(202 days)
Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia.
The TESA is a transcranial electrotherapy stimulation device. Three electrodes are applied, one to the forehead and one behind each ear. TESA delivers low amplitude AC current for a desired time of 0 to 99:59 minutes. Treatment can be stopped by pressing the "current off" button. Either the operator or patient may press this button at any time. During treatment, peak current amplitude can be adjusted over the available range of 0 - 4 mA. Treatment parameters are monitored and controlled by a built in microprocessor. The display on the front of TESA indicates remaining treatment time and shows the current setting.
During treatment, a modulated high frequency square wave is delivered to the patient electrodes. The amplitude and duration of the positive and negative going portions of this waveform have been carefully designed to deliver no DC component. Moreover, the electrodes are AC coupled to the patient to insure no DC component in the event of device failure.
Additional safety features of the TESA device include rapid measurement of electrode impedance to insure good electrode contact and to maintain controlled current output over changing load conditions (e.g. when electrode contact changes). Detection of poor electrode contact causes the device to stop treatment and illuminate an electrode fault LED. Further treatment is blocked until electrode/skin impedance is restored to nominal range.
The provided document is a 510(k) Summary for the Transcranial Electrotherapy Stimulator-A (TESA). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device, or efficacy for a therapeutic device).
The "Testing" section only states that:
- "Various tests of the hardware and software have been performed to verify that the device works as described in this document."
- "Verification procedures with pass/fail critcria were developed to ensure that the product met all the specified requirements."
- "As part of this vorification, a certified body will be used to determine that the device conforms to the recognized safety standards listed below."
- "The device will not be marketed until it has been tested and complies with the standards."
The listed standards (UL2601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10) are safety and electromagnetic compatibility (EMC) standards, not clinical performance standards for therapeutic efficacy.
Therefore, I cannot populate the requested table and information beyond acknowledging what is present in the document.
Here's what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: (e.g., reduction in symptoms of depression, anxiety, insomnia) | Not provided in this document. The document states the device's intended use is to reduce these symptoms, but no performance metrics, acceptance criteria for these metrics, or study results are presented. |
| Hardware & Software Functionality: Device works "as described," meeting "specified requirements." | "Various tests of the hardware and software have been performed to verify that the device works as described in this document." "Verification procedures with pass/fail critcria were developed to ensure that the product met all the specified requirements." (Specific criteria and results not detailed). |
| Safety Standards Conformance: | Compliance with UL2601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10. (Study results for these are not detailed, only the intent to conform). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any clinical test set or data provenance.
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/Not provided. No clinical performance study using a test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical performance study using a test set is described.
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 therapeutic stimulation device, not an AI-assisted diagnostic or interpretation tool. No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware therapeutic device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No clinical performance study requiring ground truth is described.
8. The sample size for the training set
- Not applicable/Not provided. No machine learning or AI training set is mentioned for this device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of what is present:
The document details the device's technical specifications, indications for use, and declares its substantial equivalence to other legally marketed cranial electrotherapy stimulators based on similar current amplitudes and frequencies. It also lists the safety and EMC standards it intends to conform to. It does not provide data on clinical efficacy or specific performance criteria related to its stated indications for reducing symptoms of depression, anxiety, and insomnia. This type of information is typically required for higher-risk devices or when a new mechanism of action is being introduced, often necessitating a PMA (Premarket Approval) rather than a 510(k) which focuses on substantial equivalence to existing devices. Given this device is Class III, a PMA would generally be expected for demonstrating efficacy, but a 510(k) was allowed due to substantial equivalence to older, pre-amendment devices or reclassified 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.