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The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

VNUS® Closure® System

This 510(k) summary (K030557) is for the VNUS Closure System, an electrosurgical device for treating superficial vein reflux. The summary indicates that the device met acceptance criteria based on in-vitro testing and biocompatibility. However, it does not contain the detailed information necessary to fully answer all of the questions about a typical AI/ML device study. The provided document is from 2003, and the standards for reporting AI/ML device studies were not yet established.

Here's a breakdown of the available information based on the prompt's requirements:

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

2. Sample size 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 testing was "in-vitro," meaning in a laboratory setting, not on human subjects or clinical data in the way an AI/ML device would be tested.

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 applicable/provided. The testing was in-vitro, and there's no mention of expert-established ground truth in the context of clinical images or data analysis.

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

This information is not applicable/provided. As the testing was in-vitro, there's no indication of an adjudication process for a test set in a clinical context.

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/provided. This device is not an AI/ML diagnostic or assistive device that would involve human readers.

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

This information is not applicable/provided. This device is not an algorithm, but a physical medical device.

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

The "ground truth" for the device's performance appears to be established by the functional results of the in-vitro testing for safety and effectiveness, and biocompatibility testing for material safety. This isn't a "ground truth" in the sense of clinical annotations for a diagnostic algorithm.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable/provided. The device is not an AI/ML algorithm.

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The VNUS® Closure™ System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The VNUS Closure System consists of three main components: The VNUS Closure Catheter, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Catheter is provided sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.

The RF Generator is a high frequency (460kHz) electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power, Temperature and Time (setpoints and measured values) as well as measured Impedance and user messages. Audible tones provide additional feedback to the physician. The RF Generator acts to maintain the set temperature by requlating the power delivered up to the maximum set power. By doing so, the RF Generator controls the temperature at the tip of the catheter.

The Closure Catheter is used to provide RF energy to the desired treatment site and relay temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.

The Instrument Cable is used to connect the Closure Catheter to the RF Generator.

The provided text describes the VNUS® Closure™ System and its submission for 510(k) clearance, asserting substantial equivalence to predicate devices. However, it does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information about sample sizes, expert involvement, or adjudication methods for a clinical trial.

Instead, the document states:

• Discussion of Clinical/Non-Clinical Tests and Conclusions H. Clinical/Non-Clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications.
• Summary of Safety and Effectiveness i. Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness.

This indicates that while non-clinical tests were conducted to demonstrate substantial equivalence, the document does not provide the specific details of those tests. It does not present quantifiable acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or specific clinical outcomes), nor does it report detailed device performance against such criteria.

Therefore, I cannot populate the table or answer most of the specific questions regarding a clinical study from the provided text.

Based on the provided text, here's what can be extracted and what cannot:

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

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

• Sample Size for Test Set: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text.

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 mentioned in the provided text.

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

• Not mentioned in the provided text.

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 mentioned in the provided text. The document refers to "non-clinical testing" and not specifically to a clinical comparative effectiveness study involving human readers or AI.

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

• Not mentioned in the provided text. The device described is a medical instrument (electrosurgery system), not an AI algorithm.

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

• Not mentioned in the provided text, as specific clinical or non-clinical test details are absent.

8. The sample size for the training set

• Not applicable/Not mentioned. The device is a hardware system, not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable/Not mentioned.

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The VNUS Closure™ System is indicated for use in the coagulation of blood vessels during general surgery.

The VNUS Closure™ System consists of three main components: The VNUS Closure Probe, the VNUS RF Generator and the VNUS Instrument Cable. The Closure Probe is provided Sterile, and is a single-use, disposable device. The RF Generator is non-sterile. The Instrument Cable is autoclave sterilized by the user. An optional Footswitch for RF ON/RF OFF is provided for use at the physician's discretion.

The RF Generator is a high frequency electronic, bipolar, software controlled instrument. It allows the user to set Power, Temperature and Time values, and provides user displays of Power. Temperature and Time (setpoints and measured values) as well as measured impedance and other messages. The RF Generator works in a temperature controlled, power limited manner, based on operator settings and temperature feedback provided by a thermocouple in the Closure Probe.

The Closure Probe is used to carry RF energy to the desired treatment site and provide temperature feedback to the RF Generator. It is designed to deliver the RF energy in a bipolar manner.

The Instrument Cable is used to connect the Closure Probe to the RF Generator.

The provided document is a 510(k) premarket notification for the VNUS Closure System. It focuses on demonstrating substantial equivalence to predicate devices rather than conducting a detailed performance study with acceptance criteria and specific statistical hypothesis testing as might be found in a PMA (Premarket Approval) submission or a dedicated clinical trial report for an AI/ML device.

Therefore, much of the requested information regarding "acceptance criteria," "study proving device meets acceptance criteria," "sample sizes," "expert ground truth," "adjudication methods," "MRMC studies," "standalone performance," and "training set details" cannot be found within this document. These studies are typically performed for new or significantly modified devices, or for AI/ML devices where performance claims against a defined ground truth need to be established.

The document states:

• "Non-clinical tests performed by VNUS have demonstrated the substantially equivalent performance of the Closure System with predicate electrosurgery systems used for substantially equivalent indications."
• "Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-ciinical testing performed by VNUS, it is concluded that the Closure System is substantially equivalent to the noted predicate devices in safety and effectiveness."

This indicates that non-clinical testing (bench testing, perhaps animal studies) was conducted to demonstrate equivalence, but the specific details of "acceptance criteria" and how they were "proven" in a quantitative sense are not disclosed here. The basis for approval is substantial equivalence to existing devices, not a direct demonstration of meeting detailed performance metrics in human studies.

Given these limitations, here is what can be extracted and what cannot:

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

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

• Sample Size (Test Set): Not specified. The document refers to "non-clinical tests," which typically involve bench testing and possibly animal models, not human subject test sets with specific sample sizes as would be relevant for AI/ML performance.
• Data Provenance: Not specified. "Non-clinical tests performed by VNUS" suggests internal testing.

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)

• Number of Experts: Not applicable/not specified. This type of expert assessment for ground truth is typically relevant for medical imaging or diagnostic AI/ML devices, not for an electrosurgery system described in this 510(k). The "ground truth" for this device would likely be based on physical measurements and functional performance in a laboratory setting.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified, as there is no mention of expert ground truth establishment for a test set in the context of this device and submission type.

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

• MRMC Study: No, an MRMC study was not done, and is not applicable to an electrosurgical device as described here. This type of study is specifically designed for evaluating diagnostic devices, especially those involving human interpretation of medical images or data (e.g., AI in radiology).

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

• Standalone Performance: Not applicable. An electrosurgical system is inherently a device used with human intervention. The concept of "standalone performance" as typically applied to an AI algorithm without human input doesn't fit this device. The system has automated features (temperature control, power limiting), but these are integral to its operation in human hands.

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

• Type of Ground Truth: Not explicitly stated in terms of common medical imaging 'ground truth' types. For non-clinical tests of an electrosurgical device, ground truth would relate to physical parameters and outcomes of energy delivery (e.g., precise temperature readings, coagulation efficacy in tissue models, impedance measurements, safety parameters like absence of unintended tissue damage).

8. The sample size for the training set

• Sample Size (Training Set): Not applicable/not specified. This is not an AI/ML device in the modern sense that would require a "training set" for model development. The system's software controls are likely based on engineering principles and embedded logic, not statistical machine learning from data.

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

• Ground Truth (Training Set): Not applicable/not specified, as there is no mention of a training set for an AI/ML model.

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