(148 days)
The AviClear Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared Indium Phosphide (InP) diode laser device with a nominal wavelength of 1726 nm. Similar to other well-established infrared laser devices, the device uses a combination of the treatment spot size, beam characteristics, and tissue absorption and scattering coefficients at the output wavelength to deliver energy to tissues at depth. The wavelength of the laser energy, when combined with the pre, parallel (during energy delivery), and post cooling of epidermal and superficial dermal structures, causes selective heating of dermal tissue at different depths. The 1726 nm laser energy heats the chromophore, sebum within sebaceous glands, which results in controlled thermal injury of the sebaceous glands, the ultimate treatment target, thus reducing or eliminating sebum production and causing an improvement in acne vulgaris.
The diode laser and associated beam delivery optics, laser and electronics power supplies, control electronics, and cooling system are housed inside a console equipped with a touchscreen user interface. The laser treatment parameters are selected using the touchscreen.
The treatment handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skincontact cooling window to provide thermal protection for the epidermis and superficial dermis and through which energy is delivered to the patient; and skin-contact pressure sensors that enable laser energy delivery when the system is in Ready mode and the footswitch is depressed.
The provided text describes a clinical study for the AviClear Laser System, which is indicated for the treatment of mild to severe inflammatory acne vulgaris.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Primary Effectiveness Endpoint:
"to show more than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined a subject with ≥50% fewer inflammatory acne lesions 12 weeks after their final treatment visit than at baseline."
| Metric | Acceptance Criteria | Reported Device Performance (ITT Cohort) | Reported Device Performance (Per-Protocol Cohort) |
|---|---|---|---|
| % of subjects achieving Treatment Success at 12 weeks post-final treatment | >50% | 77.9% (n=81; 95% Cl 69%-85%) | 79.8% (n=71; 95% Cl 70%-88%) |
The Primary Effectiveness Endpoint was met in both the ITT and Per-Protocol cohorts.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Clinical Study Participants: 104 subjects were enrolled and entered the Treatment Phase.
- Primary Effectiveness Analysis (ITT Cohort): n=104
- Supportive Analysis (Per-Protocol Cohort): n=89
- Data Provenance:
- Country of Origin: The study was conducted at 7 US sites.
- Retrospective/Prospective: The study was prospective. It was an "IDE-approved, prospective, multi-center, significant-risk clinical study".
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts:
- IGA Grading: A panel of three trained expert physicians.
- Acne Lesion Counting: Three trained and experienced acne lesion counters.
- Qualifications of Experts:
- IGA Grading: "trained expert physicians" (specifically for Investigator Global Assessment grading).
- Acne Lesion Counting: "trained and experienced acne lesion counters". (The document doesn't specify if they were physicians, but they were trained for the specific task.)
4. Adjudication Method for the Test Set
- IGA Grading: The "median of the three baseline IGA grades" was used for enrollment, and the "median of the three IGA grades" was assigned for follow-up timepoints. This indicates a median consensus (3-reader median) approach.
- Acne Lesion Counting: The "median of the three count values for each facial side and lesion type was assigned to the subject for each study timepoint." This also indicates a median consensus (3-reader median) approach.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. The study described focuses on the device's effectiveness in treating acne, using expert readers to establish ground truth for clinical outcomes (IGA, lesion counts), not to evaluate an AI's impact on human reading performance.
6. Standalone (Algorithm Only) Performance
This question is not applicable. The device is a laser system for treating acne directly, not an AI algorithm for image analysis or diagnosis. Therefore, there is no "algorithm only" performance to evaluate in this context. The clinical study assessed the laser system's treatment efficacy and safety.
7. Type of Ground Truth Used
The ground truth for effectiveness was established through:
- Expert Consensus (Clinical Assessment):
- Investigator Global Assessment (IGA) grades: Determined by a panel of three trained expert physicians.
- Inflammatory and noninflammatory acne lesion counts: Performed by three trained and experienced acne lesion counters.
- Outcomes Data:
- Treatment Success: Defined as ≥50% fewer inflammatory acne lesions at 12 weeks post-final treatment, based on the expert-counted lesion data.
- Subject Satisfaction: Self-reported by subjects.
8. Sample Size for the Training Set
This question is not applicable in the typical sense of an AI model's training set. The "training" here refers to the development and refinement of the physical device and its treatment parameters. The document describes a clinical study to test the device's safety and effectiveness in humans, not to train a machine learning model. There is no mention of a separate "training set" of patient data used to develop an algorithm embedded in the device.
9. How the Ground Truth for the Training Set was Established
As mentioned above, this is not directly applicable to a traditional AI training set. The ground truth for the clinical study (which serves as the "test set" for regulatory approval) was established by:
- Physician-based IGA grading: By multiple trained expert physicians taking the median.
- Trained personnel-based lesion counting: By multiple trained and experienced acne lesion counters taking the median.
- Baseline measurements: Used as the reference point for evaluating treatment effectiveness.
The document describes the study design and assessment methods to evaluate the performance of the physical laser device. It does not indicate the use of machine learning or an AI model that would typically have a "training set" with established ground truth.
§ 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.