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Epilaser Absolute is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Epilaser Absolute. Unfortunately, the provided document does not contain the detailed performance study results that would allow for a complete answer to all your questions. The "Performance Data" section lists the types of tests performed but does not elaborate on the specific acceptance criteria for each test or the reported performance data against those criteria.

However, I can extract the available information and highlight what is missing.

Description of Device and Intended Use:

The Epilaser Absolute is an over-the-counter, hand-held hair removal device that uses 808 or 980nm laser energy to kill hair follicle roots. It is intended for adjunctive use with shaving for sustained hair removal with periodic treatments, and for permanent reduction in hair regrowth, defined as a long-term, stable reduction in hair counts at 6, 9, and 12 months post-treatment.

1. Table of Acceptance Criteria and Reported Device Performance

Given the provided document, specific numerical acceptance criteria and reported performance values are NOT available for most categories. The document lists the types of tests conducted but doesn't provide the detailed results against specific thresholds.

Missing Information & Assumptions:

The document clearly states the conclusion that "Performance data demonstrate that the Epilaser Absolute is substantially equivalent to predicate devices." This implies that the device did meet relevant acceptance criteria for the tests listed, but it does not provide the criteria or the specific performance results themselves.

For the hair reduction efficacy, which is a primary claim, the document defines what "permanent reduction" means (long-term, stable reduction at 6, 9, and 12 months) but does not provide a quantitative acceptance criterion (e.g., "minimum 50% hair count reduction") or the actual percentage reduction achieved in any study.

Further Questions Based on Missing Information:

Without the full study report, it's impossible to answer the following questions with specific numbers.

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

• Not provided. The document only mentions that tests were performed but does not specify sample sizes for any human-based studies (e.g., usability, hair reduction). Data provenance (country of origin, retrospective/prospective) is also not mentioned for any performance data.

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

• Not provided. This information would typically be relevant for studies involving subjective assessments (e.g., hair count assessment by dermatologists). Since the document does not detail the hair reduction study, this information is absent. For human factors, the "experts" would typically be representative users, and their qualifications are often basic literacy and comprehension.

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

• Not provided. This would be relevant if there were subjective measurements requiring multiple opinions, such as assessments of hair count or adverse events.

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/Not provided. This device is a direct-to-consumer laser hair removal device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-assistance comparison is not relevant to its type.

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

• Not applicable/Not provided. This device is a user-operated laser system. Its "performance" inherently involves the user correctly operating it. It has a "skin tone sensor validation," which implies an algorithmic component, but no standalone performance metrics for just the algorithm are provided separate from the overall device performance.

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

• For hair reduction efficacy, the ground truth would likely involve hair counts (outcomes data) observed over time. How these counts were established (e.g., photography, expert assessment) is not specified.
• For other engineering tests (bio-compatibility, safety), the ground truth is often established by adherence to international standards and validated test methods.

8. The sample size for the training set:

• Not provided. Training sets are typically relevant for machine learning algorithms. While the skin tone sensor might have used a training set, the document does not provide any details about it.

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

• Not provided. As with point 8, this information is not present in the document.

In summary, while the document confirms that various tests were conducted to establish substantial equivalence for the Epilaser Absolute, it largely omits the specific quantitative acceptance criteria and the detailed performance results of those tests. This level of detail is typically found in the full 510(k) submission, not in the summary document provided.

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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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