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The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is an endoscopic vessel harvesting system that relies upon bipolar radio frequency (RF) energy to cauterize and seal vessels that are to be harvested. The RF current is transmitted across two electrodes in order to effect the necessary cauterization/sealing of the tissue when the tissue is appropriately positioned between the two electrodes. The device also uses bipolar RF energy for cutting tissue. The system is designed to be used with an endoscope. Components include a Trocar, Dissector Rod, Harvester Rod, and Endoscope (reusable device packaged separately).

The provided text describes a 510(k) premarket notification for the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System, seeking to expand the list of compatible electrosurgical generators. The submission aims to demonstrate substantial equivalence to its predicate device (an earlier version of the same system) by showing that the device performs safely and effectively with the additional generators.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the studies were designed "to ensure that the proposed generators each satisfy appropriate device performance specifications, and to ensure that customer requirements are met." It also concludes that "There are no appreciable differences between the performance of the VirtuoSaph® Plus System when used with the new generators verses performance when used with the existing generators."

The performance evaluations mentioned are:

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

The document states that "performance studies with each of the four additional generators that can be used with the VirtuoSaph® Plus System" were conducted. These were "in-vitro performance evaluations."

• Sample Size: Not explicitly stated. The number of samples for each test (Vessel Burst, Spot Cautery, Sealing/Hemostasis) with each of the four new generators is not provided.
• Data Provenance: In-vitro (laboratory) studies. The country of origin is not specified but assumed to be where the manufacturer (Terumo Cardiovascular Systems Corporation) conducts its testing, likely in the US (Elkton, Maryland). The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the expanded compatibility.

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

This information is not applicable and not present in the document. The studies were in-vitro performance evaluations, not clinical studies involving human observers or ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not present in the document because the studies were in-vitro performance evaluations, not involving human adjudication of clinical outcomes or 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

This information is not applicable. The device is a surgical instrument (Endoscopic Vessel Harvesting System) and not an AI-powered diagnostic or assistive tool for human readers/clinicians that would typically undergo an MRMC study.

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

This information is not applicable. The device is a surgical instrument, not an algorithm. The "performance evaluations" mentioned are for the physical device's function when used with different power generators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro performance evaluations (Vessel Burst Testing, Spot Cautery Testing, Sealing/Hemostasis), the "ground truth" would be established by objective, measurable physical parameters. For example:

• Vessel Burst Testing: Measured pressure at which a vessel bursts after sealing, compared against a predefined threshold or performance of the predicate device.
• Spot Cautery Testing: Visual assessment or measurement of the cauterized tissue's characteristics (e.g., degree of coagulation, charring) against acceptance criteria.
• Sealing/Hemostasis: Measurement of leakage or blood flow post-sealing under specified pressure conditions, compared against a predefined threshold or performance of the predicate device.

The document implies that the comparison to the existing generators serves as the benchmark for "ground truth" performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no "training set" for this device.

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The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is a device used in minimally invasive surgery for vessel harvesting. It utilizes bipolar radio frequency (RF) energy for tissue cauterization and cutting. The device is designed to be used with an endoscope and provides CO2 insufflation. It includes a full-length dissector for tunnel dissection.

This is a 510(k) premarket notification for the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System, specifically seeking to expand its indications to include Radial Artery Harvesting. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Guidant VasoView 6 Endoscopic Vessel Harvesting System.

Therefore, the "acceptance criteria" discussed are not specific performance metrics with numerical targets for a standalone device, but rather the demonstration of substantial equivalence to an existing predicate device for the expanded indication. The "study" proving this is a series of performance assessments designed to show this equivalence.

Here's an breakdown of relevant information:

1. Table of Acceptance Criteria (Demonstrated Equivalence) and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be that the performance of the VirtuoSaph® Plus for radial artery harvesting is comparable to, and demonstrably safe and effective as, the predicate VasoView® 6 device in relevant aspects.

