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Palm NRG cellulite body device (model: Palm NRG body device) is intended for delivering non thermal RF combined with massage for temporary reduction in the appearance of cellulite.

Palm NRG cellulite body device (model: Palm NRG body device) is a portable, non-invasive, at home skin care device. It works for with radio frequency (RF) to help users to enjoy the care skin. The device is a noninvasive, non-ablative device and it is supplied as non-sterile, it has 2 buttons, one for power on/off, the other one for level adjust. The main unit is equipped with accessories of an adapter and a charging base. The charging base is used to connect the adapter and the main unit.

The provided text is a 510(k) summary for a medical device (Palm NRG cellulite body device) and does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or effectiveness.

This document focuses on establishing substantial equivalence to predicate devices based on non-clinical tests and technological characteristics. There is an explicit statement: "There no Clinical Tests."

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

However, I can extract information about the non-clinical tests performed to demonstrate safety and performance:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no clinical performance acceptance criteria or results reported for this device, a table for clinical performance cannot be created. The document focuses on compliance with recognized standards for safety and non-clinical performance:

2. Sample size used for the test set and the data provenance:

• Non-clinical tests: The document does not specify sample sizes for the non-clinical tests (electrical safety, EMC, biocompatibility, software V&V). These tests are typically performed on a representative number of devices to demonstrate design conformity, rather than statistical samples like a clinical trial.
• Usability Study: The sample size for the usability study is not explicitly stated.
• Data Provenance: The tests were performed as part of the submission process to the FDA, likely by accredited labs. The country of origin of the data is not specified beyond the sponsor's affiliations in China and the USA. All tests were prospective for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Non-clinical tests: Not applicable in the context of establishing ground truth for performance. These tests evaluate adherence to engineering and safety standards, often performed by qualified engineers and technicians.
• Usability Study: The document does not specify the number or qualifications of experts involved in establishing ground truth for the usability study. Usability studies typically involve a representative user group rather than "experts" establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as no clinical test set requiring adjudication of device performance against ground truth was performed.

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, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic or interpretive tool, but rather a physical therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical therapeutic device, not an algorithm, and is intended for over-the-counter human use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• No clinical ground truth was established or used, as no clinical studies were performed. The "ground truth" for the non-clinical tests was established by compliance with the defined voluntary design standards. For the usability study, the ground truth would be the ability of users to safely and effectively operate the device according to its instructions for use.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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