(148 days)
The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).
The provided document is a 510(k) summary for the Cerebral State Monitor (CSM) and the FDA clearance letter. It states that the device is substantially equivalent to predicate devices but does not contain detailed information about acceptance criteria or specific studies showcasing performance data in the structured format requested. The document explicitly states: "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)". This indicates that the device itself is a measurement tool and not an AI or algorithm-driven diagnostic device as implied by some of the questions.
Therefore, many of the requested details, such as sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance details, and how ground truth for training was established, are not present in this regulatory document.
However, based on the information available, I can construct a table for the acceptance criteria and intended use, and provide what limited information is available regarding performance.
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Intended Use: The CSM is intended for use in monitoring the state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital. The CSM is a non-invasive measurement tool to be used by a trained professional to measure the level of consciousness during general anaesthesia or sedation by use of CSI. | The document states, "The performance data indicate that the Cerebral State Monitor - CSM meets all specified requirements, and is substantially equivalent to the predicate devices." | The specific "specified requirements" or performance metrics (e.g., accuracy, precision) that were met are not detailed in this summary. The substantial equivalence claim suggests it performs comparably to the predicate devices. |
| Technological Characteristics: Comparable to predicate devices (Danmeter A/S AEP Monitor K010965 and Aspect Medical Systems A-2000 EEG Monitor with BIS K974496). | A comparison of the technological characteristics...demonstrate that the Cerebral State Monitor - CSM is equivalent to the marketed predicate devices. | Specific functional or technical specifications are not enumerated in this summary statement. |
| Safety: Device must meet general safety requirements for medical devices. | Implied by FDA clearance. The 510(k) clearance confirms the device is safe and effective for its stated indications for use, based on substantial equivalence. | |
| Effectiveness: Device must be effective for its intended use. | Implied by FDA clearance. Stated as "substantially equivalent to the predicate devices," suggesting similar effectiveness. | The document explicitly states that the CSM displays an index (CSI) but does not perform any data interpretation. All interpretation is performed by a physician. This is a crucial distinction from an AI-driven diagnostic device. |
Study Details and Data Provenance
- Sample size used for the test set and the data provenance: Not specified in the provided document. As the device is primarily a measurement tool and does not perform "data interpretation," it is unlikely a "test set" in the context of an algorithm's diagnostic performance was used or described in this type of submission. Performance is assessed against technical specifications and equivalence to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Ground truth in the context of diagnostic accuracy is not directly applicable here as the device does not perform diagnosis. The document states "all data interpretation is performed by a physician."
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable based on the information provided.
- 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. The CSM is a monitoring device that provides an index (CSI) for human interpretation; it is not described as an AI-assisted diagnostic tool designed to improve human reader performance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states, "The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician)." This confirms that the device is not designed for standalone diagnostic performance; it is a measurement tool.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified as the device does not perform diagnosis. The "ground truth" for a monitor typically relates to the accuracy and reliability of its measurements against established physiological standards or reference devices, which is not detailed here. The "level of consciousness" is a clinical assessment made by a physician using various inputs, including the CSI.
- The sample size for the training set: Not specified and likely not applicable in the context of an AI training set, as the device is not described as an AI/ML algorithm for diagnosis.
- How the ground truth for the training set was established: Not specified and likely not applicable for the reasons stated above.
§ 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).