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The Viora V20 system is intended for dermatological procedures.

The V-ST 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 V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of: Moderate inflammatory acne vulgaris.

Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). Cutaneous lesions including warts, scars and striae.

Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations. Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The V-Form Handpiece (with BC and FC applicators) 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 a RF and IPL multi application platform with three available treatment Handpieces:

V-ST Handpiece - Bi polar radiofrequency (RF) Handpieces

V-IPL Handpiece - Intense Pulsed Light (IPL) Handpiece

V - Form Handpiece (with BC and FC applicators) - mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece.

The Main Unit (console) provides the operational and safety function of the system. The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

The provided text does not contain acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a 510(k) premarket notification for the Viora V20 System, a multi-application RF and IPL device for dermatological procedures. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting performance data from a new study against defined acceptance criteria.

Here's why the requested information cannot be extracted and what is described instead:

• Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report corresponding performance metrics for a new study. Instead, it argues for substantial equivalence by stating that the current device has "the same technological characteristics and the same performance characteristics" as its predicate devices, or that "no new safety or efficacy issues can be raised."
• Sample Size and Data Provenance: No new study data is presented, so there is no mention of sample size for a test set or data provenance.
• Number and Qualifications of Experts: No experts were used to establish ground truth because no new clinical study data is presented for performance evaluation.
• Adjudication Method: Not applicable, as no new study requiring ground truth establishment is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a 510(k) for a physical medical device, not an AI/ML diagnostic or assistive tool that would typically involve human-in-the-loop studies.
• Standalone Performance: Not applicable. The device is a physical system (RF and IPL handpieces) and not an algorithm/software with standalone performance metrics in the typical AI sense.
• Type of Ground Truth: Not applicable, as no new performance study data is presented.
• Sample Size for Training Set: Not applicable. This refers to an AI/ML training set, which is not relevant to this device's submission type.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does state regarding "proof" and "performance":

• Substantial Equivalence: The core argument is substantial equivalence to predicate devices (Viora V20 system K142093 and Viora V10 system K150035). The manufacturer asserts that the V20 system with the V-Form Handpiece is "exactly the same" or has "the same technological characteristics and the same performance characteristics" as the cleared predicate devices, thus raising "no new safety or efficacy issues."
• Bench Testing: "Bench testing demonstrated that the V20 system (with the V- Form Handpiece) is as safe and effective as the cleared predicate devices." However, specific numerical results or acceptance criteria for this bench testing are not provided in this summary.
• No Clinical Studies Required: "Since the technological parameters of the Viora V20 system with the V- Form Handpiece are well within the parameters of the previously cleared V20 and V10 systems, Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V20 system with the V- Form Handpiece." This explicitly states that no new clinical study (which would typically generate performance data against acceptance criteria) was conducted or deemed necessary for this submission.
• Compliance with Standards: The V20 system complies with several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-57), which demonstrate safety and essential performance through adherence to recognized international standards.

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The Viora V20 system is intended for dermatological procedures.

The V-ST 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 V-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:

• Moderate inflammatory acne vulgaris.
• Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
• Cutaneous lesions including warts, scars and striae.
• Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations.
• Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Viora V20 system is a RF and IPL multi application platform with two available treatment Handpieces:
V-ST Handpiece: Bi polar radiofrequency (RF) Handpieces
V-IPL Handpiece: Intense Pulsed Light (IPL) Handpiece
The Main Unit (console) provides the operational and safety function of the system.
The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

The provided text describes the Viora V20 System, a medical device, and its substantial equivalence to a predicate device (Viora V-total, K133837). However, the document does not contain the kind of detailed information typically found in a study demonstrating how a device meets specific acceptance criteria based on performance data.

Instead, this document is a 510(k) summary for the FDA, focusing on establishing substantial equivalence to a previously cleared device. It asserts that because the V20 system's technological parameters are "well within" the cleared Viora V-total system and the handpieces are "exactly the same," animal and clinical studies are not required to determine its safety and efficacy.

Therefore, many of the requested categories of information cannot be extracted from this document, as a standalone performance study with detailed acceptance criteria and results is not presented here.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document states that "animal and clinical studies are not required" to determine safety and efficacy due to technological equivalence. The mention of "performance testing" and "bench testing" does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. Since clinical studies or specific performance evaluations with a "test set" and "ground truth" (in the typical sense of expert review of patient data) were deemed unnecessary for this 510(k) submission, this information is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable / Not provided. See point 3.

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 device is an aesthetic and dermatological treatment system (IPL/RF), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical system with handpieces for treatment, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable / Not provided. The basis for clearance relies on substantial equivalence to a predicate device, which implies that the prior device's established safety and efficacy serve as the "ground truth" for the current device's performance claims. No new, specific ground truth creation for the V20 system itself is detailed.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe the development of a machine learning algorithm or an AI model that would require a training set.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. See point 8.

In summary: The provided text is a regulatory submission focused on substantial equivalence. It asserts that the V20 system is substantially equivalent to a previously cleared device (Viora V-total K133837) due to identical intended use, indications for use, and handpiece technology, along with compliance with performance standards and positive bench testing. It explicitly states that clinical studies were not required for this determination, which means the detailed performance study information requested is not present in this document.

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