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The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.

For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.

For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.

The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis.

The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC).

The BIS™ Advance Monitor displays:

• The current BIS™ number .
• . Raw EEG waveforms in real time
• . Various signal quality indicators (EMG. SQI)
• 트 Trend graphs of processed EEG parameters (including various options)
• I Processed EEG variables:
  • . Electromyography (EMG)
  • Signal Quality Index (SQI)
  • . Suppression Ratio (SR)
  • . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only)
  • . Suppression Time (ST)
  • I Spectral Edge Frequency (SEF)
  • Median Frequency (MF)
  • EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
• I Alarm Indicator and Messages

The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor.

For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows:

A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.

The acceptance criteria for the BIS™ Advance Monitoring System are primarily related to its proposed changes: a narrowed indication for use and a new monitor design. The submission aims to demonstrate substantial equivalence to the predicate device (BIS EEG Vista Monitor System and BISX, K072286).

Here's an analysis of the acceptance criteria and the studies presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating that the new device's performance is equivalent or better than the predicate, especially for the new monitor design, and that the narrowed indications for use are clinically supported.

However, based on the comparative effectiveness study for the Indications for Use, we can infer some performance aspects:

2. Sample Size for the Test Set and Data Provenance

• OLIVER Study (Adults):
  • Sample Size: 143 subjects
  • Data Provenance: Multicenter, prospective study conducted across 3 sites in the United States.
• BTIGER Study (Pediatrics):
  • Sample Size: 170 subjects
  • Data Provenance: Multicenter, prospective, randomized control study conducted across 8 sites in the United States.

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

The document does not detail the number or qualifications of experts used to establish ground truth for the clinical studies. However, for studies involving "level of consciousness" and "unresponsiveness to verbal command" in the OLIVER study, and "anesthetic administration" in the BTIGER study, licensed healthcare practitioners would have been involved in assessing these clinical endpoints. The studies were conducted under the "direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use," as stated in the Indications for Use.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? The document describes two clinical studies (OLIVER and BTIGER) that compare BIS™ guidance to standard practice or assess the correlation of BIS™ with clinical endpoints. While these are comparative studies, they are not framed as "multi-reader multi-case" studies in the typical sense of AI-assisted image interpretation. The comparison is between a device-guided approach and non-device-guided approaches or correlation with physiological states, rather than human readers interpreting cases with and without AI assistance.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable in the traditional MRMC context, as the studies are not designed to measure improved human reader performance with AI assistance for interpretation. Instead, the BTIGER study showed that the BIS™ guided treatment group achieved statistically significantly lower end-tidal sevoflurane administration compared to the standard practice group, indicating a direct effect on patient management rather than an improvement in human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The core of the BIS™ Advance Monitoring System is mentioned as processing raw EEG signals to produce a single number, the Bispectral Index (BIS value), which correlates with the patient's level of hypnosis. The device also displays raw EEG waveforms, signal quality indicators, and processed EEG parameters. The clinical studies (OLIVER and BTIGER) inherently evaluate the performance of this algorithm output (BIS Index) in a clinical setting, effectively testing its "standalone" diagnostic utility in influencing anesthetic administration and correlating with consciousness levels. The output (BIS index) as a predictor of consciousness or a guide for anesthetic use is evaluated.

7. Type of Ground Truth Used

• OLIVER Study: The ground truth for correlating BIS™ with the level of sedation appears to be based on clinical assessment of patient responsiveness, specifically "response to a verbal command."
• BTIGER Study: The ground truth for evaluating the impact of BIS™ guidance was the clinical outcome of "mean end-tidal sevoflurane (ETSevo) administration" during the maintenance phase of anesthesia, and the clinical decision-making by practitioners.

8. Sample Size for the Training Set

The document focuses on the performance of the current BIS™ algorithm and its new monitor. It states that "no software changes were performed to the BISx/BISx4 module (the unit that performs the computation for EEG acquisition), the BIS algorithm nor to the algorithm database structure." This suggests the core BIS algorithm was developed and trained prior to this submission. The document does not provide information on the sample size for the training set of the BIS algorithm itself. It only provides information for the clinical validation studies (test sets).

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

As with the training set sample size, the document does not provide information on how the ground truth was established for the training set of the BIS algorithm, as the algorithm itself was not modified in this submission. The core algorithm's development and training would have occurred during the development of earlier versions of the BIS monitoring system (e.g., the predicate device K072286).

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The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents include inhalation agents and propofol in combination with opioids.

