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The IPL Hair Removal Device is an over-the-counter device indicated for the 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 device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The IPL 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(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology 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 Quartz glass 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; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

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