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The Joule 2940 nm ProFractional System with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dernatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi: Telangiectasia: Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars).

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

This document is a 510(k) premarket notification for the Sciton, Inc. JOULE ProFractional System. It demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or presenting a new clinical study for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device is not explicitly present in the provided text.

The document primarily focuses on demonstrating that the JOULE ProFractional System is substantially equivalent to existing devices based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what is not available based on your request:

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

This document does not present specific acceptance criteria for this new device's performance in a clinical study, nor does it report new device performance data against such criteria. Instead, it compares the technical specifications and intended uses of the JOULE ProFractional System to those of predicate devices to demonstrate substantial equivalence. The table on page 4 provides a comparison of specifications:

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

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study with a test set. There is no mention of a specific test set, data provenance, or data type (retrospective/prospective) for a clinical performance evaluation of the JOULE ProFractional System.

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. No ground truth establishment for a test set is discussed in this document.

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

Not applicable. No adjudication method for a test set is discussed.

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. An MRMC study is beyond the scope of this type of 510(k) submission. There is no mention of AI assistance or human reader improvement.

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

Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, standalone performance in the context of an algorithm is not relevant.

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

Not applicable. No clinical ground truth is established for this submission. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and therefore does not have a training set in that context.

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

Not applicable, for the same reason as point 8.

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