The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.

The Brain Anaesthesia Response Monitor (BARM) is a device designed to non-invasively monitor brain function in response to anesthetic agents including inhalation agents in the operating room (OR) and clinical research laboratory. The system consists of the following three components:

• . Brain Anaesthesia Response (BAR) Terminal - Provides a user interface to control the DAM, set configuration parameters and display the DAM output for users.
• . Data Acquisition Module (DAM) - Collects and processes the signal sent by the electrodes and calculates the Composite Cortical State (CCS) index and outputs the information to the BAR Terminal.
• Disposable cutaneous electrode sensor- The electrodes collect Brain electrical activity (EEG) signals and transfers them to the DAM. The electrodes are made from pre-gelled Ag-AgCl. The electrodes are connected with patient leads which is plugged into the DAM. The electrodes are applied to the patients' forehead and behind the ear and is held in place via biocompatible adhesives.

Here's a breakdown of the acceptance criteria and the studies proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a formal table with pass/fail metrics. Instead, it demonstrates substantial equivalence to a predicate device (BIS EEG VISTA MONITOR SYSTEM) through a comparison of technological characteristics and then presents clinical performance data to support the device's intended use and show its comparable performance to existing technologies.

Here's a table synthesizing the implied acceptance criteria (based on the predicate device's features and the subject device's performance claims) and the reported device performance.

Study Details

The document describes three studies that support the performance of the BAR Monitor.

1. Study U111-1124-2523

• Sample Size: 20 subjects
• Data Provenance: Melbourne, Australia; Prospective, double-blinded, randomized controlled design.
• Number of Experts & Qualifications (Ground Truth):
  • Number of Experts: Not explicitly stated how many experts established the OAA/S ground truth for each subject. Assuming standard clinical practice, it would likely involve the anesthesiologist(s) and/or trained research staff present.
  • Qualifications: "Observer's Assessment of Alertness/Sedation (OAA/S) level 4" and "OAA/S 0" indicate clinical assessments by qualified personnel familiar with these scales. Specific qualifications (e.g., anesthesiologist experience) are not provided.
• Adjudication Method: Not explicitly stated.
• MRMC Comparative Effectiveness Study: The study compared the predictive ability of CCS with the BIS™ index for loss of response.
  • Effect Size: CCS and BIS™ were found to be equivalently predictive, with a prediction probability (Pr) of 0.9 for both devices. This indicates no significant improvement by AI (CCS) over the established technology (BIS™) in this specific outcome, but rather a comparable performance.
• Standalone (Algorithm only) Performance: Yes, the prediction probability (Pr) of 0.9 for CCS indicates its standalone performance in predicting loss of response.
• Type of Ground Truth: Clinical assessment (Observer's Assessment of Alertness/Sedation - OAA/S levels).
• Training Set Sample Size: Not specified in this document. This study appears to be a clinical validation, not part of the algorithm's training.
• Ground Truth for Training Set: Not specified in this document.

2. Study ACTRN12618000916246

• Sample Size: 21 patients (10 sevoflurane, 11 xenon)
• Data Provenance: Melbourne, Australia; Prospective, double-blinded, randomized controlled design.
• Number of Experts & Qualifications (Ground Truth):
  • Number of Experts: Not explicitly stated how many experts established the emergence criteria (first response to name, first eyes open, spontaneously ventilating). Likely clinical staff.
  • Qualifications: Not explicitly stated, but implies clinical observation by trained medical professionals (e.g., anesthesiologists, nurses).
• Adjudication Method: Not explicitly stated.
• MRMC Comparative Effectiveness Study: The study compared CCS with the BIS™ index during emergence from anesthesia.
  • Effect Size: Prediction probabilities for CCS were equivalent to or better than that for the BIS for the sevoflurane group, the xenon group, and both groups combined. This suggests comparable to slightly improved performance of CCS over BIS for emergence monitoring.
• Standalone (Algorithm only) Performance: Yes, prediction probabilities for CCS were calculated independently.
• Type of Ground Truth: Clinical assessments of emergence endpoints (first response to name, first eyes open, spontaneously ventilating).
• Training Set Sample Size: Not specified in this document.
• Ground Truth for Training Set: Not specified in this document.

