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The product is an over-the-counter device intended for removal of unwanted body and facial hair.

IPL hair removal device is a personal, light-based, hair reduction device intended to be sold over-thecounter 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 lamp and a skin tone 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 be triggered a pulse emitting.

The IPL hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.

The provided document is a 510(k) Premarket Notification for an IPL hair removal device. It focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and safety standards, rather than clinical performance or AI/software-based diagnostics. Therefore, much of the information requested, particularly regarding acceptance criteria for diagnostic performance, AI study details, expert review, and ground truth establishment in a medical imaging context, is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define explicit "acceptance criteria" in the sense of a clinical trial or AI model performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices by confirming the subject device meets the same safety and performance standards.

The table below summarizes the comparison elements used to demonstrate substantial equivalence, which implicitly act as performance criteria for the device's technical specifications. The "Reported Device Performance" column reflects the subject device's specifications.

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IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

IPL Hair Removal Device (Model: KCA423, KCA437, KCA439), is an over-the-counter, homeuse and single-person-use device for hair reduction by using 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. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only user with suitable skin tone can use this device.

Based on the provided FDA 510(k) summary, here's an analysis of the acceptance criteria and the study proving the device meets them:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing against recognized standards rather than setting specific acceptance criteria for efficacy in the traditional sense of AI/algorithm performance. The "device" in question is an IPL Hair Removal Device, not an AI or algorithm. Therefore, many of the requested points regarding AI/algorithm-specific studies (like MRMC, standalone algorithm performance, training set details, ground truth establishment methods for algorithms) are not applicable.

The acceptance criteria here are derived from compliance with recognized medical device standards for safety and performance, and the "study" is the collection of tests performed to demonstrate this compliance.

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

Since this is an IPL hair removal device and not an AI/algorithm, "performance" is demonstrated through compliance with safety and performance standards. The acceptance criteria are implicit in meeting these standards.

• IEC 60601-1 (General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-1-11 (Home Healthcare Environment)
• IEC 60601-2-83 (Particular requirements for home light therapy equipment) |
  | Eye Safety | Compliant with IEC 62471 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation (if applicable) | Consistent with moderate level of concern. System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Usability | Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
  | Functional Equivalence (e.g., energy density, wavelength) | Energy density: 2.45-5 J/cm² (Similar to predicate max 5 J/cm² and within reference 3-6 J/cm²).
  Wavelength range: 475-1200nm (Same as predicate 475nm-1200nm, similar to reference 510-1100nm).
  Pulse duration: 7-10ms (Similar to predicate 11-12ms and within reference 2-10ms).
  Other components/features: Similar source energy, power supply, product compositions, structure design, pulsing control, delivery device, number of output channels, skin proximity sensor, software/firmware/microprocessor control. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document implicitly refers to "testing" as a general practice for device compliance rather than a specific test set of patient data.

• Biocompatibility: Tests performed on materials.
• Electrical Safety, EMC, Eye Safety: Tests performed on the device itself.
• Software V&V: Validation of the software system.
• Usability: Evaluation of human interaction with the device.

There is no mention of a traditional "test set" of patient data for efficacy evaluation, nor details about its size, provenance (country), or whether it was retrospective or prospective. This type of detail is typically not required for an IPL device's 510(k) unless specific clinical efficacy claims beyond substantial equivalence without a predicate are being made or significant clinical differences from the predicate exist. The efficacy claims are tied to the predicate and the "Indications for Use" which defines permanent hair reduction based on measurements at 6, 9, and 12 months after treatment. However, no data from such an outcomes study is presented in this summary to support this specific device's 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)

Not applicable. As this is not an AI/algorithm device requiring interpretation or ground truth establishment based on expert consensus for performance evaluation, there is no mention of experts or their qualifications for a test set.

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

Not applicable. There is no test set in the context of expert adjudication for this device type.

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 diagnostic device.

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

Not applicable. This is not an AI/algorithm.

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

For the compliance aspects:

• Biocompatibility: Ground truth is established by the results of standardized biological tests (cytotoxicity, irritation, skin sensitization) against ISO 10993 criteria.
• Electrical Safety, EMC, Eye Safety: Ground truth is established by meeting the requirements of the referenced IEC standards.
• Software V&V: Ground truth is against the defined software requirements and risk mitigation strategies.
• Usability: Ground truth is derived from adherence to human factors and usability engineering principles and guidance.

