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The Exilis XP II RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Exilis XP II massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Exilis XP II is a state-of-the-art radiofrequency device that enables the application of therapy by a non-invasive. high-frequency field. The control unit of the system is fitted with a color touch screen, to facilitate use of the device. The on-screen information quides the operator through the entire therapy. For easier control, the handpiece is equipped with buttons, enabling operation of the device during therapy. Quality of the energy flow is indicated by the illuminated treatment tip. Exilis XP II comes with the opportunity of exchangeable tips for patients greater convenience when treating various body parts. Contact quality monitoring system is present for monitoring of the contact quality under the patch electrode. An easy-to-read handpiece display shows the selected treatment parameters. The Exilis XP II consists of the following main components: microprocessor-driven control unit, high-frequency electromagnetic energy generator, user interface with 8.4" color touch screen, applicator for an application of radiofrequency, exchangeable applicator tips to treat various body parts.

This document is a 510(k) premarket notification for the Exilis XP II device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Exilis XP) rather than providing detailed acceptance criteria and a study to prove meeting them in the context of typical AI/software device performance.

Therefore, many of the requested points related to acceptance criteria, sample size, ground truth, expert adjudication, and comparative effectiveness studies for AI will not be fully answerable based on the provided text.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the way a performance study for an AI/software device would. Instead, the acceptance criteria are implicitly that the Exilis XP II performs as intended, safely, and in a similar manner to the predicate device. The "performance" is demonstrated through comparison of technical characteristics and compliance with safety standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document explicitly states: "The substantial equivalence determination for the Exilis XP II system is not based upon clinical performance testing." Therefore, there is no clinical test set, sample size, or data provenance information in the context of clinical performance data. The evaluation was primarily based on non-clinical (engineering, safety, and performance as compared to the predicate) testing.

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, as no clinical performance test set was used for substantial equivalence. "Ground truth" in this context refers to compliance with engineering and safety standards, and technical specifications compared to the predicate, which would be assessed by engineers and regulatory experts.

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

Not applicable, as no clinical performance test set was used.

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. The Exilis XP II is a physical medical device (radiofrequency and massage device), not an AI/software device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this submission is established through:

• Compliance with recognized electrical safety and medical device software standards (ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993 series for biological evaluation).
• Technical specifications that match or are equivalent to the predicate device.
• "As intended" performance demonstrated through non-clinical testing.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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