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The IPL Hair Removal Device Joy Version 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. The device is used for adults with Fitzpatrick skin types I - IV.

IPL Hair Removal Device Model: CB-027, a small over-the-counter, is a home-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. A personal Light-Based Hair Removal System. Emission is by finger switch. Device includes a treatment window head, a facial adaptor and battery charger/AC cord.It is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 402g, and the size is 126 x 78 x 200mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

Here's a breakdown of the acceptance criteria and the study information for the IPL Hair Removal Device Joy Version, Model: CB-027, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting specific quantifiable acceptance criteria for clinical efficacy (e.g., specific percentage reduction in hair regrowth). Instead, the acceptance criteria are implicitly met by showing the device performs similarly or within acceptable ranges compared to its predicates and adheres to relevant safety standards.

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

• Test Set Sample Size:
  • For the Usability Study: 78 subjects.
  • For the Technical/Safety Bench Testing (Electrical safety, EMC, Software V&V, Biocompatibility): No specific sample size of "test subjects" is mentioned, as these are lab-based evaluations of the device itself (e.g., material samples for biocompatibility, the device unit for electrical tests).
• Data Provenance: The document does not explicitly state the country of origin for the usability study participants. Given the company's location (Shenzhen, China) and the correspondent's location (Guangzhou, China), it is highly probable the usability study was conducted in China. The study appears to be prospective for the usability testing as it involved new subjects interacting with the device.

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

• Usability Study: The document does not specify the number or qualifications of "experts" used to establish ground truth. Usability studies primarily focus on lay-user performance and comprehension rather than expert-established clinical ground truth. The "ground truth" here is whether the average user can successfully and safely use the device and understand its instructions, as evaluated by direct observation and feedback from the 78 subjects.
• For the technical tests (electrical safety, EMC, software V&V, biocompatibility), compliance is measured against established international standards and FDA guidance, meaning the "ground truth" is adherence to these predefined criteria, verified by qualified testing laboratories.

4. Adjudication Method for the Test Set

• Usability Study: The document does not describe a formal adjudication method (like 2+1 or 3+1). Usability studies typically involve observing participants, analyzing their actions, and reviewing their responses to questions to determine if performance objectives are met. Discrepancies might be resolved through internal review by the study team, but no specific external adjudication process is mentioned.

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

• No MRMC comparative effectiveness study was mentioned or performed. This device is an over-the-counter hair removal device. Clinical efficacy studies for such devices typically focus on hair reduction percentages rather than human reader interpretation of images. Human readers are not involved in the direct output or application of this device.

6. Standalone Performance Study

• Yes, a standalone study was done in the form of the usability study and the bench testing.
  • The usability study (78 subjects) evaluates the device's performance when used by lay users, which is the "algorithm only" equivalent for a consumer-facing device where the "algorithm" is the user interface, instructions, and intended operation.
  • The bench testing (electrical safety, EMC, software V&V, biocompatibility) evaluates the device's physical and technical characteristics in a standalone manner against predefined standards.

7. Type of Ground Truth Used

• Usability Study: The ground truth was based on lay user performance observation and comprehension metrics against predefined usability goals (e.g., successful self-selection, correct application, understanding labeling).
• Technical Bench Testing: The ground truth was based on compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, ISO10993-5, ISO10993-10) and FDA guidance ("Guidance for PreMarket Submissions and for Software Contained in Medical Devices").

8. Sample Size for the Training Set

• Not Applicable. This document describes a 510(k) submission for a physical medical device (an IPL hair removal device), not an AI/ML algorithm that requires a "training set." The software mentioned refers to internal device control, not a learning algorithm that would be "trained" on data.

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

• Not Applicable. As explained above, there is no mention or implication of a "training set" for an AI/ML algorithm in this submission.

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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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