Search Results

The IPL Hair Removal Device (Model : AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.

IPL Hair Removal Device, models: Al01, Al06, Al08, Al16, Al17 are hand-held overthe-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the 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 skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.

This document is a 510(k) summary for an IPL Hair Removal Device. The standard details for describing acceptance criteria and clinical study results typical of an AI/ML medical device submission are not available in this document because:

1. It is not an AI/ML medical device. The device is an Intense Pulsed Light (IPL) hair removal device, which is a physical device rather than an AI/ML algorithm.
2. It is not a clinical study report. This document is a premarket notification (510(k) summary) whose purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to report a comprehensive clinical trial.
3. It explicitly states "There was no clinical testing performed." This immediately negates the possibility of providing information on acceptance criteria based on clinical performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

Therefore, the requested information elements cannot be extracted from the provided text for the following reasons:

1. A table of acceptance criteria and the reported device performance:
* No clinical acceptance criteria are provided because no clinical testing was performed. The "performance" section refers to non-clinical testing against recognized standards (e.g., electrical safety, EMC, biocompatibility), not clinical efficacy metrics.

2. Sample size used for the test set and the data provenance:
* Not applicable. No clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. No clinical test set or ground truth establishment relevant to AI performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable.

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:
* Not applicable. This is not an AI-assisted device, and no MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. There is no AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable. No clinical ground truth was established for performance evaluation.

8. The sample size for the training set:
* Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:
* Not applicable.

Summary of available information related to performance/testing:

The document focuses on non-clinical testing to ensure safety and essential performance of the physical device and its electrical/biocompatibility aspects.

• Non-Clinical Tests Performed: The device underwent testing to the following standards:
  • ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
  • IEC 60601-1-2: 2014 (Electromagnetic Disturbances)
  • IEC 60601-1-11: 2015 (Medical Electrical Equipment for home healthcare environment)
  • ISO 60601-2-57: 2011 (Basic safety and essential performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
  • IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
  • ISO 10993-5:2009 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
  • ISO 10993-10:2010 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
  • IEC 62304:2006+A1:2015 (Medical device software - Software life cycle processes)
• Results: All listed non-clinical tests passed.
• Safety Features: The device includes a skin sensor for contact detection and a skin color detection system to prevent light emission if skin tone is unsuitable.

The purpose of this 510(k) was to demonstrate substantial equivalence, relying on non-clinical engineering and safety standards, rather than clinical performance data.

Ask a specific question about this device

The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.

IPL Hair Removal Device, model: Al01 is a device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). 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 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 emit the treatment light pulses. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. Device includes a main unit, an adaptor, and accessories, accessories include goggle.

The provided text is a 510(k) summary for the IPL Hair Removal Device, model: AI01. It describes acceptance criteria for safety and effectiveness based on non-clinical testing and comparison to a predicate device, as well as the study that demonstrates the device meets these criteria. No clinical study was performed.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a 510(k) submission and not a clinical study report, the acceptance criteria are primarily related to meeting recognized consensus standards for safety and biocompatibility, and demonstrating substantial equivalence to a predicate device. The "reported device performance" refers to the successful completion of these tests and alignment with the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There was no clinical testing performed." Therefore, there is no sample size for a clinical test set, nor is there data provenance from human subjects. The testing was non-clinical (device bench testing, biocompatibility, and software validation). The country of origin for the device manufacturer is China.

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)
Not applicable, as no clinical testing was performed for hair removal effectiveness. The "ground truth" for the non-clinical tests is based on adherence to recognized international standards and comparison to the predicate device's established safety and performance characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing with human subjects or expert adjudication of results was performed.

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
Not applicable. This device is an IPL hair removal device, not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical IPL hair removal device, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily:

• Adherence to Recognized Standards: The device's components and overall system passed various safety, biocompatibility, and software validation tests according to established international standards (e.g., IEC 60601 series, ISO 10993 series, IEC 62304).
• Substantial Equivalence to Predicate Device: The device's technical characteristics, operating principle, and indications for use are demonstrated to be substantially equivalent to a legally marketed predicate device (K183217). The "ground truth" here is the established safety and effectiveness profile of the predicate.

8. The sample size for the training set
Not applicable. No machine learning or AI algorithm requiring a training set for clinical performance was described in the context of hair removal effectiveness. The software referred to in the document is for device control and functionality, not for performing a diagnostic or predictive task.

9. How the ground truth for the training set was established
Not applicable, as there was no training set mentioned in the context of clinical performance.

Ask a specific question about this device