(8 days)
The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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 BISx4 is a device that houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm. The device will acquire up to four channels of referential EEG and compute BIS and other EEG parameters.
The BISx4 will have no display or user interface. Aspect Medical Systems is submitting this 510(k) in response to anesthesiologists/users who are interested in obtaining more than 2 channels of EEG.
The provided text describes a 510(k) submission for the BISx4 device, comparing it to a predicate device (BISx). However, it does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria.
The submission focuses on establishing substantial equivalence based on similarities in design, technology, indication for use, and core functionality, with the key difference being the addition of two more EEG channels. The "Testing" section only broadly mentions "Software, electrical, hazard analysis, EMI statement," without providing details of acceptance criteria or performance results.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria, as this information is not present in the provided text.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: No such criteria or performance data are listed.
- Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned beyond the general statement of "testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed.
- Adjudication method for the test set: Not applicable as no test set data is provided.
- 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 study is mentioned. This device also doesn't involve "readers" or "AI assistance" in the typical sense; it measures physiological signals.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's primary function is algorithmic processing of EEG, but no performance metrics for this are given.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not discussed.
- The sample size for the training set: No training set mentioned.
- How the ground truth for the training set was established: No training set mentioned.
The document concludes with a determination of "Substantial Equivalence" based on the comparison to the predicate device, not on specific performance data against pre-defined acceptance criteria for the new features.
§ 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).