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SedLine Sedation Monitor

The SedLine® Sedation Monitor is intended to monitor the state of the data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentany], Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors.

The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results.

SedLine Sensor

The RD SedLine Pediatric Sensor electrodes are applied directly to the patient's skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensors are indicated for pediatric patients (1 to 17 years).

The Masimo SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSi), EMG Index, Suppression Ratio (SR) and Artifact (ARTF).

The Masimo SedLine® Sedation Monitor includes the SedLine Module, SedLine EEG Sensor, and SedLine Patient Cable. The SedLine Module includes Masimo technology that processes the signal data collected from the SedLine sensor on the Host/Backboard device which provides the user interface.

This document specifies that the Masimo SedLine Sedation Monitor and Accessories (subject device) is substantially equivalent to the Masimo SedLine® Sedation Monitor (K172890) (predicate device). The key difference is the expansion of indications for use to include pediatric patients and the addition of pediatric sensors. The majority of the original acceptance criteria and performance data for the predicate device were maintained, with additional testing focusing on the new pediatric sensor and software verification for the expanded indications.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the specifications of the SedLine device and the pediatric sensor. These specifications effectively serve as acceptance criteria for the various features and functionalities of the device.

The "Reported Device Performance" for most criteria is implied by the statement "The testing was found to support the substantial equivalence of the subject device" and "The non-clinical testing was conducted in accordance with Masimo requirements to ensure that the specifications of the subject device were met." For the pediatric sensor, specific dimensions and environmental specifications are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for test sets for the performance of the device's main functionalities (EEG signal processing, PSi calculation, etc.). The non-clinical testing for the subject device focused on software verification/validation, mechanical, and environmental aspects related to the expansion of indications and pediatric sensor.

• Software Verification and Validation Testing: Conducted as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005." The software was considered a "moderate" level of concern. No specific sample size or data provenance details are provided for this testing.
• Mechanical and Environmental Testing (Pediatric Sensor): Performed, but no specific sample size or data provenance details are provided.
• The document mentions that biocompatibility, wireless and cybersecurity, and human factors usability testing were not required for this submission as there were no changes to the materials, wireless capabilities, communication capabilities, or critical user-related tasks from the previously cleared predicate device (K172890). Therefore, the test data for these aspects would pertain to the predicate device and are not detailed here.

Overall, specific sample sizes and data provenance for the tests conducted for this submission are not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information about the number or qualifications of experts used to establish ground truth for any test sets. The tests mentioned are primarily engineering/software verification and validation, and mechanical/environmental testing, which typically do not involve expert-established ground truth in the same way clinical studies might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication methods for the test sets.

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 comparative effectiveness study is mentioned in the provided text. The device is a monitor that provides processed EEG data (including PSi), not an AI assisting human readers in interpretation like in diagnostic imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as a "SedLine Sedation Monitor" that processes EEG signals to compute values like the Patient State Index (PSi). The PSi is "computed continuously from monitored changes in the QEEG when the sensor is applied." This indicates that the algorithm for generating PSi operates in a standalone manner, deriving its output directly from the EEG signals. The performance specifications for PSi (display range, resolution) are listed, and the overall non-clinical performance testing was conducted to ensure the device met its specifications. Therefore, the device's core algorithms operate in a "standalone" fashion on the incoming EEG data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the device's core functionality (PSi calculation related to anesthetic effect), the "ground truth" implicitly relates to the physiological changes in brain activity due to anesthetic agents. The PSi is described as "a proprietary computed EEG variable that is related to the effect of anesthetic agents" and "intended to provide information on the changes in sedation with the lower values reflecting lower levels of brain activity and deeper levels of sedation." The underlying validation of this relationship to actual anesthetic depth would have been established during the development and clearance of the predicate device. This document does not detail the specific ground truth used for that relationship.

For the current submission, the ground truth for the verification and validation (V&V) testing would be the predefined functional requirements, design specifications, and relevant standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).

8. The sample size for the training set

The document does not mention a training set or its sample size. The focus is on the verification and validation of the device's performance, not on the training of a machine learning model for a new diagnostic task. The PSi algorithm is described as "proprietary" and "computed continuously," suggesting a fixed algorithm rather than one that undergoes continuous training with new data.

9. How the ground truth for the training set was established

Not applicable, as no training set is discussed in the document.

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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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