3. Study 6001-004

• Sample Size: 42 subjects (14 subjects per remifentanil group: 0, 2, or 4 ng/ml)
• Data Provenance: Belgium; Retrospective re-analysis of previously recorded EEG data from a randomized, multi-arm study.
• Number of Experts & Qualifications (Ground Truth):
  • Number of Experts: Not explicitly stated from the original study that collected the OAA/S data.
  • Qualifications: OAA/S assessments imply clinical observation by qualified personnel. Specific qualifications are not provided.
• Adjudication Method: Not explicitly stated.
• MRMC Comparative Effectiveness Study: CCS was compared to GE M-Entropy™ state and response entropy measures.
  • Effect Size: Prediction probabilities for CCS across all OAA/S levels were equivalent to values obtained using GE M-Entropy™ state and response entropy measures. This indicates comparable performance of CCS.
• Standalone (Algorithm only) Performance: Yes, prediction probabilities for CCS were calculated. E.g., Prediction probabilities between OAA/S 5 and OAA/S 0 were ≥0.99.
• Type of Ground Truth: Clinical assessment (Observer's Assessment of Alertness/Sedation - OAA/S levels).
• Training Set Sample Size: Not specified in this document. This study describes a re-analysis of previously recorded EEG data, suggesting it was used for validation purposes rather than initial model training.
• Ground Truth for Training Set: Not specified in this document.

General Note on Training Data: The document focuses entirely on clinical validation studies and non-clinical performance testing. It does not provide details regarding the training set sample size or how the ground truth for the training set was established for the BAR Monitor's algorithm (Composite Cortical State - CCS). This information would typically be found in a more detailed technical report on the algorithm development, which is not included in this FDA 510(k) summary. The studies provided demonstrate the performance of the already developed algorithm against clinical ground truth and predicate devices.

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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 NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals.

The WAVCNs index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids. The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.

The NeuroSENSE Monitoring System, Model NS-901, is a 2-channel bilateral processed Electroencephalograph (EEG) monitor for brain function monitoring in the operating room and other clinical settings. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by a qualified medical professional and for use as a supplement to the anesthesia standard of care. The user interacts with the system via a touch screen interface.

The NS-901 System consists of the following main components:

• Display Module (DM-901) processes acquired EEG signals, displays EEG waveforms . and processed EEG variables, and archives them for later review
• EEG Module (EM-901)
• 1. acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead,
• 2. converts acquired analog EEG signals into digital EEG signals, and
• 3. sends the digital EEG signals to the Display Module through the integrated Data Cable
• EasyPrep Sensor Kit (EK-901) Noninvasive, disposable, single-use patient electrodes ● for acquiring the EEG signal

The NeuroSENSE Monitoring System displays EEG waveforms and the following EEG processed variables and plots for each EEG channel:

• Wavelet-based Anesthetic Value for Central Nervous System (WAVCNS) ●
• . Electromyogram (EMG)
• Suppression Ratio (SR) ●
• Spectral parameters: Density Spectral Array (DSA), Median Edge Frequency (MEF), ● Spectral Edge Frequency (SEF), and spectral powers in different EEG frequency bands

For improved reliability, the NeuroSENSE employs circuitry and algorithms for automatic detection, removal and/or filtering of physiological and environmental artifacts that commonly contaminate EEG signals. The NS-901 System also performs self-tests, automatic calibration of the amplifiers and continuous check of the electrode-skin contacts to ensure proper operation and optimal signal quality. Signal quality indicators (electrode status, 50/60 Hz noise level, artifact status) as well as system alarms, notifications and other related messages are displayed by the system. The system also provides protection for the operator and patient during cardiac defibrillation.

The provided text describes the NeuroSENSE Monitoring System, Model NS-901, and its substantial equivalence to a predicate device. While it details several performance characteristics and the clinical study conducted, it does not explicitly state acceptance criteria in a quantitative, pass/fail manner. Instead, the performance is described in terms of "correlation," "discrimination," and "agreement" with clinical observations and the predicate device.

Given this, I will infer relevant performance measures from the text and present them as "reported device performance." I will also explicitly state when information requested is not present in the provided document.

Acceptance Criteria and Device Performance

The NeuroSENSE Monitoring System, Model NS-901, was evaluated to demonstrate its substantial equivalence to the predicate device in monitoring brain function during anesthesia. While explicit, numeric acceptance criteria are not presented in a traditional table format in the provided text, the document describes the purpose of the validation and the outcomes that supported the substantial equivalence claim.

Based on the provided information, the implicit acceptance criteria are related to the device's ability to:

• Discriminate clinical endpoints related to consciousness.
• Correlate with changes in anesthetic dosing.
• Demonstrate an appropriate range for general anesthesia for its proprietary index (WAVCNS).
• Show excellent agreement with the predicate device for a specific parameter (SR).

