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510(k) Data Aggregation
(103 days)
The AVAVA™ Skin Treatment System is indicated for use in the treatment of fine lines and wrinkles, the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
The AVAVA™ Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.
The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The AVAVA™ Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
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(61 days)
The AVAVA™ Skin Treatment System is indicated for use in the treatment of acne scars, and dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The AVAVA™ Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The AVAVA™ Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
The AVAVA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the AVAVA.
The AVAVA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The AVAVA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
The provided text is a 510(k) clearance letter and summary for the AVAVA™ Skin Treatment System, a laser device. It does not describe an AI/ML device or a study proving its performance against specific acceptance criteria for such a device.
The study described is a clinical study for the device's efficacy and safety in treating acne scars. It involves human subjects, photographs, and expert evaluators, but it is not an AI/ML performance study where an algorithm's output is being evaluated against ground truth.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the provided document does not contain this information.
To illustrate, if this were an AI/ML device performance study, the sections would be filled using information that is NOT present in the provided document:
Hypothetical Section (based on the prompt's requirements, NOT the provided text):
Hypothetical AI/ML Device Performance Study Description (Illustrative, NOT from provided text)
This section outlines what would be expected for an AI/ML device performance study, but the information is not available in the provided 510(k) summary for the AVAVA™ Skin Treatment System.
1. Acceptance Criteria Table and Reported Device Performance
| Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| F1-Score for Acne Scar Detection | >= 0.85 | 0.88 |
| Sensitivity for Severe Acne Scars | >= 0.90 | 0.92 |
| Specificity for Non-Acne Lesions | >= 0.80 | 0.85 |
| Area Under ROC Curve (AUC) | >= 0.87 | 0.89 |
| Inference Time per Image | <= 5 seconds | 2.5 seconds |
2. Sample Size and Data Provenance
- Test Set Sample Size: [Information not present in document]
- Data Provenance: [Information not present in document - e.g., "Retrospective, images collected from clinical sites across North America and Europe."]
3. Experts for Ground Truth Establishment and Qualifications
- Number of Experts: [Information not present in document - e.g., "3"]
- Qualifications: [Information not present in document - e.g., "Board-certified dermatologists with an average of 15 years of experience in skin imaging and acne scar assessment."]
4. Adjudication Method for Test Set
- Adjudication Method: [Information not present in document - e.g., "Consensus-based adjudication (2+1): If two experts agreed, that was the ground truth. If all three disagreed, a fourth senior expert made the final decision."]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? [Information not present in document - e.g., "Yes"]
- Effect Size of Human Reader Improvement with AI Assistance: [Information not present in document - e.g., "Human readers showed a 15% increase in diagnostic accuracy and a 20% reduction in reading time when assisted by the AI compared to unaided reading."]
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done? [Information not present in document - e.g., "Yes, as reported in the table above."]
7. Type of Ground Truth Used
- Ground Truth Type: [Information not present in document - e.g., "Expert consensus on image annotations combined with clinical outcomes data after follow-up, used for definitive scar identification and severity."]
8. Sample Size for Training Set
- Training Set Sample Size: [Information not present in document - e.g., "10,000 images"]
9. Ground Truth Establishment for Training Set
- Training Ground Truth Method: [Information not present in document - e.g., "Annotated by a team of 5 trained medical image annotators under the supervision of a dermatologist. A subset of these annotations was independently reviewed by a senior dermatologist for quality control."]
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