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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.

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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:

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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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.

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.

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The Viora V30 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, 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-tern 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-Nd: Y AG Handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5 .5 and 9.5 mm.

The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:
· Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas.
· Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis.
· Benign pigmented lesions such as, but not limited to: lentigos (sun spots), cafe-aulait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.
· Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles.

The Handpiece with a spot size of 9.5 mm is also intended for treatment of:
· Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• The Handpiece with a spot size of 9.5 mm is also is intended for removal of 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 of pseudofollicultis barbae (PFB).

The V-Form Handpiece (with BC Small, Medium and Large 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 and V10 systems with V-Form Handpiece (with BC Small, Medium and Large applicators) are 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 a 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. The system includes four Handpieces and footswitch. The V30 system is cooled by deionized water. The Viora V30 system is available with four treatment Handpieces:

• V-ST Handpiece Bi-polar radiofrequency (RF) Handpiece .
• V-IPL Handpiece Intense pulsed light (IPL) Handpiece ●
• V-ND:YAG Handpiece Long pulse neodymium-doped yttrium aluminum ● laser Handpiece
• V Form Handpiece with BC Small, BC Medium and BC Large applicators .

The V- Form BC Medium applicator is Bi-polar radiofrequency (RF) applicator.

The applicator is supported by Viora's V10, V20 and V30 systems.

The provided text is a 510(k) summary for the Viora V30 system, V-form Handpiece Bc Medium Applicator. It states that the device is substantially equivalent to previously cleared predicate devices and therefore does not rely on new clinical studies or acceptance criteria beyond those established for the predicates. The document primarily focuses on demonstrating substantial equivalence based on identical intended use, technological characteristics, and performance characteristics to previously cleared devices.

Therefore, many of the requested items (acceptance criteria, specific study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available from this document as it explicitly states that animal and clinical studies are not required.

However, I can extract the following information:

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

Since no new clinical or performance acceptance criteria are mentioned for the V30 system or V-Form Handpiece BC Medium applicator beyond adherence to general medical device standards and equivalence to predicates, the table would reflect this.

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

• Not Applicable. The document explicitly states: "Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V30 system with the V- Form Handpiece and of the V-Form Handpice BC Medium applicator" due to the technological parameters being well within those of previously cleared systems. Therefore, no new test set was used for this 510(k) submission.

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

• Not Applicable. No new test set requiring expert ground truth was created for this submission.

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

• Not Applicable. No new test set required 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:

• Not Applicable. This is a medical device for dermatological procedures (laser, IPL, RF), not an AI-assisted diagnostic tool involving human readers. No MRMC study was performed or is relevant to this submission.

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

• Not Applicable. This is a physical medical device (laser, IPL, RF system), not an algorithm or AI. Standalone algorithm performance is not relevant.

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

• Not Applicable. No new ground truth for a test set was established for this submission. The substantial equivalence relies on previously established safety and efficacy of predicate devices.

8. The sample size for the training set:

• Not Applicable. This submission is for a physical medical device and not an AI/ML algorithm. Therefore, there is no training set in the context of machine learning.

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

• Not Applicable. As per point 8, there is no training set mentioned in the context of this device.

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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 V10 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-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 V10 system is a RF multi application platform with two available treatment Handpieces:

• V-ST Handpiece Bi-polar radiofrequency (RF) 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.

This document describes the Viora V10 system, an RF multi-application platform intended for dermatological procedures. It leverages existing predicate devices (Viora V20 system K142093 and Viora Reaction™ system K090221) to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not describe a specific test set with a sample size for evaluating the V10 system through human subject data. Instead, it relies on predicate device data and bench testing.

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

Not applicable, as no dedicated human subject test set is described with ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no dedicated human subject test set is described.

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

No MRMC comparative effectiveness study is mentioned. This device is an RF multi-application platform, not an AI-assisted diagnostic tool typically assessed with MRMC studies.

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

This is not applicable as the device is not an algorithm performing a diagnostic function. The "standalone" performance here refers to the device's functional and safety performance through bench testing, which was done.

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

For the V10 system itself, the "ground truth" for demonstrating safety and effectiveness relies on:

• Compliance with recognized international standards (IEC 60601 series).
• Bench testing results comparing its performance to predicate devices.
• Demonstrated equivalence of technological characteristics and intended use to previously cleared predicate devices.

8. The sample size for the training set

Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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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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The V-Touch is intended for dermatological procedures.

The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator:

The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

The provided text is a 510(k) summary for the V-Touch device and a letter from the FDA determining its substantial equivalence. This type of regulatory document primarily focuses on demonstrating equivalence to a predicate device based on similar technology, intended use, and safety/performance standards, rather than presenting a detailed clinical study with acceptance criteria and results.

Therefore, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

However, I can extract the following information available in the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific quantifiable metrics for the V-Touch's dermatological procedures or the ST applicator's indications. Instead, it relies on substantial equivalence to a predicate device and compliance with general safety and performance standards.

The document states:

• "V-Touch successfully passed validation and verification testing, including testing for RF power accuracy."
• "Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."

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

This information is not provided in the document. The filing focuses on bench testing and substantial equivalence, not a clinical trial with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document, as no clinical test set with expert-established ground truth is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the document. The device described is a physical medical device (RF energy system), not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical medical device, not an algorithm.