Study Details:

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 75 adult surgical patients.
   • Patient Age: 18-71 years.
   • Gender: 18 male / 57 female.
   • ASA Classification: I-III.
   • Data Provenance: The study was a "prospective clinical study." While the country of origin is not explicitly stated, the context of an FDA 510(k) submission generally implies the study adheres to U.S. regulatory standards, often conducted in the U.S. or under international standards acceptable to the FDA. The data was collected "in the operating room."

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • This information is not provided in the text. The ground truth ("clinical observations" and "drug information") was seemingly captured during standard clinical practice by the operating medical professional(s), but the number and specific qualifications of the adjudicating or ground truth-establishing experts are not specified.

3. Adjudication Method for the Test Set:

   • This information is not provided in the text. The "clinical observations" and "drug information" that served as ground truth appear to be direct clinical records, but details on how these observations were adjudicated (e.g., by multiple experts, consensus, etc.) are absent.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on the device's performance in relation to clinical observations and comparison to a predicate device's calculated parameter, rather than evaluating human reader improvement with or without AI assistance.
   • Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was described.

5. Standalone Performance (Algorithm-only without human-in-the-loop performance):

   • Yes, in essence. The study evaluated the device's calculated indices (WAVCNS, SR) against clinical observations and anesthetic dosing, as well as the agreement of the device's SR calculation with that of the predicate. The device generates these values automatically. While the interpretation of the NeuroSENSE Monitor's output and its use as an aid is "under the direction and interpretation of a qualified medical professional," the performance evaluation described (e.g., discrimination of endpoints, correlation with dosing, agreement of SR) refers to the algorithmic output's accuracy and utility.

6. Type of Ground Truth Used:

   • The ground truth relied on clinical observations (e.g., loss of consciousness (LOC) and return of consciousness (ROC)) and drug information (anesthetic dosing). Comparison for SR was against the SR calculated by a predicate device. This implies a form of clinical outcome/physiological measurement-based ground truth, observed by medical professionals during actual procedures.

7. Sample Size for the Training Set:

   • This information is not provided in the text. The document describes the "validation" study as a "prospective clinical study in 75 adult surgical patients." It does not specify whether this dataset was used for training, testing, or exclusively for validation, nor does it mention the size of a separate training set if applicable. The focus of this 510(k) is on the validation data that supports substantial equivalence.

8. How Ground Truth for the Training Set Was Established:

   • This information is not provided in the text, as details on a distinct training set are absent. If part of the 75-patient dataset was used for training (which is unlikely for a validation study unless it was a hold-out set for final performance evaluation), the ground truth would have been established via clinical observations and drug information as described for the evaluation.

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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 GE Healthcare Entropy module, E-ENTROPY, and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters. In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia. The Entropy module is indicated for use by qualified medical personnel only.

GE Healthcare Entropy Module, E-ENTROPY is a single-width plug-in parameter module for GE Healthcare modular monitoring systems. EEG signals reflect the underlying state of brain activity. As a person falls asleep or is anesthetized, the brain function (activity) starts to decrease and becomes more orderly and regular. EEG changes from irregular to more regular patterns when anesthesia deepens. Similarly, frontal EMG quiets down as the deeper parts of the brain are increasingly saturated with anesthetics. Entropy measurement is based on processing of raw EEG and FEMG signals by using the Entropy algorithm, a GE application of Spectral Entropy. The algorithm is published: Viertiö-Oja H et al. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue 2:154-161, 2004). Entropy measures irregularity of EEG and FEMG. The GE Entropy measurement devices are responsible for EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE). The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907).

Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Entropy Module, E-ENTROPY-01, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for performance in a quantitative way for the new device, other than demonstrating substantial equivalence to the predicate. Instead, it details the technical specifications of both the predicate and proposed device, and notes whether they are identical or equivalent. The "acceptance criteria" here are implicitly the specifications of the predicate device, or updated standards where applicable.

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

The document states: "No additional clinical tests were performed for proposed ENTROPY MODULE, E-ENTROPY."

Therefore, there is no distinct "test set" or data provenance information provided from new clinical studies for this submission, as the device's substantial equivalence relies on its technical specifications matching or being equivalent to the predicate device and compliance with recognized standards. The study that "proves the device meets the acceptance criteria" is primarily the non-clinical testing detailed below, demonstrating the device's adherence to relevant standards and its technical similarity to the predicate.

