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The Q-MASTER Q-Switched Nd:YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevus
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

• Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9 and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not linited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of benign vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of benign pigmented lesions including, but not limited to:
• café-au-lait birthmarks
• solar lentigines
• senile lentigines
• Becker's nevus
• freckles
• common nevus
• nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

Not Found

This document is a 510(k) clearance letter for the Q-MASTER Q-Switched Nd:YAG Laser System. It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria in the format requested. The document lists the indications for use for the device, but it does not include a clinical study design, results, or acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving device performance based on the provided text.

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The Q10 Q-Switched Nd: YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevus
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

• Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9, and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of pigmented lesions including, but not limited to:
• café-au-lait birthmarks
• solar lentigines
• senile lentigines
• Becker's nevus
• freckles
• common nevus
• nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

Not Found

This is a 510(k) premarket notification for a laser surgical instrument, and as such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a novel AI or diagnostic device. Therefore, a direct response to your detailed questions regarding acceptance criteria and study design (as might be found for a new diagnostic algorithm) is not present in the provided document.

However, I can extract the relevant information from the document and explain why other requested details are not applicable here.

Here's a breakdown based on the provided text:

Pertaining to the Device:

• Trade/Device Name: Q-Switched Nd:YAG Laser System / IDS Model Q10 Q-Switched Nd: YAG Laser
• Regulation Number: 21 CFR 878.4810
• Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX

Analysis of your specific questions:

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

   • Not Applicable. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance against specific acceptance criteria for a new diagnostic device. The device is a physical laser system, not an AI or diagnostic tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its performance is inherent in its physical specifications and intended use, which are deemed equivalent to a predicate. The "Indications for Use" section outlines what the device is cleared to do, not its diagnostic performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. As this is a 510(k) for a physical laser device, it doesn't typically involve a "test set" in the context of evaluating an AI or diagnostic algorithm. Clinical data to support the indications may have been generated, but the specific details of a test set, its size, and provenance are not outlined in this 510(k) clearance letter. The FDA's review for substantial equivalence generally focuses on technological characteristics, safety, and effectiveness compared to a predicate, which might include relying on established literature or predicate device's safety record rather than a new clinical study with a "test set" for performance evaluation.

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):

   • Not Applicable. There is no "ground truth" establishment in the context of evaluating a diagnostic algorithm mentioned. The effectiveness of the laser for its stated indications (e.g., "removal of dark ink tattoos," "treatment of wrinkles") is generally supported by the predicate device's history and the understanding of laser-tissue interaction for these applications.

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

   • Not Applicable. No test set requiring expert adjudication is discussed in this document.

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 is a physical laser device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant here.

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

   • Not Applicable. This device is not an algorithm.

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

   • Not Applicable. As explained, the concept of "ground truth" as applied to evaluating a diagnostic algorithm doesn't apply to this type of device and submission. Efficacy is generally demonstrated by clinical observations and comparisons to predicate devices over time, rather than a single "ground truth" metric.

8. The sample size for the training set:

   • Not Applicable. Training sets are relevant for machine learning algorithms, which this device is not.

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

   • Not Applicable. This device does not have a training set or associated ground truth.

In summary, the provided document is a 510(k) clearance letter for a Q-Switched Nd:YAG Laser System, indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices. The nature of this submission (a physical device, not a diagnostic or AI product) means that the requested details regarding acceptance criteria, test/training sets, ground truth, and expert evaluations in the context of diagnostic performance are not applicable or provided within this type of regulatory document.

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The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf6-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.

The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.

The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Q-Switched Nd:YAG Laser System:

Based on the provided 510(k) summary, the device is a Q-Switched Nd:YAG Laser System. The submission is for a medical device and therefore the acceptance criteria are not clinical performance metrics but rather compliance with design specifications and regulatory standards.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The provided text does not mention any clinical test set involving human subjects or data. The testing discussed is non-clinical laboratory testing to verify design specifications and compliance with standards.
   • The "data provenance" mentioned is compliance with international standards (IEC) and national regulations (US FDA, EU MDD).

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

   • This information is not applicable as there is no clinical test set described in the provided document. The "ground truth" for this submission focuses on engineering specifications and regulatory compliance.

3. Adjudication method for the test set:

   • This information is not applicable as there is no clinical test set described.

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:

   • No, an MRMC comparative effectiveness study was not done. This document describes a laser system, not an AI-assisted diagnostic device, and therefore this type of study is not relevant to this submission.

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

   • No, this is not applicable. The device is a physical laser system, not an algorithm. The "standalone performance" refers to the device's ability to meet its technical specifications and regulatory requirements.

6. The type of ground truth used:

   • For this 510(k) submission, the "ground truth" is defined by established engineering design specifications, international performance and safety standards (e.g., IEC standards), and national/regional medical device regulations (e.g., 21 CFR, MDD). The device's performance against these specifications and standards constitutes the "ground truth" for its safety and effectiveness determination via substantial equivalence.

7. The sample size for the training set:

   • This information is not applicable as there is no discussion of a training set for an algorithm. The device is a physical laser system.

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

   • This information is not applicable as there is no discussion of a training set for an algorithm.

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