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The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

The BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS: Scalp attachment, Small attachment.

The provided document is a 510(k) summary for the Beagank 4T Plus device. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards. It explicitly states: "No new clinical studies have been submitted as part of this Premarket Notification."

Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and a study proving those criteria are met, as such information is not present in the provided text.

However, I can extract information related to non-clinical performance and safety testing which serves as the basis for the FDA clearance in this case.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Based on the "Summary of Non-Clinical / Test Data," the device performance is demonstrated by compliance with specific safety standards. The "acceptance criteria" here are essentially passing these standards.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The tests are for device safety and electrical performance, typically conducted on a sample of the manufactured device. Details on the specific number of units tested and data provenance (country of origin, retrospective/prospective) are not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical safety and performance evaluation, not a clinical study involving expert ground truth for interpretation. The "ground truth" is adherence to established engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study.

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. The document explicitly states "No new clinical studies have been submitted." This is not an AI-assisted diagnostic device, and thus no MRMC study would be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical electrical stimulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" is the established requirements and limits defined within the cited IEC and ISO standards.

8. The sample size for the training set:
Not applicable. There is no machine learning or AI component that would require a training set.

9. How the ground truth for the training set was established:
Not applicable.

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