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

Not applicable, as no new clinical or comparative performance studies with human readers and ground truth were conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical or comparative performance studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an Electroencephalograph (EEG) module that processes signals to derive "Entropy" values (Response Entropy and State Entropy). It is not an AI-assisted diagnostic tool that human readers would use in a comparative effectiveness study in the typical sense of MRMC. The device provides physiological parameters to aid medical personnel.

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

The device is an "Entropy Module" which acquires EEG/FEMG signals. The "Entropy algorithm in the host monitor calculates the spectral entropies." While the algorithm itself operates "standalone" in calculating the Entropy values, the overall system is designed for use by "qualified medical personnel" as an adjunct to other physiological parameters. The document doesn't describe an isolated performance study of just the algorithm's output quality against a gold standard without the full device hardware context or human interpretation, beyond validating its technical specifications. The provided document doesn't detail a standalone study of the algorithm's diagnostic accuracy or effectiveness.

7. The Type of Ground Truth Used

For the purpose of this 510(k), the "ground truth" for the algorithm's performance is implicitly established by its equivalence to the predicate device's algorithm, which is published (Viertiö-Oja H et al., Acta Anaesthesiologica Scandinavica 2004). The "ground truth" for the device's safety and effectiveness is its adherence to recognized medical device standards (IEC, EN, UL, CAN/CSA) and its equivalence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable, as this is primarily a hardware device with an established algorithm (from the predicate). The document does not describe the development or training of a new AI algorithm.

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

Not applicable, as no new training set or new AI algorithm development is described in this submission. The algorithm itself is stated to be identical to the predicate: "The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907)." The algorithm's prior validation and publication (Viertiö-Oja H et al.) serves as its original basis.

Summary of Device Meeting Acceptance Criteria:

The GE Healthcare Entropy Module, E-ENTROPY-01, meets its acceptance criteria primarily through:

• Substantial Equivalence: Demonstrating that it is "as safe, as effective, and performance is substantially equivalent to the predicate device" (Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY-00, K061907) based on technical specification comparison.
• Adherence to Standards: Compliance with numerous national and international medical electrical equipment safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, etc.).
• Non-Clinical Testing: In-house system testing, usability validation, and software testing (DOC1221813 In-House Verification Report, DOC1208044 Usability Validation Plan, DOC1261218 Usability Testing Report, DOC1223430 E-ENTROPY-01 Verification Report) confirmed compliance with defined acceptance criteria in the verification plan (DOC1019758).

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The Mennen Medical VitaLogik BIS interface is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EBG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.

In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.

The VitaLogik is a multiparameter physiological patient monitor, capable of monitoring:

• ECG/Heart Rate
• Invasive blood pressure
• Non-invasive blood pressure
• Respiration
• Pulse oximetry
• Two temperature channels
• Cardiac output
• EtCo2
• Spirometry
• BBG
• BIS Interface (new subject of this application)

Main components of the VitaLogik: The VitaLogik system consists of:
(A) a Bed side computer with
(B) Display

(A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals.

The VitaLogik can acquire the following physiological signals of the patient:

• ECG Waveform and measures Heart Rate, ST and Arrhythmia
• Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
• Temperature As a numeric value in C or F
• SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
• NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
• EtCO2 EtCO2, inCO2 and Respiration Rate
• BIS Index of conciseness and EEG waveform

(B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message.

Operation of the VitaLogik is accomplished by interaction with front panel controls. A quickknob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is displayed.

The VitaLogik is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.

The VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display.

The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik).

In chapter 1, page 1-2 of the VitaLogik Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only"

Functional description of the new VitaLogik BIS Interface:
(Interface to Aspect BISx device cleared in K 040183)

The BIS Interface is used to monitor dual channel EBG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the VitaLogik monitor.

Here's an analysis of the provided text regarding the VitaLogik Patient Monitor with BIS Interface, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a device modification, specifically the addition of a BIS Interface to the existing VitaLogik Patient Monitor. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device (Envoy BIS Module). Therefore, the "acceptance criteria" are predominantly framed around matching the specifications and performance of the predicate device, rather than explicit numerical thresholds for clinical outcomes.

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The Datex-Ohmeda Entropy Module, E-Entropy and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters.

In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia.

The Entropy module is indicated for use by qualified medical personnel only.

