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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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