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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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