Search Results

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.

Ask a specific question about this device

The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:

1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota.

532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks: Telangiectasias; Spider angioma: Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired waveleneth and the related output energy via control panel.

The provided text describes a 510(k) submission for a Q Switched Nd: YAG Laser machine. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical performance data against specific acceptance criteria for AI/ML devices. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its safety and effectiveness in comparison to the predicate device.

Here's the information as far as it can be extracted from the provided text:

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

For a 510(k) submission, the "acceptance criteria" are typically defined by the technical specifications and adherence to recognized standards, demonstrating performance comparable to a predicate device. The "reported device performance" is then the demonstrated compliance with these specifications and standards.

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

The document states: "No clinical study is included in this submission." The testing described is non-clinical (laboratory/bench testing) verifying device specifications and adherence to standards. Therefore, an explicit "test set sample size" for patient data and "data provenance" (country of origin, retrospective/prospective) are not applicable to this type of submission. The tests involved physical device characteristics and materials.

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 studies with human "test sets" or expert-established "ground truth" were part of this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no clinical studies with expert adjudication were part of this 510(k) 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 device is a laser machine, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

Not applicable. This device is a physical laser machine, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and engineering principles and the requirements defined by the international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical and laser safety). Device characteristics were measured against predefined specifications that are deemed safe and effective in comparison to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so no "training set" in that context exists.

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

Not applicable for the same reason as above.

Ask a specific question about this device