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The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver thermal 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.

The provided text is a 510(k) Summary for the Sciton JOULE ProFractional System. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain acceptance criteria or details of a study proving the device meets specific performance criteria in the way a clinical trial report would.

Instead, the document focuses on demonstrating substantial equivalence by comparing the technological characteristics and indications for use of the JOULE ProFractional System to those of several predicate devices already on the market.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on your request and the limitations of the provided document:

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

This information is not available in the provided 510(k) summary. The document focuses on demonstrating "substantial equivalence" to predicate devices, not on meeting specific, quantitative acceptance criteria for performance as would be seen in a clinical study report. The table presents a comparison of technical specifications between the proposed device and predicate devices.

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

This information is not available in the provided 510(k) summary. The document does not describe a clinical test set or study data in this manner.

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)

This information is not available in the provided 510(k) summary. The document does not describe a process for establishing ground truth using experts.

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

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. This device is a laser surgical instrument, and the document does not mention AI assistance or MRMC studies.

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

This information is not available in the provided 510(k) summary. This is a medical device, not an AI algorithm, and thus standalone performance for an algorithm is not applicable.

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

This information is not available in the provided 510(k) summary.

8. The sample size for the training set

This information is not available in the provided 510(k) summary as it is not an AI/algorithm-based device and does not refer to a "training set."

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

This information is not available in the provided 510(k) summary for the reasons mentioned above.

Summary of what the document DOES provide regarding comparison:

The document relies on demonstrating "substantial equivalence" to predicate devices (K101916, K081352, K100270, K110907, K142376) rather than defining and meeting specific, quantitative acceptance criteria via a new study.

The comparison table on page 4 (labeled "5") shows how the JOULE 2940 Fractional Handpiece (This Application) aligns with or is comparable to predicate devices across various technical specifications:

• Indications for Use: "Yes" - indicates substantial equivalence to all listed predicates.
• Ref. 510(k): K173285 for "This Application."
• Energy Source: 2940 nm Er:YAG for all, "Yes" for substantial equivalence.
• Spot Size: Range from 1.3x1.3mm to 20x20mm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Wavelength: 2940 nm for all, "Yes" for substantial equivalence.
• Maximum Repetition Rate: Up to 3 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Pulse Duration: 0.5 to 1.5 msec for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Energy: Up to 70 mJ/microbeam for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Utilities: 230 VAC/25A, 50/60 Hz for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Aiming Beam: Red/Green for new device and some predicates. "Yes" for substantial equivalence.
• Delivery System: Articulated Arm for the new device, comparable to predicates. "Yes" for substantial equivalence.
• Cooling System: Water to Air for all, "Yes" for substantial equivalence.
• Control System: Microprocessor for all, "Yes" for substantial equivalence.
• Energy Monitor: "Display Indicates Energy Delivered to Tissue" for all, "Yes" for substantial equivalence.
• Safety: Safety Eyewear and Remote Interlock Connector for the new device and some predicates. "Yes" for substantial equivalence.
• Console Dimensions: 14" x 21" x 41" high for the new device, comparable to some predicates. "Yes" for substantial equivalence.
• Weight: 200 lbs for the new device, comparable to some predicates. "==" (presumably "Yes") for substantial equivalence.

The study that proves device meets acceptance criteria, in this context of a 510(k), is the comparison to legally marketed predicate devices, demonstrating that its technological characteristics and intended use are sufficiently similar. The "proof" is the argument of substantial equivalence, not data from a new clinical study with specific acceptance criteria.

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