(11 days)
The Aspect Medical Systems BIS EEG Monitor, A-3000, 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. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the A-3000 EEG Monitor. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily by highlighting similarities in indications for use, technological characteristics, and stating that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." This suggests the "study" was more of a validation against internal specifications rather than a comparative effectiveness or standalone performance study as might be conducted for novel AI devices.
However, based on the information provided, here's an attempt to answer the questions, assuming performance refers to meeting internal specifications rather than clinical efficacy:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) for the device's core function (EEG monitoring, BIS algorithm output) are provided in the document. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance specifications met | Device meets its performance specifications and validation test requirements. |
| Validation test requirements met | Device meets its performance specifications and validation test requirements. |
| Safe for intended use | Device is safe for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
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. The document does not describe a clinical study involving human assessment for ground truth determination. The testing mentioned (Software Validation, Hazard Analysis and Risk Assessment) appears to be internal engineering and safety validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert-based ground truth adjudication or a test set where such methods would be relevant is described.
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 MRMC comparative effectiveness study is mentioned. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, not on improving human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies the device (A-3000 EEG Monitor with BIS algorithm) was tested as a standalone system to ensure it meets its "performance specifications and validation test requirements" and is "safe for its intended use." However, specific details about the nature and results of this standalone testing (e.g., algorithm accuracy against a reference standard) are not provided. The BIS algorithm itself is stated to be identical to the predicate device, implying its performance characteristics are assumed to be consistent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. For "Software Validation" and "Hazard Analysis and Risk Assessment," the 'ground truth' would likely refer to internal design specifications, international standards, and safety requirements. For the BIS algorithm itself (which is stated as unchanged from the predicate), its original validation would have established its efficacy, likely against clinical outcomes or expert assessment of anesthetic depth, but these details are not provided for the A-3000 device itself in this submission.
8. The sample size for the training set
Not applicable. This device is an updated version of an existing EEG monitor with an identical BIS algorithm. The document does not refer to a "training set" in the context of machine learning model development. The BIS algorithm's training (if any) would have occurred during its initial development, prior to the predicate device's clearance.
9. How the ground truth for the training set was established
Not applicable. 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).