(329 days)
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)
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- acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead,
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- converts acquired analog EEG signals into digital EEG signals, and
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- 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).
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance |
|---|---|
| WAVCNS Index: Discriminate effectively between clinical endpoints (LOS, ROC). | The WAVCNS index was shown to discriminate effectively between clinical endpoints such as loss of consciousness during propofol induction and return of consciousness during emergence from inhalational anesthesia. |
| WAVCNS and SR: Correlate with changes in inhalational anesthetic dosing. | Both the WAVCNS and SR were shown to correlate with changes in inhalational anesthetic dosing. |
| WAVCNS Index: Appropriate range for general anesthesia. | The WAVCNS range of 40 to 60 was found to be appropriate for general anesthesia. |
| SR: Excellent agreement with predicate device's SR calculation. | The re-processed data from the clinical trial to compare the SR parameter calculated by the subject device with that calculated by the predicate showed an excellent agreement between the two SR measures in this patient population. |
| Safety: No new questions of safety or effectiveness compared to predicate. | Clinical data collected in the operating room showed no adverse effects or complications. The nonclinical and clinical performance data demonstrate the subject device is as safe and effective as the predicate device. Additionally, the device complies with electromagnetic compatibility (EMC), electrical safety, and other safety standards (IEC 60601-1, 60601-2-26, 60601-1-2, 60601-1-8, 62133, etc.). |
| Overall: Substantial equivalence to predicate for intended use. | The study concluded that the subject device is substantially equivalent to its predicate for use as an aid in monitoring the hypnotic effect of anesthetics, as its indications for use are a subset of (narrower than and encompassed by) the predicate device's indications, and no new questions of safety or effectiveness arise. |
Study Details:
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).