(173 days)
The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.
The Ceribell Instant EEG Headcap is comprised of the following components:
- An elastic fabric headcap
- An elastic chin strap
- A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes
- A cable attached to the headcap to allow connection to an EEG acquisition/recording device
The Ceribell Instant EEG Headcap is a cutaneous electrode device. The provided text outlines the acceptance criteria and performance data for this device, comparing it to a predicate device (Wuhan Greentek Disposable EEG Electrodes, K200162) to establish substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ceribell Instant EEG Headcap are based on the same requirements as its predicate device and defined by FDA-recognized consensus standards, primarily ANSI/AAMI EC12 Disposable ECG Electrodes and ISO 10993 series for biocompatibility.
| Attribute | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Electrical Performance | ||
| Average AC Impedance | ≤ 2 kΩ (individual pairs ≤ 3kΩ) (ANSI/AAMI EC12) | Met the same requirements per FDA guidance document. |
| DC Offset Voltage | ≤ 100 mV (ANSI/AAMI EC12) | Met the same requirements per FDA guidance document. |
| Combined Offset Instability and Internal Noise | ≤ 150 μV (ANSI/AAMI EC12) | Met the same requirements per FDA guidance document. |
| Bias Current Tolerance (DC Voltage Offset) | ≤ 100 mV (ANSI/AAMI EC12) | Met the same requirements per FDA guidance document. |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1". |
| Sensitization, Irritation or Intracutaneous Reactivity | ISO 10993-10 | Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1". |
| Electrical Connection Compliance | Conductive Connection Compliance per ES 60601-1, IEC 60601-1 clause 8.5.2.3, 21 CFR 898.12 | Met the same requirements per FDA guidance document. |
| Shelf Life | ANSI/AAMI EC12 and IEC 60601-2-2 | Testing completed (results not explicitly detailed, but implied compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test sets (e.g., number of EEG headcaps or subjects) used for each performance test. It only mentions that performance data was "provided" and "completed testing" was done.
Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The Ceribell Instant EEG Headcap is a physical medical device (an electrode headcap), not an AI algorithm or diagnostic tool that requires expert interpretation for ground truth establishment. The performance criteria are objective measurements of electrical properties and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable as the tests performed are objective physical and electrical measurements, not interpretive clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. The Ceribell Instant EEG Headcap is a hardware device for signal acquisition.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical electrode headcap, not an algorithm. Its performance is measured through objective electrical and biocompatibility testing, not algorithmic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed on the Ceribell Instant EEG Headcap is based on established industry standards and objective measurable physical and electrical properties. For example:
- Electrical Performance: The ground truth is defined by the limits set in ANSI/AAMI EC12.
- Biocompatibility: The ground truth is defined by the pass/fail criteria of ISO 10993 tests (e.g., absence of cytotoxicity, sensitization, irritation).
8. The Sample Size for the Training Set
This is not applicable. The Ceribell Instant EEG Headcap is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 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).