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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 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 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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