Search Results

The Viora V10 system is intended for dermatological procedures.

The V10 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The Viora V20 system is intended for dermatological procedures.

The V20 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The Viora V30 system is intended for dermatological procedures.

The V30 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

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. 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 V-VR Handpiece is supported by Viora's V10, V20 and V30 systems.

The provided text describes a 510(k) premarket notification for the Viora V-VR Handpiece compatible with V30, V20, V10 Systems. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new clinical claim.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating a new clinical claim or an AI/ML device, are not present in this regulatory submission. This submission is for a modified accessory (handpiece) with similar intended use to an already cleared device, primarily relying on bench testing and software validation to show equivalence and safety, not on a new clinical study.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance standards for safety and electrical characteristics rather than clinical efficacy metrics. The primary "acceptance criterion" demonstrated through bench testing is the capability of the V-VR Handpiece to safely maintain superficial skin therapeutic temperature between 40-45 ℃ during 14 minutes of treatment.

2. Sample size used for the test set and the data provenance:
The document does not mention a clinical test set or patient data. The validation relies on bench testing for performance, electrical safety, EMC, and software. There is no mention of country of origin or whether data was retrospective or prospective, as it's not a data-driven clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth for a diagnostic or AI claim was conducted. The "ground truth" for the engineering and safety tests is based on established industry standards (IEC, ISO) and internal device specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was conducted.

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 not an AI/ML device for diagnostic or interpretive purposes, nor a device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (handpiece) that performs a physical therapeutic action, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this regulatory submission is adherence to safety and performance standards (IEC, ISO), as measured by technical bench tests and software validation. For the clinical claims (temporary relief of minor muscle aches and pain, etc.), the device relies on substantial equivalence to the predicate devices which had already established these indications.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary of the Study:

The "study" described in this 510(k) summary is primarily a series of non-clinical bench tests and engineering analyses to demonstrate that the new V-VR Handpiece, when used with existing Viora systems (V10, V20, V30), is as safe and effective as the predicate V-ST Handpiece, and meets applicable safety standards. The core argument for acceptance is substantial equivalence to already cleared devices, rather than a de novo clinical demonstration of efficacy.

The key tests performed were:

• V-VR IR temperature assessment: To verify its capability to safely maintain superficial skin therapeutic temperature (40-45 ℃ for 14 minutes).
• Electrical Safety & EMC Testing: Conformance to IEC standards (60601-1, 60601-1-2, 60601-2-57, 60601-2-22, 60825-1).
• Biocompatibility Testing: Conformance to ISO 10993-1.
• Software Verification and Validation: To ensure the software supporting the handpiece functions correctly and as intended.

The acceptance criteria are therefore implicit in meeting these standards and demonstrating performance per device specifications, without needing a separate clinical study with patient samples or expert adjudication for this specific submission.

Ask a specific question about this device