The Entropy Module, E-ENTROPY, is a single-width plug-in parameter module for Datex-Ohmeda modular perioperative monitors, the S/5 AM. E-ENTROPY is a module used to calculate parameters from electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The E-ENTROPY module provides two spectral entropy parameters State Entropy (SE) and Response Entropy (RE). The E-ENTROPY module uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). Entropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm - a Datex-Ohmeda application of spectral entropy based on information theory. Calculated parameters are: Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FEMG. State Entropy, SE (range 0-91), continuous processed variable calculated from the EEG. SE is designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain. Burst Suppression Ratio, BSR (range -0-100%), the percentage of epochs in the pass 60 seconds in which the EEG signal is considered suppressed.

The provided document, a 510(k) premarket notification summary, primarily focuses on demonstrating substantial equivalence to a predicate device for updated indications for use, rather than presenting a detailed study supporting specific device performance acceptance criteria. The submission states that the proposed modifications to the indications for use do not involve changes to the module's hardware, software, or accessories, and that the device uses the identical Entropy algorithm as the predicate device (K050835). Therefore, the information typically found in a study demonstrating performance against acceptance criteria for a new device is largely absent.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria or present a table of reported device performance in the way a clinical study report would. Instead, it justifies the expanded indications for use based on the existing device's proven technology and scientific literature.

• Acceptance Criteria (Inferred from context): The implicit acceptance criteria are that the device, with its unchanged hardware/software, continues to perform as safely and effectively as the predicate device (K050835) for the expanded indications (pediatric patients > 2 years, aiding in titrating anesthetic drugs, reducing anesthetic use, and enabling faster emergence from anesthesia in adults).
• Reported Device Performance: The document states that the Datex-Ohmeda S/5™ Entropy Module, E-ENTROPY uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). The calculated parameters are:
  • Response Entropy (RE): range 0-100, continuous processed variable for fast detection of activation of facial muscles (FEMG).
  • State Entropy (SE): range 0-91, continuous processed variable calculated from the EEG, sensitive to the hypnotic effect of anesthetic drugs.
  • Burst Suppression Ratio (BSR): range 0-100%, percentage of epochs in the past 60 seconds where the EEG signal is suppressed.
    The document asserts that the updated indications are "based on independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare." This implies that external research and internal studies provided the evidence for the efficacy related to the new claims, but the details of these studies are not provided in this 510(k) summary.

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

This information is not explicitly stated in the provided 510(k) summary. The submission refers to "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare" for the scientific justifications. The specific sample sizes, study designs (retrospective/prospective), and data provenance (e.g., country of origin) for these underlying studies are not detailed here.

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

This information is not explicitly stated in the provided document. As the submission relies on existing scientific literature and internal studies, the details of expert involvement in establishing ground truth for those studies are not available here.

4. Adjudication Method for the Test Set

This information is not explicitly stated in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (and effect size)

This information is not explicitly stated in the provided document. The submission focuses on the device's technical characteristics being identical to the predicate and the justification for expanded indications based on existing literature.

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

The device itself is an "algorithm only" component (an Entropy module calculating parameters from EEG/FEMG signals). The document states, "The F-F.NTROPY module uses the identical Entropy algorithm... as the predicate device." It describes the module's function to "calculate parameters" (RE, SE, BSR). Therefore, the device operates in a standalone manner to generate these parameters. However, the application of these parameters is "to be used as an adjunct to other physiological parameters" and "by qualified medical personnel only," implying a human-in-the-loop for interpretation and clinical decision-making. No separate "standalone performance study" of the algorithm independent of a human is detailed, as its core function is the calculation itself, which is already established by the predicate device.

7. The Type of Ground Truth Used

Based on the nature of the device (monitoring neurophysiological status and effects of anesthetic agents), the ground truth for the "scientific justifications" would likely involve:

• Clinical Outcomes/Physiological Correlates: For claims like "titrate anesthetic drugs according to the individual needs," "reduce the amount of certain hypnotic drugs," and "enable faster emergence from anesthesia," the ground truth would be established through clinical outcomes (e.g., patient awakening times, actual drug dosages administered, clinical assessment of depth of anesthesia) correlated with Entropy parameter readings.
• Expert Clinical Assessment/Consensus: The determination of "state of the brain" or "effects of certain anesthetic agents" would typically involve an expert's clinical judgment, potentially supported by other physiological monitors and patient responses.
• Pathology/Biomarkers: Unlikely to be the primary ground truth for this type of device, but could potentially be part of broader research into anesthetic mechanisms.

The document states these justifications come from "independent, peer-reviewed and published scientific articles in medical journals, as well as studies made internally at GE Healthcare," suggesting that the ground truth methods used in these underlying studies would be diverse and appropriate for clinical research in anesthesiology.

