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

The subject device IPL Cooling 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.

The provided text is a 510(k) Pre-market Notification for an IPL Cooling Hair Removal Device. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not contain the specific information required to complete the table and answer all the questions about acceptance criteria and the study proving the device meets those criteria.

The document primarily focuses on:

• Device Description: What the device is and how it works (IPL technology for hair reduction).
• Comparison to Predicate Device: Technological characteristics like wavelength range, energy density, spot size, pulse duration, and indications for use.
• Performance Data: This section outlines types of testing performed (Biocompatibility Safety, Electrical Safety and EMC Safety, Eye Safety, Software Verification and Validation) and states that the tests passed.

Missing Information:

The document explicitly states that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." However, it does not provide quantitative acceptance criteria or the specific numerical results of those tests (reported device performance) for comparison. It only lists the types of tests performed and the standards they adhered to.

Specifically, the document does not contain any information regarding clinical performance studies, human reader studies, or the establishment of ground truth for such studies. The performance data provided are related to electrical safety, biocompatibility, eye safety, and software validation, which are typically assessed against published standards rather than through clinical effectiveness studies with explicit acceptance criteria for diagnostic or treatment accuracy.

Therefore, I cannot fully complete the table or answer questions 2-9 based on the provided text.

Here's how I can address what is available and highlight the missing parts:

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

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 document describes engineering and biocompatibility tests, not clinical studies with patient test sets.

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 no clinical effectiveness study with human assessment of ground truth is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical effectiveness study requiring expert adjudication is detailed.

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 provided. The device is an IPL hair removal device, not an AI-assisted diagnostic tool, so an MRMC study is not applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This is not an AI algorithm, but a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests mentioned (biocompatibility, electrical safety, eye safety, software), the "ground truth" is defined by the technical standards (e.g., ISO, IEC). For clinical effectiveness (hair removal), no specific ground truth methodology is described for the subject device, although it is asserted to be "as effective as" the predicate.

8. The sample size for the training set
This information is not provided as it's not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established
This information is not provided as it's not an AI/machine learning device requiring a training set.

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

IPL Cooling 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 two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. 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. The IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided text is a 510(k) summary for an IPL Cooling Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data from non-clinical tests. However, it does not include a study proving the device meets acceptance criteria in terms of clinical efficacy (e.g., hair removal effectiveness).

The "Performance Data" section primarily focuses on non-clinical aspects:

• Biocompatibility Testing: Confirms the materials are safe for body contact.
• Electrical Safety and EMC: Ensures the device meets electrical safety and electromagnetic compatibility standards.
• Eye Safety: Indicates compliance with photobiological safety standards.
• Software Verification and Validation: Verifies the software functions as intended and mitigates risks.

There is no mention of a clinical study or specific acceptance criteria for hair removal efficacy (such as a target percentage of hair reduction). The substantial equivalence is based on the device having the "same intended use, mode of action and similar operational characteristics as the predicate devices" and that "Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy." The performance data provided supports the safety and general operation of the device, rather than its clinical effectiveness in hair removal.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for clinical efficacy cannot be extracted from this document, as such a study and criteria are not detailed.

However, based on the provided document, I can describe the non-clinical performance data and the context of the substantial equivalence determination:

Summary of Non-Clinical Performance Data for IPL Cooling Hair Removal Device (K230360)

This 510(k) submission establishes substantial equivalence for the IPL Cooling Hair Removal Device based on non-clinical performance data, primarily focusing on safety and technical specifications compared to predicate devices. There is no clinical study presented in this document that proves the device meets specific acceptance criteria for hair removal efficacy.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

2. Sample Size Used for the Test Set and Data Provenance

• For Biocompatibility, Electrical Safety, EMC, Eye Safety, Software Validation: The document does not specify sample sizes for these tests. It indicates that testing was performed and passed according to the referenced standards. This type of testing typically involves standardized protocols on product samples or component materials rather than human subjects.
• Data Provenance: The document does not explicitly state the country of origin for the testing facilities. It mentions "reliable third-party lab" for biocompatibility. The submission itself is from "Shenzhen Jizhimei Technology Co., Ltd." in China. The testing described is non-clinical/pre-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for these non-clinical tests. The "ground truth" for biocompatibility, electrical safety, etc., is defined by the international standards themselves, and the testing laboratories verify compliance to these standards.

