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The Fotona SkinPlus Er. YAG surgical laser system is indicated for the cutting, ablation, vaporization, coagulation of soft tissue, and for skin resurfacing.

The Totona SkinPlus system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er.YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handoiece. The laser is used in non-contact mode.

The System is capable of emitting up to 2.0 J of pulsed light at 2,94 um. This light has a pulsewidth which varies in the range 100 - 500 us. The laser is intended to be used for curting, ablating, vaporizing, coagulating of soft tissue, and skin resurfacing.

The SkinPlus system is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main tringgering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) An Er: Y AG laser rod, capable of generating 2.0 J optical pulses at a frequency up to 15 liz.

d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

e) The microproccssor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided text is a 510(k) premarket notification for the Fotona SkinPlus Laser System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel device.

The core of this submission is to show that the Fotona SkinPlus has the same intended use and technological characteristics as its predicate devices, the Continuum Diomedical (Con-Dio) CB Erbium/2.94 Er:YAG laser (K970934) and the Fotona Skinlight laser system (K962902).

Therefore, there isn't a "study" with specific acceptance criteria and reported device performance in the way one might expect for a new performance claim. Instead, the "acceptance criteria" are effectively that the device's characteristics and intended use align with those of the cleared predicate devices, thereby ensuring no new questions of safety or effectiveness are raised.

Given this context, here's how the requested information would apply:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Since this is a 510(k) submission for substantial equivalence rather than a de novo approval requiring extensive performance studies, the "acceptance criteria" relate to the comparison with predicate devices.

Additional Information on the "Study" (Substantial Equivalence Justification)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a traditional performance study. The "test set" here refers to the comparison of the Fotona SkinPlus's specifications and intended use against those of the predicate devices. No patient or sample data is presented for performance testing.
   • Data Provenance: The data provenance for the predicate devices' clearance would have been from their original submissions, but details are not provided in this document. This submission itself is from Slovenia (Fotona d.d.), and the review is by the US FDA.

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

   • Not applicable. Ground truth as typically understood in performance studies (e.g., disease presence/absence confirmed by pathology or clinical outcome) is not established here. The "truth" is the regulatory status and specifications of the predicate devices a priori. The FDA (specifically the Division of General and Restorative Devices) acts as the expert body confirming substantial equivalence.

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

   • Not applicable. This is not a study requiring adjudication of individual cases. The FDA's review process serves as the adjudication, where they assess the entire submission for substantial equivalence.

4. 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 is a laser system, not an AI-powered diagnostic device. No MRMC study was performed or required for this type of submission.

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

   • Not applicable. This is a medical device, not an algorithm. Therefore, "standalone" performance in the AI sense does not apply.

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

   • The "ground truth" for this 510(k) submission is the regulatory clearance and established safety/effectiveness profile of the predicate devices. The Fotona SkinPlus leverages the existing "truth" that similar devices (Er:YAG lasers) are safe and effective for the stated indications when used appropriately.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI component requiring a training set.

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

   • Not applicable, as no training set exists.

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