(88 days)
The AviClear Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgaris.
The AviClear Laser System is an infrared 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. Two treatment handpieces are available. Each handpiece has an integrated scanner for delivering treatment spot(s) in an operator-selected pattern; a temperature-controlled skin-contact 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 FDA 510(k) clearance letter and summary for the AviClear Laser System (K251149) indicate that this submission is for a modification of an already cleared device (K230660), rather than a completely new device or a device incorporating AI for diagnostic or predictive purposes. As such, the study described is a safety study comparing the modified device to the predicate device, not a performance study to prove the device meets specific diagnostic efficacy acceptance criteria in the way an AI/ML medical device would.
Therefore, many of the requested categories related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and detailed performance metrics (sensitivity, specificity, AUC), are not applicable to this specific submission type. The "acceptance criteria" here primarily relate to the comparable safety and thermal effects to the predicate device.
However, I will extract and present the information available from the provided text in the closest applicable format.
Device Acceptance Criteria and Study Overview for AviClear Laser System (K251149)
The AviClear Laser System (K251149) is a modified version of a previously cleared device (K230660). The Acceptance Criteria, in this context, are not about diagnostic performance metrics for an AI system, but rather demonstrating comparable safety and efficacy to the predicate device, specifically regarding its thermal effects and adverse event profile, despite changes to the handpiece and cooling duration.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a safety study for a modified laser system, the "acceptance criteria" are implied by the study's primary and secondary outcomes, focusing on comparability to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance (K2511149 vs. K230660) |
|---|---|
| No new or unexpected Adverse Device Effects (ADEs) observed. | No new or unexpected ADEs were observed with the modified device. Reported ADEs were consistent with the previously cleared device. |
| Incidence of blistering or scarring is not increased. | No cases of blistering or scarring were reported in any subjects. |
| Comparable thermal effect/extent of thermal impact (epidermal/dermal changes, cellular changes, inflammatory changes, overall tissue architecture). | Comparable thermal effects at highest available settings for both modified and previously cleared devices. No epidermal injury, similar depths of selective, noninvasive sebaceous gland destruction, no associated inflammation, and no denaturation of adjacent collagen. |
| Safety profile is not significantly different. | The thermal safety profile of the modified device is not significantly different from that of the previously cleared device. |
| Device can be safely and effectively used for the indicated treatment. | Modified device can be safely and effectively used for the long-term treatment of mild to severe inflammatory acne vulgaris. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 10 subjects.
- Data Provenance:
- Country of Origin: Not explicitly stated, but assumed to be the United States as it is an FDA submission.
- Retrospective/Prospective: Prospective, comparative double-arm safety study. Subjects underwent procedures specifically for the study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: At least one independent dermatopathologist.
- Qualifications of Experts: Independent dermatopathologist. No further details on experience (e.g., years) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The histological assessment was done by "an independent dermatopathologist," suggesting a single expert's assessment was used, not a consensus or adjudication process involving multiple reads.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed. This type of study (comparing human reader performance with and without AI assistance) is not applicable to a laser system clearance without AI integration. The study was a safety and comparability study of a medical device itself.
6. Standalone Performance (Algorithm Only)
- Was standalone performance done? Not applicable. This phrase typically refers to the performance of an AI algorithm on its own. The AviClear Laser System is a physical medical device (laser system), not primarily a software algorithm. Its "performance" is evaluated through clinical safety and histological outcomes rather than diagnostic metrics.
7. Type of Ground Truth Used
- Ground Truth Type:
- Observed Adverse Events (AEs) and Adverse Device Effects (ADEs): Self-reported or clinician-observed events during follow-up.
- Histological Tissue Evaluation: Microscopic examination of excised tissue by a dermatopathologist to assess thermal impact, cellular changes, etc. This is considered a pathology-based ground truth for thermal effects.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a laser system hardware, not a machine learning algorithm that requires a "training set" in the conventional AI/ML sense. The "training" for the device, if any, would be its design and engineering iterations, followed by verification and validation testing (nonclinical and clinical) as described.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.
§ 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.