Search Results
Found 1 results
510(k) Data Aggregation
V30 system, V20 system, V10 system, V-FC Handpiece
The Viora V10 system is intended for dermatological procedures. The V10 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V20 system is intended for dermatological procedures. The V20 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V30 system is intended for dermatological procedures. The V30 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The V-FC Handpiece is supported by Viora's V10, V20 and V30 systems. The V10, V20 and V30 systems are multi-application, multi-technology platform devices 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. Cooled by deionized water 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 document does not contain information about specific acceptance criteria related to a diagnostic or AI-based device's performance metrics (e.g., sensitivity, specificity, AUC) or a study proving that such criteria were met.
Instead, this document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence for the Viora V30, V20, V10 systems with the V-FC Handpiece to previously cleared predicate devices. The "performance criteria" and "study" described are focused on proving that the new handpiece and system configurations are as safe and effective as the existing predicate devices for their indicated uses.
Therefore, I cannot populate the requested table or answer most of the questions as they pertain to a type of study and acceptance criteria not present in this regulatory document.
However, I can extract information related to the device's technical performance and safety testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present acceptance criteria in terms of diagnostic performance metrics. The "performance" discussed is primarily related to safety and maintaining therapeutic temperature.
| Acceptance Criteria (Internal/Safety-focused) | Reported Device Performance |
|---|---|
| Maintain superficial skin therapeutic temperature between 39-42 °C during 14 minutes of treatment. | "The V-FC handpiece can be easily operated to ensure therapeutic body temperature between 39-42 ℃, while treating in operating room temperature between 10° C to 30° C..." |
| System stops RF energy delivery if the handpiece IR sensor detects body temperature above 47°C. | "In cases of temperature decreasing below 39C or increasing above 42C the practitioner investigator was able to react immediately to increase /decrease the RF power. In addition to increase the safety profile, the system software is designed in such way that once the handpiece IR sensor detects body temperature above 47C. the system stops delivery of RF energy." |
| Compliance with Electrical Safety and Electromagnetic Compatibility (e.g., IEC 60601-1, IEC 60601-1-2). | "The V-FC Handpiece compatible with V30, V20, V10 Systems was determined to be in conformance with applicable IEC standards..." |
| Biocompatibility of skin-contacting components (tip, electrodes) meeting ISO 10993-1 requirements. | "Thus, all components that come into contact with the skin (tip, electrodes) are biocompatible and meet the requirement of the ISO 10993-1." "Additional biological evaluation for the V-FC Handpiece is considered to have meet the requirements for a surface device with limited to transient contact and can be considered safe and suitable for its intended use." |
| Software verification and validation demonstrating acceptable results for release and performance to specifications. | "Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release. All performance testing demonstrated that the Viora V10, V20, V30 system with V-FC Handpiece performs according to specifications and functions as intended." |
| As safe and effective as predicate devices. | "In conclusion, the V-FC Handpiece compatible with V30, V20, V10 Systems is substantially equivalent to its predicate device." "The differences do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
The document mentions "Dedicated tests were performed during three days" to assess temperature maintenance. It refers to "participants" but does not specify the number of human participants for this test. It also mentions "previous ex-vivo tests on the chicken breast" for the 47°C safety cutoff.
- Sample Size (human): Not specified, only refers to "participants."
- Sample Size (ex-vivo): Not specified (e.g., number of chicken breasts).
- Data provenance: The testing was done internally as part of the safety and performance verification for the 510(k) submission. No specific country of origin is mentioned for these particular tests, but the submitter Viora Ltd. is based in Netanya, Israel. It's a prospective internal test for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes safety and performance bench tests and not a clinical diagnostic performance study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a diagnostic study with a test set requiring adjudication.
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
This information is not applicable. This is a device for dermatological procedures involving RF and massage, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document describes safety and performance bench tests where "ground truth" was based on:
- Measured temperature: Using an integrated IR thermometer and LED indications.
- System response: Observing if the system stopped RF energy delivery when a certain temperature threshold was reached (tested on chicken breast).
- Compliance with defined standards: Such as IEC and ISO for electrical safety, EMC, and biocompatibility.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable.
Ask a specific question about this device
Page 1 of 1