(53 days)
The SEDLine Sedation Monitor 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.
SEDLine 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 SEDLine System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and SEDTrace EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SEDLine Sedation Monitor:
It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, some of the requested information, particularly regarding the specifics of clinical trials (like sample sizes for a test set, expert qualifications for ground truth, MRMC studies, and detailed training set information), is not present. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device through technical similarities and compliance with safety standards, rather than extensive clinical performance data specific to diagnostic accuracy or reader improvement.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for clinical performance (e.g., minimum sensitivity or specificity targets with confidence intervals). Instead, it highlights the device's technical specifications and adherence to safety and performance standards as the basis for equivalency.
The "Test Results" section broadly states: "The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing." It then lists compliance with several UL, CSA, and IEC standards for electrical safety and electromagnetic compatibility. This implies that the 'acceptance criteria' are primarily related to meeting these technical and safety standards, as well as demonstrating that the device functions as intended for monitoring EEG signals and calculating the PSI.
Given the information, here's a table summarizing what can be inferred:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with recognized electrical safety standards. | UL 60601-1, CSA 22.2 No. 60601-1, IEC 60601-1, IEC 60601-2-26 |
| Electromagnetic Compatibility (EMC) | Compliance with EMC standards. | FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, Electromagnetic Compatibility dated November 1993 |
| Functional Performance | Ability to acquire and display real-time EEG waveforms. Ability to process EEG data using digital signal processing. Ability to display processed EEG data in various formats. Ability to archive real-time or processed EEG data. Automatic self-tests upon power-up. PSI algorithm accurately converts EEG into a proprietary index related to anesthetic effects. | (Implied by device description and intended use) "The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data... calculates the processed parameters and displays the real-time EEG data and processed data." "Performs automatic self tests upon power up." "The PSI is an EEG variable that is related to the effect of anesthetic agents." |
| Software Validation | Software functions as intended and is validated. | "software... validation testing" |
| Mechanical Validation | Mechanical components function as intended and are validated. | "mechanical... validation testing" |
| Electrical Validation | Electrical components function as intended and are validated. | "electrical validation testing" |
| Predicate Equivalence | Similarities in function, processed parameters, PSI, self-tests, materials, and electrode locations to the predicate device. | All "Similarities" listed in the text (see below). |
Similarities to Predicate Device (part of the equivalence argument):
- Both systems are EEG monitors.
- Both systems provide processed parameters (EMG, SR, ART, PSI).
- Both systems include PSI, a proprietary computed EEG variable related to anesthetic effects.
- Both conduct self-tests at startup.
- Both electrodes use the same materials.
- Both electrodes collect data from the same electrode locations.
Study Information
Based on the provided text, a detailed clinical study report proving specific diagnostic performance metrics (like sensitivity, specificity, or reader improvement) is not included. The document describes the device and its technical validation for substantial equivalence purposes.
-
Sample size used for the test set and the data provenance:
- Not specified. The document mentions "software, mechanical and electrical validation testing and EMC testing," but does not detail any clinical test set or its sample size.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. There is no mention of a clinical test set requiring expert-established ground truth in this document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No clinical test set requiring adjudication is described.
-
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 such study is mentioned or implied. The SEDLine Sedation Monitor provides a Patient State Index (PSI) as a computed EEG variable related to anesthetic agents, not an AI that assists human readers in interpreting images or data. The device itself is the 'AI' portion (the PSI algorithm), providing a quantitative output.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The PSI algorithm within the SEDLine monitor would function in a standalone manner to compute the PSI value from EEG signals. The output (the PSI number, EMG, SR, ART values, and EEG waveforms) is then presented to the human clinician. The "performance" in this context is the accuracy and reliability of these computed values in reflecting the brain state as intended. The document states the PSI "is related to the effect of anesthetic agents," implying its ability to provide this standalone metric.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the PSI algorithm's "ground truth." For devices that measure a physiological state (like depth of anesthesia), ground truth is typically correlated with clinical outcomes, pharmacokinetic/pharmacodynamic studies of anesthetic agents, and expert clinical assessment of patient response to simulation scenarios. The statement "The PSI is an EEG variable that is related to the effect of anesthetic agents" suggests that its development and validation would have involved correlating PSI values with known anesthetic concentrations/doses and their clinical effects, but the specifics are not in this document.
-
The sample size for the training set:
- Not specified. There is no mention of a training set size for the PSI algorithm. Algorithm development often involves data sets for training, but this is not detailed in a 510(k) summary focused on substantial equivalence.
-
How the ground truth for the training set was established:
- Not specified. Similar to the point above, the method for establishing ground truth for any potential training data used for the PSI algorithm is not described.
§ 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).