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The Dermatological Diode Laser 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.

The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration.

The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

This document describes a 510(k) submission for a Dermatological Diode Laser System, which is a medical device for hair removal and permanent hair reduction. The submission aims to demonstrate substantial equivalence to a predicate device.

Key Findings on Acceptance Criteria and Studies:

The submission explicitly states:

• "No clinical study is included in this submission."

This immediately indicates that no study was conducted to prove the device meets specific performance acceptance criteria for hair removal or permanent hair reduction. The acceptance criteria and performance reported in the table below are based on the device's technical specifications and intended use, and the claim of substantial equivalence to a predicate device, rather than on clinical efficacy data.

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was performed, there are no reported clinical performance metrics directly demonstrating hair removal or permanent hair reduction efficacy for this specific device. The acceptance is derived from the device's technical specifications being sufficiently similar to a legally marketed predicate device, and compliance with safety and electrical standards.

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

• No test set for clinical performance was used, as no clinical study was performed. Only non-clinical tests (electrical safety, EMC, laser safety, biocompatibility, software validation) were conducted on the device itself.

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 test set requiring expert ground truth was used.

4. Adjudication method for the test set:

• Not applicable, as no clinical test set requiring adjudication was used.

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 system for physical hair removal, not an AI-assisted diagnostic or interpretation tool. 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 a physical laser system, not an algorithm or AI.

7. The type of ground truth used:

• For non-clinical tests: Ground truth was defined by compliance with established international standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10) and the device's own design specifications.

8. The sample size for the training set:

• Not applicable. This device is a hardware laser system, not an AI/machine learning model that requires a training set.

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

• Not applicable. As above, no training set was used.

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The Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The Dermatological Carbon Dioxide Laser Systems, and it is also a gas laser. With its own wavelength of 10600 nm, the laser energy density is high and the divergence angle is very small. The focus light beam was used to vaporization, coagulation the human tissue.

The provided document is a 510(k) summary for a Dermatological Carbon Dioxide Laser System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (a laser system) to a predicate device through non-clinical testing and comparison of technical specifications.

Therefore, many of the requested criteria related to AI/ML study design (ground truth, expert readers, MRMC studies, training/test sets, etc.) are not applicable to this submission.

However, I can extract the acceptance criteria and performance as presented for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the comparison to a predicate device and compliance with established safety and performance standards. The "performance" in this context refers to the device's technical specifications matching or being acceptably different from the predicate, and its compliance with safety standards.

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

• Sample Size: Not applicable. This is a physical device submission, not an AI/ML diagnostic or predictive model that uses a "test set" of patient data. The "testing" involved non-clinical performance and safety evaluations of the device itself.
• Data Provenance: Not applicable. The "data" are technical specifications and test results from the device manufacturer, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment is based on engineering specifications, safety standards, and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

• Not applicable. There is no test set or expert adjudication process for this type of device submission.

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 not an AI-based device, and therefore no MRMC study was conducted or relevant.

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

• Not applicable. This is not an algorithm or software-only device.

7. The type of ground truth used:

• Not applicable. The "ground truth" or basis for acceptance in this submission relies on:
  • Predicate Device Specifications: The technical and performance characteristics of a previously cleared device (K192528).
  • International Standards Compliance: Adherence to recognized medical device safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825, IEC 60601-1-2, ISO 10993 series).
  • Non-Clinical Testing: Results of tests performed on the device to confirm its specifications and safety.

8. The sample size for the training set:

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

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

• Not applicable. There is no training set for this device.

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