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The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Smart RF Handpiece:
The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V.
The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles.

Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.

Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.

The VirtueRF device is a radio frequency output device using 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the human body with 3 applicators that attach to the connecting cable. The energy is applied to the human body using sterile disposable needle arrays consisting of 36 needles, 12 needles, o 1 needle. This product consists of main body, SmartRF Bipolar handpiece, DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, connector cable, grounding plate for ExactRF, cooling plate for the DeepRF, foot switch and power cord.

The provided text is a 510(k) summary for the Virtue RF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial to prove de novo effectiveness or meeting specific performance acceptance criteria for a novel device. As such, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria involving human or animal subjects, ground truth, or statistical measures of performance like AUC, sensitivity, or specificity.

Instead, the submission demonstrates substantial equivalence primarily through:

1. Bench testing: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and biological compatibility (ISO 10993-1).
2. Thermal effect tests: Performed on four types of tissues (liver, kidney, muscle, and skin) as guided by FDA for electrosurgical devices.
3. Direct comparison of technological characteristics: Side-by-side tables comparing the proposed device's various handpieces (Smart RF, Exact RF, Deep RF) with its own predicate device (Virtue RF K202415) and other reference devices (Primaeva Medical Miratone System K082391, Agnes K192728, and Agnes K160469, though K160469 is not explicitly listed as a reference device, it appears in a comparison table for Exact RF).

Therefore, I cannot provide the detailed acceptance criteria and study information requested in the prompt, as these elements are not part of this specific type of regulatory submission. The document concludes that "Substantial equivalence is supported by the performance testing and there are no new questions of safety or effectiveness."

To explicitly address your points:

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

• Acceptance Criteria for Bench Testing: Adherence to the listed IEC standards (e.g., meeting specific safety thresholds for electrical current, electromagnetic emissions, and biological compatibility). The "reported device performance" is that it passed these tests.
• Acceptance Criteria for Thermal Effect Tests: The criteria would be to demonstrate substantial equivalence to the predicate device in terms of thermal effects on tissues. The "reported device performance" is that the "Test shows that the VirtueRF is substantially equivalent to the predicate device."
• Acceptance Criteria for Technological Characteristics: The criteria are for the proposed device's features (Source of energy/Modality, Radiofrequency, Output energy type, Electrode type, Max Power, RF Duration, Number of Needles, Grounding Mechanism, Cooling Modality) to be "Same" or "Similar" to the predicate/reference devices, with justifications where there are differences (e.g., "Similar; same as reference device" or "Same as reference; similar to predicate device"). The "reported device performance" is detailed in the comparison tables provided in the document (pages 6-8).

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

• Not applicable for this type of submission. The "tests" here are bench tests on the device's hardware and thermal effects on tissues, not clinical trials on human subjects. The tissue tests would likely use an ex vivo or in vivo animal model, but details on sample size or provenance are not provided.

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):

• Not applicable. Ground truth from human experts is not used for this type of technical and bench testing-focused submission.

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

• Not applicable. No expert adjudication is involved.

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 not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

• Not applicable. This is not a software algorithm; it's an electrosurgical device.

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

• For the thermal effect tests, the "ground truth" would be objective measurements of tissue coagulation or heating, compared to measurements from the predicate device. For technical standards, the "ground truth" is adherence to the specified parameters in the IEC and ISO standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning device.

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

• Not applicable.

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