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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

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.

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