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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 Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Machine, 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.

The provided text is a 510(k) summary for a Diode Laser Hair Removal Machine. This document outlines the rationale for establishing substantial equivalence to a predicate device, focusing on non-clinical performance and safety data rather than a detailed study evaluating specific acceptance criteria for AI performance or clinical outcomes directly.

Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to AI/ML device performance or human reader improvement) are not present in this document. This document describes a medical device, but it is not an AI/ML device, and thus the acceptance criteria and study description won't align with questions about AI performance, human-in-the-loop studies, or extensive clinical trials as typically seen for AI-driven diagnostic tools.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

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

The document doesn't present "acceptance criteria" in the traditional sense of a specific performance threshold (e.g., accuracy > X%). Instead, it demonstrates through non-clinical testing that the device meets safety and performance standards relevant to a laser hair removal machine by comparing it to a predicate device and showing compliance with specific technical standards (e.g., IEC standards, ISO for biocompatibility).

The "performance" is more about compliance with technical specifications and safety standards. The table "Table 1 Comparison of Technology Characteristics" (Page 7) serves as the primary comparison point.

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

• Test set sample size: Not applicable in the context of clinical performance testing for a device like this. The "test set" primarily refers to the device itself and its components undergoing non-clinical bench testing.
• Data provenance: The testing was non-clinical (bench testing, electrical safety, biocompatibility, software V&V). The document does not specify geographic origin for these tests. It states "No clinical study is included in this submission" (Page 6).

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 or human reader interpretation for ground truth was performed or required for this 510(k) submission. Ground truth for non-clinical tests would be established by standard measurement equipment and lab protocols.

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

• Not applicable. This is not a study involving human reader interpretation or adjudication of medical images/data.

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, an MRMC study was not done. This is not an AI-assisted device.

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

• No, this refers to an AI/ML algorithm. This device is a laser hair removal machine, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" is based on engineering specifications, direct measurements of physical properties (e.g., wavelength, power output, dimensions), and established laboratory testing standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). There is no "pathology" or "outcomes data" in this context as no clinical study was conducted.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As above, this is not an AI/ML device.

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