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The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Not Found

I am sorry, but the provided text from the FDA letter about the "ClosureFAST™ Intravascular Catheter" (K082890) does not contain the specific details required to answer your request regarding acceptance criteria and a study proving device performance.

The document is a 510(k) clearance letter, which primarily states that the device has been found substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, product code, and indications for use. However, it does not include information about:

• Acceptance criteria or reported device performance metrics.
• Details of any specific study (sample size, data provenance, ground truth, expert qualifications, adjudication methods).
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
• Training set details for any AI/algorithm (which isn't applicable here as this is a catheter, not an AI device).

Therefore, I cannot generate the requested table and study details based on the provided text.

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

Not Found

The provided text describes the 510(k) premarket notification for the VNUS® ClosureFAST™ Catheter. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Instead, the submission focuses on establishing substantial equivalence to a predicate device.

Here's an attempt to answer your questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:

Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide explicit numerical acceptance criteria (e.g., "The device must achieve X% vein closure rate" or "Temperature control must be within Y degrees"). The primary "acceptance" is based on substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. (The submission does not detail any specific clinical or in-vitro tests that would involve a "test set" in the context of algorithm evaluation).

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

• Not applicable/Not specified. This information is typically relevant for studies involving human interpretation or expert review, which is not described as part of the evidence provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. (Likely not relevant as no expert consensus or ground truth establishment based on human review is described).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable/Not specified. The device is a physical catheter, not an AI algorithm, so the concept of "standalone performance" for an algorithm doesn't apply here. The performance evaluation is implicitly around the device's physical and functional capabilities, as compared to a predicate device.

7. The Type of Ground Truth Used

• The "ground truth" for the device's functional performance is implicitly established by the performance of the predicate device (VNUS® ClosurePlus™ Catheter, K030557) and the underlying scientific understanding of RF energy's effect on blood vessels for coagulation. There's no mention of pathology, outcomes data, or expert consensus being specifically used as "ground truth" in new studies for this 510(k). The focus is on substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This concept applies to algorithms that learn from data, which is not the case for this device.

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

• Not applicable/Not specified, as there is no training set mentioned.

Summary of Device and Evidence Presented:

The VNUS® ClosureFAST™ Catheter's acceptance criteria and proof of effectiveness are primarily based on its substantial equivalence to an existing, legally marketed predicate device (VNUS® ClosurePlus™ Catheter, K030557). The 510(k) summary states:

• "The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlus™ Catheter (K030557)."
• "The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to an intravascular catheter that heats a blood vessel to a specific temperature to achieve the intended use."
• "Performance is substantially equivalent to the predicate device effective for its intended function."
• Biocompatibility of materials was confirmed.

Therefore, the "study" for acceptance is an argument for substantial equivalence, rather than a detailed presentation of new clinical trial data against novel, explicit acceptance criteria. The FDA agreed with this assessment, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."

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The VNUS RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including: Treatment of incompetent (i.e., refluxing) perforator and tributary veins.

The VNUS RFS family of devices is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where blood vessel and tissue coagulation is desired. These devices are compatible with separately cleared Radiofrequency (RF) Generator, and the Instrument Cable manufactured by VNUS Medical Technologies. The VNUS RFS family of devices are sterile disposable devices intended for a singleuse only. The device's function is to deliver bipolar RF energy to the desired treatment site and relay temperature and other feedback to the RF Generator. The disposable device is available in 2 bipolar configurations and multiple lengths for selection by the physician based on preference for method of vessel access, location and length of the vessel to be treated. This submission reflects a name change, minor modification of the indication statement (more specific inclusion of perforator and tributary veins), and minor design changes.

The provided text indicates that the VNUS® RFS and RFSFlex Devices were evaluated for substantial equivalence to predicate devices (VNUS® Closure® System and VNUS® Vessel and Tissue Coagulation System) rather than undergoing a de novo clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the given document.

