(252 days)
The Diode Laser Hair Removal System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth. The Free Setting Mode is intended for hair removal of unwanted hair, and permanent reduction in hair regrowth The Diode Laser Hair Removal System is intended for use on all skin types (Fitzpatrick skin types I-V), including tanned skin. The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regiment
The diode laser hair removal system is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The proposed diode laser removal system has two models. GP900A and GP900O. Both GP900A and GP900Q have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free setting mode. The GP900A is a standard case with wheels to allow easy movement on the floor. The GP900Q is a desktop case.
This document is an FDA 510(k) premarket notification for a medical device, specifically a "Diode Laser Hair Removal System." This type of document is focused on demonstrating substantial equivalence to a previously approved device, not on proving new clinical efficacy through de novo studies with specific acceptance criteria as you might see for novel AI/ML devices. Therefore, much of the information you've requested regarding acceptance criteria, sample sizes for test/training sets, experts for ground truth, MRMC studies, and effect sizes of human readers with AI assistance, is not applicable to this type of submission.
The "acceptance criteria" here are essentially compliance with recognized safety and performance standards for similar laser devices and demonstrating that the proposed device is functionally equivalent to an existing predicate device.
Here's an attempt to answer your questions based on the provided document, indicating what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, hair reduction percentage). Instead, "acceptance criteria" are implied by compliance with established safety and performance standards and direct comparison of technical specifications to a predicate device.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance (as compared to predicate) |
|---|---|
| Electrical Safety Standards Compliance: |
- IEC 60601-1: General requirements for safety
- IEC 60601-1-2: Electromagnetic compatibility
- IEC 60601-2-22: Basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating electrical safety equivalent to the predicate device. |
| Laser Safety Standards Compliance: - IEC 60825-1: Equipment classification and requirements | The proposed device (GP900A/GP900Q) complies with this standard, demonstrating laser safety equivalent to the predicate device. |
| Biocompatibility Standards Compliance: - ISO 10993-5: In Vitro Cytotoxicity
- ISO 10993-10: Irritation and skin sensitization | The proposed device (GP900A/GP900Q) complies with these standards, demonstrating biocompatibility equivalent to the predicate device. |
| Technical Specifications Equivalence to Predicate: - Energy Source: Diode laser
- Wavelength: 808 nm
- Fluency (energy density): ≤ 10 J/cm2 (Fast Mode), ≤ 120 J/cm2 (Free Setting Mode)
- Repetition Rate: ≤10 Hz (Fast Mode), ≤3 Hz (Free Setting Mode)
- Pulse Duration: ≤ 20 ms (Fast Mode), 5-200 ms (Free Setting Mode) | The proposed devices (GP900A/GP900Q) match the predicate device in these key technical specifications, indicating equivalent performance characteristics for hair removal. (Minor differences in spot size and max power were noted but deemed not to affect substantial equivalence). |
| Intended Use Equivalence: - Hair removal of unwanted hair
- Permanent reduction in hair regrowth
- Use on all skin types (Fitzpatrick I-VI), including tanned skin | The proposed devices have identical intended uses as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket submission based on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications. It does not present clinical study data with a "test set" in the context of AI/ML or efficacy trials. The "test results" mentioned in Section 7 refer to compliance testing with various international standards (e.g., IEC, ISO) for electrical safety, laser safety, and biocompatibility, not clinical performance data on human subjects.
Therefore, questions about sample size for a test set and data provenance are not applicable to this document.
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)
As there is no "test set" in a clinical sense with ground truth established by experts for performance evaluation, this question is not applicable. The "truth" in this submission relies on compliance with engineering and safety standards executed by certified testing laboratories and the established safety and efficacy profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since there is no clinical test set requiring expert adjudication for ground truth, this question is not applicable.
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
An MRMC comparative effectiveness study is designed for evaluating AI-assisted diagnostic or clinical decision support systems. This document is for a physical laser device, not an AI/ML software device. Therefore, an MRMC study was not done, and questions about effect size of human readers with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm. Since this is a physical laser device, not an algorithm, a "standalone algorithm performance" study was not done. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that this is a 510(k) for a physical laser hair removal device, the "ground truth" for its safety and performance is established through:
- Compliance with international safety and performance standards: (e.g., IEC 60601-1, IEC 60825-1, ISO 10993). This is typically shown by testing conducted by accredited labs.
- Demonstration of substantial equivalence to a legally marketed predicate device: This relies on the FDA having previously determined the predicate device to be safe and effective. The comparison table (Tables 3-1 and 3-2) in the document serves this purpose, showing that the proposed device's technical specifications and intended use closely match the predicate.
There is no "ground truth" derived from expert consensus, pathology, or outcomes data in this submission for clinical efficacy of the proposed device itself, as it is relying on the established record of the predicate and compliance with technical standards.
8. The sample size for the training set
This document describes a submission for a physical laser device, not an AI/ML system that requires a "training set." Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.