (aEEG),
(2) peak envelope,
(3) envelope asymmetry,
(4) spectrogram,
(5) band power,
(6) power ratio.
(7) spectral entropy,
(8) burst suppression ratio.
(9) inter-burst interval, and
(10) bursts-per-minute.
In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold.
Thresholding is available for the following trends:
. peak envelope,
. envelope asymmetry,
spectrogram, .
band power, and ●
power ratio. .
The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include:
Output display color
Output display size ●
Output display name
Epoch length ●
Notch filter ●
Selected inputs (bipolar or referential)
. Output display time scale (y-axis)
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (for graphical and morphological comparison) | Greater than 0.80 | All reported correlation values were $\geq$ 0.900 for Peak Envelope, Envelope Asymmetry, Spectrogram, Band Power, Power Ratio, Spectral Entropy, Burst Suppression (IBI, BSR, BPM). Specific values are provided in the tables below. |
| Percent Difference (for quantitative output amplitude comparison) | Less than 10% | Spectral Entropy: Reported percent differences were 5.3%, 3.4%, 8.7%, 7.2%. |
| Burst Suppression (IBI, BSR, BPM): Reported percent differences were 1.25%, 1.37%, 1.94%. |
Specific Performance Data from the Study:
| Analyzer / Measurement | Time Period | Correlation Coefficient | Percent Difference |
|---|---|---|---|
| Peak Envelope | 15-minute | 0.951 | N/A |
| 1-hour | 0.917 | N/A | |
| 4-hour | 0.913 | N/A | |
| 8-hour | 0.896 | N/A | |
| Envelope Asymmetry | 15-minute | 0.909 | N/A |
| 1-hour | 0.859 | N/A | |
| 4-hour | 0.857 | N/A | |
| 8-hour | 0.819 | N/A | |
| Spectrogram | 15-minute | 0.938 | N/A |
| 1-hour | 0.969 | N/A | |
| 4-hour | 0.825 | N/A | |
| 8-hour | 0.852 | N/A | |
| Band Power | 15-minute | 0.955 (All 10/20 7-12Hz) | N/A |
| 1-hour | 0.898 (All 10/20 7-12Hz) | N/A | |
| 4-hour | 0.874 (All 10/20 7-12Hz) | N/A | |
| 8-hour | 0.891 (All 10/20 7-12Hz) | N/A | |
| Power Ratio | 15-minute | 0.938 | N/A |
| 1-hour | 0.923 | N/A | |
| 4-hour | 0.902 | N/A | |
| 8-hour | 0.867 | N/A | |
| Spectral Entropy | 15-minute | 0.957 | 5.3% |
| 1-hour | 0.961 | 3.4% | |
| 4-hour | 0.998 | 8.7% | |
| 8-hour | 0.972 | 7.2% | |
| Burst Suppression (IBI) | N/A | 0.992 | 1.25% |
| Burst Suppression (BSR) | N/A | 0.999 | 1.37% |
| Burst Suppression (BPM) | N/A | 0.999 | 1.94% |
2. Sample size used for the test set and the data provenance:
The document states that "Arbitrary data of known value was input" and "sample EEG data at various time scales and with various montages and/or frequency bands" were used. However, it does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing involved "analyzing known arbitrary EEG data and confirming that the expected output was obtained" and comparing results with predicate devices, but it does not mention the involvement or qualifications of experts for establishing ground truth on the test data.
4. Adjudication method for the test set:
This information is not provided in the document. The evaluation involved a comparison of calculated metrics (correlation coefficient and percent difference) against predetermined thresholds, not an adjudication process by experts.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document describes a standalone performance evaluation of the software's quantitative output compared to predicate devices, not impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The study focused on the Cadwell Bolt Software's ability to calculate and display quantitative EEG measures, and its outputs were compared against those of predicate devices. The device is intended for post-hoc analysis by qualified medical practitioners who exercise professional judgment, implying it functions as a tool rather than a diagnostic algorithm that provides conclusions or replaces real-time monitoring by an expert.
7. The type of ground truth used:
The ground truth for this performance study appears to be established through "known arbitrary EEG data" and by comparing the device's output to the output of legally marketed predicate devices, which serve as a reference for "substantial equivalence." The document states that the software "implements public domain (nonproprietary) quantitative analysis measures that are identical or similar to the predicate devices."
8. The sample size for the training set:
This information is not provided in the document. The document describes verification and validation but does not detail a training set for the Cadwell Bolt Software, implying it uses established algorithms rather than a machine learning model that requires a distinct training phase.
9. How the ground truth for the training set was established:
This information is not provided in the document, as no training set is explicitly mentioned or described.
§ 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).