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When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.

When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions:

• Relief of minor muscles aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel.

The Venus Legacy Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

The provided text describes the Venus Legacy Pro device, its intended uses, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement with AI assistance.

Instead, the performance data presented focuses on engineering and regulatory compliance, not clinical outcomes.

Here's an analysis based on the information available in the text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles by a certain percentage, pain relief score, cellulite reduction percentage). The "Performance Data" section primarily addresses engineering and regulatory compliance.

However, based on the bench tests mentioned, we can infer some performance targets for temperature control:

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

No information is provided regarding sample sizes for clinical test sets as the document focuses on technical performance and regulatory equivalence rather than clinical efficacy studies for this 510(k) submission. The "bench tests" mentioned are likely laboratory tests, not clinical studies with patients.

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. The document discusses device safety, performance verification, and substantial equivalence to predicates, not the establishment of ground truth for a clinical test set.

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

Not applicable. This information is relevant for clinical studies involving human assessment, which are not detailed in this document.

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 or interpretation tool for human readers. It is a physical medical device for treatment.

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

Not applicable. This device is not an algorithm for standalone performance assessment.

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

For the bench tests, the "ground truth" would be the device's design specifications for temperature output, electrical safety, and electromagnetic compatibility. For clinical efficacy (e.g., wrinkle reduction, pain relief), the document does not describe studies that would establish such ground truth for the Venus Legacy Pro device. It relies on the indications for use of its predicate devices.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of what the document focuses on:

The entire document pertains to a 510(k) premarket notification for the Venus Legacy Pro Device. This type of submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than performing de novo clinical efficacy trials to establish new acceptance criteria.

The "Performance Data" section discusses:

• Bench Testing: To ensure the device's outputs meet specifications (e.g., temperature ranges for applicators) and are comparable to predicate devices.
• Electrical Safety and Electromagnetic Compatibility: Compliance with international standards (IEC 60601 series).
• Software Testing: Verification and validation to confirm the software performs as intended.

The acceptance criteria are therefore implicitly tied to meeting these engineering and regulatory standards, and demonstrating that any differences from the predicate devices do not raise new safety or effectiveness concerns. The study described is a series of engineering and regulatory compliance tests, not a clinical trial with human subjects to prove clinical efficacy against specific, measurable outcomes that would typically be described with metrics like sensitivity, specificity, or reader improvement.

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