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

This information is not provided in the document. For the bench testing, the "ground truth" would likely refer to engineering specifications and performance benchmarks, not clinical outcomes or expert consensus.

8. The sample size for the training set

This information is not provided in the document. The device is not an AI/machine learning model, so there is no "training set" in that sense.

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

This information is not provided in the document, as there is no training set mentioned in the context of AI/machine learning.

Summary regarding information gaps:

The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (V-Touch) based on shared technology, intended use, and compliance with general safety standards and bench testing. It explicitly states: "Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."

This type of submission typically does not include detailed clinical study designs with acceptance criteria, patient sample sizes, expert ground truth, or MRMC studies, especially if relying on the substantial equivalence of a previously cleared component (the ST applicator).

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The Viora V-total™ is intended for dermatological procedures.

The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

The 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, rosace, erytherna of rosacea, angiomas and spider 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 Nd: YAG Laser handpiece with wavelength 1064 mm comes with 4 different applicator spot diameters: 2x4, 3.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:
· Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiecasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosseea, venus lake, leg veins, poikiloderma of civatte and angiomas.
· Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis.
· Benign pigmented lesions such as, but not limited to: lentigos (sun spots), cale-aulait macules, sebortheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.
· Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
· The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles and perioral wrinkles.
· The handpiece with a spot size of 9.5 mm is also intended for treatment of: Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• The handpiece with a spot size of 9.5 mm is also is intended for removal of 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 of pseudofolioulitis barber (FFB).

The Viora V-total™ system is a multi application, multi-technology platform with four available treatment handpieces (applicators):

• . ST Bi-polar radiofrequency (RF) handpiece
• Intense pulsed light (IPL) handpiece .
• Long pulse neodymium-doped yttrium aluminum (Nd:YAG) laser handpiece .

The Viora V-total™ device is a multi-application, multi-technology platform for dermatological procedures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or a specific table with reported device performance metrics in the format usually seen for medical devices with measurable performance outcomes (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Instead, the submission for V-total™ relies on demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied to be that the V-total™ is as safe and effective as the predicate devices and complies with relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that no new animal or clinical studies were conducted for the Viora V-total™ device to determine its safety and efficacy. Therefore, there is no "test set" in the traditional sense for this submission. The basis for safety and efficacy relies entirely on the established performance of the predicate devices.

• Sample Size for Test Set: Not applicable (no new clinical studies performed).
• Data Provenance: Not applicable (reliance on existing data from predicate devices and scientific literature, not new data from this device).

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:

Since no new clinical studies were performed for the V-total™ device, there were no experts recruited specifically to establish ground truth for a test set related to this submission. The ground truth for the predicate devices' studies would have been established by medical professionals in those respective studies.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set was used for the V-total™ device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or referenced for this device. The device is a physical therapy/aesthetic device, not a diagnostic imaging device that would typically involve human readers interpreting results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a treatment system that requires operation by a human professional (practitioner) and does not involve an "algorithm only" performance that can be evaluated separately from human interaction in a diagnostic sense.

7. Type of Ground Truth Used:

The "ground truth" for the V-total™'s safety and efficacy claims is implicitly based on:

• Clinical Efficacy/Outcomes Data from Predicate Devices: The submission relies on the established clinical results, safety profiles, and indications for use of the predicate devices for their respective technologies (ST applicator, IPL, Nd:YAG laser). These predicate devices would have undergone their own studies where treatment outcomes (e.g., hair reduction, lesion clearance, muscle pain relief) served as the ground truth.
• Scientific Literature: The document mentions that the safety and efficacy of RF bipolar energy treatments are "well established in scientific research and literature."

Therefore, the ground truth is essentially derived from previously established clinical outcomes and scientific consensus through the predicate device pathway.

8. Sample Size for the Training Set:

Not applicable. The V-total™ is not an AI/machine learning model where a "training set" would be used to develop an algorithm. Its development relies on established engineering principles and the existing designs/technologies of identified predicate devices.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device in the context of an AI/ML model.

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The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators 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.

Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite

The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas.

The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST.

The Reaction™ console houses the following components:

• Power supply
• Hand piece
• Vacuum pump
• RF Generator
• Main CPU
• Display unit

The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage.

The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.

The provided text is a 510(k) summary for the Reaction™ System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than on detailed clinical study results and acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly stated in this document.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. The claim of "substantial equivalence" implies that the Reaction™ System's performance characteristics are comparable to those of the predicate devices for the stated indications.

2. Sample Size Used for the Test Set and Data Provenance:

No clinical test set or study data is described that would involve a "sample size" in the context of efficacy or performance evaluation for this 510(k) summary. The submission is based on comparison to predicate devices, not on a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
4. Adjudication Method:

Not applicable, as no new clinical study data requiring ground truth establishment or expert adjudication is described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. This 510(k) summary focuses on demonstrating equivalence to existing devices, not on comparing AI-assisted vs. non-AI-assisted human reader performance.

6. Standalone Performance:

Not applicable. The Reaction™ System is a physical device (combining RF technology with mechanical vacuum massage) and does not involve an "algorithm only" or "human-in-the-loop" AI performance as implied by this question. Its performance is inherent to its physical operation.

7. Type of Ground Truth Used:

Not applicable, as no new clinical study requiring ground truth is described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set:
9. How the Ground Truth for the Training Set Was Established:

Not applicable. The Reaction™ System is not an AI/machine learning device that would involve a training set.

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