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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

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.

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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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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.

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The EpiLaser™ Normal Mode Ruby Laser is intended to effect a permanent reduction of hair in patients with skin types I-IV through selective targeting of melanin in hair follicles.
The LipiLaser® is intended to effect temporary hair reduction in skin types I-IV . The LipiLaser® is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

The EpiLaser™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 0.2 to 3.0 milliseconds (msec). The laser energy is delivered to the treatment sites by an articulated arm. Energy fluences of 10-60 J/cm2 are achieved under conditions of intended use. A water-cooled handpiece (spot sizes of 7 or 10 mm) is held firmly against the treatment site.

This document describes the Palomar EpiLaser™ Normal Mode Ruby Laser, a device intended for permanent hair reduction.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria with numerical thresholds. Instead, it describes a clinical study that demonstrated the device's effectiveness. The core acceptance criterion, as implied by the FDA's "substantial equivalence" finding, would be that the device achieves "permanent reduction of hair." The FDA further clarifies this as "a long term, stable reduction in the number of hairs regrowing after a treatment regime," explicitly stating it "shall not permit a claim using the terms permanent elimination or permanent removal of all hair in the treated area after a treatment."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document only states "Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, 12 and 24 months after treatment." It does not specify the number of subjects included in the clinical study.
• Data Provenance: The data appears to be prospective as observations were recorded at various time points after treatment. The country of origin of the data is not specified but is presumably the United States, given the FDA submission context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide details on how the assessment of "permanent reduction of hair" was independently verified or by whom. It states "Observations of hair and skin responses were recorded," which could imply clinical observation by study investigators. No information about external experts or their qualifications is provided.

4. Adjudication Method for the Test Set:

No adjudication method is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or mentioned. This is a medical device for hair removal, not an AI diagnostic tool, so an MRMC study would generally not be applicable.

6. Standalone Performance Study:

This device is a hardware laser system; therefore, the concept of a "standalone algorithm only" performance study is not applicable. The device's performance inherently involves the direct application of the laser by a user.

7. Type of Ground Truth Used:

The ground truth used was clinical observation and assessment of hair regrowth over a 24-month period. The FDA defines "permanent hair reduction" based on this observable outcome.

8. Sample Size for the Training Set:

This document describes a clinical study for a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI. The study described is an efficacy and safety evaluation.

9. How the Ground Truth for the Training Set was Established:

As there is no AI training set, this question is not applicable. The "ground truth" for the device's performance was established through clinical follow-up as described in point 7.

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The Epilaser I is intended to effect hair removal of patients with skin types 1 - 4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

The upgrade kit for the Epilaser® I consists of a laser head with a slightly higher energy output, a fiber optic beam connector with a standard SMA 905 connector, a fiber optic, and modified hand pieces adapted with a quick connect to the fiber optic.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes an upgrade kit for an existing device, the Epilaser I Normal Mode Ruby Laser. The core of the submission is to demonstrate that the upgrade kit does not negatively impact the safety and effectiveness of the original device, and therefore, no new performance data is required.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No test set involving human subjects or performance data was required for this submission. The submission is based on the premise that the upgrade does not alter the device's performance.
• Data Provenance: Not applicable, as no new performance data was generated or analyzed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No ground truth establishment related to a test set was required as no new performance data was generated for the upgrade kit.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication was performed.

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 a laser for hair removal, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

• Not applicable. This is a medical device (laser), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No new ground truth was established for the upgrade kit. The regulatory decision hinges on the substantial equivalence to the predicate device, which inherently relied on the predicate possessing established safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device (laser), not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this case is not a traditional clinical or performance study with new data generation. Instead, the "proof" is a regulatory argument of substantial equivalence to a legally marketed predicate device (the Epilaser I before the upgrade).

