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510(k) Data Aggregation
V30 System, V20 System, V10 System, V-FR Handpiece
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V20 system is intended for dermatological procedures. The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V30 system is intended for dermatological procedures. The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The V-FR Handpiece is fractional Bi-polar radiofrequency (RF) Handpiece is supported by Viora's V10, V20 and V30 systems.
V30: Multi-application, multi-technology platform device intended for use in dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel.
V20: dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. Cooled by deionized water
V10: based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel.
The FDA 510(k) clearance letter and summary for the Viora V30, V20, V10 Systems and V-FR Handpiece (K201064) provides information about the device's substantial equivalence to predicate devices, but it does not include acceptance criteria or the specifics of a study proving the device meets those criteria in the typical sense of a clinical performance study with predefined endpoints and statistical analysis.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of technological characteristics with predicate devices.
- Non-clinical testing, including electrical safety, electromagnetic compatibility, performance bench tests, biocompatibility, and software verification/validation.
- An animal study to evaluate safety and effectiveness for the indicated use.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document in the traditional format. However, I can provide the available information:
1. Table of "Acceptance Criteria" (interpreted as performance standards and study findings) and Reported Device Performance:
| Category | Acceptance Criteria (from performance standards / study goals) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2012 | Device was determined to be in conformance with IEC 60601-1:2012. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2:2014 | Device was determined to be in conformance with IEC 60601-1-2:2014. |
| Non-Laser Light Source (V20, V30) | Conformance to IEC 60601-2-57:2011 | V20, V30 systems determined to be in conformance with IEC 60601-2-57:2011. |
| Surgical Laser (V20, V30) | Conformance to IEC 60601-2-22:2007 | V20, V30 systems determined to be in conformance with IEC 60601-2-22:2007. |
| Laser Product Safety (V20, V30) | Conformance to IEC 60825-1:2014 | V20, V30 systems determined to be in conformance with IEC 60825-1:2014. |
| General Performance | Performs per device specifications; safe and effective as cleared predicate devices (Bench testing goal) | Bench testing demonstrated that the V-FR Handpiece performs per its device specifications and is as safe and effective as the cleared predicate devices. All performance testing demonstrated it performs according to specifications and functions as intended. |
| Biocompatibility (V-FR tip) | Meet requirements of ISO 10993-1 for surface device contacting breached/compromised skin in limited duration (Cytotoxicity, Irritation, Sensitization tests) | Results showed that the V-FR tip materials meet the requirement of ISO 10993-1 for indicated contact type. |
| Software Functionality | Software verification and validation testing results found acceptable for release (Software goal) | Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release. |
| Animal Study (Safety/Effectiveness) | Evaluate safety and effectiveness for dermatological procedures requiring ablation and resurfacing of the skin; no device-related serious adverse events | Action of V-FR handpiece (coagulation and ablation of epidermis/superficial dermis) was confirmed. Histopathological evaluation indicated well-circumscribed coagulation necrosis limited to treated tissue, with intact skin in-between. Healing initiated from intact areas without adjacent tissue complications (inflammation, thrombosis). Clear, consistent, time-related progressive healing without adverse reactions. No device-related serious adverse events. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Animal Study): "female domestic pigs (Sus scrofa domestica)" were used, but the specific number (sample size) is not provided.
- Data Provenance: The animal study was "prospective" as described, but the country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document mentions "Histopathological evaluation of the tissue samples" but does not specify the number or qualifications of experts performing this evaluation in the animal study.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the animal study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned or conducted, as this device (V-FR Handpiece) is a fractional radiofrequency device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This is not applicable as the device is a physical medical device (RF handpiece) and not an AI algorithm. Its performance is evaluated through bench testing and animal studies.
7. Type of Ground Truth Used (Animal Study):
- Histopathology/Histopathological evaluation: This involved examining skin biopsies for depth/width of ablated tissue, coagulative necrosis, and signs of healing/complications.
- Macroscopic evaluation: Local reactions were evaluated grossly.
8. Sample Size for the Training Set:
- Not applicable/Not provided: This device does not involve an AI algorithm with a distinct "training set" in the context of machine learning. The "training" for the device, if one considers it, would be its design, engineering, and manufacturing based on existing medical device knowledge and standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable: As noted above, there is no AI training set in the context of this device. Ground truth for the device's design and functionality would stem from established medical physics, dermatology principles, and engineering standards.
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