(445 days)
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.
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Hair Reduction Efficacy | Permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime, measured at 6, 9, and 12 months after the completion of the treatment regimen. (Specific quantitative thresholds for "reduction" are not provided in this document) | Implicitly, the device met this, as it applied for "permanent reduction in hair regrowth." No specific percentage reduction or hair count data is provided. |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation) standards. (Specific pass/fail criteria from these standards apply) | Testing performed per ISO 10993-5 and ISO 10993-10. Implicitly passed to achieve substantial equivalence. No specific test results (e.g., irritation index) are provided. |
| Software Validation | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Specific requirements for documentation, testing, and risk management apply) | Software documentation and validation performed. Implicitly met. No details on software bugs or validation metrics are provided. |
| Electrical/EMC/Laser Safety | Compliance with AAMI/EN 60601-1, AAMI/EN IEC 60601-1-2, IEC 62471, IEC 60825-1, and IEC 60335-2-23. (Specific safety limits and performance criteria from these standards apply) | Electrical, EMC, and laser safety testing performed. Implicitly passed. No specific measurements (e.g., leakage current, EMC emissions/immunity in dB) are provided. |
| Skin Tone Sensor Validation | Ensured the user has the correct skin tone prior to laser activation. (Specific accuracy/reliability metrics for skin tone detection are not provided) | Skin tone sensor validation performed. Implicitly met its purpose. No specific accuracy metrics (e.g., sensitivity, specificity for skin tones) are provided. |
| Self-selection and Usability (Human Factors) | Demonstrated continued OTC use, despite user interface modification. (Specific usability metrics like completion rates, error rates, SUS scores, or risk identified/mitigated are not provided) | Self-selection and usability human factors testing performed. Implicitly demonstrated continued OTC use. No specific human factors study results are detailed. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.