The acceptance criteria are effectively that the upgraded device maintains the safety and effectiveness of the predicate device. The study to prove this involved:

• Comparison of Technical Specifications: The submission details that the upgrade kit consists of a laser head with slightly higher energy output, a fiber optic beam connector, a fiber optic, and modified hand pieces.
• Assessment of Impact on Operational Specifications, Performance, and Intended Use: The core argument is stated as: "The operational specifications, performance and intended use of the Epilaser® I are not affected by the installation of the upgrade kit. The changes in specifications after installation of the upgrade kit, e.g., a fiber optic in place of an articulated arm, do not affect the performance characteristics of the Epilaser® I."
• Conclusion of Substantial Equivalence: Based on the above, the manufacturer concludes that the Epilaser I with the upgrade kit is substantially equivalent to the Epilaser I without the upgrade kit.

Therefore, the "study" is a technical and regulatory justification rather than a data-driven performance study. The FDA's letter (K980160) confirms their agreement with this assessment, stating, "We have determined the device is substantially equivalent... You may, therefore, market the device..." and that "The FDA finding of substantial equivalence... results in a classification for your device and thus, permits your device to proceed to the market." The underlying performance data for the original Epilaser I (K963947) served as the basis for its initial market clearance, and this submission leverages that existing clearance by demonstrating that the upgrade causes no adverse change.

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The Epilaser" Normal Mode Ruby Laser is Intended Use: to hair removal intended effect of patients with skin types 1 - 4 through photothermolysis hair selective of in dermatology and plastic follicles surgery. This results in a prolonged growth delay.

The Epilaser" Normal Mode Ruby Laser operates 694.3 at nanometers with pulse durations of 0.2 - 3.0 msec. uhe delivered energy 18 to the treatment site by an articulated arm. A water-cooled handpiece (7 mm or 10 mm) is firmly held against the skin for 2-3 seconds and the laser is then fired. The Bpilaser Normal Mode Ruby Laser is capable of producing energy fluences of 10-75 J/cm4.

Acceptance Criteria and Study for Epilaser™ Normal Mode Ruby Laser (K963947)

The provided document describes the Epilaser™ Normal Mode Ruby Laser (K963947) for hair removal. The information available centers on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative acceptance criteria with corresponding performance data. The device's intended effect is "prolonged growth delay" of hair through selective photothermolysis.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical targets (e.g., a percentage reduction in hair growth, or a score on a scarring scale) that would typically constitute explicit acceptance criteria. The criteria are inferred from the safety and effectiveness claims made.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "an initial study" and "subsequent studies, including patients treated for facial hair." However, specific sample sizes for these clinical studies are not provided.
• Data Provenance: The studies were prospective clinical studies conducted on human subjects ("Observations in an initial study were recorded prior to treatment and at 1, 3 and 6-months after treatment," and "Subsequent studies, including patients treated for facial hair, confirmed the results of the initial study."). The country of origin of the data is not specified, but the applicant's address is Lexington, MA, USA, which suggests the studies may have been conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not detail how ground truth was established for the clinical studies. It mentions "Observations in an initial study were recorded," implying clinical assessments, but it does not specify the number of experts or their qualifications. For animal studies, "biopsies" and "examination of irradiated skin" suggest histological analysis, which would typically be performed by veterinary pathologists, but this is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported) in the provided information. The study focuses on the device's standalone performance and its substantial equivalence to predicate devices, not on comparing human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is a physical device, a laser, not an algorithm. Therefore, the concept of a "standalone (i.e. algorithm only without human-in-the-loop performance)" study does not apply in the usual sense. The clinical studies described assessed the performance of the device when operated by trained personnel on human subjects.

7. Type of Ground Truth Used

• Clinical Studies: The ground truth for the clinical studies appears to be based on clinical observation of hair reduction and the absence of scarring over 1, 3, and 6 months post-treatment. This is a form of direct clinical outcome assessment.
• Animal Studies: The ground truth for the animal studies was based on histopathological examination of biopsies from control and irradiated skin, assessing follicular epithelium, dermal collagen, and damage.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the Epilaser™ is a physical device and not an AI algorithm, there is no "training set" in this context. The animal and clinical studies are performance evaluation studies, not training.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for a physical medical device, this question is not applicable. The ground truth for the performance studies was established through clinical observations and histopathological examinations as described in point 7.

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