(241 days)
The CES Ultra is indicated for the treatment of insomnia. depression or anxiety.
The CES Ultra is a device designed to deliver therapeutic electrical and stimulation for cranial electrotherapy stimulation (CES) applications. The stimulator is powered by a standard 9-volt alkaline battery and delivers a single channel of low-level, constant current electrical stimulation to electrodes connected to the patient's skin via conductive lead wires. Stimulation current is applied to the patient via either standard self-adhering conductive electrodes placed on the head or conductive clip-type electrodes attached to the patient's ear lobes. The stimulator's user controls include: a rotary stimulation amplitude control which allows user adjustment of stimulation current and includes an integral power on/off switch; and a pushbutton timer selector switch which allows user selection of either continuous stimulation or timed stimulation sessions with automatic stimulation shut-off.
The provided text is a 510(k) summary for the CES Ultra™ Stimulator, which is a Cranial Electrotherapy Stimulator (CES). Based on the information provided, no specific acceptance criteria or a study proving the device meets those criteria were required or conducted for this 510(k) submission.
Here's a breakdown of why and what information is available based on your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Reasoning: The document explicitly states: "Neither nonclinical nor clinical testing was required to demonstrate the substantial equivalence of the CES Ultra to the designated predicate devices." This means no specific performance criteria linked to clinical outcomes were set for this submission. The basis for clearance was substantial equivalence to already marketed devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable, as no clinical or nonclinical testing was required or conducted to demonstrate substantial equivalence against specific performance criteria.
- Data Provenance: Not applicable.
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)
- Not applicable, as no clinical or nonclinical testing was required or conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical or nonclinical testing was required or conducted.
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
- No MRMC study was done. The device is a direct therapeutic device (Cranial Electrotherapy Stimulator), not an AI-assisted diagnostic or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, the substantial equivalence determination is a form of standalone evaluation. The FDA reviewed the device's technological characteristics (frequency, pulse width, amplitude) and compared them to those of legally marketed predicate devices to determine that the CES Ultra was "substantially equivalent." This means the device itself, based on its design and parameters, was deemed equivalent without needing a human-in-the-loop study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: The ground truth for this submission was the established safety and effectiveness of the predicate devices (NF-1 Mindpeace CES, K895175, and HP-1 Healthpax CES, K883812). The "ground truth" for the CES Ultra's substantial equivalence was that its stimulation parameters (frequency, pulse width, and amplitude) were "well within the established range of such parameters that are generally accepted as safe and effective for CES" as demonstrated by the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" here refers to existing knowledge about CES devices from prior marketing clearances.
9. How the ground truth for the training set was established
- Not applicable in the context of an AI/ML training set. The "ground truth" for establishing substantial equivalence was based on the prior regulatory clearances and established safety and effectiveness of the predicate CES devices. These predicates had previously gone through their own approval processes, which may have involved clinical studies or other data to establish their safety and effectiveness. The CES Ultra leveraged this existing "ground truth" by demonstrating its similarity to these already-approved devices.
§ 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.