For the Indications for Use regarding "permanent reduction in hair regrowth," the ground truth would typically come from outcomes data (measurements of hair regrowth at specific time points after treatment). However, the 510(k) summary provided does not include such outcomes data for the subject device, instead relying on substantial equivalence to the predicate device which presumably did provide such data.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

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

The IPL hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The IPL hair removal is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

The IPL hair removal includes FZ-610, FZ-612, FZ-611, FZ-613, and FZ-608 six models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance and its spot size of the treatment window, but these differences do not affect or change the intended use of the device.

The provided document is an FDA 510(k) clearance letter for an IPL hair removal device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria for a novel AI or medical imaging device.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and multi-reader comparative effectiveness are not applicable or cannot be extracted from this document, as it describes a non-AI, non-diagnostic device.

However, I can extract information related to the device's performance data and safety testing:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other points:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document describes safety and performance testing against standards, not a clinical efficacy study with a test set of patient data in the context of AI or diagnostics.

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/Not provided. This document does not describe a study involving expert-established ground truth for a test set.

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

• Not applicable/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

• Not applicable. This is not an AI-assisted diagnostic or imaging device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" here is the adherence to established international safety and biocompatibility standards (e.g., ISO, IEC). This is a technical compliance assessment, not a clinical diagnostic performance assessment.

8. The sample size for the training set

• Not applicable. This is not an AI device that undergoes a "training set" process.

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

• Not applicable.

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IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The BR2020 IPL hair removal machine 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 treatment 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 treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.

This document is a 510(k) Premarket Notification from the FDA regarding an "IPL hair removal machine." It does not include information about AI/ML device performance, acceptance criteria for an AI/ML model, or a study proving it meets such criteria.

The document discusses substantial equivalence to a predicate device based on:

• Intended Use: Removal of unwanted hair.
• Technological Characteristics: Similar wavelength range, energy medium, energy density, spot size, pulse duration, and pulsing control as predicate devices.
• Performance Data: Biocompatibility testing, electrical safety, eye safety, and software verification and validation.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The device described is an "IPL hair removal machine," which is a hardware device, not an AI/ML software.

The concepts of "acceptance criteria," "test set," "training set," "ground truth," "expert consensus," "MRMC study," and "standalone performance" are relevant to the evaluation of AI/ML software as a medical device, which is not what this document addresses.

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Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The Home Use IPL Beauty 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 IPL technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.

The difference of MELSYA-M5 and MS-206B two models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of MELSYA-M5 is 3.9cm² and MS-206B is 3.0 cm², as well as the energy density of the both models is 5.5 J/cm2.

The provided text is a 510(k) summary for the "Home Use IPL Beauty Device" and details its substantial equivalence to predicate devices. It covers various performance data but does not include a table of acceptance criteria and reported device performance for a hair removal efficacy study.

Here's an analysis of the available information:

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

• Not provided in the document. The document discusses various safety and usability tests but does not present acceptance criteria or reported performance for hair removal efficacy directly. It broadly states, "Performance data supports that the device is safe and as effective as the predicate device for its intended use," but no specific metrics for hair removal are given in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test set for OTC Usability Study: A total of 20 participants were enrolled.
• Data Provenance: Not explicitly stated for the usability study. The manufacturer is Shenzhen Mismon Technology Co., Ltd, 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 / Not provided. The "OTC Usability Study" focused on layperson understanding of labeling, not on establishing a ground truth for device performance by experts.

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

• Not applicable / Not provided. For the usability study, the focus was on gathering data from participants regarding their understanding, not on adjudication of results by experts.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a hair removal device, not an AI-powered diagnostic or imaging device where such a study would typically be performed.

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

• Not applicable. This device is a direct-use consumer product, not an algorithm.

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

• For the OTC Usability Study: The "ground truth" was related to whether participants understood the labeling and how the device works, measured by their responses and comments. This is a form of user feedback/understanding data, not clinical ground truth in the traditional sense of efficacy.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe a machine learning model with a training set.

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

• Not applicable / Not provided. As there is no mention of a machine learning model or training set, this information is not relevant to the provided text.

In summary, the document details safety and usability testing, but does not provide specific performance data or a structured study on hair removal efficacy with acceptance criteria. Its primary focus for performance data mentioned is on biocompatibility, electrical safety, eye safety, software verification, and OTC usability, all of which were reported as "passed" or "completed successfully" without issues.

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The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.

The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:

• . Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
• External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
• Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
• . Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.

