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IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. The device 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.

IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 510-1200m and 600-1200mm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

AI/ML Overview

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for clinical outcomes like hair removal efficacy, is not present. The document primarily details non-clinical testing for safety and electrical characteristics.

Here's a breakdown of the information that is available, and what is not:

1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and then report performance against those criteria. Instead, it demonstrates compliance with recognized standards for safety and electrical aspects.

However, based on the comparative elements section (pages 7-9), we can infer the acceptance criteria for substantial equivalence are aligned with the predicate device's technical specifications and intended use. The performance data provided is primarily for non-clinical testing, as detailed below:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility: No cytotoxicity, skin sensitization, or skin irritation. (ISO 10993-5, -10, -23)	Passed all specified biocompatibility tests.
Electrical Safety: Compliance with general and collateral standards for medical electrical equipment, including home healthcare environments and light therapy equipment. (IEC 60601-1, -1-2, -1-11, -2-83)	Passed all specified electrical safety and EMC tests.
Eye Safety: Compliance with photobiological safety standards. (IEC 62471)	Passed the specified eye safety standard.
Software Verification and Validation: Software fulfills requirements and mitigates hazards.	All software requirement specifications met and hazards mitigated to acceptable risk levels.
Technical Specifications (e.g., Wavelength, Energy Density, Spot Size, Pulse Duration): Similar to predicate devices.	Specifications are listed and compared to predicate devices, showing similarities. These implicitly serve as "acceptance criteria" for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for any clinical performance or efficacy studies. The document only mentions non-clinical (laboratory) testing for biocompatibility, electrical safety, eye safety, and software, which do not typically involve patient "test sets" in the same way clinical studies do.

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)
This information is not provided as there is no mention of a human-centric "test set" for clinical efficacy or ground truth establishment. The testing described is non-clinical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

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
This device is an IPL hair removal device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not involve an algorithm with "standalone" performance in the context of diagnostic or assistive AI. It is a physical medical device. The "Software Verification and Validation" section confirms the software meets its requirements, which is a form of standalone testing for the software component, but not in the sense of an independent diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the standards themselves. For example, a successful biocompatibility test result (e.g., no cytotoxicity) is the "ground truth" that the device is biocompatible according to the standard. There is no mention of clinical outcomes data for demonstrating hair removal efficacy in this summary.

8. The sample size for the training set
This information is not provided as the document does not describe any machine learning or AI training, nor any clinical trials with a patient training set.

9. How the ground truth for the training set was established
This information is not provided as no training set or machine learning components are described in the summary.

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K Number

K232499

Device Name

IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)

Manufacturer

Shenzhen Lescolton Electrical Appliance Co., Ltd.

Date Cleared

2023-10-11

(55 days)

Product Code

OHT

Regulation Number

878.4810

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K230097,K230739,K230060,K220222,K230360

Intended Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.

Device Description

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. The device 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 IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.

The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data from non-clinical testing. It does not present any clinical study data or acceptance criteria related to device efficacy for hair removal based on human trials.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to a clinical outcome (e.g., hair reduction percentage).
Sample size and data provenance for a test set for clinical performance.
Number of experts and their qualifications for establishing clinical ground truth.
Adjudication method for a clinical test set.
MRMC comparative effectiveness study results.
Algorithm-only (standalone) performance.
Type of ground truth used for clinical efficacy.
Sample size and ground truth establishment for a training set.

The document primarily covers non-clinical performance data, which includes:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria for this device are implied by its conformance to various international standards for safety and biocompatibility, as well as the demonstration of similar technological characteristics to predicate devices. The "reported device performance" is framed as successfully meeting these standards and being comparable to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Testing)	Reported Device Performance
Biocompatibility	Device must not cause adverse biological reactions when in contact with the body. Conformance to ISO 10993-5, ISO 10993-10, and ISO 10993-23.	Passed: Testing conducted per ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), and ISO 10993-23 (Skin irritation). (Section VIII.1)
Electrical Safety & EMC	Device must be electrically safe and comply with electromagnetic compatibility standards for medical electrical equipment, including home healthcare use. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83.	Passed: Testing performed to and passed the following standards: ANSI AAMI ES60601-1 (Medical electrical equipment for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-11 (Home Healthcare Environment), and IEC 60601-2-83 (Basic safety and essential performance of home light therapy equipment). (Section VIII.2)
Eye Safety	Device emissions must meet photobiological safety standards. Conformance to IEC 62471.	Passed: Testing performed to IEC 62471 (Photobiological safety of lamps and lamp systems). (Section VIII.3)
Software V&V	Software must be verified and validated to meet requirements and mitigate hazards, consistent with a moderate level of concern.	Demonstrated: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. (Section VIII.4)
Technological Equivalence	Key technical specifications (wavelength, energy density, spot size, pulse duration, light source, etc.) must be similar to legally marketed predicate devices, with any differences not raising new safety or effectiveness concerns.	The device's wavelength range (LS-T106: 610-1200nm, LS-T107: 560-1200nm, LS-T108: 470-1200nm) is considered similar to predicates (e.g., predicate device 550-1200nm, reference device 1 470-1200nm). Differences like the min wavelength of LS-T106 being identical to reference device 4's range are noted. (Note 2, Section VII)
Energy density (LS-T106: 2.0-4.87J/cm², LS-T107: 2.16-5.18J/cm², LS-T108: 2.0-5.62J/cm²) and output energy are considered similar, accounting for a ±20% error, and falling within the range of predicate and reference devices. (Note 3, Section VII)
Spot sizes (LS-T106: 3.2 cm², LS-T107: 3.7 cm², LS-T108: 3.2 cm²) are similar to reference devices (3.0-3.6cm²). (Note 4, Section VII)
Pulse durations (LS-T106: 0.64-2.4ms, LS-T107: 7.2-10.8ms, LS-T108: 6.8-10.2ms) are within or overlap with the ranges of predicate and reference devices. (Note 5, Section VII)
The differing number of output intensity levels (3 for subject vs. 5-9 for others) is deemed not to raise safety or effectiveness issues due to comparable wavelength, energy, and density, and compliance with relevant standards. (Note 6, Section VII)

Regarding your specific questions related to clinical efficacy studies (which are NOT in this document):

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth for efficacy is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not describe such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device, but a physical hair removal device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical efficacy study reported. For the non-clinical tests, the "ground truth" is defined by the specific requirements and passing criteria of the referenced international standards.
8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set of patient data.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided FDA 510(k) summary for the IPL Hair Removal Device focuses on demonstrating substantial equivalence through non-clinical performance data (biocompatibility, electrical safety, eye safety, software validation) and comparison of technological characteristics with legally marketed predicate devices. It does not include any data or studies related to its clinical efficacy in hair removal (e.g., percentage of hair reduction) on human subjects. For medical devices like this, approval based on substantial equivalence often relies on demonstrating that the new device has similar technology and performance/safety characteristics to products already on the market, rather than requiring new clinical efficacy trials if the intended use and technological principles are well-established.

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