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The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary:

This device is a Diode Laser Hair Removal System. The provided document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical trial results for novel devices. Therefore, a clinical study documenting device performance against specific acceptance criteria for efficacy (e.g., hair reduction percentage) is explicitly stated as not included in this submission. The acceptance criteria primarily revolve around demonstrating safety and performance equivalence through non-clinical testing.

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

This 510(k) submission explicitly states: "No clinical study is included in this submission."

The "study" or evidence provided to meet the acceptance criteria is primarily a non-clinical testing report demonstrating compliance with recognized safety and performance standards, and a comparison to the predicate device's specifications.

1. Sample size used for the test set and the data provenance: Not applicable for a clinical study, as none was included. For non-clinical tests, the "sample" would refer to the device itself or its components. The provenance of the data is from in-house testing and external laboratory testing for standard compliance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is established by adherence to recognized international standards (e.g., IEC, ISO) and laboratory testing protocols.

3. Adjudication method for the test set: Not applicable. Non-clinical tests typically involve objective measurements against pass/fail criteria defined by the standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for this type of device and submission (no clinical study was conducted).

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

6. The type of ground truth used:

   • For Safety Criteria: Adherence to established international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22 for electrical and laser safety; ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility). These standards define the test methods and acceptance limits that constitute "ground truth" for safety.
   • For Performance (Functional Equivalence): Engineering rationale comparing the proposed device specifications (Fluence, Pulse Duration, Power Supply) to the predicate device, asserting that minor differences do not impact safety or effectiveness, supported by successful completion of the aforementioned non-clinical safety standards.

7. The sample size for the training set: Not applicable, as no clinical study or machine learning component (requiring a training set) was mentioned or conducted.

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

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The Diode Laser Hair Removal System (Model: MBT-Diode Laser) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by footswitch or handle button.

The Diode Laser Hair Removal System consists of the following major components

• The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module
• Handpiece
• Footswitch

The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (MBT-Diode Laser). It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific, quantified acceptance criteria for the new device as would be seen in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and adherence to recognized standards.

The table below summarizes the technical comparison provided, where "acceptance criteria" can be interpreted as demonstrating equivalence or justification for differences compared to the predicate/reference devices:

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no "test set" in the context of clinical performance data. The evaluation relies on non-clinical (bench) testing and comparison to predicate devices, not human subject data.

Since no clinical study was conducted, there is no data provenance (country of origin, retrospective/prospective) for a test set.

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

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no ground truth for a test set established by experts.

4. Adjudication Method for the Test Set

Not applicable. As no clinical study was conducted and no clinical test set was used, there was no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was conducted.

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

The device is a hardware product (Diode Laser Hair Removal System), not an algorithm or software-only device. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/software as a medical device (SaMD) is not applicable here. The performance is evaluated based on its physical/electrical characteristics and safety standards.

7. The Type of Ground Truth Used

For the non-clinical tests regarding electrical safety, EMC, laser safety, and biocompatibility, the "ground truth" is defined by compliance with internationally recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.

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

Not applicable. No training set was used.

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The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.

The provided document is a 510(k) summary for the Diode Laser Hair Removal System (SH-VD910). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance in terms of hair removal. The document explicitly states: "No clinical study is included in this submission." Therefore, it does not contain information about:

• A table of acceptance criteria and reported device performance (in terms of hair removal efficacy).
• Sample size used for a test set for clinical performance.
• Data provenance for a clinical test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used for performance validation.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document details non-clinical tests to demonstrate that the new device meets safety and performance standards equivalent to a predicate device, focusing on technical specifications and compliance with recognized standards.

Here's the relevant information that is provided:

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

The document doesn't provide specific quantitative acceptance criteria for hair removal efficacy and corresponding reported performance metrics (e.g., percentage hair reduction). Instead, it compares technical specifications of the proposed device to a predicate device and states that the proposed device complies with various safety and electrical standards.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study was conducted.

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 study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was conducted.

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 this device is a laser hair removal system, not an AI-assisted diagnostic tool. No clinical study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a laser hair removal system, not an algorithm. No clinical study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was conducted. The ground truth for the non-clinical tests is based on compliance with established international standards (e.g., IEC, ISO).

8. The sample size for the training set: Not applicable, as this is a laser device, not a machine learning algorithm.

9. How the ground truth for the training set was established: Not applicable, as this is a laser device, not a machine learning algorithm.

