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THE MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.

The MedRF4000 consists of the following parts: The generator, The pedal, The output cable, The neutral electrode cable (optional), The needle holder. The following consumables can be used with the MedRF4000: The Ballet needles, The neutral electrode (optional).

The provided text is a 510(k) summary for the MED RF4000 device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (EVRF) based on technological characteristics and performance testing.

However, the document does not contain the level of detail requested for acceptance criteria, study design, or ground truth establishment that would be typical for an AI/ML device or a device requiring specific performance metrics for regulatory clearance. The MED RF4000 is an electrosurgical cutting and coagulation device, and its clearance seems to rely more on demonstrating functional equivalence to a predicate device and compliance with electrical safety standards, rather than clinical performance metrics in the way an AI diagnostic device would.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for "acceptance" in the sense of accuracy, sensitivity, specificity, etc., as one would expect for a diagnostic AI device. Instead, the "acceptance" seems to be based on demonstrating similar effect on tissue and compliance with electrical safety standards.
• Reported Device Performance:
  • Comparison of output signal of EVRF (predicate) and MedRF4000 (subject device) on pork tissue.
  • Result: "results indicate the EVRF (predicate device) and the MedRF4000 (subject device) with and without neutral electrode have equivalent effect."
  • The document implies that the acceptance criterion is "equivalent effect" to the predicate device, especially regarding the neutral electrode connection.

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

• Test Set Sample Size: Not explicitly stated. The "test set" appears to be pork tissue, not human patient data.
• Data Provenance: Pork tissue (laboratory setting). This is a pre-clinical, non-human study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely assessed by engineers or technicians given the nature of the test (output signal and tissue effect).
• Ground Truth Establishment: The "ground truth" seems to be the observed "effect" on pork tissue, which is compared to the predicate device's effect. It's not a diagnostic "truth" requiring expert consensus.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/specified. The comparison of tissue effects likely involved direct observation or measurement in a laboratory setting, not reviewer adjudication as for diagnostic imaging.

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, an MRMC study was not done. This device is not an AI-assisted diagnostic tool for human readers. It's an electrosurgical device for treatment.

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

• Not applicable in the context of typical AI/ML standalone performance. The device is a "standalone" electrosurgical generator in that it operates independently, but its performance isn't evaluated as an algorithm's diagnostic accuracy. The performance testing was on its physical output on tissue.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for the performance testing was the observed "effect" of the radiofrequency energy on pork tissue, aiming for equivalence with the predicate device. This is a technical, physical effect, not clinical pathology or outcomes directly.

8. The sample size for the training set

• Not applicable. This device does not use machine learning in a way that requires a "training set" for model development. Its software manages impulse duration, power, and delay, but this is fixed programming, not learned behavior.

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

• Not applicable, as there is no "training set" in the AI/ML sense.

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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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The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The VeinGogh instrument is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Users could wear a magnification aid to ensure adequate vision of the treatment area. The user could wear a face shield and gloves as indicated by office practices. The user inserts the needle point in a telangiectasia at a right angle to the vein after setting the instrument's control panel setting of time and pulse or using the instrument's Auto-Pulse functionality. Pulses are intended to be created every 2-3 mm along a vein. The user should clean the needle point frequently between vein insertions with a sterile compress.

The instrument's regulated, small, high frequency current is delivered to the vessel, in a process called "Ohmic Thermolysis," during which the electrical resistivity selectively thermocoagulates small blood vessels using microbursts of high-frequency electrical energy delivered into the vessel. This Microburst Technology™ of fixed amplitude energy within the vessel is converted to heat instantly, coagulating the blood and collapsing the vessel wall. The pulse train encompasses sharp, precise peaks to minimize the risk of damage and deliver consistent results.

The high frequency current is delivered into each vessel through the sterile needle as positioned and inserted by the medical professional. Trained medical professionals can deliver fast, immediate results, which are consistent and repeatable, with little or no discomfort to the patient.

Experienced medical professionals can treat vessels up to 0.3 mm throughout the body. Typically, only a single treatment is required. Multiple spider veins or telangiectasias are treated subepidermally along each veins length, typically every 2-3 mm.

The instrument has a foot switch that is used to cause the instrument to send one pulse with each pressing of the switch. The instrument also has a Ballet Needle holder and uses single use Ballet K3 and K2 stainless steel and gold needles, which are not intended for reuse. The instrument is designed to accommodate needle holders and needles which are equivalent to Ballet Needle Holders and Needles, specifically, those products having the same or similar labeling and listed by their manufacturer under the same regulation and product code.