8. The Sample Size for the Training Set

This information is not applicable or not provided.

• It's "not applicable" in the context of this submission because the device's algorithm is identical to the predicate. The algorithm itself was already developed and validated with a "training set" for the predicate device (K050835). This submission is for expanded indications, not a new algorithm.
• If we consider the original development of the Entropy algorithm, the details of its training set would reside in the documentation for the predicate device (K050835), or the external peer-reviewed literature and internal GE Healthcare studies referenced. These specifics are not provided in this document.

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

Similar to point 8, this information is not applicable or not provided in this specific 510(k) submission. The ground truth for the original algorithm development (i.e., for the predicate device) would have been established through clinical trials and expert correlation of EEG/FEMG signals with anesthetic depth and patient state. The precise methods would be detailed in the documentation for K050835 or the scientific literature that informed its development.

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A. Indications for use for BIS EEG Monitor System (VISTA Monitor and BISx4): The BIS EEG VISTA Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. B. Indications for use for BISx device: The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The BISx, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the BISx output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.

A. BIS EEG VISTA Monitor System: The BIS EEG VISTA Monitor System, is comprised of the BISx4, the VISTA Monitor, and associated cables. When the System is connected to a BIS Sensor (which is applied to the patient's forehead, acquires EEG signals from the brain, and is 510(k) cleared) the monitor displays 2 channels of EEG. When the System is connected to a BIS Bilateral Sensor (also 510(k) cleared), the monitor displays 4 channels of EEG. The BISx4 houses the digital signal converter as well as the BIS algorithm (it has no display or user interface), and it performs the computations necessary to produce the Bispectral Index (BIS). It also calculates SQI, EMG, Burst count and Suppression Ratio. The BISx4 may be distributed to business partners that have the ability to display BIS on their patient monitors. The Monitor displays a maximum of 4 channels of EEG, as well as SQI, EMG, Burst Count, Suppression Ratio and a BIS value. The BIS value is acquired using 2 channels of EEG. The Monitor has secondary trend and trend review screens, as well as results of self tests. In addition to the above, when connected to a Bilateral Sensor, the System provides additional capability as follows: BISx4 calculates DSA, Asymmetry, sBIS, and sEMG. The Monitor displays DSA, Asymmetry, sBIS, and sEMG numerically and graphically. B. BISx device: The BISx is a component that processes up to 2 channels of EEG and computes BIS and other EEG parameters (same as the cleared BISx device). The BISx connects to Aspect sensors on one side and the Aspect Monitor or OEM patient monitoring systems on the other, allowing them to display BIS on their integrated patient monitoring systems. The OEMs are responsible for the regulatory pathway to integrate the BISx in their systems. The software is a moderate level of concern. This submission is updating the indications for use statement for the BISx device, to reflect the addition of clinical benefits added at FDA request to the BIS EEG VIEW Monitor, 510(k) (K#062613, recently cleared on 6/18/07). No change is being made to the cleared BISx device (#K040183).

The provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that rigorously proves the device meets those criteria in a quantitative sense suitable for a table. The submission is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than independent performance validation against predefined clinical acceptance criteria.

The "Summary of Testing" section (in {3}) states: "The following tests/analyses have been completed for the BIS EEG VISTA Monitor System: Software Validation, Hazard Analysis and Risk Assessment. Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use."

This statement confirms that internal tests were conducted to ensure the device performs as intended and is safe, but it does not provide details on:

• Specific performance specifications or acceptance criteria.
• Quantitative results from these tests.
• Methodology of how these criteria were established or evaluated.
• Any clinical study (e.g., MRMC, standalone) involving human readers or a comparison against a clinical ground truth.

Therefore, I cannot provide the requested table or detailed study information based on the given text.

Here's an assessment of the other requested points based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the document. The document states "Results indicate the device meets its performance specifications and validation test requirements," but does not list these specifications or the corresponding performance outcomes.

2. Sample size used for the test set and the data provenance:

   • Not provided in the document. The document mentions "Software Validation" and "Hazard Analysis and Risk Assessment" as completed tests, but does not specify any test set size or data provenance for these. This typically implies internal engineering and software testing rather than a clinical trial with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not provided in the document. Since no clinical test set is detailed, information about experts and ground truth establishment is absent.

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

   • Not applicable/Not provided. No clinical test set or adjudication process is described.

