(266 days)
Application of electrical current to the head to treat insomnia, depression, or anxiety.
The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered. The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.
The provided text describes the NET-2000 Microcurrent Stimulator, a device used for the treatment of anxiety, depression, or insomnia. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:
1. A table of acceptance criteria and the reported device performance
The provided information does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the submission relies on a comparison table to demonstrate the NET-2000's features are equivalent to its predicate device, the Alpha-Stim 100. This is the primary method of showing "performance" in this context.
| Feature | NET-2000 | Alpha-Stim 100 (Predicate) | Equivalence Justification/Reported Performance |
|---|---|---|---|
| Indication | Treats anxiety, depression, and insomnia | Treats anxiety, depression, and insomnia | Identical |
| Classification | CES, Class III Prescription, 882.5800 | CES, Class III Prescription, 882.5800 | Identical |
| Contraindications | None | None | Identical |
| Power Source | 9 volt battery | 9 volt battery | Identical |
| Current | 0-600 microamperes | 10-600 microamperes | Within comparable range |
| Frequency | 0.5, 1.5, 100 Hz | 0.5, 1.5, 100 Hz | Identical |
| Waveform | Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current | Bipolar asymmetric rectangular waves, 50% duty cycle, 0 net current | Identical |
| Electrodes | Silver, self-adhesive pads with conduction solution, clip style. Applied to earlobes. | Silver, self-adhesive pads with conducting solution, clip style. Applied to earlobes. | Identical |
| Timer Treatment Settings | 16.5 minutes | 10, 20, 60 minutes and continuous | Similar (device offers a specific timed setting, predicate offers options) |
| Electrical Safety | Confirmed by testing and passing requirements under EN60601-1-2 and EN60601-1 | (Implied predicate meets similar standards for marketing) | Demonstrated through compliance with standards |
| Biocompatibility | For the electrode patient contact is confirmed by testing. | (Implied predicate materials are biocompatible) | Demonstrated through testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any clinical study with a test set involving human subjects or data. The "performance testing" mentioned is comparative testing to the Alpha-Stim 100 and electrical safety and biocompatibility testing. This implies bench testing rather than clinical data from a sample size.
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. No clinical data or human evaluation with a "ground truth" established by experts is mentioned for this device. The assessment is based on technical specifications and safety/performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical study with a test set is described, there is no adjudication method.
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
Not applicable. This device is a microcurrent stimulator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This section is typically relevant for AI/ML-based algorithms. The NET-2000 is a physical medical device; its "performance" is assessed through its electrical characteristics, safety, and functional equivalence to a predicate, not through an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of 510(k) submission and device, the "ground truth" for demonstrating substantial equivalence is primarily the technical specifications and established safety and effectiveness of the predicate device, alongside adherence to recognized electrical safety and biocompatibility standards. There is no mention of clinical outcomes data in terms of "ground truth" for the device's efficacy. The claim of "safe and effective" is based on the equivalence to a device already deemed safe and effective.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
In summary:
This 510(k) submission for the NET-2000 Microcurrent Stimulator focuses on "substantial equivalence" to a predicate device (Alpha-Stim 100) based on technical specifications, indications for use, and a demonstration of electrical safety and biocompatibility. It does not present evidence from clinical trials or studies involving human subjects with a "test set" and "ground truth" as typically seen in submissions for diagnostic algorithms or devices requiring new clinical evidence of efficacy. The "study that proves the device meets the acceptance criteria" in this context refers to the comparative analysis of features, electrical safety testing, and biocompatibility testing, all demonstrating the NET-2000's similarity to the predicate and compliance with relevant standards.
§ 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.