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

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 technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology 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 Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

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

The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The Ice Cooling IPL Home Use 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 technology and it has the cooling function that effectively cools the skin.

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 sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process or when the user want to activated to provide users with a more comfortable experience.

The provided document is a 510(k) summary for an Ice Cooling IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

Therefore, it is not possible to fully answer all aspects of your request based on the provided text alone, as it lacks a standalone clinical study section with detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment for performance.

However, I can extract information related to the device's alignment with safety and performance standards which serve as a form of acceptance criteria in the context of a 510(k) submission.

Here's the information that can be gleaned from the document:

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

The document lists several international and FDA-recognized standards that the device conforms to. While these are not "performance" metrics in terms of hair reduction efficacy, they represent acceptance criteria for safety, electrical compatibility, usability, and photobiological safety.

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 in the document. The submission focuses on non-clinical engineering and biocompatibility testing against standards, and comparison to predicate devices, rather than a clinical performance study with a specific test set of human subjects.

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 applicable and therefore not provided, as the document does not describe a clinical study with a ground truth established by experts.

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

This information is not applicable and therefore not provided, as the document does not describe a clinical study with a test set requiring adjudication.

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 information is not applicable and therefore not provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

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

This information is not applicable and therefore not provided. The device is a hardware product for hair removal, not an algorithm.

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

For the non-clinical tests (electrical safety, photobiological safety, biocompatibility, software V&V), the "ground truth" or reference is adherence to the specified international and FDA-recognized standards. For the claimed "permanent reduction in hair regrowth," the document states it is "defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime." However, explicit outcomes data from a clinical trial to prove this ground truth for the subject device is not presented in this summary, rather the substantial equivalence to predicate devices that have this indication is leveraged.

8. The sample size for the training set

This information is not applicable and therefore not provided. There is no mention of machine learning or AI models with training sets for this device.

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

This information is not applicable and therefore not provided, as there is no training set for a machine learning model.

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The Home use hair removal 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 with Fitzpatrick Skin Phototypes I-V.

The Home use 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 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 sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses.

The provided document is a 510(k) summary for a medical device called "Home Use Hair Removal Device." It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. This type of document is not an academic study or a report of clinical trial results directly proving the device meets specific performance criteria for efficacy in the same way a diagnostic AI device would.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic AI device is largely not applicable to this regulatory submission for a hair removal device.

The "performance data" section in this document refers to:

• Biocompatibility Testing: Ensuring the materials are safe for contact with the human body.
• Electrical Safety and Eye Safety Testing: Verifying the device's electrical components and light emission are safe according to established standards.
• Software Verification and Validation: Confirming the software functions as intended and mitigates hazards.

These are safety and engineering performance criteria, not clinical efficacy metrics for hair removal, which are typically assessed through different types of studies not detailed here. The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing independent clinical proof of efficacy against strict, quantitative acceptance criteria for clinical performance like sensitivity or specificity.

However, I can extract and structure the information that is present, noting where the requested details are not available or not relevant to this type of device and submission.

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

Since this is a 510(k) submission for a physical, light-based hair removal device, the "acceptance criteria" are primarily related to safety, electrical performance, and biocompatibility, rather than clinical efficacy metrics like sensitivity or specificity for a diagnostic algorithm. The document states that the device "passed" these tests, implying they met the requirements of the cited standards.

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 in the 510(k) summary. The listed "performance data" refers to technical safety tests rather than clinical studies with human subjects and test sets for efficacy measurement. The summary does not provide details on the number of units tested for electrical safety, biocompatibility, or software validation, nor does it specify the provenance of such test data.

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 applicable and not provided. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices that interpret complex medical images or data. For a hair removal device, the "ground truth" would be the physical removal of hair, often evaluated in clinical trials which are not explicitly detailed in this 510(k) summary beyond a general assertion of "safety and effectiveness profile that is similar to the predicate device."

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

This information is not applicable and not provided. Adjudication methods are used in studies involving expert review of diagnostic findings to establish ground truth, which is not the focus of the performance data presented 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 information is not applicable and not provided. MRMC studies are specific to evaluating diagnostic algorithms, often with human-in-the-loop components. This device is a standalone hair removal product, not an AI-assisted diagnostic tool.

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

This information is not applicable in the context of diagnostic AI. The device itself is a standalone physical product that performs hair removal. The "software verification and validation" addresses the performance of the embedded software, but not as a diagnostic algorithm.

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

This information is not explicitly detailed for hair removal efficacy as it relates to clinical studies. For the technical performance data provided:

• Biocompatibility: Ground truth is established by standardized chemical and biological assays that evaluate material interactions with biological systems against predefined acceptable limits.
• Electrical and Eye Safety: Ground truth is established by physical measurements and tests against the specified limits of the IEC standards.
• Software: Ground truth is established by predefined software requirements and hazard mitigations, verified through testing.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML-based diagnostic algorithm that requires a "training set" in the conventional sense.

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

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

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