Non-Clinical Test Conclusions:
The manufacturer performed non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests demonstrated compliance with the following standards:

• IEC 60601-1 Edition 3.2 2020-08 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2 Edition 4.1 2020-09 (Medical Equipment - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests)
• IEC 60825-1:2014 (Safety of laser products - Part 1: Equipment classification, and requirements)
• IEC 60601-2-22: 2012 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)
• ISO 10993-5: 2009 (Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10 Fourth edition 2021 (Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
• ISO 10993-23 First edition 2021-01 (Biological evaluation of medical devices - Part 23: Tests for irritation)

The conclusion is that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K162659) based on these non-clinical tests.

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Diode Laser Hair Removal System (RD-SLD600) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Hair Removal System (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI). The complete system consists of its console, module and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.

The provided text is a 510(k) Summary for a Diode Laser Hair Removal System (RD-SLD600). It asserts substantial equivalence to predicate devices based on non-clinical testing. Crucially, no clinical studies were performed for this device as part of the submission. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria through clinical performance.

The document states:

• "Clinical testing was not performed for the subject device as part of the submission." (page 8)
• The conclusion is based on non-clinical tests (Electrical Safety and Electromagnetic Compatibility, and Biocompatibility) which determined the device to be "safe and effective for its intended use, and performs as well or better than the predicate devices" (page 8).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study was explicitly not conducted according to this document.

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Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².

The provided text describes the acceptance criteria and study proving the device's substantial equivalence to predicate devices, focusing on technical and safety aspects rather than clinical performance data with specific acceptance criteria related to a clinical outcome.

Here's a breakdown of the requested information based on the provided text:

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

The document does not present a formal table of clinical acceptance criteria. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical specifications and adherence to safety and performance standards. The "performance" reported is primarily the device's compliance with these standards and its technical similarity to the predicates.

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

The document describes bench testing and compliance with various standards, not a clinical study with a "test set" of patient data or a specific sample size of subjects. The verification tests were performed on the device itself.
Therefore, there is no mention of a "sample size" for a test set in the clinical sense, nor data provenance like country of origin or retrospective/prospective status as it pertains to human subjects.

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 provided as the device's clearance is based on technical performance and safety standards, not on a clinical performance study requiring expert ground truth in diagnostics or treatment outcomes.

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

This information is not applicable/provided because the submission focuses on technical specifications, safety, and substantial equivalence to predicate devices, not a clinical trial with a test set requiring adjudication of findings.

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 is not applicable. The device is a "Diode Laser Hair Removal Systems for Medical Use." It is a treatment device, not an AI-powered diagnostic tool used by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission.

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

This is not applicable. The device is a physical laser system for hair removal. While it contains software, the "standalone" performance described in the context of AI algorithms is not relevant here. The software plays a role in the user interface and system control, validated according to general software principles.

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

The "ground truth" for this device's performance is compliance with established international and national safety and performance standards for medical electrical equipment, laser products, and biocompatibility (e.g., IEC 60601 series, IEC 60825-1, ISO 10993 series). The functional aspects (wavelength, energy, frequency, cooling) were verified through bench testing against specified requirements. For the software, the "ground truth" was established by validating it against FDA Final Guidance-General Principles of Software Validation and IEC62304-2015 to ensure it does not raise unacceptable risks.

8. The sample size for the training set

This is not applicable/provided. The submission does not describe an AI model or machine learning algorithm that requires a "training set" of data in the typical sense. The software validation refers to the software embedded within the device, not a separate AI algorithm trained on a dataset.

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

This is not applicable/provided as there is no mention of an AI training set in the document.

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The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device are Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch.

The provided document is a 510(k) summary for a medical device (Diode Laser Hair Removal System). It describes the device, its intended use, and compares it to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria for device performance, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in terms of efficacy or performance on hair removal.

Here’s a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of acceptance criteria and reported device performance: The document lists technical specifications for the proposed device and compares them to the predicate device (e.g., laser type, wavelength, spot size, fluence, frequency). However, it does not define specific acceptance criteria related to efficacy (e.g., "X% hair reduction in Y% of patients") nor does it present study data against such acceptance criteria. The "Remarks" column in Table 4 simply states "SE" (Substantially Equivalent) or "Discussion 1" if there's a difference in a parameter. "Discussion 1" clarifies that the proposed device's fluence range is within the predicate's, which doesn't equate to performance acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study data is presented. The document explicitly states: "No clinical study is included in this submission."

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical performance study requiring ground truth establishment is presented.

4. Adjudication method for the test set: Not applicable, as no clinical performance study requiring adjudication is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. The device is a laser hair removal system, not a diagnostic device requiring human reader interpretation or AI assistance in the same way.

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

7. The type of ground truth used: Not applicable, as no clinical performance study requiring ground truth is presented.

8. The sample size for the training set: Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this device does not involve machine learning or AI algorithms.

