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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: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal 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 treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).

This document is a 510(k) summary for an IPL Hair Removal Device (models UI04 SD, UI04 DG). It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.

Based on the provided text, the device in question is an IPL Hair Removal Device. The 510(k) submission primarily focuses on non-clinical performance data to support substantial equivalence, rather than a clinical study involving human readers or AI-assisted diagnostic performance. Therefore, many of the requested elements related to MRMC studies, ground truth establishment for AI, and expert adjudication are not applicable to this type of device and submission.

Here's an analysis of the acceptance criteria and performance as described in the document, focusing on the information that is present:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device's 510(k) clearance are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing related to safety and fundamental functionality. The document doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC, as would be typical for AI/diagnostic devices. Instead, the "performance" is demonstrated by meeting various safety and usability standards and having comparable technical characteristics to cleared predicates.

Study That Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of non-clinical tests and a detailed comparison to predicate devices, rather than a clinical trial or an AI performance study as might be expected for diagnostic algorithms.

1. Sample size used for the test set and the data provenance:

   • Test Set (for non-clinical validation): The document does not specify "sample sizes" in the way one would for patient data (e.g., number of patients or images). Instead, testing was performed on physical units of the device and its components to verify their compliance with various electrical, safety, biocompatibility, and usability standards. The number of devices or components tested is not specified but is assumed to be sufficient for standard regulatory compliance testing.
   • Data Provenance: The testing appears to be conducted by the manufacturer or third-party labs on the device itself. The document implicitly suggests this is prospective testing done specifically for this submission. The country of origin of the data is not explicitly stated beyond the manufacturer being in Shenzhen, China.

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

   • Not Applicable. This submission is for an IPL hair removal device, not an AI diagnostic device requiring expert interpretation of medical images or patient outcomes for ground truth. Ground truth in this context means compliance with engineering and safety standards, verified by testing according to those standards.

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

   • Not Applicable. As there are no human readers interpreting data, an adjudication method is irrelevant. Test results against established standards (e.g., pass/fail for electrical safety tests) serve as the "ground truth."

4. 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 study was not conducted as this is not an AI-assisted diagnostic device.

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

   • No. This is not a standalone AI algorithm. The software mentioned is for controlling the device's functions, not for diagnostic or analytical purposes.

6. The type of ground truth used:

   • For Biocompatibility: Positive/negative controls in in vitro cytotoxicity and skin sensitization tests, and adherence to ISO standards.
   • For Electrical Safety/EMC/Eye Safety: Pass/fail criteria defined by the respective international standards (e.g., IEC 60601 series, IEC 62471).
   • For Software V&V: Fulfillment of software requirement specifications and mitigation of identified software hazards.
   • For Usability: Compliance with usability standards and FDA guidance on human factors, likely demonstrated through risk analysis and verification activities.
   • For Functional Equivalence: Comparison of technical specifications (wavelength, energy density, etc.) against those of legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This device does not use an AI model trained on a data set in the typical sense (e.g., medical images for diagnosis). The term "training set" doesn't apply to the non-clinical performance and safety testing described.

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

   • Not Applicable. See point 7.

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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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD), is an over-the-counter, home-use and personal 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 sapphire treatment window and the spot size is 3.3cm2 that is suitable for multiple hair removal areas. It contains a skin 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided document is a 510(k) Summary for an IPL Hair Removal Device (K223618). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for the device's hair removal efficacy.

Therefore, the following information cannot be fully provided based on the given text:

• A table of acceptance criteria and the reported device performance for hair removal efficacy: The document states the device is indicated for "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." However, it does not provide specific numerical acceptance criteria (e.g., "X% reduction in hair regrowth") or reported performance data from a primary efficacy study for the subject device. The comparison table (page 5) lists "Indication for use/Intended use" which is descriptive but not a performance metric.

• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for hair removal efficacy: No information about a clinical study's test set for hair removal efficacy is provided.

• 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 would be relevant to a clinical study assessing efficacy, which is not detailed in the document.

• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as a clinical efficacy study with ground truth adjudication is not described.

• 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 diagnostic tool that human readers would use.

• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc) for hair removal efficacy: Not detailed for hair removal efficacy.

• The sample size for the training set: Not applicable, as this is not an AI/ML algorithm that requires a training set in the sense of predictive modeling.

