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The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.

The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.

The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.

The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.

The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.

This document describes the FDA's 510(k) premarket notification for the "Diode Laser Therapy System" by Beijing ADSS Development Co., Ltd. A 510(k) submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo through clinical trials, as would be required for a PMA (Premarket Approval) device.

Therefore, the provided document does not contain information typically found in a study proving a device meets acceptance criteria derived from a clinical trial for AI/ML-based medical devices. The device in question is a laser therapy system, not an AI/ML-based device that would require complex performance metrics like sensitivity, specificity, or AUC, nor would it involve human readers, expert ground truth adjudication, or MRMC studies.

The "acceptance criteria" discussed in this document relate to the substantial equivalence to predicate devices and compliance with relevant performance and safety standards for laser devices.

Here's an analysis based on the provided text, addressing the points you raised where applicable to a non-AI/ML device:

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

The document does not present a formal table of "acceptance criteria" in terms of performance metrics like sensitivity/specificity for an AI/ML device. Instead, "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.

The tables provided in Section 6, "Summary of technological characteristics of device compared to the predicate device," serve as the primary comparison metrics to show substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) and Reported Device Performance:

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

• No clinical test set was used. Section 8 explicitly states: "There was no clinical testing performed."
• The "test set" for this submission consists of non-clinical bench testing for performance and compliance with relevant standards. The data provenance is implied to be from Beijing ADSS Development Co., Ltd. (China), given their location and the submission coming from them.

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. As there was no clinical testing or AI/ML component, there was no need for experts to establish ground truth in the context of diagnostic or treatment efficacy. The "ground truth" for substantial equivalence is the predicate device's proven characteristics and compliance with recognized standards.

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

• Not applicable. No clinical data requiring adjudication was generated.

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 relates to AI/ML device assessment, which this product is not.

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

• Not applicable. This relates to AI/ML device assessment, which this product is not.

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

• The "ground truth" in this context is the established safety and performance of the legally marketed predicate devices and compliance with internationally recognized performance and safety standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, IEC 60825-1 for laser safety).

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML device.

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

• Not applicable. No training set was used.

In summary:

This document is a 510(k) clearance letter for a diode laser therapy system. The "study" proving the device met "acceptance criteria" was primarily a non-clinical assessment based on:

• Bench testing: To confirm the device's technical specifications and performance (e.g., laser wavelength, pulse characteristics, energy fluence).
• Comparison to predicate devices: Demonstration of "substantial equivalence" in terms of intended use, technological characteristics, and safety features to legally marketed devices.
• Compliance with recognized standards: Adherence to national and international safety and performance standards for medical electrical equipment, laser devices, and biocompatibility.

The "acceptance criteria" are implied by meeting these requirements and showing that any differences from predicate devices do not raise new questions of safety or effectiveness. Clinical testing, human reader studies, and AI/ML specific evaluations (like those mentioned in your prompt) were not part of this clearance process for this type of device.

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The Diode Laser Therapy Systems 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 Therapy Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The Diode Laser Therapy 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 handpiece. The emission laser is activated by a foot-switch. The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.

The provided text is a 510(k) summary for a medical device (Diode Laser Therapy Systems) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical study reports with specific performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and general safety standards.

Therefore, many of the requested fields cannot be directly populated from the provided text. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to support its safety and performance.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

The document does not specify formal "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) that the device must meet. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:

• Matching intended use and fundamental technology.
• Complying with recognized safety and performance standards (IEC, ISO).
• Showing that any differences in technical specifications do not raise new questions of safety or effectiveness.

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 explicitly states: "No clinical study is included in this submission."
• Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance relevant to clinical performance. The testing mentioned (non-clinical) refers to bench testing on the device hardware and materials.

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 with ground truth established by experts is mentioned.

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

• Not applicable. No clinical test set.

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 therapy system, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted.

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

• Not applicable. This device is not an algorithm. Performance was assessed through non-clinical bench testing of the physical device.

