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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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