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The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

• Tattoo removal: dark ink (black, blue, and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma

1064nm in Genesis (long-pulse) mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Lentigines
• Treatment of Café-au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyperpigmentation
• Treatment of Becker's Nevi, Freckles, and Nevi spilus

The Pastelle laser system consists of an Nd:YAG laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains two Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed ,in the special adjustable holders composed the laser cavity.

The provided text is a 510(k) clearance letter and summary for the Pastelle Laser System. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, the document explicitly states: "No clinical studies were considered necessary and performed." This means there is no section describing clinical performance data, acceptance criteria, sample sizes for test/training sets, expert involvement, or ground truth establishment for clinical efficacy.

The "Performance Testing" section under "Non-Clinical Test Summary" describes the technical specifications of the laser's output, not clinical performance or acceptance criteria related to treating conditions. These are technical parameters of the device itself, verified through bench tests, not measures of patient outcomes.

Therefore, since the 510(k) relies on substantial equivalence to predicate devices and states no clinical studies were performed, there is no information available in the provided text to describe acceptance criteria and the study that proves the device meets those acceptance criteria in a clinical context.

The document focuses on demonstrating that the new Pastelle device is technically similar to already cleared predicate devices, thus inferring that it will perform similarly.

Based on the provided text, the device's acceptance criteria and proven performance related to clinical outcomes cannot be detailed. The data provided pertains to technical specifications and regulatory compliance through bench testing.

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The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

• Tattoo removal: dark ink (black, blue, and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma

1064nm in Genesis (long-pulse) mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Lentigines
• Treatment of Café-au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyperpigmentation
• Treatment of Becker's Nevi, Freckles, and Nevi spilus

The Pastelle Pro laser system consists of an Nd: YAG laser head, a power supply, a cooling system and other electrical components. The laser head contains two Nd. YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity.

To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Nd: YAG laser rod, causing the emission of a pulse of laser energy.

The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The basic frequency of 1064 nm can be doubled by a KTP crystal, which can be inserted to a working area. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head.

The system delivers laser energy at a wavelength of 1064 nm. 532 nm and 660 nm. The output of the laser is delivered to the area of treatment through an Articulated Arm with a handpiece. A trigger (foot switch) controls the delivery of pulses. The user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

The provided text is a 510(k) summary for the Pastelle Pro laser system. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence for regulatory clearance. However, it explicitly states:

"No clinical studies were considered necessary and performed."

This means that the document does not contain information about acceptance criteria, reported device performance from clinical studies, sample size, data provenance, expert adjudication, MRMC studies, standalone performance, or how ground truth was established for clinical data.

Therefore, I cannot provide the requested table and study details. The 510(k) summary focuses on non-clinical bench testing to demonstrate compliance with electrical safety, EMC, software validation, and biocompatibility standards, and on comparing technical characteristics to previously cleared devices.

Based on the provided text, here's what can be stated about the testing and lack of clinical study information:

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

• Cannot be provided. The text explicitly states, "No clinical studies were considered necessary and performed." The performance testing mentioned (Laser wavelength, output power, pulse duration, pulse frequency) are technical specifications and not acceptance criteria or reported performance from a clinical study on human subjects or patient outcomes.

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

• Not applicable for clinical studies.
• For non-clinical bench tests (Electrical Safety, EMC, Performance Testing), the sample sizes are not explicitly mentioned but typically refer to test units of the device itself rather than patient data.
• Data provenance for bench tests would be the manufacturer's testing facilities.

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

• Not applicable. No clinical test set with ground truth established by experts was performed.

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

• Not applicable. No clinical test set requiring adjudication was performed.

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. No clinical studies, and therefore no MRMC studies, were performed. The device is a laser system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The device is a physical laser system, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" would be the device's adherence to engineering specifications and safety standards as measured by calibrated test equipment.

8. The sample size for the training set:

• Not applicable. As no clinical studies were performed, there are no training sets of patient data mentioned.

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

• Not applicable. As no clinical studies were performed, there are no training sets or ground truth establishment methods for clinical data mentioned.

Summary of what the document does provide regarding testing:

The manufacturer conducted non-clinical bench tests to demonstrate that the Pastelle Pro device meets design specifications and complies with relevant safety and performance standards:

• Electrical Safety & Electromagnetic Compatibility (EMC) Testing: The device complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
• Software Validation: The software (classified as MODERATE level of concern) was designed, developed, verified, and validated according to a software development process and FDA guidance (May 11, 2005, for software in medical devices).
• Biocompatibility: The handpiece tip (Aluminum Powder) was assessed for intact skin contact for limited duration (

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WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories. This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.

The WON Technology Pastelle Q-Switched Nd:YAG Laser (K123293) did not conduct a clinical study. Instead, its performance was evaluated through a comparison of its technological characteristics with a legally marketed predicate device, the Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser (K014234). The device also underwent bench testing, which included software validation, electrical safety, electromagnetic compatibility, transit testing, and functional testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
No clinical test set was used for this device. The evaluation was based on a comparison of technological specifications and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set was used.

4. Adjudication method for the test set:
Not applicable, as no clinical test set was used.

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, as no MRMC study or AI component was involved.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a laser device, not an algorithm.

7. The type of ground truth used:
For the comparison of technological characteristics, the ground truth was the published specifications of the legally marketed predicate device (Continuum Electro-Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser, K014234). For the bench studies, the ground truth was the expected functional performance and compliance with relevant safety and electromagnetic compatibility standards.

8. The sample size for the training set:
Not applicable, as this device does not involve a training set as it's not an AI/ML-based device.

9. How the ground truth for the training set was established:
Not applicable.

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