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The SedLine Sedation Monitor is intended to monitor the state of the 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 agents include: Alfentanil, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor designed specifically for intraoperative or intensive care use. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSI), EMG Index, Suppression Ratio (SR) and Artifact (ARTF). The operator controls the unit using menus and dedicated buttons to select various display options. The system consists of 4 major components: Root, SedLine Module, SedLine Patient Cable, and SedLine Sensor.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This 510(k) submission is for a modification to an existing device (SedLine Sedation Monitor), specifically a modified Patient State Index (PSI) algorithm and an optional additional DSA display. The primary goal is to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of a clinical trial results table that would define specific metrics and thresholds for success for the new PSI algorithm. Instead, the non-clinical testing section lists various standards and guidances it aimed to satisfy, and the clinical testing section describes how the new algorithm was compared to the predicate.

However, based on the context of a 510(k) submission for a device modification, the implicit acceptance criteria would revolve around demonstrating that the modified device performs at least as well as, or is substantially equivalent to, the predicate device. The general performance specifications for the SedLine Sedation Monitor are provided in Table 5.2.

Implicit Acceptance Criteria and Reported Performance (derived from document):

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: 100 surgical patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the FDA (USA), and typically, studies cited in such submissions are either US-based or explicitly noted if international.
  • Retrospective or Prospective: Retrospective analysis of clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. For this type of device (Sedation Monitor), the "ground truth" for the PSI algorithm's performance is typically related to the administered anesthetic drug doses and observed physiological responses, rather than expert interpretation of EEG waveforms alone for classifying sedation depth. The study states "Clinical data used for the analysis includes continuous EEG, anesthetic drug dose information, and other physiological vital signs such as mean arterial blood pressure and heart rate," which would serve as the reference against which the PSI algorithm's output is compared.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given it's a retrospective analysis of clinical data including objective measurements (EEG, drug doses, vital signs), an adjudication process involving multiple human readers for "ground truth" might not have been applied in the same way as, for example, in an imaging study.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described. This study focused on the performance of the modified algorithm itself in comparison to its predicate, using retrospective clinical data. The SedLine Sedation Monitor is an monitoring device that provides a computed index (PSI) for clinicians to interpret, it's not a diagnostic AI intended to assist human interpretation of complex images in an MRMC setting.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of the algorithm was done. The clinical study describes a "retrospective analysis of the clinical data" where "The subject PSi algorithm was compared to the predicate PSi algorithm" using collected physiological and drug administration data. This directly assesses the algorithm's output (PSI) based on its input (EEG signals, etc.) without human intervention in its calculation or interpretation to determine its output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for evaluating the PSI algorithm's relation to anesthetic depth would be based on:

• Anesthetic drug dose information: The type and amount of anesthetic agents administered.
• Physiological vital signs: Mean arterial blood pressure and heart rate.
• Continuous EEG data: The raw EEG signals from which the PSI is derived, allowing for comparison of the algorithm's output against the expected EEG changes under anesthesia.

Combined, these elements serve as the reference for the "effect of anesthetic agents" that the PSI is designed to reflect. It's not a single "expert consensus" or "pathology" but rather a composite of objective clinical data related to the patient's state of anesthesia.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It only mentions the "validation" of the subject algorithm through retrospective analysis of clinical data in 100 surgical patients. This 100-patient dataset appears to be the test/validation set for assessing the modified algorithm, not necessarily a training set. Given that this is a modification of an existing algorithm, the original algorithm would have been developed and trained using prior data, but details about that are not included here.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set (if a separate training set was used for the modified algorithm) was established. It only describes the data used for the validation comparison of the subject algorithm against the predicate. For the original development of the PSI, ground truth would typically involve correlating EEG patterns with known states of consciousness/sedation induced by controlled anesthetic administration, likely established by expert assessment (e.g., Riker Sedation-Agitation Scale, Observer's Assessment of Alertness/Sedation Scale) and objective physiological markers during prospective studies. However, these details are absent for this specific submission's context.

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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:

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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