(134 days)
The Spacelabs Medical 90482 BIS Module is intended to monitor the state of the brain by data acquisition of EEG signals in the intensive care unit, operating room and for clinical research. The Bispectral Index (BIS), a processed EEG variable, may be used as an aid in monitoring the effects of certain anesthetic agents.
The Spacelabs Medical 90482 BIS Module is a slim, lightweight singular modular unit that, when used in conjunction with a Spacelabs Medical Patient Care Information System (PCIS), provides the capability to acquire, process and display one (1) or two (2) channels of brain electrical activity (EEG). The EEG data is processed to derive a Bispectral Index (BIS) to correlate the EEG activity to the state of the brain. Other trended parameters may also be processed, including spectral edge frequency, electromyogram activity, median power frequency, a signal quality index, and suppression of the EEG signal. The Module is the primary interface to the patient monitored. The Module is capable of acquiring and processing EEG signals for a single patient. The Module accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical Patient Care Information System (PCIS) monitor via SDLC communications. The PCIS system provides the display, review and editing capabilities for the care provider.
The provided text describes a 510(k) submission for the Spacelabs Medical 90482 Bispectral Index Analysis (BIS) Module. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, specific study details, and quantifiable performance cannot be fully extracted from this document. However, based on the information available, here's what can be provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study. Instead, it relies on the concept of substantial equivalence to an existing predicate device. The primary "performance" stated is that the device uses the identical bispectral analysis algorithm as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate EEG/BIS monitor | Acquires, processes, and displays EEG and derived BIS values. |
| Utilizes identical bispectral analysis algorithm | Uses bispectral analysis algorithm licensed from Aspect Medical Systems. |
| Safe for its intended use | Final testing for system includes various performance tests ensuring functional specifications. Safety testing (IEC 601-1, C22.2 No. 601-1, IEC 601-2-26) performed by third-party agencies. |
| Effective for its intended use (aid in monitoring anesthetic effects) | Stated as "as safe and effective as the predicate device... no new safety or effectiveness issues." |
| Compatible with Spacelabs Medical Patient Care Information System (PCIS) | Designed for modular compatibility with Spacelabs PCIS systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a specific "test set" in the context of clinical data or patient samples being used to evaluate the device's performance against ground truth. The testing described is primarily performance testing (ensuring functional specifications) and safety testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a clinical study with a test set requiring expert-established ground truth. The "ground truth" for the device's functionality is implicitly derived from its ability to implement the same algorithm as a previously cleared device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication 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
Not applicable. This document describes a medical device, the BIS Module, which is an EEG processing and display system. It does not describe an AI system that assists human readers in interpreting images or data. The BIS Module itself provides a processed numerical value (BIS) that aids clinicians, but it's not framed as an "AI assistance" in the typical sense of a diagnostic interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself, the Spacelabs Medical 90482 BIS Module, functions as a standalone algorithm (or set of algorithms) to acquire, process, and display EEG signals and derived BIS values. Its performance is inherent in its design and implementation of the licensed bispectral analysis algorithm. The "testing" mentioned confirms its functional specifications and safety. The entire device essentially represents the "algorithm only" performance in extracting the BIS index from EEG data, which is then presented to human clinicians for interpretation in the context of patient care.
7. The Type of Ground Truth Used
For the functional and safety testing described, the "ground truth" would be:
- Functional Specifications: The device's internal design and expected output values based on known input signals.
- Safety Standards: Compliance with recognized international safety standards (e.g., IEC 601-1, C22.2 No. 601-1, IEC 601-2-26).
- Algorithm Equivalence: The gold standard is the Aspect Medical Systems' bispectral analysis algorithm, as the Spacelabs device explicitly licenses and uses this identical algorithm.
8. The Sample Size for the Training Set
Not applicable. This device utilizes a licensed algorithm. It is not described as involving a machine learning model that would require a separate training set. The algorithm's development (by Aspect Medical Systems) would have involved its own dataset for validation, but that information is not part of this 510(k) submission for the Spacelabs device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned in the context of this device. The ground truth for the licensed algorithm's development (done by Aspect Medical Systems) would likely have been established through correlation of BIS values with clinical states of anesthesia, potentially using expert consensus, pharmacological studies, and patient outcomes, but these details are not in this document.
§ 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).