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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 such as legs, in patients 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.

This document describes the regulatory approval for a home-use hair removal device (models T4, T5, T8, T4-01, T5-01, T8-01, T7) based on Intense Pulsed Light (IPL) technology. The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for de novo devices. Therefore, the "acceptance criteria" and "study" described below are within the context of a 510(k) submission, primarily focusing on non-clinical performance and comparison to a predicate, rather than a clinical efficacy study with human participants.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a 510(k) are implicitly met by demonstrating substantial equivalence to a predicate device through various tests. The direct "performance data" presented in this document primarily relates to the safety and engineering aspects of the device, rather than its efficacy in hair removal (which is generally inferred from the predicate).

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

• Sample Size for Test Set: The document does not specify sample sizes for human subjects for efficacy testing. The tests conducted (biocompatibility, electrical safety, eye safety, software V&V) are typically in vitro or engineering tests and do not involve "test sets" in the clinical trial sense with human participants. For functional equivalence, the "samples" are the device models themselves (T4, T5, T8, etc.) and a comparison is made to the predicate device's specifications.
• Data Provenance: The document does not explicitly state the country of origin for the data itself, but the applicant (Shenzhen Mareal Tech Co., Ltd) is based in China. The data would have been generated from laboratory and engineering tests, likely conducted at the manufacturer's facility or certified testing labs. The data is retrospective in the sense that it supports a pre-market notification for a device that has already been developed and tested. There is no mention of prospective clinical trials in this 510(k) summary.

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

This question is not applicable in the context of this 510(k) submission. "Ground truth" for medical device performance (like hair removal efficacy) is typically established through clinical data, often involving expert assessments (e.g., dermatologists or image analysis). However, for a 510(k) of a device like this, the "ground truth" for the safety and basic functionality is established by adherence to recognized international consensus standards (like IEC and ISO standards) and engineering principles, which represent the collective expertise in device design, safety, and testing. There's no mention of expert radiologists or similar clinical experts establishing ground truth for efficacy in this document, as the submission relies on substantial equivalence to a predicate.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving human readers or evaluators where there might be subjective interpretations of results. This 510(k) relies on objective engineering and performance data against set standards, not subjective assessments 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

Not applicable. This device is a direct-to-consumer home-use hair removal device. It does not involve "human readers" or "AI assistance" for interpretation of medical images or data. Therefore, an MRMC study is not relevant to proving its substantial equivalence.

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

Not applicable. This is a physical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily based on:

• Compliance with recognized international consensus standards: For electrical safety (IEC 60601 series), biocompatibility (ISO 10993 series), and photobiological safety (IEC 62471). These standards represent established scientific and engineering principles for safety.
• Software verification and validation outputs: Demonstrating the software meets specifications and mitigates hazards.
• Comparison to the predicate device's specifications: The predicate device, having already been cleared, serves as a benchmark for acceptable performance characteristics (energy density, pulse duration, wavelength, etc.) for a home-use IPL hair removal device.
• Functional testing: Implied by the successful completion of the safety tests and the comparison to the predicate, ensuring the device operates as intended.

There is no mention of "expert consensus" on hair removal efficacy, pathology, or outcomes data from a clinical trial, as those are typically not primary requirements for a 510(k) where substantial equivalence to a cleared predicate is claimed.

8. The Sample Size for the Training Set

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

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

Not applicable, as it's not an AI algorithm.

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The Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair from small areas such as, but not limited to, underarm and facial hair below the chin line and large areas such as legs, in patients 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 IPL technology. And it consists of IPL main device and AC adapter, and a detachable lamp cap located in the IPL main device which is the source of optical radiation, namely a Xenon flashlamp.

The Home Use Hair Removal Device includes three models, T1, T2 and T3. All three models are exactly the same with the exception of the LCD display contents (mainly as the symbol of treatment level). T1 and T3 both adopt shape identification to display the treatment levels, which T1 adopts fan-shaped display and T3 adopts rectangle-shaped display. And T2 direct adopts digital symbol to display treatment levels.

The provided text is a 510(k) Summary for a medical device (Home Use Hair Removal Device). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory purposes.

However, it does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in hair removal. Instead, it focuses on the engineering and safety performance of the device to demonstrate that it is as safe and effective as a previously approved device.

Therefore, many of the requested sections below cannot be populated with information from the provided text.

Here is the information that can be extracted or derived from the text, with an explanation of why other sections cannot be completed:

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

The document does not explicitly state acceptance criteria in terms of hair reduction efficacy or clinical outcomes, as it primarily focuses on the technical and safety equivalence to predicate devices. It reports on various engineering and safety tests.

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

The document does not describe a clinical study or a "test set" in the context of hair removal efficacy. The "performance data" mentioned refers to engineering and safety testing. Therefore, there is no sample size for a test set or data provenance related to clinical performance.

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

Not applicable. The document does not describe a clinical study with a test set requiring expert ground truth for hair removal efficacy.

4. Adjudication method for the test set

Not applicable. No clinical test set described.

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. The device is a physical hair removal device, not an AI-assisted diagnostic or imaging tool. There are no "human readers" or AI assistance involved in its direct function.

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

Not applicable. The device is a physical hair removal device, not an algorithm.

7. The type of ground truth used

For the engineering and safety performance data, the "ground truth" is defined by the requirements of the international standards listed (e.g., ISO 10993, IEC 60601, IEC 62471). Deviations from these standards would indicate failure.

8. The sample size for the training set

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

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

Not applicable. This device is not an AI/ML algorithm.

Ask a specific question about this device