4. Adjudication Method for the Test Set

Not applicable for these non-clinical tests. Compliance is determined by whether the device's performance meets the quantitative or qualitative requirements specified in the relevant international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was mentioned or performed as this report does not contain any clinical efficacy data. The substantial equivalence is based on technical and safety comparisons, not clinical performance metrics involving human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is a hardware product relying on physics (Intense Pulsed Light) for its function, not an algorithm requiring standalone performance evaluation in the context of AI/software interpretation. The "Software Verification and Validation" section confirms the device's internal software functions correctly and safely, which is a component of its standalone operation rather than a separate AI algorithm evaluation.

7. Type of Ground Truth Used

• For Biocompatibility: Ground truth is established by the specified ISO 10993 standards.
• For Electrical Safety/EMC/Eye Safety: Ground truth is established by the specified IEC/ANSI standards.
• For Software: Ground truth is established by "software requirement specifications" and "acceptable risk levels."

8. Sample Size for the Training Set

Not applicable for this type of device and testing. There is no mention of a machine learning model or algorithm that requires a training set in the context typically discussed for AI/ML devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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

The subject device IPL Cooling 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.

The provided document is a 510(k) summary for an IPL Cooling Hair Removal Device, which does not typically include information on clinical studies with acceptance criteria as would be found for a diagnostic device. The device is for cosmetic hair removal and its substantial equivalence is based on engineering performance tests and comparison to a predicate device, rather than a clinical effectiveness study with human subjects in the same way an AI-driven diagnostic device might be evaluated.

Therefore, many of the requested categories for a clinical effectiveness study are not applicable or not provided in this document. The device is regulated as a Class II laser surgical instrument for use in general and plastic surgery and in dermatology, but it is indicated for over-the-counter use for unwanted body hair removal.

Here's a breakdown of the information that is available or applicable based on the provided text, and what is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, acceptance criteria are generally based on meeting specified engineering and safety standards, and demonstrating substantial equivalence to a predicate device.

The study that proves the device meets the acceptance criteria is a set of safety and performance tests conducted in accordance with recognized international standards, along with a comparison of technological characteristics to a legally marketed predicate device (K221001).

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

• Not Applicable/Not Provided. The document describes engineering and safety testing, not a clinical trial with a "test set" of patient data. The tests are performed on the device itself or on components (e.g., biocompatibility on materials).

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

• Not Applicable/Not Provided. This is not a diagnostic device requiring expert consensus for ground truth on medical images or diagnoses. Compliance with standards is typically assessed by testing laboratories and regulatory bodies.

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

• Not Applicable/Not Provided. Adjudication methods are relevant for clinical trials or diagnostic accuracy studies, not for device safety and performance testing against engineering standards.

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/Not Provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

• Not Applicable/Not Provided. This is not an algorithmic device in the context of an AI-driven medical device. Its "software" (for moderate level of concern) would be for device control and safety features, not for standalone diagnostic or analytical performance.

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

• The "ground truth" for this device's acceptance is based on compliance with established international safety and performance standards (e.g., ISO for biocompatibility, IEC for electrical and eye safety), and demonstrating substantial equivalence in technological characteristics and intended use to a legally marketed predicate device. For hair removal effectiveness, the substantial equivalence to an already cleared device implies assumed effectiveness, but no specific effectiveness study data is detailed in this summary.

8. The sample size for the training set

• Not Applicable/Not Provided. This is not an AI/machine learning device that would have a "training set."

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

• Not Applicable/Not Provided. As there is no training set mentioned, this question is not applicable.

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