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The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.

The provided document is a 510(k) summary for the EVRF System. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or effectiveness beyond establishing substantial equivalence to a predicate device.

The 510(k) submission process is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove clinical efficacy through a comprehensive clinical trial with specific performance metrics and acceptance criteria.

However, based on the provided text, here’s an extraction of relevant details and an explanation of why a full table of acceptance criteria and a study proving their fulfillment isn't present in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify "acceptance criteria" in the sense of predefined performance targets for clinical outcomes (e.g., success rates, complication rates, or specific measurements of improvement). Instead, it focuses on demonstrating substantial equivalence to the predicate device, the Veinwave TC3000. The comparison table highlights that the key technological characteristics are identical or highly similar, suggesting that if the predicate device performs acceptably, then the new device, being substantially equivalent, should also perform acceptably.

Important Note: The "Acceptance Criteria" and "Reported Device Performance" in the table above are largely implied by the substantial equivalence argument within a 510(k) summary. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, not necessarily meeting specific clinical efficacy metrics.

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

The document mentions "Comparison bench testing was performed" for the device. This testing focused on comparing output power and pulse settings between the EVRF System and the predicate device.

• Sample Size for Test Set: Not explicitly stated for the bench testing. It would typically involve multiple measurements to confirm consistency and accuracy of the device's output.
• Data Provenance: The bench testing was presumably conducted by F Care Systems NV or a contracted lab. The document does not specify country of origin for bench testing data beyond the sponsor's location (Belgium). This was retrospective testing performed on the device to support its 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. The 510(k) summary does not mention a clinical study that required expert-established ground truth for a test set. The comparison was primarily technical between the new device and a predicate.
• Qualifications of Experts: Not applicable for this type of submission.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

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

• MRMC Study: No, a MRMC comparative effectiveness study was not done or reported in this 510(k) submission. The submission relies on substantial equivalence regarding technological characteristics and indications for use.
• Effect Size with AI vs. without AI Assistance: Not applicable, as this device is an electrosurgical device and not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. Standalone Performance Study (Algorithm Only):

• Standalone Study: No, this is not an algorithm-only device. It is a physical electrosurgical system. The concept of "standalone performance" as typically applied to algorithms for diagnostics does not directly apply here. The "standalone" performance that was assessed was the device's ability to accurately control and deliver energy, which was evaluated via bench testing.

7. Type of Ground Truth Used:

For the bench testing, the "ground truth" was likely instrumentation standards and measurements of electrical output (power, frequency, pulse duration). The device's output measurements were compared to its specified settings and to the known characteristics of the predicate device. There was no "clinical" ground truth like pathology or outcomes data presented to support a standalone clinical efficacy claim. The ground truth for the overall submission is implicitly that the predicate device is safe and effective when used as labeled.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is an electrosurgical hardware system, not a machine learning algorithm that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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