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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

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 (IPL) 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 Quartz Lamp Tube to emit light and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse emitting.

The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.

The provided text is an FDA 510(k) summary for an IPL Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and non-clinical studies performed to demonstrate substantial equivalence. However, this document does not contain information about studies proving the device meets acceptance criteria related to its clinical efficacy (e.g., hair reduction percentage, number of treatments for efficacy). The non-clinical studies focus on electrical safety, photobiological safety, and biocompatibility, as well as software validation, which are all important for safety and performance but do not address the clinical effectiveness of hair removal.

Therefore, for aspects related to the clinical performance criteria (like hair reduction), the information requested in your prompt (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be extracted from this document as it does not describe clinical trials for efficacy. The document primarily focuses on demonstrating equivalence to predicate devices based on technical characteristics and safety standards.

Here's what can be extracted and what cannot:

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

• Cannot be extracted for clinical efficacy: The document does not state clinical acceptance criteria such as a required percentage of hair reduction or number of treatments. Instead, it focuses on non-clinical performance standards.
• For non-clinical performance (safety):

  Acceptance Criteria (Standard Conformance)	Reported Device Performance
  ANSI AAMI ES 60601-1 (Basic Safety and Essential Performance)	Meets standard
  IEC 60601-1-2 (Electromagnetic Disturbances)	Meets standard
  IEC 60601-1-11 (Home Healthcare Environment)	Meets standard
  IEC 60601-2-83 (Home Light Therapy Equipment)	Meets standard
  IEC 62471 (Photobiological Safety)	Meets standard
  ISO 10993-5 (In Vitro Cytotoxicity)	Meets standard
  ISO 10993-10 (Irritation and Skin Sensitization)	Meets standard
  FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices (Software Verification and Validation)	Meets requirements

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

• Cannot be extracted for clinical efficacy: Not mentioned as no clinical efficacy study is described.
• For non-clinical testing: Sample sizes are not specified for the safety and performance tests (e.g., how many devices were tested for electrical safety). Data provenance is implicitly from the manufacturer or third-party labs contracted by the manufacturer (Shenzhen Yangyi Technology Co., Ltd. in China). These are non-clinical tests, not human data.

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)

• Cannot be extracted: No clinical trial involving expert assessment of outcomes is described. Ground truth for non-clinical tests is established by adherence to documented test procedures and standards.

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

• Cannot be extracted: Not applicable as no clinical trial with human assessment 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

• Cannot be extracted: Not applicable. This document describes an IPL hair removal device, not an AI-assisted diagnostic device.

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

• Cannot be extracted: Not applicable. This refers to the performance of a diagnostic algorithm, not a therapeutic device. The device itself is "standalone" in that it performs the therapy.

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

• Cannot be extracted for clinical efficacy: No clinical efficacy data is presented.
• For non-clinical testing: Ground truth is established by the specified international and national performance and safety standards (e.g., IEC, ISO, ANSI AAMI ES). Compliance with these standards indicates the "ground truth" of the device's technical safety and performance.

8. The sample size for the training set

• Cannot be extracted: No machine learning model is being trained for clinical decision-making or diagnosis. The device has "Software/Firmware/Microprocessor Control? Yes," and "Software verification and validation test" was done, but this refers to the internal operating software, not an AI trained on a large dataset.

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

• Cannot be extracted: Not applicable, as no external training set for an AI/ML model for clinical application is mentioned. Ground truth for internal software validation would be derived from functional requirements and test specifications.

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