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510(k) Data Aggregation
(29 days)
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. 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
This FDA 510(k) summary for the Ceribell Instant EEG Headband (K232052) explicitly states "Performance Data: None required." and that the device is identical to its predicate (K210805) with only a modified Indications for Use Statement and associated labeling.
Therefore, the provided document does not contain the information necessary to answer the questions regarding acceptance criteria and a study that proves the device meets those criteria. It indicates that no performance data was needed for this specific submission because the device is essentially a re-labeled version of a previously cleared device.
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(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.
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(95 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 6 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 (K170363) 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 Ceribell Instant EEG Headband is a Class II medical device (product code GXY) intended for single-patient use in recording EEGs for patients aged 6 years and older. It is disposable, non-sterile, and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363). The headband comprises an elastic fabric headband, a cable for connection to an EEG acquisition/recording device, and 10 electrode assemblies. Each electrode assembly contains a passive silver/silver-chloride electrode, a reservoir filled with conductive electrolyte gel, a mechanism for dispensing gel, and scalp-contacting prongs for scalp preparation.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
|---|---|---|
| Electrode Impedance | Meets ANSI/AAMI EC12 5.2.2.1 requirements. | All samples passed. |
| Electrode DC Offset Voltage | Meets ANSI/AAMI EC12 5.2.2.2 requirements. | All samples passed. |
| Combined Offset Instability and Internal Noise | Meets ANSI/AAMI EC12 5.2.2.3 requirements. (Peak-to-peak passband voltage measured over 5 min after 1 min stabilization) | All samples passed. |
| Defibrillation Overload Recovery | Meets ANSI/AAMI EC12 5.2.2.4 requirements. (DC offset voltage and AC impedance after 4 simulated defibrillation discharge events) | All samples passed. |
| Bias Current Tolerance | Meets ANSI/AAMI EC12 5.2.2.5 requirements. (DC offset voltage over 8 hours with 200 nA bias current) | All samples passed. |
| Conductive Gel Delivery/Skin Prep Testing | • Integrated conductive gel can be properly dispensed. • Additional gel can be added by the user.• Aluminum oxide powder is present on scalp-contacting surfaces. | All samples passed. |
| Headband Size Range Testing | Measured headband sizes match specified ranges (Small, Medium, Large). | All samples passed. |
| Simulated Use Testing | Device functions correctly under simulated use conditions with mannequin heads (including long hair). | All samples passed. |
| Packaging Performance Testing | Device remains visually intact, functions, and performs electrically after environmental conditioning and shipping tests (per ASTM D7386). | All samples passed. |
| Biocompatibility Testing | • Cytotoxicity: Meets ISO 10993-5.• Irritation and Sensitization: Meets ISO 10993-10. | All samples passed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each test in the performance data section. It consistently uses the phrase "All samples passed" for each test. The provenance of the data is that it was generated from performance testing conducted on the subject device (Ceribell Instant EEG Headband). The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though performance testing studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the performance data presented primarily consists of engineering and biocompatibility testing against recognized standards (e.g., ANSI/AAMI EC12, ISO 10993) and functional verification tests. These tests do not involve expert interpretation or establishing ground truth in the way clinical studies with human assessors would.
4. Adjudication method for the test set
This section is not applicable for the same reasons above. The performance tests involve objective measurements against predefined criteria in established standards rather than subjective assessments requiring adjudication.
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
The document does not indicate that an MRMC comparative effectiveness study was done. The device described is an EEG electrode array (cutaneous electrode), not an AI-powered diagnostic algorithm or analysis tool. Its purpose is for the recording of EEG signals, not their interpretation or analysis using AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) for signal acquisition, not a standalone algorithm.
7. The type of ground truth used
For the performance tests:
- The "ground truth" or reference for the electrical performance tests (e.g., Impedance, DC Offset Voltage, Bias Current Tolerance, Defibrillation Overload Recovery, Combined Offset Instability and Internal Noise) was the specific requirements and methodologies outlined in the ANSI/AAMI EC12 standard.
- For the biocompatibility tests, the ground truth was the specific requirements and methodologies outlined in ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
- For functional tests (e.g., Conductive Gel Delivery/Skin Prep Testing, Headband Size Range Testing, Simulated Use Testing, Packaging Performance Testing), the ground truth was the pre-defined functional specifications and expected performance criteria established for the device.
8. The sample size for the training set
This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set mentioned for this hardware device.
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