(29 days)
The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic 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 BISx is a component that processes up to two channels of EEG and computes the Bispectral (BIS) Index and other EEG parameters (same as predicate device), uniting the functionality of the Digital Signal Converter (DSC-XP) and the BIS algorithm into a single enclosure. The BISx mates on one side with Aspect's BIS sensors (up to 2 channel, all currently marketed). On the other side, the BISx attaches to OEM (other equipment manufacturers) patient monitoring systems, allowing them to display Aspect's proprietary BIS Index on their integrated patient monitoring display.
Combining the functions of the DSC-XP and the BIS algorithm into a single enclosure provides our OEM Business Partners with a more durable, more compact, and less expensive way to include the BIS Index parameter into their patient monitoring systems.
The provided text describes a 510(k) summary for the BISx EEG Monitor, focusing on its substantial equivalence to a predicate device, the Aspect Medical Systems A-2000 (XP) EEG Monitor with BIS System. The summary primarily details the device's technical specifications, intended use, and a comparison with the predicate device, along with verification and validation testing.
Based on the provided document, the following information regarding acceptance criteria and device performance can be extracted:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Risk analysis PASS Software validation PASS Electronic verification PASS Mechanical/environmental validation PASS Device is substantially equivalent to predicate device Yes, all tests/analyses PASS, device determined substantially equivalent. Safe for its intended use Yes, all tests/analyses PASS, device determined safe and effective for intended use. Note: The document states "Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use." This serves as the overarching performance statement for the listed criteria.
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Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "analysis/verifications/validations" but does not detail the specific test sets, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.
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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 specified in the provided text. The device is a monitor intended for data acquisition and display, not an AI-assisted diagnostic tool that aids human readers in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the BISx as a component that processes EEG and computes the Bispectral (BIS) Index, uniting the functionality of a Digital Signal Converter and the BIS algorithm. The testing described ("Software validation," "Electronic verification") would inherently assess the standalone performance of these components and the algorithm. However, no specific "standalone performance study" with clear metrics like sensitivity/specificity for a clinical endpoint is detailed. The focus is on the device's equivalence to a predicate, which implies its computational output is comparable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided text. The "ground truth" for the verification and validation tests would be the established engineering and functional specifications for the device's performance, but the clinical "ground truth" (e.g., actual anesthetic depth for BIS index accuracy) is not discussed in the context of specific studies for this submission. The device is intended to monitor the state of the brain; its clinical efficacy is primarily established through its predicate.
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The sample size for the training set: Not applicable for this submission. The BISx is described as building upon existing and validated BIS technology from the predicate device. There is no mention of a particular "training set" in the context of machine learning model development for this specific submission. The BIS algorithm itself would have been developed and validated previously.
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How the ground truth for the training set was established: Not applicable for this submission (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).