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The IPL Salon Hair Reduction System (Model: F60001) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. It is also intended for permanent reduction in unwanted 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.

IPL Salon Hair Reduction System, Model: F60001, a small over-the-counter device, is a homeuse device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). Emission activation 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 650g, and the size is 143 x69.5 x 43mm (HWD).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

The provided text details a 510(k) premarket notification for the "IPL Salon Hair Reduction System." It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparisons of technical specifications.

However, there is explicitly no clinical testing performed for this device.
Therefore, the document does not contain information on acceptance criteria for device performance based on a clinical study, reported device performance from such a study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data. These elements are typically found in clinical study reports, which are absent here.

The document states:

• "No clinical testing was performed" (page 9).

This means the request to describe the acceptance criteria and study that proves the device meets acceptance criteria based on clinical performance cannot be fulfilled from the provided text. The submission relies on demonstrating substantial equivalence through non-clinical tests (electrical safety, EMC, software V&V, biocompatibility, usability) and comparison of technological characteristics with predicate devices.

Therefore, the only 'acceptance criteria' implicitly conveyed are adherence to applicable safety standards and similarity in technical specifications to legally marketed devices.

Here's what can be extracted based on the provided text, focusing on the non-clinical aspects and the lack of clinical study data:

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

• Acceptance Criteria: Based on the information provided, the "acceptance criteria" are not quantitative performance metrics from a clinical study for hair reduction efficiency or safety endpoints (e.g., specific percentage of hair reduction, or complication rates). Instead, they are defined by compliance with recognized safety and performance standards for medical devices and demonstration of substantial equivalence to predicate devices in terms of technical characteristics and intended use.

  • Compliance with IEC 60601-1 (Electrical safety)
  • Compliance with IEC 60601-1-2 (Electromagnetic compatibility)
  • Compliance with IEC 60601-2-57 (Specific requirements for light sources for aesthetic and therapeutic applications)
  • Compliance with FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" (Software V&V)
  • Compliance with ISO 10993-5 (Biocompatibility - cytotoxicity)
  • Compliance with ISO 10993-10 (Biocompatibility - irritation and skin sensitization)
  • Usability as intended.
  • Technical specifications (e.g., wavelength, Max Fluence) within comparable ranges or not raising new safety/effectiveness concerns compared to predicate devices.

• Reported Device Performance: The document only reports the results of non-clinical tests indicating compliance with the above standards and the device's technical specifications. It does not provide performance metrics related to hair reduction efficacy or safety from a clinical perspective.

Regarding the device's efficacy for "permanent hair reduction":
The document states the device's intention for "permanent reduction in unwanted hair," 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." However, no clinical study data is provided in this submission to demonstrate that the device achieves this stated efficacy. The 510(k) process allows for substantial equivalence claims based on non-clinical data if the device is sufficiently similar to legally marketed predicate devices.

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

• Not applicable for clinical efficacy studies. No clinical test set data is provided as no clinical testing was performed.
• For non-clinical tests (e.g., electrical safety, EMC, biocompatibility), the "sample size" refers to the number of devices or components tested to demonstrate compliance. This is typically one or a few units as required by standards, not a patient sample. The provenance of such lab testing data would be the testing laboratories, likely in China or an accredited international lab.

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 applicable. No clinical test set where "ground truth" related to hair reduction efficacy or side effects would be established by experts.

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

• Not applicable. No clinical test set 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 an IPL hair reduction system, not an AI diagnostic imaging tool or a system requiring human interpretation with AI assistance. No MRMC study was conducted.

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

• Not applicable. This is a hardware device; no standalone algorithm performance was assessed as part of this submission. The "Software/Firmware/Microprocessor Control?" states "Yes," and "Software verification and validation test" was performed, but this refers to the internal operating software of the device itself, not a separate diagnostic algorithm.

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

• Not applicable for clinical efficacy. For non-clinical tests, "ground truth" relates to compliance with standard specifications (e.g., electrical parameters must be within a defined range, materials must not elicit a cytotoxic response). The ground truth is the standard's defined acceptance limits.

8. The sample size for the training set

• Not applicable. No machine learning model or "training set" for clinical data was used or described in this submission.

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

• Not applicable. (See point 8).

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