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

• For the non-clinical tests, the "ground truth" or reference for compliance is established by international standards (IEC, ISO) for electrical safety, laser safety, electromagnetic compatibility, and biocompatibility, as well as the technical specifications of the predicate device.

8. The sample size for the training set

• Not applicable. No AI model or training set is mentioned as this is a physical medical device.

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

• Not applicable. No AI model or training set is mentioned.

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The Diode laser therapy 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 therapy system, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handle. The emission laser is activated by handle and footswitch linkage.

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).

The provided text describes a 510(k) submission for a medical device, the "Diode laser therapy system," which is intended for permanent hair reduction.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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

   The document does not explicitly present a table of acceptance criteria and reported device performance in the way a diagnostic AI would have with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by the comparison to a predicate device (K210168, Diode Laser Therapy Systems by Beijing Kes Biology Technology CO., LTD.) and compliance with relevant non-clinical standards.

   The "performance" is primarily demonstrated through this substantial equivalence comparison and through non-clinical testing.

   Here's a summation of the comparison table provided, which implicitly serves as the performance assessment against the predicate:

   Item	Acceptance Criteria (Predicate K210168)	Reported Device Performance (Proposed Device K212978)	Remark
   Product Code	GEX	GEX	Same
   Regulation No.	21 CFR 878.4810	21 CFR 878.4810	Same
   Class	II	II	Same
   Indications for Use	Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment.	Permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Defined as long-term, stable reduction in hair regrowing at 6, 9, and 12 months after treatment.	Same
   Configuration	Main Unit, Handpiece, Foot Control	Main Unit, Handle, Foot Control	Same
   Laser Type	Diode Laser	Diode Laser	Same
   Laser Classification	Class IV	Class IV	Same
   Laser Wavelength	808 nm	808 nm	Same
   Spot Size	12 mm × 12 mm = 1.44 cm²	1.2 cm × 2.4 cm = 2.88 cm²	Different
   Fluence	10-125 J/cm²	10-120 J/cm²	Different
   Frequency	1-10 Hz	1-10 Hz	Same
   Pulse Duration	10-400 ms	10-300 ms	Different
   Power Supply	99V-121V, 50/60Hz, 1400VA	AC 100~230V/50/60Hz, 2000VA	Different
   Dimension	450 × 430 × 1000 mm	430 × 500 × 1030 mm	Different
   Weight	52 kg	65 kg	Different
   Patient contact material	Aluminum alloy, ABS	Aluminum alloy, Sapphire	Different
   Cytotoxicity	No Cytotoxicity (Comply with ISO 10993-5:2009)	No Cytotoxicity (Tested according to ISO 10993-5:2009)	Same
   Sensitization	No evidence of Sensitization (Comply with ISO 10993-10:2010)	No evidence of Sensitization (Tested according to ISO 10993-10:2010)	Same
   Irritation	No evidence of Irritation (Comply with ISO 10993-10:2010)	No evidence of Irritation (Tested according to ISO 10993-10:2010)	Same
   Electrical Safety	Comply with ANSI/AAMI ES60601-1:2005, IEC 60601-2-22	Comply with ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R) 2012 and IEC 60601-2-22:2012, IEC 60825-1:2014	Same
   EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2:2014	Same
   Software Validation & Verif	N/A (implied by predicate clearance)	Software verification & validation conducted as per FDA guidance for "Moderate" level of concern.	N/A (New test)

   Explanation for "Different" remarks: The document states that despite the differences, non-clinical tests were conducted to demonstrate that these differences do not affect the safety and effectiveness of the proposed device. For example:

   • Spot Size: Non-clinical tests were done, and the results show the proposed device meets requirements.
   • Fluence: The proposed device's fluence range is within the predicate's range.
   • Pulse Duration: The proposed device's pulse duration range can be covered by the predicate's range.
   • Power Supply: Electrical safety and EMC tests were conducted, and the device works normally.
   • Dimension and Weight: These are physical specifications and do not raise safety/effectiveness issues.
   • Patient contact material: Biocompatibility tests met ISO 10993 requirements.

