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YOULASER CO2 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.

YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm.

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, articulated arm with CO2 scanner, the control electronics.

The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

This submission describes a medical device, the YOULASER CO2 laser system, seeking 510(k) clearance. The device is a Class II laser surgical instrument for use in general and plastic surgery and dermatology. It operates in both traditional (non-fractionated) and fractionated modes.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state specific quantifiable acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance evaluation is described qualitatively as "safety and effectiveness" and "ablation, coagulation depth and the healing evolution of the skin at the typical settings of use of Youlaser CO2."

   Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The overall acceptance criterion is "substantial equivalence" to the predicate devices. The reported device performance is that it was found to be "as safe as effective as the predicated devices" based on the described non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

   The document mentions a "specific non clinical testing was conducted on the proposed YOULASER CO2 device." However, it does not provide details about the sample size used for this test set.

   Regarding data provenance, the testing was conducted on the "proposed YOULASER CO2 device," implying this was a prospective study using the actual device. The country of origin of the data is not explicitly stated, but the applicant/manufacturer is Quanta System SPA, based in Italy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   The document does not mention the use of experts to establish ground truth for the non-clinical testing. The assessment of "ablation, coagulation depth and the healing evolution of the skin" would likely be through objective measurements and potentially histological analysis rather than expert consensus on subjective outcomes.

4. Adjudication Method for the Test Set:

   Since no experts are mentioned for establishing ground truth, there is no adjudication method described. The non-clinical testing appears to be based on objective measurements related to the laser's effects on tissue.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No, an MRMC comparative effectiveness study was not done. The device in question is a surgical laser, not an imaging diagnostic tool that would typically involve multiple readers interpreting cases. The testing described is non-clinical and assesses direct tissue interaction.

6. Standalone (Algorithm Only) Performance Study:

   No, a standalone (algorithm only) performance study was not done. This device is a physical surgical laser, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used:

   The "ground truth" for the non-clinical testing appears to be based on objective measurements of tissue response to the laser parameters. This includes "ablation, coagulation depth and the healing evolution of the skin." This would involve direct physical or biological measurements/observations, likely including histological analysis, rather than expert consensus on a subjective interpretation, pathology of a disease state, or patient outcomes data in an extensive clinical trial setting.

8. Sample Size for the Training Set:

   Since this is a physical medical device and the testing focuses on its physical effects rather than an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned.

9. How the Ground Truth for the Training Set Was Established:

   As the concept of a "training set" for an AI algorithm is not applicable, there is no information on how ground truth for a training set was established.

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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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