(66 days)
The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A dcrived measure provided by the SNAP II, the SNAP Index, indicates the patient's brain activity level.
The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.
The Everest Biomedical SNAP II EEG monitor is an Electroencephalograph per 21 CFR 882.1400, which has an intended use that is consistent with the CAV/ classification.
The SNAP II is substantially equivalent in design, construction, materials, intended use and performance characteristics to the predicate devices.
The provided FDA submission for the Everest SNAP II EEG Monitor (K660997) does not contain detailed information regarding acceptance criteria or the specific study that proves the device meets such criteria in terms of clinical performance or accuracy of the "SNAP Index."
Instead, the submission primarily focuses on establishing substantial equivalence to a predicate device (Nicolet SNAP EEG Monitor, K020218) by demonstrating similar design, construction, materials, intended use, and performance characteristics. The "performance" mentioned in this context refers to in-vitro testing confirming the device meets "similar performance specifications" to the predicate, likely related to electrical safety, EMC, and basic signal acquisition, rather than a clinical performance study evaluating the accuracy of the SNAP Index.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for the "SNAP Index" or overall clinical performance of the device. It only states: "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance or SNAP Index accuracy. The document focuses on regulatory compliance and equivalence to predicate device specifications without detailing specific performance metrics for the SNAP Index. | "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "in vitro testing" but gives no details about participant sample size, characteristics, or data provenance for any performance evaluation specific to the SNAP Index.
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)
This information is not provided. The document makes no mention of expert-established ground truth or clinical studies with expert reviewers for the SNAP Index.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No adjudication method is described, as there are no details of a clinical test set with expert review.
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
An MRMC comparative effectiveness study is not mentioned or implied. The device is an EEG monitor with a derived index, not an AI-assisted diagnostic tool for human readers in the context of the typical MRMC study design.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study specifically for the "SNAP Index" (algorithm only) is not detailed. The submission primarily focuses on the device's electrical safety and functional equivalence, not the clinical accuracy or performance of the SNAP Index as a standalone measure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for evaluating the "SNAP Index" is not specified. The document does not describe how the accuracy or clinical utility of the SNAP Index was validated with a ground truth.
8. The sample size for the training set
This information is not provided. The document does not discuss any training sets, implying that the device's development and validation for regulatory purposes did not involve machine learning models with specific training data as might be expected in modern AI submissions.
9. How the ground truth for the training set was established
This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also absent.
§ 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).