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Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

Apollo Duet has RF handpiece attached to the main body, and consists of an electrode cable and a power adapter. This equipment has RF mode, which is the main function, RF mode is a mode in which Radio-frequency is output in a bipolar method. An RF handpiece is used, and a high frequency is output through 4ea RF handpiece electrodes. In addition, the RF handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 45 C

The provided text describes the regulatory clearance of a medical device called "Apollo Duet" (Model: APD-4000) by the FDA. It does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in terms of effectiveness for its intended use.

The document focuses on demonstrating substantial equivalence to a predicate device (InMode RF Pro System) based on technical, safety, and operational characteristics, rather than a clinical effectiveness study with defined acceptance criteria for efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The information requested regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not present in the provided text.

Here's what can be extracted regarding testing and related safety:

Acceptance Criteria and Study Information (Based on provided text)

The document outlines safety and performance bench testing and adherence to international standards to demonstrate substantial equivalence and safety, rather than effectiveness acceptance criteria for its therapeutic claims (relief of muscle aches, spasm, and improved blood circulation).

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

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

• RF Ablation Thermal Effects (Ex-vivo testing): Not specified (type of tissue: porcine abdominal skin).
• Skin temperature measurement: 6 healthy volunteers (3 light skin, 3 dark skin). Data provenance: Not specified (implied to be from the manufacturer, WEERO Co., Republic of Korea). This appears to be a prospective safety test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not specified in the document. The tests seem to be objective measurements (e.g., temperature, compliance with standards) rather than expert-derived ground truth for performance.

4. Adjudication method for the test set:
Not applicable/Not specified.

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 MRMC study was done, as this is not an AI-assisted diagnostic device, but an electrosurgical cutting and coagulation device and accessories.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not directly applicable in the context of typical AI standalone performance. The device itself is a standalone medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For safety/technical testing, the "ground truth" is compliance with established international standards (e.g., IEC 60601 series, ISO 14971) and objective measurements (e.g., temperature thresholds). For ex-vivo testing, direct measurement of thermal effects on tissue.

8. The sample size for the training set:
Not applicable. This device does not appear to involve machine learning models that require a training set.

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

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