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The Lasya-Trinity diode laser system is intended for use in dermatology procedures requiring coagulation with the following indications:
The trinity applicator is indicated for benign vascular and vascular dependent lesions.
The 808 applicator is indicated for permanent reduction in hair regrowth.
Use on all skin types (Fitzpatric I-VI), including tanned skin.

The Subject device, Trinity-Lasya is a diode laser instrument that use diode as a medium to emit a laser beam of 755 & 808 & 1064nm wavelength.
There are two handpiece, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.
the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are the main console unit, foot switch, and individual modules.
The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
Lasya-Trinity Laser System consists of:

• System console (contains the system software, power supply, and various other electronic ● and mechanical parts)
• . Operator control panel with touch-screen technology (GUI)
• Trinity applicator(handpiece) with 1064 nm, 808nm and 755 nm wavelengths applied simultaneously
• . 808 applicator(handpiece) with 808nm wavelength
• . Footswitch and etc.

The provided text is a 510(k) summary for the Lasya-Trinity diode laser system, detailing its substantial equivalence to a predicate device. It does not contain information about the device's acceptance criteria, reported performance, or associated studies in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, clinical endpoints, expert panel review).

Specifically, for the questions asked:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and adherence to general safety and performance standards for laser devices, rather than explicit performance metrics or acceptance criteria for clinical outcomes.

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 provided. The document states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission." Therefore, there was no clinical test set in the traditional sense discussed.

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 provided as no clinical studies were deemed necessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical studies were deemed necessary.

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 provided and is not applicable. The Lasya-Trinity is a laser surgical instrument, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The device is a physical laser system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no clinical studies were deemed necessary for establishing ground truth regarding clinical outcomes. The "ground truth" for this submission would be regulatory compliance and successful demonstration of substantial equivalence based on technical specifications and safety standards for laser devices.

8. The sample size for the training set
This information is not provided. As no clinical studies were deemed necessary, there would not be a clinical training set in the context of device performance evaluation. Software verification and validation were performed, but details of "training sets" for such are not typically disclosed in 510(k) summaries unless it's a machine learning device.

9. How the ground truth for the training set was established
This information is not provided.

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Non-fractional 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), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing

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This document (K230268) is an FDA 510(k) clearance letter for the ZenPro 40 device, a laser surgical instrument. It outlines the device's indications for use and confirms its substantial equivalence to predicate devices. However, this letter does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria.

The information requested in your prompt typically comes from the technical documentation or a clinical study report submitted to the FDA as part of the 510(k) application, which is not included in this clearance letter.

Therefore, I cannot provide the details you've asked for based on the provided text. To answer your questions, one would need access to the actual submission or summaries of the performance data that were part of the 510(k) application for the ZenPro 40.

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