The instrument has firmware that interacts with the Control Panel push buttons to provide the professional user with operational controls. The firmware cannot be edited or changed by the user.

No bandage or other treatment of the thermocoagulated area is required. Typical treatment times are under 20 minutes and the treatment area (40-50 cm) may receive 300 to 600 impulses during a treatment.

The instrument is not designed to treat feeder vessels or larger vessels deep beneath the skin's surface.

The instrument's dimensions, 16.1 in wide x 13 inches deep x 5.9 inches high and weight, 5.7 pound, allow the device to be used in small or large medical offices on any convenient flat surface. The instrument is intended to be moved in a safe and effective manner, such as movement from one room to another in a medical office or clinic environment.

The instrument is powered by a grounded 120 Volt power source from a wall or floor electrical receptacle. The electrical components are intended to be safe and effective and easily accessed by a qualified technician for any appropriate replacement or repair.

The VeinGogh instrument has a 4MHz frequency wave output, and a maximum voltage output of 205Vpp +/-10%.

Microburst Technology is a Trade Mark of Refine USA, LLC, Jacksonville Beach, FL

The provided text describes a 510(k) premarket notification for the VeinGogh™ instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to establish new safety and effectiveness. Therefore, the document does not present "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical efficacy testing.

Instead, the submission aims to show that the VeinGogh™ instrument is as safe and effective as its predicate device (Veinwave/TC3000) by demonstrating identical intended use and largely similar technological characteristics, and addressing any differences through non-clinical testing.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" for performance are primarily based on demonstrating equivalence to the predicate device's characteristics and meeting relevant safety standards. The performance is reported through a comparative table and non-clinical testing summaries.

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

The document explicitly states that no animal or clinical testing was deemed necessary because "both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions." Therefore, there is no "test set" in the sense of patient data.

The "testing" mentioned is non-clinical performance data testing and review, which includes:

• Bench testing of major electronic components.
• Verification testing of firmware modules.
• Validation testing of the finished instrument's intended use, requirements, and hazard mitigation.
• Electrical safety testing (conformance to IEC and EN standards).
• Plastic flammability testing (conformance to UL 94).

The data provenance is therefore from laboratory bench testing and technical conformance assessments. There is no mention of country of origin for such data, as it's typically internal product development and testing.

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

Given the absence of patient data or clinical studies, there's no "ground truth" derived from expert clinical assessment of patient outcomes in this submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-2-2, EN 60601-1-2, UL 94) and the design specifications of the device. The experts involved would be the engineers and technicians performing the tests and verifying compliance with these standards, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication is described.

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

No. The document states, "The submitter believes that both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions, which negates a requirement for the submission of animal or clinical testing." This indicates that efficacy was assumed based on equivalence to the predicate, and no human reader/clinician study was performed to assess comparative effectiveness or improvement with AI assistance (as no AI is described).

6. Standalone (Algorithm Only) Performance Study

Not applicable. The VeinGogh™ instrument is a physical electrosurgical device, not an algorithm, and the submission does not describe any AI component.

7. Type of Ground Truth Used

The "ground truth" for this submission are:

• Predicate Device Equivalence: The performance and safety profile of the legally marketed Veinwave/TC3000 device.
• Engineering and Safety Standards: Conformance to electrical safety standards (IEC 60601-2-2, EN 60601-1-2), EMC standards (EN 55011/CISPR 11), and flammability standards (UL 94).
• Device Design Specifications: The stated requirements and design specifications established during the device's development.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and no software "training set" is mentioned. The firmware is proprietary and developed by a contract supplier, with verification testing performed on its modules.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The Veinwave/TC3000 system consists of a power generator and a needle through which a controlled dose of radio frequency energy is delivered and is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The provided text is a 510(k) summary for the Veinwave/TC3000 device. While it details the device's technical characteristics and its substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The document states: "The information discussed above demonstrates that the Veinwave/TC3000 device is substantially equivalent to the predicate devices." This implies that the demonstration of substantial equivalence serves as the primary basis for market clearance, rather than a specific performance study with predefined acceptance criteria. Clinical studies with detailed methodology and results are not typically required for 510(k) submissions when substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, safety and performance testing to established standards).

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or details on MRMC and standalone studies, as this information is not present in the provided 510(k) summary.

In summary, the document does not provide the requested information regarding acceptance criteria and studies demonstrating their fulfillment.

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