Here's a breakdown of the information that is available based on the provided text, and where gaps exist:

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 applicable. The submission relies on "in-vitro testing" and comparison to the "well-established history" of predicate devices, rather than a clinical test set with a defined sample size for subjects.
• Data provenance: Not explicitly stated for specific test data. The submission refers to "in-vitro testing." The predicate device's history (over 100,000 procedures) is cited as evidence of efficacy, but this is a general statement about the technology, not specific data from the device under review.

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. There is no mention of an expert panel establishing ground truth for a clinical test set in the context of this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication is described.

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 a surgical instrument (bipolar electrosurgical system), not an AI diagnostic tool that would involve human readers or AI assistance.

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

• Not applicable. This device is a surgical instrument, not an algorithm. Its "standalone" performance would relate to its physical and energetic output, as confirmed by in-vitro testing.

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

• For the "in-vitro testing," the ground truth would likely be defined by engineering specifications, physical/chemical measurements, and potentially histological analysis of treated tissue in laboratory settings. The document does not specify the exact nature of this "ground truth."
• For the claim of "well-established history of safe an efficacious use" for RF ablation/coagulation, the ground truth would be historical clinical outcomes data, morbidity, and mortality statistics associated with the predicate technology over thousands of procedures.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. There is no training set for this type of device.

In summary, this document is a 510(k) submission for "substantial equivalence," not a report of a new clinical efficacy study. Therefore, the details requested about acceptance criteria, clinical test sets, expert ground truth, and AI performance are largely absent because they are not typically part of a substantial equivalence determination for this class of medical device. The safety and effectiveness are primarily supported by in-vitro testing and the established history of the predicate devices.

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The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.

The VNUS RF Generator, model RFG2 is a bipolar, high frequency electronic, microprocessor and software controlled instrument. It allows the user to set Power, Temperature and Time (Set-points and measured values) as well as measured impedance and user messages. It is provided non-sterile. The model RFG2 is compatible only with the disposable RF delivery devices (e.g., catheters) marketed by VNUS Medical Technologies under separate clearance(s). The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile and is user sterilizable by autoclave. It has been validated to eliminate multiple steam sterilization cycles. If the disposable device has an integrated cable, a separate instrument cable is not necessary.

The provided 510(k) notification for the VNUS Radiofrequency Generator, Model RFG2, does not include detailed acceptance criteria or a comprehensive study demonstrating direct quantitative performance against such criteria in the way a modern AI/device submission would. Instead, it relies on substantial equivalence to predicate devices and general performance claims based on in-vitro testing.

Here's a breakdown of the information that can and cannot be extracted from the provided document, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations from the document:

• The document does not provide specific, quantitative acceptance criteria for metrics like accuracy, sensitivity, specificity, or objective performance benchmarks.
• The "reported device performance" are general statements that the device is "safe and effective" and "substantially equivalent." There are no numerical results or performance statistics presented.
• The document mentions "in-vitro testing" but does not provide any details about the methodology, results, or how these results specifically demonstrate safety and effectiveness against explicit criteria.

Given the nature of this submission (a 510(k) from 2004 for an electrosurgical generator, focusing on substantial equivalence), much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and large-scale clinical trials in the context of diagnostic/AI performance is not applicable or present in this document.

Here's an assessment of the other requested information based on the document:

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

• Sample Size: Not applicable/not specified. The document refers to "in-vitro testing" but provides no details on sample size, types of samples, or specific tests conducted. This is not a study involving a "test set" of patient data in the way an AI algorithm would be evaluated.
• Data Provenance: Not applicable. The "testing" mentioned is in-vitro, meaning likely bench testing or laboratory experiments, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. This device is an electrosurgical generator, not a diagnostic imaging or AI device that requires expert-established ground truth for a test set. The validation would likely involve engineering and electrical performance testing.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a "test set" or adjudication in the context of expert review for this device.

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. This is not an AI device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.

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

• Not applicable. This device is an electrosurgical generator, not an algorithm. Its operation inherently involves a human operator.

7. The Type of Ground Truth Used

• Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). For an electrosurgical generator, "ground truth" for performance would be based on engineering specifications, electrical safety standards, and functional performance in in-vitro models (e.g., tissue impedance, temperature control, power output). The document states "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective."

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense.

