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The Medical 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.

Medical Diode Laser Hair Removal System adopts 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. The Medical Diode Laser Hair Removal System 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.

Based on the provided FDA 510(k) clearance letter for the "Medical Diode Laser Hair Removal System (MNLT-D1)", it is important to note that no in-vivo clinical studies were conducted or presented in this submission to demonstrate device performance against acceptance criteria in a clinical setting. The clearance is based on substantial equivalence to a predicate device, supported by non-clinical (bench) testing and compliance with relevant safety and performance standards.

Therefore, the following answers describe the absence of a study proving the device meets acceptance criteria in a clinical sense, and instead focus on what was presented:

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study was conducted as part of this 510(k) submission to demonstrate device performance in terms of hair removal efficacy or permanent hair reduction against clinical acceptance criteria, a table showing "reported device performance" in that context cannot be generated.

Instead, the acceptance criteria and performance were focused on non-clinical tests to demonstrate compliance with recognized standards and substantial equivalence to a predicate device in terms of safety and technical specifications.

Table: Non-Clinical Acceptance Criteria and Reported Device Performance

Study Details (Relevant to Non-Clinical Testing and Equivalence)

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

   • No clinical test set was used.
   • For the non-clinical tests (e.g., electrical safety, EMC, laser safety, biocompatibility), the device itself (Medical Diode Laser Hair Removal System MNLT-D1) served as the "sample." These tests are typically conducted in a laboratory setting on one or a few units to ensure design compliance.
   • Data provenance is from non-clinical laboratory testing reports conducted by the manufacturer (Shandong Moonlight Electronics Tech Co.,Ltd.) or their designated testing facilities in China. The documentation implicitly indicates these were prospective tests performed for regulatory submission.

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

   • Not applicable. Since no clinical study or test set requiring human assessment of performance (like image interpretation or clinical outcomes) was conducted, there was no need for experts to establish "ground truth" in the typical sense for clinical performance.
   • The "ground truth" for non-clinical tests is established by objective measurements and adherence to international standards (e.g., IEC, ISO). The expertise involved would be that of test engineers, metrologists, and quality assurance personnel performing and verifying the tests.

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

   • Not applicable. No clinical test set requiring human rater adjudication was involved. Non-clinical compliance testing relies on quantitative measurements and pass/fail criteria from international standards.

4. 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 hair removal system, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a hardware medical device; it is not an AI algorithm. Its performance is inherent to its physical and functional specifications.

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

   • For the non-clinical tests, the "ground truth" was based on objective, verifiable measurements against the specified requirements of international consensus standards (e.g., maximum allowable leakage current, specific electromagnetic emission limits, defined biocompatibility thresholds).

7. The sample size for the training set:

   • Not applicable. There was no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. As there was no training set, no ground truth needed to be established for it.

Summary of Reliance for Clearance:

The FDA clearance for the Medical Diode Laser Hair Removal System (MNLT-D1) was based on:

• Demonstration of substantial equivalence to an existing legally marketed predicate device (K221312) in terms of indications for use, fundamental technology (diode laser), and principle of operation.
• Non-clinical testing to prove the device's compliance with electrical safety, EMC, laser safety, and biocompatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10, ISO 10993-23).
• Engineering analysis confirming that any differences in technical specifications (e.g., spot size, fluence, pulse duration) compared to the predicate device did not raise new questions of safety or effectiveness.

The submission explicitly states: "No clinical study is included in this submission." This indicates that the clearance for this specific device relied entirely on non-clinical data and the regulatory pathway of substantial equivalence.

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The Medical Diode Laser Hair Removal System is used 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. Use on all skin types ( Fitzpatrick I-VI), including tanned skin.

Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through an LCD touch-screen. In the handpiece of the machine, the light emitted by each discharge at 808nm.

This appears to be a 510(k) summary for a Medical Diode Laser Hair Removal System. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not available in this document.

Here's an analysis of the provided text in relation to your request:

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

This document does not present a formal table of "acceptance criteria" for clinical performance. Instead, it demonstrates "substantial equivalence" to predicate devices, meaning it aligns well with the performance and safety profiles of already cleared devices.

The "performance" discussed is primarily technical compliance with electrical, EMC, and laser safety standards, and matching the intended use of predicate devices.

2. Sample sized 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, sample size, or data provenance from a clinical study to report. The evaluation is based on non-clinical (bench) testing and comparison to predicate devices.

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. This device is a laser hair removal system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a laser hair removal system, not an algorithm.

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

Not applicable, as no clinical study was conducted to establish performance against a clinical ground truth. The "ground truth" equivalent for this submission is regulatory compliance with standards and equivalence to predicate devices.

8. The sample size for the training set

Not applicable, as no clinical study was conducted.

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

Not applicable, as no clinical study was conducted.

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