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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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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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