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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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The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).

The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 usec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.

This 510(k) summary for the K955612 Spectrum Epilaser® Normal Mode Ruby Laser does not contain the detailed information required to answer the requested questions about acceptance criteria and a study proving device performance.

The document is a regulatory summary for device clearance, not a clinical study report. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance metrics from a dedicated study with defined acceptance criteria.

Here's why each point cannot be addressed with the provided information:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states "The Epilaser® was demonstrated to be substantially equivalent to the predicate devices on the basis of similar mechanisms of action and indications for use." This is a general statement about regulatory clearance, not a quantitative performance report.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or study data is described. The document vaguely mentions "Data from in vitro, in vivo and clinical results found in the open literature were also provided," but this refers to supporting information for substantial equivalence, not a dedicated performance study for this specific device.
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): No ground truth establishment is described because no specific test set or clinical study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as no specific test set or study is detailed.
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: This is a laser device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As this is a medical device (laser), not an algorithm or AI system, the concept of "standalone performance" in that context does not apply. Performance would typically involve treatment outcomes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth is described. The indications for use are "treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black)," implying clinical efficacy would be based on visual assessment of lesion reduction/removal, but no study details are given.
8. The sample size for the training set: There is no training set mentioned, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable, as there is no training set.

In summary, the provided document is a 510(k) summary for a laser device focused on demonstrating substantial equivalence for regulatory clearance. It does not contain the information requested about specific acceptance criteria and detailed performance studies with sample sizes, expert ground truth, or AI-related metrics.

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