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The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.

The proposed LED Therapy Device is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

The provided text is a 510(k) summary for the Shenzhen Leaflife Technology Co., Ltd's LED Therapy Device. It details the device's characteristics and compares them to predicate devices, but it explicitly states that "No clinical study is included in this submission."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the document.

Here's what I can extract based on the provided text, primarily about the technical specifications and comparison:

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

Since no clinical study with acceptance criteria is provided, I cannot create such a table for performance against clinical endpoints. However, the document does compare technical characteristics to predicate devices. Here's a table focusing on the technical characteristics comparison, noting where they are "Same," "Similar," or "Discussion" (implying a difference that the manufacturer argues does not impact substantial equivalence):

2. Sample sized used for the test set and the data provenance:
Not applicable as no clinical study or test set for performance evaluation is mentioned. The non-clinical tests mentioned are for safety and technical standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study or ground truth for performance evaluation is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study or test set for performance evaluation is mentioned.

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 as no clinical study, MRMC study, or AI component is mentioned. This is a physical LED therapy device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a physical LED therapy device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable as no clinical study or ground truth for performance evaluation is mentioned. Non-clinical tests were conducted to verify compliance with safety and electrical standards.

8. The sample size for the training set:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

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The IPL HAIR REMOVAL (Model: SG-8025) 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.

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.

The IPL HAIR REMOVAL SG-8025 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 it's 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 applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only.

The provided document is an FDA 510(k) summary for an IPL (Intense Pulsed Light) Hair Removal device (Model SG-8025). This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical trials.

Therefore, the document explicitly states: "No clinical tests was performed on the subject device." This means there is no study described within this document that proves the device meets specific acceptance criteria based on its own clinical performance. Instead, the device's equivalence to a legally marketed predicate device (IPL Salon Hair Reduction System, K181568) is asserted through a comparison of technical and functional characteristics.

Because no clinical study was performed for the IPL HAIR REMOVAL SG-8025 to establish its own performance against acceptance criteria, much of the requested information cannot be provided from this document.

However, I can extract the comparative information and the non-clinical performance data provided to support the substantial equivalence claim.

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

Since no clinical study was performed for the subject device (IPL HAIR REMOVAL SG-8025) directly against acceptance criteria, this table will instead present the comparison of technological characteristics between the subject device and its predicate device, which is the basis of its FDA clearance for substantial equivalence. "Acceptance criteria" in this context refers to the FDA's determination that the differences between the subject device and the predicate device do not raise new questions of safety or effectiveness.

Comparison of Technological Characteristics: IPL HAIR REMOVAL SG-8025 vs. Predicate Device (K181568)

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

• Sample size for test set: Not applicable. No clinical tests were performed on the subject device.
• Data provenance: Not applicable.

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 tests were performed to establish the device's efficacy. The substantial equivalence relies on technical comparison and compliance with recognized standards.

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

• Not applicable.

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 diagnostic tool involving human readers.

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

• Not applicable.

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

• Not applicable for the subject device's efficacy. The "ground truth" for the clearance is the established safety and effectiveness profile of the predicate device, as well as compliance with various international standards for medical electrical equipment, photobiological safety, and biocompatibility.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of Device Performance (Non-Clinical):

The document provides non-clinical performance data to support the safety aspects of the device, which contributes to the claim of substantial equivalence:

• Biocompatibility Testing:
  • Conducted per ISO 10993-1.
  • Passed ISO 10993-5:2009/(R)2014 (Tests for In Vitro Cytotoxicity).
  • Passed ISO 10993-10:2010/(R)2014 (Tests for Irritation and Skin Sensitization).
• Electrical Safety:
  • Passed IEC 60601-1-2 (Electromagnetic compatibility).
  • Passed IEC 60601-1 (General requirements for basic safety and essential performance).
  • Passed IEC 60601-1-11 (Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment).
  • Passed IEC 60601-2-57 (Particular requirements for non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use).
• Eye Safety:
  • Compliance with IEC 62471 Photobiological safety of lamps and lamp systems.
  • Compliance with ISO 14971 Medical Devices Applications of Risk Management to Medical Devices.
• Software Verification and Validation:
  • Software documentation consistent with a moderate level of concern was submitted.
  • System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

Conclusion from the document:

"IPL HAIR REMOVAL SG-8025 was found to be substantially equivalent to the predicate devices and shares the same or similar indications for use, design, operational and functional features as the predicate devices. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness."

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