(217 days)
The PSA4000 is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI™), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
The PSA4000 is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. The PSA4000 consists of three main components, the monitor, the amplifier and the archive media (optional). The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.
The provided text describes a 510(k) premarket notification for the "PSA4000 EEG Monitor with Frontal PSI." However, it does not contain a detailed study with specific acceptance criteria and performance data for the device in the way a clinical trial report would.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (PSA4000 EEG Monitor with PSI K001069) and fulfilling regulatory requirements. It mentions general validation testing but lacks the quantitative details to complete the requested table and answer many of the specific questions about clinical study design and outcomes.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states:
"The test results are all positive and indicate that the device meets product requirements and satisfies customer needs and expectations."
However, it does not specify what those "product requirements" or "acceptance criteria" were in a measurable format, nor does it present quantitative performance data. The tests mentioned are:
- Software validation testing
- Mechanical validation testing
- Electrical validation testing
- EMC testing
- Compliance with UL 2601, CSA 22.2 No. 601-1, IEC 601-1, IEC 601-2-26, and FDA Reviewer Guidance for Premarket Notification Submissions (EMC).
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "test results" but does not detail the number of subjects, cases, or data points involved in any testing, particularly for the performance of the "Frontal PSI" component.
- Data Provenance: Not specified. There is no information about the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. This information is typically relevant for studies evaluating the accuracy of a diagnostic or prognostic tool against expert judgement. The document does not describe such a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not specified. As no expert- Adjudicated test set is detailed, no adjudication method is mentioned.
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 study was mentioned. The device is an EEG monitor that calculates a "Patient State Index (PSI)". The document does not describe studies where human interpretation of EEG or patient state was compared with and without the aid of the PSA4000's PSI.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
While the device calculates a proprietary "Patient State Index," the document does not provide a standalone performance evaluation of this algorithm in terms of specific metrics (e.g., sensitivity, specificity, accuracy) against a reference standard. The "Test Results" section refers to engineering and compliance testing, not clinical "standalone" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified. Due to the lack of detailed performance studies, the type of ground truth used to validate the accuracy or effectiveness of the PSI is not mentioned.
8. The sample size for the training set
Not applicable/Not specified. The document does not describe the use of machine learning in a way that typically involves distinct "training" and "test" sets for algorithmic development in the context of diagnostic accuracy. The PSI is described as a "proprietary computed EEG variable," implying an algorithm, but no details of its development or training are given.
9. How the ground truth for the training set was established
Not applicable/Not specified. 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).