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 explicitly states: "No clinical study is included in this submission."
   Therefore, there is no clinical test set, sample size, or data provenance related to clinical performance. The evaluation is based on non-clinical testing and substantial equivalence to a predicate device.

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)

   Since no clinical study was performed, there was no clinical "test set" and thus no experts or ground truth established for clinical performance as would be the case for a diagnostic AI device.

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

   Not applicable, as no clinical test set or human interpretation was involved.

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. The device is a laser therapy system, not a diagnostic AI system that assists human readers.

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

   Not applicable. The device is a physical laser therapy system, not a standalone AI algorithm. It operates as a medical instrument for treatment.

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

   For the non-clinical tests, the "ground truth" or reference was compliance with international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility, IEC 60825-1 for laser safety) and demonstrating that parameter differences did not negatively impact safety and effectiveness compared to the predicate.

8. The sample size for the training set

   Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for such a device would be its design and manufacturing process to meet specifications and standards.

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

   Not applicable for the same reason as above.

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The Diode Laser Therapy Systems are 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 Therapy System, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.

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, such as arm, chest, leg, underarm etc.

The provided text is a 510(k) summary for a medical device called "Diode Laser Therapy Systems," which is intended for hair reduction. It details the device, its indications for use, and a comparison to predicate and reference devices.

However, the document does not contain information about acceptance criteria, the study design, ground truth establishment, or performance metrics typically associated with proving a device meets acceptance criteria through clinical or standalone studies for an AI/algorithm-based medical device.

Specifically, the document states: "No clinical study is included in this submission." This means there is no clinical performance data for this specific device in this submission to draw from to describe acceptance criteria or study results as requested in the prompt. The "study" mentioned in the prompt refers to a performance evaluation (often a clinical trial or a robust standalone study for AI devices).

The comparison table (Table 1: Comparison of Technology Characteristics) on page 6 primarily focuses on technical specifications (e.g., laser wavelength, spot size, fluence, electrical safety) and regulatory compliance with standards like ISO and IEC, rather than clinical performance metrics or AI algorithm performance.

Therefore, I cannot fulfill most of the request based on the provided text, as the information regarding clinical performance studies, acceptance criteria for such studies, and all related details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present.

The document concludes that the device is "Substantially Equivalent (SE)" based on non-clinical tests and technological comparisons to predicate devices, not on the basis of a clinical performance study with defined acceptance criteria and tested results.

To answer your request based on the provided text, I must state that the information is absent.

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The Diode Laser Therapy 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, 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. Power System
b. Microprocessor Control System
c. Operation Display System
d. Cooling System
e. Handpiece module

The provided text is a 510(k) premarket notification for a medical device, specifically a "Diode Laser Therapy System" intended for hair reduction. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove the device meets specific acceptance criteria in the way a new, novel device might.

Therefore, the document explicitly states: "No clinical study is included in this submission." As such, there is no study described that proves the device meets specific acceptance criteria in terms of clinical performance metrics. The acceptance criteria for this submission are primarily focused on "substantial equivalence" to a predicate device based on technical characteristics and safety standards.

However, I can extract the information relevant to the assessment requested, based on the non-clinical tests performed and the comparison to an existing predicate device.

Here's the information structured as requested, noting the limitations due to the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the comparison to the predicate device and the adherence to recognized safety standards. Performance is indicated by matching the predicate's technical specifications and safety compliance.

