Search Results
Found 3 results
510(k) Data Aggregation
(121 days)
Epilaser Pro 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 the number of hairs regrowing) when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
The Epilaser Pro 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 includes an algorithm that automatically targets individual hairs over the treatment area and the laser activates when it is pressed against the skin. A skin tone sensor ensures the correct skin tone prior to laser activation.
The Epilaser Pro is an over-the-counter device intended for hair removal and permanent reduction in hair regrowth. This device utilizes an algorithm to automatically target individual hairs over the treatment area. The following outlines the acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| True Hits | Above 90% and a greater number of True Hits than the predicate device |
| False Hits | A smaller number of False Hits than the predicate device |
| Not Safe Hits | No Not Safe Hits (indicating safe operation on the skin) |
| Skin Tone Identification | Correctly identified in all subjects |
| Safety (Adverse Effects) | At most, mild erythema and/or mild blistering, resolving within 48 hours |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 69 subjects for the efficacy study.
- Data Provenance: Not explicitly stated, but the submission is from "Epilady 2000 LLC" located in "Hazor Haglilit, Israel." Assuming the studies were conducted locally or within the submitting company's capabilities, it is reasonable to infer the data provenance is likely related to Israel. The study type is prospective, as it involved direct treatment and assessment of subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: One dermatologist.
- Qualifications of Experts: A dermatologist was used to identify the location of hairs and pigments, and to assess skin tone. Specific years of experience are not provided, but being a dermatologist implies a high level of qualification in skin and hair assessment.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated that an adjudication method was used between multiple experts. The ground truth was established by a single dermatologist. The device performance was compared against this single expert's "Ground Truth."
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
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted in the traditional sense of evaluating human readers' diagnostic performance with and without AI assistance. The study compared the performance of the device (Epilaser Pro with its automatic hair targeting algorithm) to the predicate device and to a dermatologist's "Ground Truth." It did not assess human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The efficacy study evaluated the "Epilaser Pro" (which includes the automatic hair targeting algorithm) and compared its performance (True Hits, False Hits, Not Safe Hits) against a dermatologist's "Ground Truth" and the predicate device. This assessment of the device's ability to detect and target hairs independently aligns with a standalone performance evaluation of the algorithm embedded within the device.
7. The type of ground truth used
- Type of Ground Truth: Expert consensus (from a single dermatologist) and objective assessment. The dermatologist used a dermatoscope to objectively determine the location and number of hairs, pigmented spots, tattoos, and skin tone. This forms the "Ground Truth" for comparison.
8. The sample size for the training set
- The document does not provide information regarding the sample size for the training set of the algorithm.
9. How the ground truth for the training set was established
- The document does not provide information regarding how the ground truth for the training set was established. The focus of the provided text is on the validation/test set.
Ask a specific question about this device
(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.
Ask a specific question about this device
(154 days)
Epilaser 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 is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
The provided text is a Food and Drug Administration (FDA) 510(k) summary for the "Epilaser" device. It outlines the device's intended use, technological characteristics, and performance data to establish substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria for device performance (e.g., efficacy in hair reduction rates) nor the results of a study that directly proves the device meets such criteria. Instead, it focuses on demonstrating safety, usability, and technical equivalence to a predicate device.
Therefore, many of the requested items (e.g., a table of acceptance criteria with reported performance, sample sizes for test/training sets with ground truth details, MRMC study results, standalone performance) cannot be extracted from this document as the information is not present.
Here's an attempt to answer the questions based only on the provided text, indicating where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific performance acceptance criteria (e.g., a minimum percentage of hair reduction) or corresponding measured performance values for the Epilaser. The "Performance Data" section lists various tests conducted (biocompatibility, software, safety, usability, laser energy characterization) rather than efficacy-based acceptance criteria or results.
Efficacy is implicitly addressed by stating it has "identical laser output parameters" to the predicate, implying similar efficacy without explicitly stating performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Usability testing that showed that all subjects were successful at determining who should use the device and on what anatomic locations the device should be used." It also states, "In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure."
- Sample Size for Test Set: The exact number of subjects for usability testing is not specified, only "all subjects" and "one user."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
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)
This information is not provided in the document. The usability testing seems to rely on user performance rather than expert-established ground truth related to clinical efficacy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of a multi-reader multi-case (MRMC) study or any AI component in the Epilaser device. The device described is a direct-use laser hair removal system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Epilaser is a physical device used by a human, not an algorithm. The "standalone" concept for algorithms does not apply here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the usability testing, the "ground truth" was likely the successful completion of tasks by the users. For the substantial equivalence claim regarding efficacy, it relies on the predicate device's established efficacy, indirectly using its original "outcomes data" or clinical evidence, but no direct ground truth generation for the Epilaser's efficacy is described in this document.
8. The sample size for the training set
Not applicable. The document describes a physical medical device, not a machine learning algorithm requiring a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an algorithm.
Ask a specific question about this device
Page 1 of 1