(86 days)
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The Leaf Smooth (LH-LIPLB) is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Arc Flashlamp, capacitive sensor to detect appropriate skin contact and a skin sensor to detect appropriate skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. The Leaf Smooth has 6 levels output intensity.
This document is a 510(k) Premarket Notification for the "Leaf Smooth" hair removal device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance metrics defined by acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested criteria for an AI/ML device (e.g., sample size for AI test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it's for a non-AI hardware device (Intense Pulsed Light hair removal device).
However, I can extract the relevant "acceptance criteria" (which are more akin to design specifications and regulatory compliance) and the "study" (non-clinical testing) that proves the device meets these.
Here's the information based on the provided document:
Acceptance Criteria and Device Performance for Leaf Smooth (LH-LIPLB)
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (IPL hair removal), "acceptance criteria" are derived from recognized consensus standards and comparisons to predicate devices. The "reported device performance" indicates compliance or similarity.
| Criterion Type | Acceptance Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Device Characteristics & Intended Use | ||
| Intended Use | Over-the-counter device intended for removal of unwanted body and/or facial hair. (Same as predicates) | Leaf Smooth: Over-the-counter device intended for removal of unwanted body and/or facial hair. (Matches predicates) |
| Product Code | OHT (Same as predicates) | Leaf Smooth: OHT (Matches predicates) |
| Classification (Regulation) | 21 CFR 878.4810 (Laser surgical instrument for use in general and plastic surgery and in dermatology) (Same as predicates) | Leaf Smooth: 21 CFR 878.4810 (Matches predicates) |
| Prescription Use | Over-The-Counter Use (Not Prescription) (Same as predicates) | Leaf Smooth: OTC (Matches predicates) |
| Pulsing Control | Finger switch (Same as predicates) | Leaf Smooth: Finger switch (Matches predicates) |
| Delivery Device | Direct illumination to tissue (Same as predicates) | Leaf Smooth: Direct illumination to tissue (Matches predicates) |
| Energy Medium | Xenon Arc Flashlamp (Same as predicates) | Leaf Smooth: Xenon Arc Flashlamp (Matches predicates) |
| Wavelength Range | Similar to predicates (e.g., Predicate K192432: 510-1100nm) | Leaf Smooth: 475-1100 nm (Similar to predicates - "Remark: Similar") |
| Spot Size | Similar to predicates (e.g., Predicate K192432: 4.5 $cm^2$, 2.0 $cm^2$, 3.0 $cm^2$) | Leaf Smooth: 3.8 $cm^2$ (Similar to predicates - "Remark: Similar") |
| Fluence | Similar to predicates (e.g., Predicate K192432: 2.0-4.0 J/ $cm^2$, 2.5-4.5 J/ $cm^2$; Predicate K181568: Max 5 J/ $cm^2$; Predicate K160968: 3-6 J/ $cm^2$) | Leaf Smooth: 4-6 J/ $cm^2$ (Similar to predicates - "Remark: Similar") |
| Pulse Duration | Similar to predicates (e.g., Predicate K192432: 7.5-14ms; Predicate K181568: 11-12ms; Predicate K160968: 2-10ms) | Leaf Smooth: 2-10ms (Similar to predicates - "Remark: Similar") |
| Safety & Performance Standards | ||
| Biocompatibility (Cytotoxicity) | No Cytotoxicity (as per ISO 10993-5) | Leaf Smooth: No Cytotoxicity (Matches predicates) |
| Biocompatibility (Sensitization) | No evidence of sensitization (as per ISO 10993-10) | Leaf Smooth: No evidence of sensitization (Matches predicates) |
| Biocompatibility (Irritation) | No evidence of irritation (as per ISO 10993-10) | Leaf Smooth: No evidence of irritation (Matches predicates) |
| Electrical Safety | Comply with ANSI/AAMI ES60601-1, IEC 60601-1-11 | Leaf Smooth: Comply with ANSI/AAMI ES60601-1, IEC 60601-1-11 (Matches predicates) |
| EMC | Comply with IEC 60601-1-2 | Leaf Smooth: Comply with IEC 60601-1-2 (Matches predicates) |
| Light Safety | Comply with IEC 60601-2-57, IEC 62471 | Leaf Smooth: Comply with IEC 60601-2-57, IEC 62471 (Matches predicates) |
| Software | "Moderate level of concern" software documentation. All software requirement specifications met and hazards mitigated to acceptable risk levels. (Per 510(k) requirements for software in medical devices) | Leaf Smooth: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Performance Testing | Spot Size Accuracy and Energy Output Accuracy verified. | Leaf Smooth: Performance Testing for Spot Size Accuracy and Energy Output Accuracy was conducted. (Implied compliance with specifications, as stated in the conclusion that non-clinical tests verified all design specifications). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "samples" in the context of a typical AI/ML test set. The testing conducted was primarily non-clinical (bench testing, electrical, light, EMC, biocompatibility).
- Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer (Shenzhen Leaflife Technology Co., Ltd) or a contract testing organization. The document does not specify a country of origin for data, but the manufacturer is based in Shenzhen, China.
- Retrospective/Prospective: Not applicable to this type of non-clinical device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for non-clinical tests (e.g., electrical safety, light output) is established by adherence to recognized international standards (e.g., IEC, ISO, ANSI/AAMI) and the results are measurements from calibrated equipment, not expert consensus (as would be for image interpretation).
4. Adjudication Method for the Test Set
- Not applicable. This is not a study assessing diagnostic performance where adjudication of ambiguous cases is required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is a hardware device submission, not an AI/ML device requiring an MRMC study to assess human reader improvement.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in a sense. The "non-clinical tests" represent the standalone performance of the device against its design specifications and relevant safety standards. The device is intended for over-the-counter use by lay users, so there isn't a "human-in-the-loop" professional interpretation component that would differentiate from a "standalone algorithm." The device itself is the "algorithm" that produces the hair reduction effect.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests are the requirements set by the consensus standards (e.g., IEC 60601-1, ISO 10993 series) for electrical safety, biocompatibility, light safety, EMC, and the device's own design specifications for output (fluence, wavelength, spot size accuracy). These are objective, measurable criteria.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The device's "knowledge" is embedded in its hardware design and manufacturing processes based on engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (see #8).
In summary, the "study" proving the device meets its "acceptance criteria" for the Leaf Smooth (LH-LIPLB) device consists of a series of non-clinical bench tests (e.g., electrical safety, EMC, light safety, biocompatibility, performance accuracy) that confirm the device adheres to recognized international standards and its own design specifications, thereby demonstrating substantial equivalence to predicate devices and ensuring safety and effectiveness for its intended use. Clinical studies were explicitly stated as not included in this submission.
§ 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.