(166 days)
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 2 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.
The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording.
The Ceribell Instant EEG Headband is comprised of the following components:
- An elastic fabric headband
- A cable attached to the headband to allow connection to an EEG acquisition/recording device
- 10 electrode assemblies, each consisting of the following:
- Passive Silver/silver-chloride electrode
- Reservoir filled with conductive electrolyte gel
- Mechanism for dispensing gel onto patient scalp
- Scalp-contacting prongs to prepare scalp for electrode contact
The provided document is a 510(k) premarket notification decision letter from the FDA to Ceribell, Inc. regarding their Instant EEG Headband. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the device's diagnostic performance against established acceptance criteria.
The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The "Performance Data" section within the 510(k) Summary lists the types of testing performed:
- Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10
- Bench testing and simulated use testing to verify system performance including testing and evaluation to ANSI EC12-2000 and IEC 60601-1 requirements.
- Shelf life testing
These tests are related to the safety and functionality of the electrode array itself (biocompatibility, electrical safety, durability, and signal acquisition quality) and not to the diagnostic performance of an AI algorithm or human-in-the-loop performance related to interpreting EEG signals. The device described is a cutaneous electrode array, not an AI-powered diagnostic tool.
Therefore, the requested information regarding acceptance criteria for AI algorithm performance, sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance is not present in this document because the device being cleared is an EEG headband (hardware), not a software algorithm for interpreting EEG.
To answer your request, if this were an AI/software as a medical device (SaMD) submission, the following sections would typically be present, but they are absent here due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance: This would typically define metrics (e.g., sensitivity, specificity, AUC) and their target values, along with the actual results from the study. (Not applicable/Not present)
2. Sample size used for the test set and data provenance:
* Sample Size: Not applicable.
* Data Provenance: Not applicable.
3. Number of experts used to establish ground truth and qualifications:
* Number of Experts/Qualifications: Not applicable, as there is no diagnostic AI component requiring ground truth for interpretation.
4. Adjudication method for the test set:
* Adjudication Method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* MRMC Study: No, this is a hardware device.
6. If a standalone (algorithm only) performance was done:
* Standalone Performance: No, this is a hardware device.
7. The type of ground truth used:
* Ground Truth: Not applicable.
8. The sample size for the training set:
* Training Set Sample Size: Not applicable.
9. How the ground truth for the training set was established:
* Training Set Ground Truth Establishment: Not applicable.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).