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The Red Wave Hair Removal Device is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. 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. The device is used for adults.

Red Wave Hair Removal, Model: ARH001, is a small prescription-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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is 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 regimen. Emission is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 285g, and the size is 152.9x101.5x94.8mm (HWD). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

Based on the provided text, the document is specifically a 510(k) summary for the Red Wave Hair Removal device. It mostly focuses on demonstrating substantial equivalence to predicate devices rather than detailing a direct acceptance criteria study for its performance in hair removal. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, and detailed ground truth establishment for a performance study is not present. The document mainly describes safety and electrical performance testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria for hair removal efficacy/performance. Instead, it describes a substantial equivalence comparison to predicate devices, implying that its performance is comparable.

The "Test Summary" section (on page 9) does list safety and electrical tests. For these, the acceptance criteria are generally "compliance" with the mentioned IEC standards.

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

For the safety and electrical tests, the sample size is not specified but typically involves a small number of devices (e.g., a few units) for bench testing. The data provenance is "lab bench testing" conducted by or for Shenzhen Accompany Technology Co., Ltd. (the manufacturer). This is a prospective test for the device, not retrospective human data.

For hair removal performance, no specific test set or sample size for a clinical study is described within this document.

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

This information is not provided because no clinical study for device performance is detailed in this 510(k) summary. The document does mention the device is to be used "under the direction of a physician, after training by a healthcare professional."

4. Adjudication method for the test set

Not applicable, as no clinical study for device performance with expert adjudication is 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. This device is an IPL hair removal device, not an AI-powered diagnostic system that would involve human readers or AI assistance in interpretation.

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

The device is a standalone hardware device that performs physical light-based treatment. There is no AI algorithm component described for standalone performance evaluation in this context.

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

For the safety and electrical tests, the "ground truth" is adherence to the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57) and FDA guidance for software. For biocompatibility, it's compliance with ISO 10993-5 and -10.

For hair removal performance, the document relies on 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." However, it does not explicitly state that a clinical trial was conducted for this device to establish this outcome as part of the 510(k) submission, instead implying equivalence to predicates which likely supported this claim with clinical data.

8. The sample size for the training set

Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.

9. How the ground truth for the training set was established
Not applicable, as this is a hardware device submission, not an AI/ML software submission with a training set.

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