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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" 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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