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

The document primarily focuses on non-clinical performance data for safety (biocompatibility, electrical safety, EMC, eye safety), software verification, and usability. It concludes that the device is "as safe, as effective, and performs as well as the legally marketed predicate devices and reference device" based on a comparison of technological characteristics and these non-clinical tests.

Acceptance Criteria and Study Details (Based on available information)

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria for hair reduction efficacy are not provided in this document. The document primarily focuses on demonstrating safety and general performance equivalence to predicates through compliance with various standards.

2. Sample size used for the test set and the data provenance (for hair removal efficacy)

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The document relies on equivalence to previously cleared devices rather than providing primary clinical data for the subject device's efficacy.

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

• Not applicable as no clinical efficacy study with ground truth assessment is described for the submitted device.

4. Adjudication method 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 device is an IPL hair removal device, not an AI diagnostic tool.

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

• Not applicable.

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

• For efficacy related to hair reduction, the document refers to the definition of permanent reduction (long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months), but does not describe a study where this ground truth was established for the subject device. It hinges on the predicate devices having already met this.
• For safety (biocompatibility, electrical safety, eye safety), the ground truth is established by meeting the specific requirements and passing the tests outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that learns from a training set. The "software" mentioned refers to embedded control software, not a machine learning model.

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

• Not applicable.

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The IPL Hair Removal is an over-the-counter device intended for 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 re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime.

IPL Hair Removal (Models: SB01, SB01A, SB01C, SN02, SN02, SN03), is an over-the-counter, single-person-use 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. Model SB01, SB01A, SB01C are powered by lithium battery and can be charged by power adapter, while model SN02 and SN03 are only power adapter. Their IPL emission activation is by finger switch. All models of IPL Hair Removal adopt irreplaceable flash window and are suitable for multiple hair removal areas, including small areas (e.g. underarms, bikini lines) and large areas (e.g. arms, legs). IPL Hair Removal contains a Xenon Arc Flashlamp 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 treatment light pulses.

The provided document is an FDA 510(k) clearance letter for an IPL Hair Removal device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use, Mode of Action, and Operational Characteristics: The subject device has the same intended use (hair removal and permanent reduction in hair regrowth) and mode of action (Intense Pulsed Light) as the predicate devices.
• Safety Standards Compliance: The device passed tests for biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety and EMC (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83), and eye safety (IEC 62471).
• Software Verification and Validation: Software documentation consistent with a moderate level of concern was submitted, demonstrating that all software requirement specifications are met and hazards mitigated.

Since this document is for an IPL hair removal device using traditional medical device testing for substantial equivalence, it does not contain the detailed information about AI/ML acceptance criteria and studies (like those involving expert readers, ground truth establishment, or MRMC studies) that you requested.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance and validation.

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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: UI04A, UI04B, UI04C), is an over-the-counter, home-use 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 treatment window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a study proving the device meets specific acceptance criteria related to its primary intended use (hair removal/reduction effectiveness). The "Performance Data" section focuses on safety and regulatory compliance aspects, not clinical performance for efficacy.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is an attempt to answer the questions based on the available information:

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

The document does not provide specific acceptance criteria or reported device performance for hair removal efficacy. The "Performance Data" section focuses on demonstrating compliance with safety standards and biocompatibility.

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

Not provided in the document. The document refers to "usability evaluation has been conducted to verify these skin types can use the device safely and effectively," but does not detail the study design, sample size, or data provenance for this evaluation, nor does it provide the results for hair removal 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 provided in the document.

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

Not provided in the document.

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 tool that would typically involve a multi-reader, multi-case study for diagnostic accuracy.

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

This refers to the performance of the device itself. While there is no detailed efficacy study presented, the statement "usability evaluation has been conducted to verify these skin types can use the device safely and effectively" implies some form of standalone evaluation was performed. However, the details of what was measured for "effectively" in terms of hair reduction are missing, as are the quantitative results.

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

Not explicitly stated for efficacy outcomes. For safety evaluations (biocompatibility, electrical safety, eye safety), the ground truth is established by adherence to recognized international standards and passing criteria within those standards. For the usability evaluation, the "ground truth" would likely be subjective user feedback and expert observation, but no details are provided.

8. The sample size for the training set

Not provided, as this is not an AI/algorithm training scenario as commonly understood for this question.

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

Not applicable for a training set in this context.

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