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Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.

The provided document is a 510(k) Summary for a Light Based Hair Removal Device GP592. It discusses the device's substantial equivalence to a predicate device but does not include information about clinical studies with human participants to demonstrate specific acceptance criteria or device performance in terms of efficacy or safety. The document primarily focuses on nonclinical tests for safety and electromagnetic compatibility.

Therefore, requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it outlines nonclinical testing and substantial equivalence, not results from a human study demonstrating efficacy against acceptance criteria.

The document states:

• Nonclinical tests submitted:
  • Safety test: IEC 60601-1: 2005+A1: 2012+A2:2020, IEC 60601-1-11: 2015
  • EMC test: IEC 60601-1-2: 2020
  • Reliability test: IEC 62471: 2006, IEC 60601-2-83: 2019
  • Biocompatibility test: ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021
• Conclusion: "None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests."

This indicates that the device met the requirements of these specific technical and safety standards, which serve as the "acceptance criteria" in this context. However, these are not performance metrics like sensitivity, specificity, or outcomes from a human clinical trial.

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The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-VI), 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 regime.

The Diode Laser 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 (810 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 System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 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 mode.

The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.

I am sorry, but the provided text does not contain information about acceptance criteria and device performance for an AI/ML device or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a Diode Laser System, which is a physical medical device, not an AI/ML software. It primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications, intended use, and non-clinical safety tests.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If an MRMC comparative effectiveness study was done and its effect size.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.

The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.

The model GP908D is a handheld device, consisting of a main body, power cord and adapter.

308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.

The provided text describes a 510(k) submission for a medical device, the "308nm Excimer UV-light Skin Therapy System," and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI/software algorithm efficacy.

Specifically, the document discusses:

• Device Description: A UV light therapy system for psoriasis and vitiligo.
• Technological Characteristics: Comparison of wavelength, light source, mode of operation, etc., with a predicate device.
• Nonclinical Tests: Safety (IEC 60601-1), EMC (IEC 60601-1-2), Reliability (IEC 60601-2-57), Biocompatibility (ISO 10993-5, ISO 10993-10), and Software Validation. These are primarily engineering and compliance tests, not clinical performance studies measuring treatment efficacy or algorithm accuracy.

Therefore, I cannot fulfill your request for the tables and study details as this information is not present in the provided text. The document states that "None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests." This refers to its safety and performance as a device, not its clinical effectiveness in treating patients or the performance of a diagnostics interpreting AI/software.

The provided document is a 510(k) summary for a physical medical device (an excimer UV-light system), not an AI/software as a medical device (SaMD) or an AI-assisted diagnostic system. The "software validation & verification testing" refers to the embedded control software for the device itself, not an AI intended for diagnostic or prognostic purposes, which would require the kind of clinical validation and ground truth establishment you are asking about.

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The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.

The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.

This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.

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

Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.

The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.

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Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

The Light based hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.

This document, K180383, is a 510(k) summary for the "Light based hair removal device" by Shenzhen GSD Tech Co., Ltd. It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA approval.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for efficacy or hair reduction. The core of the submission is to demonstrate that the new device is as safe and effective as previously cleared devices.

The "acceptance criteria" in this context are interpreted as compliance with relevant regulatory standards and demonstrating similar technological and performance characteristics to the predicate device, implying similar safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and not a study with specific efficacy endpoints, there isn't a direct "acceptance criteria" table in terms of clinical performance metrics (e.g., % hair reduction). Instead, the performance shown is in relation to safety and regulatory compliance.

2. Sample Size Used for the Test Set and Data Provenance

• No human clinical study data is presented for efficacy. The studies described are engineering/laboratory tests (biocompatibility, electrical safety, eye safety, software validation).
• Therefore, there is no "test set" in the context of human subjects, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. As no human clinical efficacy study is described, there is no "ground truth" established by experts in that context. The "ground truth" for the engineering tests would be the established international standards themselves, and the expertise lies with the testing laboratories performing the assessments.

4. Adjudication Method for the Test Set

• Not applicable. There is no human clinical test set requiring adjudication in the 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 device is a light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was done or mentioned.

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

• Not applicable. This is not an algorithmic device in the sense of AI. The software validation is for the device's operational software, not for an AI algorithm.

7. The Type of Ground Truth Used

• For the engineering tests, the "ground truth" is the established and recognized international standards (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). Compliance with these standards indicates safety and performance.

8. The Sample Size for the Training Set

• Not applicable. There is no machine learning or AI component mentioned that would require a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary:

This 510(k) submission demonstrates the substantial equivalence of the "Light based hair removal device" by showing that it meets recognized safety and performance standards through engineering and biocompatibility testing, and that its technological characteristics are similar to those of predicate devices. It does not include clinical efficacy studies with human subjects or AI performance evaluations.

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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.

• IEC 60601-1: General requirements for safety
• IEC 60601-1-2: Electromagnetic compatibility
• IEC 60601-2-22: Basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating electrical safety equivalent to the predicate device. |
  | Laser Safety Standards Compliance:
• IEC 60825-1: Equipment classification and requirements | The proposed device (GP900A/GP900Q) complies with this standard, demonstrating laser safety equivalent to the predicate device. |
  | Biocompatibility Standards Compliance:
• ISO 10993-5: In Vitro Cytotoxicity
• ISO 10993-10: Irritation and skin sensitization | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating biocompatibility equivalent to the predicate device. |
  | Technical Specifications Equivalence to Predicate:
• Energy Source: Diode laser
• Wavelength: 808 nm
• Fluency (energy density): ≤ 10 J/cm2 (Fast Mode), ≤ 120 J/cm2 (Free Setting Mode)
• Repetition Rate: ≤10 Hz (Fast Mode), ≤3 Hz (Free Setting Mode)
• Pulse Duration: ≤ 20 ms (Fast Mode), 5-200 ms (Free Setting Mode) | The proposed devices (GP900A/GP900Q) match the predicate device in these key technical specifications, indicating equivalent performance characteristics for hair removal. (Minor differences in spot size and max power were noted but deemed not to affect substantial equivalence). |
  | Intended Use Equivalence:
• Hair removal of unwanted hair
• Permanent reduction in hair regrowth
• Use on all skin types (Fitzpatrick I-VI), including tanned skin | The proposed devices have identical intended uses as the 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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