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

• Test Set Sample Size: No clinical test set data is provided as "No clinical study is included in this submission." The "test set" for this 510(k) relies on the general comparison of technical specifications and safety test results against established standards and predicate devices.
• Data Provenance: The data provenance for non-clinical tests (electrical safety, EMC, laser safety, biocompatibility) would be from laboratory testing performed on the Diode Laser Therapy System (LFS-K8) by San He Lefis Electronics Co., Ltd. The document does not specify the country of origin for these specific test results, but the manufacturer is based in China. These non-clinical tests are inherent to the device itself and are essentially prospective in the sense that they are performed on the device being submitted for clearance to demonstrate compliance with standards.

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 performed, there was no "test set" in the sense of patient data requiring expert ground truth establishment for clinical endpoints.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set and no expert adjudication for clinical endpoints.

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 therapy system, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a non-AI hardware medical device.

7. The Type of Ground Truth Used

The "ground truth" in this 510(k) submission relates to:

• Established Standards: Ground truth for safety and performance parameters is defined by recognized international standards (e.g., IEC 60601 series, ISO 10993 series, IEC 60825-1).
• Predicate Device Specifications: The technical specifications and established safety profile of the legally marketed predicate device (K181019) serve as a comparative ground truth for evaluating substantial equivalence.
• There is no pathology, outcomes data, or expert consensus used for clinical ground truth in this submission because clinical studies were explicitly excluded.

8. The Sample Size for the Training Set

Not applicable. No AI/machine learning component requiring a training set. This is a physical medical device.

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

Not applicable. No AI/machine learning component requiring a training set.

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The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI).

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 Therapy Systems has one model WLA-01, which mainly consist of the main console, treatment hand piece and a foot switch. The treat hand piece consist of the laser aperture, laser emission indicator, laser emission and hand piece display screen. The main console consist of power switch, hand piece holder, LCD touch screen, emergency shut off, hand-grip grab bar, connector hand piece, access door, observation Window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain and fans. The device has an embedded software named Diode Laser Therapy Systems Control Software.

The principle of laser hair removal is selective photothermolysis, 808nm wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.

The laser window of the hand piece will contact the skin directly and the laser output will contact the skin through the window. The Diode Laser Therapy System is suitable for use in healthcare facility/hospital.

Here's an analysis based on the provided text, outlining the acceptance criteria and study information for the Diode Laser Therapy Systems:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission states, "no clinical studies were needed to support this 510(k) Premarket Notification." The performance data submitted was for non-clinical aspects (biocompatibility, electrical safety, EMC, software V&V). These tests were conducted on the device itself or its components.
• Data Provenance: The origin of the non-clinical test data (biocompatibility, electrical safety, EMC, software V&V) is not specified as a country of origin in the provided text. It is assumed to be internal testing or conducted by accredited labs on behalf of the manufacturer, Wingderm Electro-Optics Ltd. (China). The data is described as "performance data were provided in support of the substantial equivalence determination," indicating it's retrospective relative to the 510(k) submission date.

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

• Not applicable for the non-clinical tests.
• For clinical performance (hair reduction), the ground truth was established by prior studies or general acceptance of the predicate devices. The document does not specify experts or their qualifications for the predicate devices' studies.

4. Adjudication method for the test set

• Not applicable for the non-clinical tests.

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

• No MRMC comparative effectiveness study was done. This device is a laser therapy system, not an AI-assisted diagnostic or interpretive device that would typically involve human readers.

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 standalone algorithm. Its software is embedded and controls device function, but it doesn't operate as an "algorithm only" in the sense of AI or diagnostic software.

7. The type of ground truth used

• For non-clinical tests (biocompatibility, electrical safety, EMC, software V&V): The ground truth is the adherence to established international and national standards (e.g., ISO 10993, ANSI AAMI ES60601-1, IEC 60601-1-2, FDA software guidance). Passing these tests constitutes meeting the "ground truth" for safety and performance in these areas.
• For clinical performance (hair reduction): The ground truth for hair reduction efficacy is based on the performance of the predicate devices, which are legally marketed and presumed to achieve "permanent hair reduction" as defined. The substantial equivalence argument relies on the subject device operating on the same principles and having comparable technical specifications to achieve the same clinical outcome as the already-cleared predicates.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for the software would involve traditional software development and testing cycles, not data-driven machine learning.

