(274 days)
SILKPRO is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for 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 regume.
The SILKPRO Laser Hair Removal System emits a pulse of laser light, which heats up the dark pigment inside the hair and deactivates the follicles in the skin that produce hair.
Here's a breakdown of the acceptance criteria and study information for the SILKPRO Laser Hair Removal System, based on the provided FDA 510(k) summary:
The provided document (510(k) summary) does not contain a detailed study design with specific acceptance criteria that demonstrate the device's clinical performance for "permanent hair reduction" backed by numerical efficacy data. Instead, it focuses on demonstrating substantial equivalence to a predicate device (TRIA Laser Hair Removal System) based on technological characteristics and safety standards.
However, it does mention an "intended use" that defines permanent hair reduction, which can be interpreted as the functional acceptance criterion the device aims to meet. It also describes a human factors usability study.
1. Table of Acceptance Criteria & Reported Device Performance
Note: The FDA 510(k) summary typically doesn't present a table of numerical acceptance criteria for clinical efficacy and reported device performance in the same way a clinical trial report would. Instead, it argues for substantial equivalence based on intended use and technological characteristics that are comparable to a predicate device, along with safety and usability studies.
| Acceptance Criteria (Inferred from Intended Use & Predicate Comparison) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Clinical Efficacy (Permanent Hair Reduction) | Implied to be equivalent to predicate: "SILKPRO is also intended for 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." The document asserts substantial equivalence to the TRIA Laser Hair Removal System (K090820), which has the same intended use. No specific numerical efficacy data (e.g., percentage hair reduction) for SILKPRO is provided in this document. |
| Safety and Electrical/Mechanical Performance | Meets recognized standards: The device claims compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 10993-5, and ISO 10993-10 for electrical, mechanical, thermal safety, electromagnetic compatibility, and biocompatibility. |
| Usability by Layperson | Demonstrated as acceptable: A Human Factors Usability study was conducted, showing that a layperson could understand the user manual, correctly use the device for hair removal, attach the power cord, recognize activation, correctly place and move the device, and understand contraindications. The study reported "no failures in terms of correct selection of appropriate site for treatment or correct application of laser to the targeted site." No numerical metrics (e.g., success rate, error rate) are provided. |
| Technological Characteristics | Comparable to predicate: Wavelength (810nm), Laser Type (Diode), Laser Material (GaAs), Operating Temperature/Humidity/Pressure, Power Supply. Differences in Max Energy Density (25J/cm² vs 22J/cm²), Energy Density levels, and Laser Beam dimensions were assessed as not affecting safety and effectiveness due to compliance with relevant IEC standards. |
2. Sample Size and Data Provenance
- Test Set (Human Factors Usability Study):
- Sample Size: The document does not specify the exact sample size for the Human Factors Usability study. It only states, "A Human Factors Usability study was conducted to demonstrate that a layperson was capable..."
- Data Provenance: Not explicitly stated, but typically, human factors studies for medical devices are conducted in a simulated or real-use environment within the country of manufacture or intended market. Given the manufacturer is Chinese, and it's for FDA submission, it could be either. It is a prospective study as it involved participants performing tasks with the device.
3. Number of Experts and Qualifications for Ground Truth
- Human Factors Usability Study: The document does not mention the use of "experts" to establish ground truth for this usability study in the context of clinical outcomes. The "ground truth" for usability was likely defined by the instructions in the user manual and objective observation of whether participants performed actions correctly.
- Clinical Efficacy (Permanent Hair Reduction): The document does not describe a clinical study for SILKPRO where experts established ground truth for hair reduction. The claim of "permanent hair reduction" is made by declaring substantial equivalence to a predicate device that likely had such studies.
4. Adjudication Method for the Test Set
- Human Factors Usability Study: Not specified. For usability studies, adjudication might involve multiple observers assessing participant performance against a checklist, but this detail is not provided.
- Clinical Efficacy: Not applicable as a primary clinical efficacy test set for SILKPRO is not described for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned in this document. This type of study typically involves comparing physician performance (e.g., diagnostic accuracy) with and without an AI-assisted device. The SILKPRO device is a direct-to-consumer hair removal system, not a diagnostic tool requiring expert interpretation.
6. Standalone Performance Study
- For clinical efficacy (permanent hair reduction), a standalone algorithm-only or device-only performance study (meaning, clinical trial data for the SILKPRO device specifically measuring hair reduction) is not detailed or provided in this 510(k) summary. The summary relies on substantial equivalence to the predicate device for this claim.
- A Human Factors Usability study was performed, which assesses the device's performance in the hands of a lay user for its intended purpose. This is a form of standalone performance evaluation for usability.
7. Type of Ground Truth Used
- For Clinical Efficacy: The ground truth for the claim of "permanent hair reduction" for the predicate device (TRIA Laser Hair Removal System) would have historically been established through clinical measurements of hair counts at specified time points (6, 9, and 12 months post-treatment) following a treatment regimen. For SILKPRO, this 510(k) relies on the intended use matching the predicate and technological similarity.
- For Human Factors Usability Study: The ground truth was based on correct adherence to the instructions provided in the device's User Manual.
8. Sample Size for the Training Set
- This 510(k) summary does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device is a laser hair removal system, not an AI-driven diagnostic or treatment planning system. Therefore, this question is not applicable to the information provided.
9. How Ground Truth for Training Set Was Established
- As there is no mention of an AI or machine learning component requiring a 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.