The provided text describes a 510(k) premarket notification for the Lumilisse IPL Hair Remover. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing rigorous clinical trial data with predefined acceptance criteria and detailed statistical analyses. While a clinical study was conducted, it is not presented in the format of a typical clinical trial report with specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria and the study proving the device meets them cannot be fully extracted from the provided text.

Here's a breakdown of what can be inferred and what information is missing:

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

The document does not specify quantified acceptance criteria (e.g., a specific percentage of hair reduction to be achieved) in a table format. The conclusion of the clinical study states:

• "Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested."
• "The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects."
• "The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip."
• "The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions."

From this, we can infer the following as performance outcomes, but not explicitly stated as acceptance criteria that were defined beforehand:

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

• Sample Size: Not explicitly stated. The text mentions "the large majority of the test Subjects" but does not give a number.
• Data Provenance: The study compared the "G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover)". This suggests the data might be retrospective from a European market launch or a study conducted for European regulatory purposes, but this is an inference. It doesn't explicitly state "retrospective or prospective" or the specific "country of origin of the data" beyond "European pre-cursor".

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

• This information is not provided. The assessment was a "dermatological evaluation," implying dermatologists were involved, but details on their number or qualifications (e.g., years of experience) are missing.

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 is not applicable. The device is an IPL hair remover, not an AI-assisted diagnostic or imaging device used by human readers. The study performed was a clinical study on hair reduction and cutaneous acceptability.

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

• This is not applicable. The device is a physical IPL hair remover, not a software algorithm. Its performance is inherent to the device itself when used by a person.

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

• The ground truth for effectiveness appears to be clinical outcome data (reduction in hair amount and density, duration of hair reduction, and cutaneous acceptability) assessed via direct observation.

8. The sample size for the training set

• This is not applicable. As a physical device, there isn't a "training set" in the context of machine learning algorithms.

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

• This is not applicable.

In summary, the provided FDA 510(k) summary focuses on substantial equivalence based on technological characteristics and a general review of non-clinical and limited clinical performance data. It does not contain the detailed structure of a typical clinical study report that would specify exact acceptance criteria, sample sizes beyond general statements, and granular details about expert involvement or ground truth establishment as would be present for software or AI medical devices.

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The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The PerfectSmooth 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 IPL technology. And it consists of IPL base unit and AC adapter, and a detachable lamp cap located in the IPL base unit which is the source of optical radiation, namely a Xenon flashlamp. The device is power from AC adapter via an external power.

The provided text describes a 510(k) premarket notification for the "PerfectSmooth" device, which is an over-the-counter light-based hair reduction device. While it details performance data, it primarily focuses on nonclinical testing (biocompatibility, electrical safety, software, eye safety) and a usability study. It does not provide specific acceptance criteria or the results of a study designed to prove the device meets those criteria in terms of clinical effectiveness for hair removal.

Therefore, many of the requested details about acceptance criteria and clinical performance studies cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The document lists performance data categories (biocompatibility, electrical safety, software, eye safety, usability, appearance, function, package, reliability) but does not define specific acceptance criteria or report quantitative results for these beyond stating that testing was "completed" or "demonstrated" compliance. Importantly, no clinical performance data for hair reduction is presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Performance Test Set: Not applicable, as a clinical performance study for hair reduction is not detailed.
• Usability Study Test Set:
  • Sample Size: 20 subjects
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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 in the document. For the usability study, it's not specified how "device human factors" and "label comprehension" were evaluated or if experts were involved in establishing "ground truth" for these assessments. For a clinical study, this information would be critical, but such a study is not described.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where expert consensus on outcomes is required, which is not detailed 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

This is not applicable. The device described is a physical hair reduction device (IPL technology), not an AI-assisted diagnostic or imaging device that would involve human readers.

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

This is not applicable. The device is a physical hardware device, not an algorithm, and its intended use is direct application by the end-user (human-in-the-loop).

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

For the usability study, the "ground truth" would implicitly be the observed human factors and comprehension levels. However, the method of establishing this "ground truth" (e.g., through structured observation, questionnaires, or expert assessment) is not detailed. For clinical efficacy, no ground truth is described because no clinical efficacy study is reported.

8. The sample size for the training set

This is not applicable. The document does not describe an AI/ML model that would require a training set. It refers to "Software verification and validation," implying traditional software development and testing, not machine learning.

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

This is not applicable for the same reason as point 8.

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