(195 days)
Cervella Cranial Electrotherapy Stimulator (CES) is indicated for treatment of insomnia, depression, or anxiety.
Cervella Cranial Electrotherapy Stimulator (CES) is a device that delivers small pulses of electrical current through patient's brain. The stimulator is powered by an internal rechargeable battery which provides a low-level constant current to the cranium via a pair of conductive electrodes placed bilaterally on the mastoid process. The electrodes are incorporated into earpads of stereo over-ear noise-cancelling headphones. The patient can use the audio (through a separate dedicated Bluetooth connection) and noise cancelling features of the stereo headphones during treatment (e.g. music listening). The stimulator is controlled via a software application (app) installed on the patient's smart device (e.g. smartphone). The app communicates with the device through a dedicated Bluetooth® LE connection that is independent of the optional Bluetooth connection for audio listening purposes. The patient uses the app to adjust the intensity level, frequency, and duration of the treatment. The app also allows the patient to automatically store the treatment history for review by the patient's healthcare provider.
This submission lacks specific acceptance criteria and detailed study results to demonstrate device performance against those criteria. The provided document is a 510(k) summary, which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined performance acceptance criteria through clinical studies.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of clinical or technical performance metrics (e.g., specific reduction in anxiety scores, minimum current output accuracy, etc.) and then report the device performance against those criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared design, operating principles, and compliance with general safety and performance standards.
The table presented in the "IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE" and "X. SUMMARY OF SIMILARITIES AND DIFFERENCES" sections compares the Cervella device's characteristics to its predicate devices, CES Ultra and Alpha-Stim CS. This comparison serves as the de facto "performance data" that the manufacturer presented for substantial equivalence, rather than a direct measurement against pre-defined acceptance criteria for a new clinical claim.
| Property | Cervella (Reported Performance) | Predicate 1 (CES Ultra) | Predicate 2 (Alpha-Stim CS) | Differences and Comments |
|---|---|---|---|---|
| Indications for Use | Treatment of insomnia, depression, or anxiety. | Treatment of insomnia, depression, or anxiety. | Treatment of insomnia, depression, or anxiety. | None |
| Waveform | Symmetrical Biphasic Square Wave | Symmetrical Biphasic Square Wave | Symmetrical Biphasic Square Wave | None |
| Current Intensity Range | 0µA – 500µA adjustable in 50µA increments | 0µA — 1500µA continually adjustable | 0µA — 500µA adjustable in 50µA increments | Same range as Alpha-Stim, narrower range than CES Ultra |
| Pulse Width Range | 5ms - 1s (varies depending on frequency selection) | 2ms | 250ms - 1s | Pulse width varies depending on frequency selection |
| Number of electrodes | Two | Two | Two | None |
| Electrode Placement | Head (Mastoid process) | Head (Mastoid process or Earlobes) | Head (Earlobes) | Same placement as CES Ultra |
| Power Source | Li-ion Battery (3.7V) (rechargeable) | Alkaline Battery (9V) | Alkaline Battery (3V) | Cervella battery is rechargeable |
| Frequency selections | 0.5Hz, 1.5Hz, 100Hz | 100Hz | 0.5Hz, 1.5Hz, 100Hz | Same frequency selection as Alpha-Stim CS |
| Treatment Range | 10 min – 60 min in 10 min intervals | 30 min, 60min, or continuous | 10, 20, 60 minutes or continuous | Same min-max range as Alpha-Stim |
| Unit Controls | Via Bluetooth-enabled smart device featuring Cervella app | Built into the device | Built into the device | Wireless operation |
| Treatment history logging | Automatic | Not available | Not Available | New feature |
| Ability for patient to use audio and noise cancelling feature of headset during treatment | Optional via dedicated separate Bluetooth connection | Not available | Not Available | New feature |
| Dimensions and weight | 7cm x 7cm x 2cm | 13.5cm x 6.4cm x 3.3cm | 9.8cm x 6.3cm x 2cm | Cervella is slightly smaller |
| Enclosure | Plastic | Plastic | Plastic | None |
2. Sample size used for the test set and data provenance:
The document (a 510(k) summary) does not describe a clinical "test set" in the context of typical AI/ML performance evaluation (e.g., a cohort of patients whose data is used to validate an algorithm's diagnostic or therapeutic efficacy).
The performance data cited are primarily bench testing against electrical safety and performance standards for medical devices (ES60601-1:2005, IEC 60601-1-2, IEC 60601-2-10, IEC 62133). These tests do not involve patient data or clinical outcomes. Therefore, there is no information on sample size, country of origin, or whether it was retrospective or prospective data in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. As noted above, there was no clinical test set requiring expert ground truth establishment for diagnostic or therapeutic accuracy. The ground truth for electrical safety and performance standards is defined by the standards themselves, not by expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The Cervella device is a Cranial Electrotherapy Stimulator (CES), a standalone therapeutic device, not an AI-assisted diagnostic or interpretive tool that would typically be evaluated in an MRMC study with human readers. The document does not describe any such study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone therapeutic device. Its core function – delivering electrical stimulation – is algorithm-driven in terms of current intensity, frequency, and duration programming, but it's not an "AI algorithm" in the typical sense of a diagnostic or predictive model. The performance data provided is mainly about its physical and electrical characteristics conforming to standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy.
7. The type of ground truth used:
For the evaluation described, the "ground truth" was compliance with mandatory and voluntary medical device safety and performance standards (e.g., IEC 60601 series). These standards define the expected electrical output, safety features, and battery performance. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the purpose of this 510(k) submission, as it focuses on substantial equivalence of physical and electrical parameters.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the typical sense to learn patterns or make predictions. Its operation is based on predefined electrical parameters.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 882.5800 Cranial electrotherapy stimulator.
(a)
Identification. A cranial electrotherapy stimulator is a prescription device that applies electrical current that is not intended to induce a seizure to a patient's head to treat psychiatric conditions.(b)
Classification. (1) Class II (special controls) when intended to treat insomnia and/or anxiety. The special controls for this device are:(i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety.
(ii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified.
(vi) The labeling for the device must include the following:
(A) The intended use population and the intended use environment;
(B) A warning that patients should be monitored by their physician for signs of worsening;
(C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur;
(D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur;
(E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device;
(G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and
(H) Information on validated methods for reprocessing any reusable components between uses.
(vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
(2) Class III (premarket approval) when intended to treat depression.
(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.