Summary of what the document does provide regarding acceptance and testing:

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for approval. This typically involves showing that the new device has the same intended use, technological characteristics, and safety profile as a legally marketed device.

The non-clinical testing detailed in section 7 confirms that the device complies with relevant safety and electrical standards:

• IEC 60601-1: General Requirements For Basic Safety And Essential Performance
• IEC 60601-2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• IEC 60825-1: Safety of laser products Part 1: Equipment classification and requirements
• IEC 60601-1-2: Electromagnetic compatibility
• ISO 10993-5: Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
• ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
• AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

The "acceptance criteria" here are implicitly the adherence to these standards and the demonstration of equivalent technical specifications (Table 4) and safety characteristics (Table 5) to the predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests that confirmed compliance with these standards and the comparison tables showing technical equivalence.

The document explicitly states "No clinical study is included in this submission." This means that the 510(k) clearance was based on demonstrating equivalence, not on providing new clinical performance data to meet specific efficacy acceptance criteria.

In conclusion, the document's purpose is to establish substantial equivalence based on technical specifications and safety standards, rather than proving performance against specific efficacy acceptance criteria via clinical trials.

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The Diode Laser System is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.

b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.

c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.

d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.

e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

This document is a 510(k) premarket notification for a medical device, specifically a Diode Laser Hair Removal System. It does not describe a study involving acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) but rather focuses on verifying that the proposed device meets design specifications and is substantially equivalent to a predicate device.

Therefore, many of the requested categories (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission. This document details engineering and safety compliance rather than a clinical performance study.

Here's a breakdown of the available information based on your request:

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

The document does not present acceptance criteria in terms of clinical performance metrics for diagnosis (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as comparison to a predicate device's technical specifications. The "reported device performance" is essentially that the device complies with these standards and its technical specifications are comparable to the predicate.

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

• Not Applicable: No clinical test set data is presented in this 510(k) submission for the proposed device's performance. The review relies on non-clinical testing for compliance with standards and a comparison of technical specifications to predicate devices. The section explicitly states "No clinical study is included in this submission."

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 and thus no ground truth established by experts is mentioned in this submission.

4. Adjudication method for the test set

• Not Applicable: No clinical test set requiring adjudication is mentioned.

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 laser hair removal system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study is irrelevant.

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

• Not Applicable: This is a physical medical device (laser system), not a software algorithm.

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

• Not Applicable: For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence fundamentally relies on:
  • Compliance with recognized industry standards (e.g., IEC, ISO) through non-clinical testing.
  • Comparison of technical specifications and intended use to legally marketed predicate devices.
  • The "permanent hair reduction" definition references long-term stable reduction measured at 6, 9, and 12 months after treatment, but this is an indication for use definition and not performance data from the current submission.

8. The sample size for the training set

• Not Applicable: No training set data for an algorithm is relevant to this device submission.

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

• Not Applicable: No training set data for an algorithm is relevant to this device submission.

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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 Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs 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 (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 system provides two working modes, which are standard hair removal mode (HR) and fast hair removal mode (FHR). They are different in the combination of frequency and fluence. Compared with HR mode, the FHR Mode (Fast Hair Removal) has low fluence and high repetition rate (10Hz).

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, including Axillary, Chest, Arm, Back, Leg, Hairline, Cheek, Lip, Beard, and Bikini;

The provided document describes a 510(k) premarket notification for a Diode Laser Hair Removal System L808. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria and a study to prove performance.

Therefore, many of the requested items (e.g., acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or available in this document. The submission explicitly states: "No clinical study is included in this submission."

However, I can extract information related to the non-clinical tests and the comparison to the predicate device, which serves as the basis for the substantial equivalence determination.

Here's a breakdown of the available information:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., percentage of hair reduction, safety outcomes) for the proposed device's approval in this 510(k) summary because no clinical study was conducted. Instead, the "acceptance criteria" are implied by meeting various international safety and performance standards and demonstrating technological similarity to 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)

• Not Applicable. No clinical study (test set) was conducted or presented in this 510(k) submission. Non-clinical tests listed are primarily engineering and bench testing, not human subject 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)

• Not Applicable. No clinical test set requiring expert ground truth was established within this submission.

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

• Not Applicable. No clinical test set requiring adjudication was established within this submission.

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 laser hair removal system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this device.

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

• Not Applicable. This is a hardware device (laser system), not an algorithm. Therefore, standalone algorithm-only performance is not applicable.

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

• Not Applicable for clinical performance. For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the referenced IEC and ISO standards. For the substantial equivalence comparison, the "ground truth" is the established technological characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm was used as no AI/software algorithm for clinical interpretation is part of this device submission.

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

• Not Applicable. As no training set was used, no ground truth for it was established.

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