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 study was not described. The document focuses on substantial equivalence and safety/performance specifications, not on comparative effectiveness with human readers.

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

   • Implied, but details not provided. The BISx4 and BISx calculate the Bispectral Index (BIS) and other parameters algorithmically. The "Software Validation" mentioned implies testing of this algorithm's performance against its specifications, which is a form of standalone testing. However, no specific metrics, methods, or results of this standalone performance are given beyond a general statement of meeting specifications.

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

   • Not provided in the document. Without details on specific performance tests, the type of ground truth used to validate the algorithms (e.g., against reference EEG signals or clinically established states of anesthesia) is not mentioned.

8. The sample size for the training set:

   • Not applicable/Not provided. This device calculates physiological parameters based on established algorithms (e.g., for EEG signal processing, Bispectral Index). It's unlikely to be a machine learning model that requires a distinct "training set" in the modern sense. The algorithms are likely fixed based on biomedical engineering principles and prior research.

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

   • Not applicable/Not provided. (See point 8).

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The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

• The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.
• In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring:

• ECG/Heart Rate .
• Invasive blood pressure .
• Non-invasive blood pressure ●
• Respiration ●
• Pulse oximetry
• Two temperature channels ●
• Cardiac output ●
• EtCo2 .
• Spirometry ●
• EEG ●
• BIS module (new subject of this application) .

The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.

The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA.

The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.

The Mennen Medical Envoy BIS module is a modification to the existing Envoy Patient Monitor, adding Bispectral Index (BIS) monitoring capabilities. The device claims substantial equivalence to the predicate device, the Spacelab Medical Bispectral Index (BISx) Analysis Module 91482 (K060900).

The provided text outlines the functional description of the new BIS module and its comparison to the predicate device, focusing on display formats, data storage, and alarm functionalities. It also references "performance testing" and "SW Validation" but lacks specific details regarding acceptance criteria and the results of these studies.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence by comparing the functional and technical specifications of the Envoy BIS module with the predicate device. The primary claim for acceptance is that the Envoy BIS module's function to display BIS parameters and quality parameters, and its alarm capabilities, are equivalent to the predicate device.

The document highlights the following parameters and their ranges as displayed and stored by the Envoy monitor, which are derived from the BISx unit:

The "Similarities" and "Differences" sections (Page 9) act as an indirect comparison of performance criteria, stating that differences in display options between the two devices "do not change the efficiency of BIS and EEG displays of both monitors," implying an equivalence in performance.

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

The document does not provide details on the sample size used for any specific test set related to the BIS module. There is no mention of human subject data, country of origin, or whether it was retrospective or prospective. The testing described primarily appears to be technical validation against the predicate device's performance.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for any test set. The validation primarily focuses on comparing technical specifications and functional equivalence.

4. Adjudication Method for the Test Set

No information on an adjudication method for a test set is provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned, nor is any effect size for human reader improvement with or without AI assistance. The device is a patient monitor, not an AI diagnostic tool involving human reader interpretation. The BIS module aids in monitoring the effects of anesthetic agents to help guide administration and potentially reduce awareness with recall, but this is a clinical utility, not a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The BIS module itself processes EEG signals to generate the BIS index and related parameters. This processing can be considered "standalone" in the sense that the algorithm generates these outputs without direct human intervention in the calculation process. The device functions to "display the BIS parameter and the quality parameters" and to "provide alarm limits for the BIS index and provide visual and audible alarms." These outputs are generated by the device's algorithms based on the input from the BISx unit. However, the context of the question often implies a comparison to a clinical ground truth, which is not detailed here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this submission is the established performance and output of the predicate device, the Spacelab Bispectral Index (BISx) Analysis Module 91482. The entire submission is built on demonstrating substantial equivalence to this legally marketed device. The "Substantial Equivalence Discussion" (Page 5) directly compares the Envoy BIS module's specifications and functionality to the predicate.

8. The Sample Size for the Training Set

No information is provided regarding a training set sample size. The device is not described as utilizing machine learning or AI that would typically involve a training set for model development. Its function appears to be based on established algorithms for processing EEG signals and deriving the BIS index, which are derived from the OEM (Aspect BISx).

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

As no training set is mentioned for the Envoy BIS module itself, there is no information on how its ground truth was established. The core processing capabilities for the BIS index are derived from the Aspect BISx unit (OEM agreement), suggesting that any fundamental ground truth for the BIS algorithm would have been established during the development and clearance of the original BISx device (K040183 and subsequently K060900 for the predicate).

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