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

• Not applicable. As this is not an AI device, there is no training set or ground truth establishment relevant to machine learning.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states: "Results of in-vitro testing will demonstrate that the VNUS Radiofrequency Generator is safe and effective for its intended use." It further concludes based on "the design, materials, functioning performed by VNUS" and "comparison with currently marketed devices" that the device is "substantially equivalent to predicate devices in safety and effectiveness."

Key points regarding the "study":

• The "study" is described as in-vitro testing. No details about the specific tests, methodologies, or results are provided in this summary.
• The primary mechanism for demonstrating compliance is substantial equivalence to previously cleared predicate devices (VNUS RF Generator models RF-110 and RF-220, cleared under K0033547). This means the device relies on demonstrating that it is as safe and effective as a legally marketed device, often by showing it has the same technological characteristics, intended use, and performs similarly in relevant (often non-clinical) tests.
• The document implies that the in-vitro testing would have assessed factors like the generator's ability to deliver bipolar RF energy, maintain set power/temperature, and operate safely, consistent with the technological characteristics and principle of operation of the predicate devices.

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The VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is intended for use in vessel and tissue coagulation.

The VNUS Vessel and Tissue Coagulation System is a bipolar, high frequency electrosurgical system designed for use in general surgical procedures where lood vessel and tissue coagulation is desired. It consist of three main components The VNUS Vessel and Tissue Coagulation Device (proprietary name; TBD), the Radiofrequency (RF) Generator, and the Instrument Cable.

The VNUS Vessel and Tissue Coagulation Device is sterile disposable device intended for a single-use only. The device's function is to deliver bipolar RF energy to the intenired treatment site and relay temperature and other feedback to the RF General The disposable device is available in three bipolar configurations for selection by the physician based on preference for method of vessel access.

The RF Generator is a high frequency electronic, bipolar, microprocessor / software controlled instrument. It allows the user to set Power, Temperature and Time viruals, and provides user displays of Power, Temperature and Time (set-noints and meanured values) as well as measured Impedance and user messages. The RF Generator remains out of the sterile field during use, and is provided non-sterile.

The instrument cable connects the disposable device to the RF generator. The Instrument Cable is provided non-sterile, and is user sterilizable by autoclave. It has been validated to multiple steam sterilization cycles. Both ends of the cable are identical to eliminate connection errors.

The provided document describes the "VNUS Vessel and Tissue Coagulation System" and details its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance.

Here's why and what information is missing:

• Acceptance Criteria & Reported Performance: The document states, "Results of in-vitro testing demonstrate that the VNUS Vessel and Tissue Coagulation System (proprietary name: TBD) is safe and effective for its intended function." However, it does not provide a table of specific quantitative acceptance criteria (e.g., coagulation time, tissue penetration depth, temperature thresholds) or the reported device performance metrics against those criteria.
• Sample Size and Data Provenance: This information is not provided. The document generally mentions "in-vitro testing" but gives no details about the sample sizes used, whether it was animal or human tissue, or the origin of any data.
• Number of Experts & Qualifications: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, and highly unlikely for this type of electrosurgical device. MRMC studies are typically for diagnostic imaging interpretation.
• Standalone Performance: While "in-vitro testing" implies standalone performance, no specific metrics or study details are provided.
• Type of Ground Truth: Not explicitly stated, although for in-vitro coagulation tests, the ground truth would likely be based on direct measurement of tissue coagulation effects.
• Training Set Sample Size & Ground Truth Establishment: This device is a hardware system, not an AI/ML algorithm. Therefore, there wouldn't typically be a "training set" in the sense of machine learning. The "training" would be related to device validation against engineering specifications and predicate device performance.

Conclusion:

The provided document is a 510(k) summary for a medical device that establishes substantial equivalence based on technological characteristics and general safety/effectiveness. It does not contain the detailed, quantitative performance study data or acceptance criteria typically found in reports for AI/ML devices or more complex clinical trials.

If this were a document about an AI device, the missing information would be critical for evaluating its performance. As it pertains to an electrosurgical device, the 510(k) focuses on demonstrating equivalence to existing, legally marketed devices.

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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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