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510(k) Data Aggregation
(88 days)
AviClear Laser System
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.
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(88 days)
AviClear Laser System
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 |
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(148 days)
AviClear Laser System
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.
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