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

• Not applicable (as the device does not use a "training set" in the AI/ML context).

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The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Note: This document is a 510(k) summary for a medical device (Diode Laser Therapy Systems, Model SDL-B) and focuses on establishing substantial equivalence to a predicate device, not necessarily on demonstrating clinical efficacy through a traditional comparative effectiveness study with pre-defined acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to meeting regulatory standards and demonstrating equivalence in function and safety.

1. Table of Acceptance Criteria and Reported Device Performance

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The Diode Laser Therapy System (DenLase-810/7 & DenLase-980/7) is indicated for intraoral use for the following soft tissue applications:

• Incision
• · Excision
• · Vaporization
• · Ablation
• · Coagulation.

The DenLase is a surgical device designed with compactness, portability, reliability and user-friendliness. It provides the operator with a tool for surgical and cosmetic procedures on oral soft tissue. The Denlase utilizes a semiconductor diode with invisible infrared radiation as a laser source (810nm or 980nm). The laser power is delivered to the treatment area via a flexible fiber, which has a handpiece. The emission laser is activated by a footswitch. The Denlase adopts advanced semiconductor lasers (AIGAAs) and semiconductor refrigeration technology. By laser sent out by optical fiber, it can fast and accurately dispose tissue and lesion. The device includes three operation modes as continuous. single pulse and continuous pulse, and each operation mode is adjustable respectively by three parameter of emitting power, pulse width and pulse interval. The user can save total five groups of operation mode parameter combination under different mode.

The provided text describes a 510(k) summary for a Diode Laser Therapy System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria through the kind of study described in the original request.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not applicable or not explicitly detailed in this type of regulatory document for this specific device.

The document primarily addresses non-clinical testing for safety and performance against established standards, and a comparison to predicate devices to establish substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• IEC 60825-1: Safety of laser products Part 1: Equipment classification, requirements and user's guide.
• IEC 60601-2-22: Medical Electrical Equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
• IEC 60601-1: Medical Electrical Equipment Part1: General requirements for safety.
• IEC60601-1-2: Medical Electrical Equipment Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
• ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
• ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity. |
  | Substantial Equivalence to Predicate Devices: | The device "shares the similar indications for use, design features, functional features, same safety compliance" with predicate devices (Odyssey Navigator Diode Laser (K062258), KaVo GENTLEray 980 (K072262), Picasso (K083142), SiroLaser(K053161)). Differences in dimension, weight, duty cycle, and frequency of pulse are noted, but the document states these do not result in marked differences because the device meets the same safety and performance standards. |

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

• Not Applicable/Not Provided. The document states that "Laboratory testing was conducted to validate and verify that the proposed device... met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required." This indicates that the regulatory pathway did not necessitate a clinical study with a "test set" in the context of typical AI/diagnostic device validation. The testing focused on non-clinical performance against standards.

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

• Not Applicable/Not Provided. As no clinical study or specific "test set" requiring ground truth establishment by experts is mentioned, this information is not available.

4. Adjudication method for the test set:

• Not Applicable/Not Provided. See point 3.

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 diode laser therapy system, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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

• Not Applicable. The device is a physical laser therapy system, not an algorithm. Its performance is inherent to its physical operation and energy delivery for therapeutic procedures, not an algorithmic output that could be tested "standalone."

7. The type of ground truth used:

• Not Applicable. For this device, the "ground truth" for non-clinical testing refers to compliance with engineering specifications and safety standards (e.g., laser emission parameters, biocompatibility, electrical safety), rather than a clinical ground truth like pathology or outcome data.

8. The sample size for the training set:

• Not Applicable/Not Provided. This is a hardware medical device, not an AI model requiring a "training set."

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

• Not Applicable/Not Provided. See point 8.

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