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The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-V), including tanned skin. The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regiment

The diode laser hair removal system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed diode laser removal system has two models. GP900A and GP900O. Both GP900A and GP900Q have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free setting mode. The GP900A is a standard case with wheels to allow easy movement on the floor. The GP900Q is a desktop case.

This document is an FDA 510(k) premarket notification for a medical device, specifically a "Diode Laser Hair Removal System." This type of document is focused on demonstrating substantial equivalence to a previously approved device, not on proving new clinical efficacy through de novo studies with specific acceptance criteria as you might see for novel AI/ML devices. Therefore, much of the information you've requested regarding acceptance criteria, sample sizes for test/training sets, experts for ground truth, MRMC studies, and effect sizes of human readers with AI assistance, is not applicable to this type of submission.

The "acceptance criteria" here are essentially compliance with recognized safety and performance standards for similar laser devices and demonstrating that the proposed device is functionally equivalent to an existing predicate device.

Here's an attempt to answer your questions based on the provided document, indicating what is (and isn't) present:

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

The document does not present explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, hair reduction percentage). Instead, "acceptance criteria" are implied by compliance with established safety and performance standards and direct comparison of technical specifications to a predicate device.

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

This document describes a premarket submission based on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. It does not present clinical study data with a "test set" in the context of AI/ML or efficacy trials. The "test results" mentioned in Section 7 refer to compliance testing with various international standards (e.g., IEC, ISO) for electrical safety, laser safety, and biocompatibility, not clinical performance data on human subjects.

Therefore, questions about sample size for a test set and data provenance are not applicable to this document.

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)

As there is no "test set" in a clinical sense with ground truth established by experts for performance evaluation, this question is not applicable. The "truth" in this submission relies on compliance with engineering and safety standards executed by certified testing laboratories and the established safety and efficacy profile of the predicate device.

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

Since there is no clinical test set requiring expert adjudication for ground truth, this question is not applicable.

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

An MRMC comparative effectiveness study is designed for evaluating AI-assisted diagnostic or clinical decision support systems. This document is for a physical laser device, not an AI/ML software device. Therefore, an MRMC study was not done, and questions about effect size of human readers with AI assistance are not applicable.

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

This refers to the performance of an AI algorithm. Since this is a physical laser device, not an algorithm, a "standalone algorithm performance" study was not done. This question is not applicable.

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

Given that this is a 510(k) for a physical laser hair removal device, the "ground truth" for its safety and performance is established through:

• Compliance with international safety and performance standards: (e.g., IEC 60601-1, IEC 60825-1, ISO 10993). This is typically shown by testing conducted by accredited labs.
• Demonstration of substantial equivalence to a legally marketed predicate device: This relies on the FDA having previously determined the predicate device to be safe and effective. The comparison table (Tables 3-1 and 3-2) in the document serves this purpose, showing that the proposed device's technical specifications and intended use closely match the predicate.

There is no "ground truth" derived from expert consensus, pathology, or outcomes data in this submission for clinical efficacy of the proposed device itself, as it is relying on the established record of the predicate and compliance with technical standards.

8. The sample size for the training set

This document describes a submission for a physical laser device, not an AI/ML system that requires a "training set." Therefore, this question is not applicable.

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

As there is no training set, this question is not applicable.

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The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:

1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
2. Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
3. Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.

The GSD Intense Pulsed Light System (GP666C4 and GP666C) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

This appears to be a 510(k) summary for the GSD Intense Pulsed Light System, which is a device for various dermatological treatments. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria, study design, or performance metrics that would allow me to fill out the requested table and answer the detailed questions about a study proving the device meets acceptance criteria.

The 510(k) summary primarily focuses on:

• Device Description: What the device is and how it generally works (selective photothermolysis).
• Standards Compliance: Listing IEC 60601-1 and IEC 60601-1-2 as standards the device is designed, tested, and manufactured in accordance with. These are general safety and EMC standards, not performance criteria for clinical effectiveness.
• Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices.
• Intended Use/Indications for Use: Listing the medical conditions the device is intended to treat and the associated wavelength ranges.

Therefore, I cannot provide the requested information because the input text does not contain a study report or data on device performance against specific acceptance criteria.

To answer your questions, I would need a section detailing:

• Specific clinical performance endpoints (e.g., clearance rate for acne, hair reduction percentage, lesion fading percentage).
• Quantitative acceptance criteria for these endpoints (e.g., "90% hair reduction after X treatments").
• Results from a clinical study demonstrating achievement of these criteria.
• Details about the study design, sample size, data provenance, ground truth establishment, etc.

Since this information is absent, I must state that a direct response with the requested table and study details is not possible based on the provided text.

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