(353 days)
The Aspect A-2000 EEG Monitor with BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The Aspect Medical Systems, Inc. EEG BIS Monitor, model A-2000 is an easy to use, nicroprocessor-based, 2 channel maximum, EEG monitoring system. It aso, interoprobes.bor of the brain by data acquisition of EEG of the anesthetized or sedated patient, as well as monitoring the effects of certain anesthetic agents by use of the processed parameter BIS.
The system configuration consists of the monitor, digital signal converter (DSC), cables, electrodes, and an optional printer.
The provided FDA 510(k) summary for the Aspect A-2000 EEG Monitor with BIS primarily focuses on demonstrating substantial equivalence to predicate devices and the addition of a new feature (Burst Count). It does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving those criteria are met.
Here's an analysis of the available information and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. The general acceptance appears to be "meets its performance specifications and validation test requirements, and is safe for its intended use." No specific quantitative metrics (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's core functions (EEG monitoring, BIS calculation, or the new Burst Count feature) are provided.
- Reported Device Performance: The document states, "Results indicate the device meets its performance specifications and validation test requirements." However, no specific performance data (e.g., accuracy, precision, correlation with clinical outcomes, or specific metrics for Burst Count) are reported.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative metrics for device function. | "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." |
| (Presumably, the Burst Count feature should accurately count EEG bursts.) | No specific performance data for Burst Count accuracy is provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "Software validation" and "Verification of new feature," but does not detail the size of any test sets (e.g., number of patients, number of EEG recordings) used for these validations.
- Data Provenance: Not specified. It's unclear if the data used for testing (if any clinical data was involved) was retrospective or prospective, or its country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- This level of detail is typically only provided if the device's performance relies heavily on human interpretation as a gold standard, which isn't the primary focus of this submission (which is comparing a software update to an existing device).
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No MRMC study is mentioned. This submission is for a software update to an existing EEG monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The device provides processed parameters (BIS, Burst Count) directly to the clinician, rather than requiring human interpretation of raw data assisted by AI.
- Effect Size: Not applicable as no such study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The testing described ("Software validation" and "Verification of new feature") implicitly indicates standalone algorithm performance was assessed for the new Burst Count feature and the overall software. However, no specific metrics or results of this standalone performance are provided beyond the general statement that "Results indicate the device meets its performance specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified for the software validation or verification of the new feature. For EEG processing devices, ground truth might involve simulated EEG signals, carefully annotated clinical EEG recordings verified by neurologists, or comparison to established gold-standard algorithms if available. This document does not elaborate.
8. The sample size for the training set
- Sample Size: Not specified. This submission is about a software update for a device; it doesn't describe the development/training of new AI models. The original BIS algorithm would have been developed using a training set, but that information is not part of this 510(k) for a software update.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not specified. Similar to point 8, this information pertains to the original development of the BIS algorithm, not the current software update.
Summary of what is present:
- Device Name: A-2000™ EEG Monitor with BIS (with Burst Count added in this update).
- Intended Use: Monitoring the state of the brain via EEG, aiding in monitoring effects of anesthetic agents to reduce awareness with recall in adults during general anesthesia and sedation.
- Type of Study Conducted: Software validation, verification of new feature (Burst Count), hazard analysis, and risk assessment.
- Conclusion: The device meets performance specifications and validation requirements, is safe for intended use, and is substantially equivalent to predicate devices.
Missing Information:
The 510(k) summary is designed to establish substantial equivalence, not to provide a detailed scientific publication of clinical trial results. Therefore, it lacks the specifics on acceptance criteria, sample sizes, expert involvement, and ground truth establishment that you've requested. This level of detail is generally found in more comprehensive clinical study reports submitted to the FDA, or in peer-reviewed scientific literature that might accompany such device development, but it is not typically summarized in the 510(k) filing itself unless a specific clinical study was integral to the equivalence argument for a new device or a major change. In this case, the change is described as a software modification to add a Burst Count feature to an already cleared device.
§ 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).