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510(k) Data Aggregation
(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.
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.
This document describes the regulatory clearance (K230660) for the AviClear Laser System. It is a 510(k) summary, which means the manufacturer is asserting their device is substantially equivalent to a legally marketed predicate device. In this case, the predicate device is a previous version of the AviClear Laser System (K213461). The current submission (K230660) appears to be primarily for minor design modifications to the handpiece and user interface, while leveraging clinical data from the prior clearance for efficacy and safety.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to the clinical study supporting the original clearance (K213461), which is then referenced to support the current substantial equivalence claim.
Here's the breakdown based on the provided text, focusing on the clinical study details:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on a single primary effectiveness objective and several secondary objectives rather than a predefined "acceptance criteria" table in the typical sense of a rigorous statistical hypothesis test with predefined alpha or beta. However, based on the primary effectiveness objective, we can construct the following:
| Acceptance Criteria (Primary Effectiveness Objective) | Reported Device Performance |
|---|---|
| Objective: Show that more than 50% of subjects enrolled were Responders who achieved Treatment Success. | Primary Endpoint (12-weeks): Results for this primary endpoint are not explicitly reported in the provided text for K230660, but are stated to have resulted in FDA 510(k) clearance for K213461, implying the criterion was met. The document states: "The study's primary effectiveness objective was to show more that than 50% of subjects enrolled were Responders who achieved Treatment Success, where Treatment Success was defined as a subject with ≥50% fewer inflammatory acne lesions with respect to baseline." |
| Long-Term Effectiveness (52-weeks): | Reported: At the 52-week post-final treatment follow-up visit, 91.5% of subjects achieved treatment success (p<0.001). |
Secondary Effectiveness Analyses & Safety Performance:
| Assessment | Reported Performance |
|---|---|
| Improvement in Investigator's Global Assessment (IGA) | By the 52-week follow-up visit, the number of subjects had increased to 66.2% for the "Clear or Almost Clear" skin categories. |
| Improvement from Baseline in Non-Inflammatory Lesion Counts | Reduced from 25% (p=0.001) at 12-week mark to 57.6% reduction from Baseline at the 52-week follow-up assessment (p<0.001). |
| Subject Satisfaction | Approximately 70% of subjects reported they were either "Very likely" or "Likely" to have the laser treatment again at both the 12- and 52-week follow-up visits. |
| Treatment Discomfort | All treatment sessions were well tolerated with an average discomfort score of 5.23 ± 1.15. No treatment sessions ended prematurely due to excessive treatment discomfort. |
| Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) | No reports of SAEs and unanticipated adverse device effects of any severity (SUADEs/UADEs). No residual adverse events at the 52-week mark. |
| Common Adverse Events (at 12-weeks) | - Mild, transient erythema (all subjects) - Edema (98.1% of subjects); self-resolved within hours to days - Mild acne purging/flare-up (45.2% of subjects); typically resolving with no medical intervention - Mild dryness (18.3% of subjects); typically resolving with topical skin moisturizers |
| Lack of Specific Adverse Events | No reports of blistering, hyper- or hypopigmentation, or scarring adverse events in any subjects. |
2. Sample size used for the test set and the data provenance
- Sample Size: 104 subjects
- Data Provenance:
- Country of Origin: Not explicitly stated in this document but typically for FDA submissions, clinical trials are often conducted in the US or under ICH GCP guidelines.
- Retrospective or Prospective: Prospective, multi-center, clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts or their specific qualifications. For acne studies, the "Investigator's Global Assessment (IGA)" is typically determined by a qualified dermatologist or clinical investigator. The primary effectiveness measure ("≥50% fewer inflammatory acne lesions") would likely be a count performed by study personnel or automated systems, validated by clinical examination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth, such as multi-reader consensus.
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
Not applicable. This is a laser system for acne treatment, not an AI-assisted diagnostic device that would typically involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a direct treatment device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for effectiveness was based on:
- Clinical Assessment: Reduction in inflammatory acne lesions (counted), and Investigator's Global Assessment (IGA) scores.
- Patient Reported Outcomes: Subject Satisfaction data.
- Safety Data: Adverse event reporting and discomfort scores.
8. The sample size for the training set
Not applicable. This is a direct treatment device, not a machine learning algorithm that requires a "training set" in the computational sense. The "training set" for the device's development would be the pre-clinical research and engineering associated with its design.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from scientific understanding of laser-tissue interaction and acne pathophysiology.
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