(90 days)
The Diode Laser 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 System, 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. Control Panel
b. Main Control Module
c. Constant current board module
d. Temperature and humidity control system
e. Handpiece module
The provided document is a 510(k) Summary for a Diode Laser System intended for hair reduction. It does not contain information about specific acceptance criteria for device performance beyond general safety and effectiveness. The document states "No clinical study is included in this submission." Therefore, the requested information regarding acceptance criteria, device performance, study details, expert involvement, and ground truth cannot be fully provided from the text.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for hair reduction. Instead, it defines the intended use based on "permanent hair reduction... 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."
Performance is primarily addressed through non-clinical tests comparing the proposed device's specifications and safety compliance to predicate devices.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Proposed Device) |
|---|---|
| Safe and effective for permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. | "Diode Laser 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." | |
| Compliance with relevant electrical safety, EMC, and laser safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). | Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. |
| Biocompatibility of patient-contacting materials (no cytotoxicity, no sensitization, no irritation). | Patient contact materials (Sapphire and aluminum alloy) passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization), showing "No Cytotoxicity," and "No evidence of sensitization" or "irritation." |
| Performance of key parameters (Laser Type, Wavelength, Power Supply) comparable to predicate devices. | Diode Laser, 808 nm wavelength, 100-240V~ 50/60Hz power supply. These are within ranges or similar to predicate devices. |
| Acceptable safety and effectiveness for Fluence and Pulse Duration despite differences from some predicates. | Fluence: 5-40 J/cm². Argued as having "acceptable safety" (lower max than some predicates) and "capable to achieve it's indication for use" (higher max than some predicates). |
| Pulse Duration: 30ms-200ms. Argued as having "acceptable safety" (longer or same as some predicates) and "capable to achieve it's indication for use" (similar to some predicates). | |
| Spot Size within ranges found in predicate devices. | 1.20cm² |
| Frequency within ranges found in predicate devices. | 1-5Hz |
2. Sample size 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 clinical test set, sample size, or data provenance information. Non-clinical tests were conducted to verify design specifications and compliance with standards.
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)
Not applicable, as no clinical study or test set for efficacy was conducted or provided in this submission for hair reduction. Safety and technical compliance were assessed through non-clinical testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study or test set for efficacy 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 system for hair reduction, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of a physical medical device (Diode Laser System) for hair removal. The "algorithm" in this context refers to the device's control logic, which determines energy output, pulse duration, and frequency. The device operates in a standalone manner in the sense that it mechanically delivers laser energy based on programmed parameters, but its application requires a human operator for treatment and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the primary indication (hair reduction efficacy), no clinical study was presented to establish ground truth from patient outcomes data. The submission relies on substantial equivalence to predicate devices that have established their effectiveness and safety for permanent hair reduction.
For safety (biocompatibility, electrical, EMC, laser safety), the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series, ISO 10993 series).
8. The sample size for the training set
Not applicable, as no machine learning algorithm requiring a "training set" is mentioned or implied for the intended use and performance assessment described.
9. How the ground truth for the training set was established
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.