(154 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No scarring in any subject | Achieved: "There was no scarring in any subject." |
| Effective selective photothermolysis of hair follicles for prolonged growth delay | Achieved: "The initial study demonstrated that selective photothermolysis targeting melanin in the human hair follicle is an effective tool for hair removal, resulting in a prolonged growth delay." |
| No alterations to follicular epithelium or dermal collagen in control skin | Achieved: "Biopsies of control skin showed no alterations the follicular epithelium or dermal collagen." |
| Damage to follicular epithelium in irradiated skin | Achieved: "Examination of irradiated skin showed damage to the follicular epithelium." |
| Focal collagen damage in reticular dermis immediately adjacent to hair follicle in irradiated skin | Achieved: "Focal collagen reticular dermas occurred damage in immediately adjacent to the hair follicle." |
| Observed effects increase with fluence levels | Achieved: "Observed effects increased with fluence levels." |
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.
§ 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.