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PicoLO Premium is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064nm

The 1064nm wavelength of the PicoLO Premium is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

532nm

The 532nm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

PicoLO Premium is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Premium consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided text, the device in question is the PicoLO Premium, a multi-wavelength pulsed laser system intended for use in dermatology, general, and plastic surgery. The approval is based on a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device, not through a clinical study that proves the device meets specific performance acceptance criteria in terms of accuracy or effectiveness in a typical AI/diagnostic device sense.

Therefore, the requested information regarding acceptance criteria and a study proving performance in the context of an AI/diagnostic device (e.g., sensitivity, specificity, MRMC study, expert ground truth) cannot be found in this document. This document focuses on demonstrating the substantial equivalence of the PicoLO Premium to a previously cleared laser system (PicoLO Nd:YAG Picosecond Laser System, K203491) based on technical characteristics and safety standards.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating compliance with recognized safety and performance standards for laser products, not a study evaluating diagnostic accuracy or human reader performance.

Here's a breakdown of what can be extracted and what is missing based on the prompt:

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

Acceptance Criteria (Safety and Technical Performance – Not Clinical Efficacy):
The acceptance criteria are not presented in a table format with specific thresholds for clinical efficacy measures (like sensitivity or specificity). Instead, they are compliance with recognized consensus standards for laser devices. The "reported device performance" is that it was tested and found to be compliant with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This type of information is not provided in the document, as it describes a 510(k) clearance based on substantial equivalence to a predicate device, relying on non-clinical performance and safety testing, not a clinical trial with patient data.

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 applicable/not provided. The "ground truth" here is compliance with engineering and safety standards, not clinical diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. No clinical ground truth adjudication process 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:
This information is not applicable/not provided. This is not an AI-assisted diagnostic device, but a therapeutic laser system.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission focuses on compliance with established international and FDA-recognized consensus standards for medical device safety, electrical performance, laser specific requirements, usability, and risk management. No clinical ground truth (like pathology or outcomes data) for efficacy is required for this type of 510(k) submission, as it relies on equivalence to a predicate device.

8. The sample size for the training set:
This information is not applicable/not provided. This is a physical laser device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, no training set for a machine learning model is involved.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" in this context refers to non-clinical performance and safety testing to demonstrate that the PicoLO Premium is equivalent in terms of safety and effectiveness to the predicate device, PicoLO Nd:YAG Picosecond Laser System (K203491).

• Test Set: The device itself and its components were the "test set" for various engineering and safety evaluations. The "data" are the results of these tests (e.g., electrical measurements, laser energy output, adherence to design specifications).
• Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturer's (Laseroptek Co., Ltd.) regulatory submission process. The country of origin for the device manufacturing and testing would be South Korea, where the applicant is located. The process is inherently prospective as it involves creating a new device and then testing its compliance.
• Experts/Ground Truth Establishment: The "experts" involved are likely engineers and quality assurance professionals responsible for device design, manufacturing, and testing, ensuring compliance with the specified standards. The "ground truth" is defined by the technical specifications outlined in the consensus standards themselves, against which the device's performance is measured.
• Adjudication Method: Not applicable for this type of compliance testing.
• MRMC Study/Standalone AI Performance: Not applicable as it's not an AI device.

In essence, the document confirms that the PicoLO Premium underwent a series of technical and safety evaluations to ensure it meets the established benchmarks for laser surgical instruments and is substantially equivalent to its predicate device, rather than providing data from a clinical trial demonstrating its efficacy on a patient population.

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