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

The IPL Hair Removal Device is a hand-held device that utilizes Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes three models with the only difference in enclosure color. It is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a cooling function for a better hair remove experience.

This document is a 510(k) summary for an IPL Hair Removal Device (BE932C, BE932D, BE932E). It's a submission to the FDA seeking to demonstrate substantial equivalence to legally marketed predicate devices.

The document states that clinical testing was NOT applicable, and there is NO clinical data. This means there is no study described that proves the device meets specific acceptance criteria based on human performance or improvement. Instead, the focus is on demonstrating substantial equivalence through technological comparison and non-clinical testing.

Therefore, many of the requested details about acceptance criteria and study proving device performance are not present in this document, as they relate to clinical studies that were not performed.

However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence.

Here's a breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit from non-clinical testing standards): The device is required to meet various international and FDA-recognized standards for safety, electrical compatibility, and biocompatibility.
  • IEC 60601-1: 2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • IEC 60601-1-2: 2020 (Electromagnetic disturbances)
  • IEC 60601-1-11: 2020 (Home healthcare environment)
  • IEC 60601-2-83: 2022 (Home light therapy equipment)
  • IEC 62471: 2006 (Photobiological safety)
  • ISO 10993-5: 2009 (Biocompatibility - In Vitro Cytotoxicity)
  • ISO 10993-10: 2021 (Biocompatibility - Skin Sensitization)
  • ISO 10993-23: 2021 (Biocompatibility - Irritation)
  • FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" (Software verification and validation)
  • "Applying Human Factors and Usability Engineering to Medical Devices" (Product usability)
• Reported Device Performance: The document states that "The testing results demonstrate that the subject device complies with the following standards" and lists the standards above.
  • Technological similarities to predicates are also presented as a form of performance equivalence (e.g., wavelength, output energy, pulse duration within range of predicates).

2. Sample size used for the test set and the data provenance

• This document is for a non-clinical submission. There is no "test set" in the sense of a clinical trial. The testing refers to engineering tests performed on the device itself.
• Data provenance: Not specified, but generally, these tests are conducted by the manufacturer or accredited testing labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as there is no clinical test set or human "ground truth" establishment in this filing. The "ground truth" for non-clinical testing is adherence to the specified engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There's no human reader component that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The clinical test is not applicable, there is no clinical data."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of an AI algorithm as this is an IPL device, not an AI diagnostic tool. Software verification and validation were performed for the device's inherent software.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is compliance with established international and FDA-recognized engineering, electrical, photobiological safety, and biocompatibility standards. The device is being compared to its predicate devices for technological equivalence rather than against a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

• Not applicable. There is no AI model or training set described.

9. How the ground truth for the training set was established

• Not applicable.

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IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair.

The IPL HAIR REMOVAL HANDSET 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 Quartz Lamp Tube to emit light and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse emitting.

The provided document is a 510(k) summary for the IPL HAIR REMOVAL HANDSET, Model: IPL-666. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or extensive clinical study outcomes.

Therefore, much of the requested information regarding specific acceptance criteria, device performance, sample sizes, expert involvement, efficacy studies (MRMC or standalone), and training set details for AI/algorithm performance cannot be extracted from this document. This type of document typically focuses on technical and safety equivalence to a legally marketed predicate.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance related to hair removal efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety testing.

2. Sample size used for the test set and the data provenance
The document does not detail a clinical test set with human subjects for performance evaluation. The "tests" mentioned are non-clinical (electrical safety, biocompatibility, software V&V) and do not involve a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document does not describe a clinical test set requiring expert-established ground truth for efficacy.

4. Adjudication method for the test set
Not applicable, as no clinical test set for efficacy is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence based on technical specifications and safety testing, not direct clinical performance comparison with human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an IPL hair removal handset, which is a physical medical device, not an AI/algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth for efficacy is described. The "ground truth" in this context would generally relate to measured hair reduction, which is not presented here.

8. The sample size for the training set
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a training set.

9. How the ground truth for the training set was established
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a training set.

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

The IPL Hair Removal Device 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 to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for efficacy in hair removal.

Therefore, many of the requested details about acceptance criteria, device performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

The document primarily covers:

• Device identification and classification.
• Comparison to predicate devices based on technical specifications (wavelength, energy density, spot size, etc.) and intended use, asserting similarity.
• Performance data related to safety standards: Biocompatibility, Electrical Safety, Eye Safety, and Software Verification and Validation. These are laboratory/engineering tests, not clinical efficacy studies for hair removal.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for hair removal efficacy or provide reported device performance data in terms of hair reduction percentage or similar metrics. It focuses on demonstrating safety and technical similarity to a predicate device.

However, it does list several safety standards that the device "passed." If we interpret "acceptance criteria" as meeting these standards and "reported device performance" as passing them, then:

No performance metrics related to hair removal efficacy are provided.

2. Sample sizes 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 in the document. The document refers to engineering and safety testing, not clinical trials on human subjects for efficacy.

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. Ground truth in the context of hair removal efficacy usually refers to clinical assessment of hair count or density, often by experts. The document focuses on meeting general safety and electrical standards, not on clinical efficacy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are relevant for subjective assessments, typically in expert-based ground truth establishment for clinical trials, which is not described here.

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

An MRMC study is relevant for AI-assisted diagnostic devices. This document is for an IPL Hair Removal Device, which does not involve human "readers" interpreting images with AI assistance. Therefore, this question is not applicable to the content of this document.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is an IPL hair removal device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the safety and electrical standards testing, the "ground truth" is defined by the specific requirements and measurement methods outlined in each referenced ISO/IEC standard. For example, for biocompatibility, it's about whether the device materials cause a specific biological reaction (toxicity, irritation). For electrical safety, it's about whether it meets specified limits for leakage current, insulation, etc.

However, for hair removal efficacy, which is the device's intended function, no ground truth or study data is provided in this summary.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML model that would have a "training set" in the context of deep learning.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML model with a training set.

Summary of what is present in the document:

The provided document is an FDA 510(k) summary, which is primarily focused on demonstrating "substantial equivalence" to a previously cleared predicate device. It strongly emphasizes meeting various safety and electrical standards through testing (biocompatibility, electrical safety, eye safety, software validation). It does not contain direct clinical performance data for hair removal efficacy, nor does it describe trials with human subjects for that purpose. The basis for clearance is the demonstrated safety and technical similarity to an already cleared device for the same indication.

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