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YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.

YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars

The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.

The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device

The YOULASER CO2 Laser System includes 1 model: YOULASER CO2 with Wavelength 10.6μm and Laser Power 30W. The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located. The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, arm with CO2 scanner, the articulated control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

The provided text is a 510(k) summary for the Quanta System YOULASER CO2. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.

Here's what can be extracted based on the provided text:

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

This information is not present. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics that meet defined acceptance criteria. The statement "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices" is a general claim of equivalence, not a report of specific performance against numerical acceptance criteria.

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

No dedicated clinical or performance test set data is described. The 510(k) summary structure for this device does not include such a study.

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

Not applicable, as no dedicated test set requiring expert ground truth is described.

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

Not applicable, as no dedicated test set requiring adjudication is described.

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. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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.

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

Not applicable. No ground truth for device performance is described. The ground for "substantial equivalence" is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable, as this is a hardware device (laser surgical instrument) and not a machine learning algorithm that requires a training set.

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

Not applicable, as this is a hardware device and does not involve a training set.

Summary of what the document does state regarding acceptance and proof:

The document states:

• "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices."
• "The YOULASER CO2 has the same intended uses and similar indications, technological characteristics, and principles of operation As its predicate device."
• "The minor technological differences between the YOULASER CO2 and its predicate devices raise no new issues of safety or effectiveness."
• "Thus, the YOULASER CO2 is substantially equivalent."

The proof that the device meets "acceptance criteria" (which in this context is "substantial equivalence") comes from a comparison of its technological characteristics, intended uses, and indications for use to the predicate devices (El.En S.p.A Smart CO2 Laser System (K072159)). The document explicitly states "Performance Data: None" under the Substantial Equivalence section, indicating that no separate performance studies were conducted or provided to demonstrate novel criteria. The acceptance is based on the argument that the new device is fundamentally similar to an already cleared device, implying that the established safety and effectiveness of the predicate device extends to the new device due to these similarities.

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