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

• Sample Size: Not explicitly stated in terms of number of cases/animals/cadavers. The document mentions "animal studies, cadaver studies and bench evaluations" for performance assessments. No specific numbers are provided for these studies.
• Data Provenance: Not specified regarding the country of origin. The studies are described as "performance assessments" conducted by Terumo Cardiovascular Systems. They are effectively prospective studies performed to demonstrate equivalence for this submission.

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/Not mentioned. The "ground truth" for these performance assessments would likely be objective measurements (e.g., burst pressure, sealing effectiveness, visual observation of dissection quality) rather than expert consensus on interpretive tasks. The studies were performed to evaluate physical device performance characteristics.

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

• Not applicable/Not mentioned. This type of adjudication is typically used for medical image interpretation or clinical outcomes where there's subjectivity and potential for disagreement among experts. The studies described are performance tests with objective endpoints.

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 an electrosurgical vessel harvesting system, not an AI diagnostic tool that assists human readers.

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

• Yes, the performance assessments were for the device itself. While the device is used by a human surgeon, the tests performed (e.g., burst pressure, cauterization effectiveness) are evaluations of the device's physical and functional capabilities, standing alone in its ability to perform its intended functions when operated correctly. These are not human-in-the-loop studies in the sense of AI-assisted decision-making.

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

• The ground truth for these performance assessments would have been objective measurements and observations from the animal, cadaver, and bench studies for parameters such as:
  • Successful Radial Artery Dissection and Harvesting (visual assessment, integrity of harvested vessel).
  • Effective Insufflation (measurement of pressure, visual assessment of tunnel creation).
  • Successful Cauterization/Sealing (e.g., lack of leakage, burst pressure tests where relevant).
  • Absence of significant tissue damage.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set. The "development" of the device would involve engineering, design, and internal verification testing, not data training in the modern AI sense.

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

• Not applicable, as there is no training set mentioned or implied for this type of device.

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The VirtuoSaph™ Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. lt is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafing.

The system consists of a disposable trocar, dissector, and harvester. The trocar is inserted into the leg incision and stays in place with the clip securely placed on the skin allowing fast conversion between procedural steps. The dissector or harvester rod accesses the saphenous vein by entering the trocar through the port. A reusable endoscope (which is not in the scope of this submission) enters the body through dissector or harvester, and has optical components that send an image from inside of the body to a video monitor for the clinician to view. Dissector rod dissects the saphenous vein and surrounding branches. Harvester cauterizes and cuts the branches of the saphenous vein allowing for the harvesting of it.

The provided text does not contain detailed acceptance criteria and a study proving the device meets them as typically presented for AI/ML devices. Instead, it is a 510(k) summary for a medical device (VirtuoSaph™ Plus Endoscopic Vessel Harvesting System) seeking substantial equivalence to predicate devices, not an AI/ML-based device requiring performance metrics like sensitivity, specificity, etc.

Therefore, most of the requested information regarding acceptance criteria, study design for AI, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the given document.

The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices based on design, materials, and intended use. Performance is likely assessed through bench testing and possibly animal or cadaver studies, but not in a way that generates the quantitative metrics requested for AI/ML performance.

Based on the provided text, the following can be inferred and explicitly stated:

• Device Name: VirtuoSaph™ Plus Endoscopic Vessel Harvesting System
• Purpose of Submission: Traditional 510(k) for substantial equivalence to predicate devices, not for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics (e.g., sensitivity, specificity) for an AI/ML device. The acceptance criteria for this type of device would generally revolve around demonstrating safety and effectiveness comparable to predicate devices. This would typically involve:
  • Functional performance: The device performs its intended functions (cutting tissue, controlling bleeding through coagulation, blunt dissection, vessel harvesting) as safely and effectively as predicates.
  • Biocompatibility: Materials are safe for human contact.
  • Sterility: The device can be sterilized and maintained sterile.
  • Mechanical Integrity: The components withstand forces during use.
  • Electrical Safety (for electrosurgical components): Meets relevant standards.
• Reported Device Performance: The document states: "The VirtuoSaph™ Plus Endoscopic Vessel Harvesting System is substantially equivalent to both predicate devices in terms of intended use, principles of operation, technology, design, materials, and performance. Any noted differences between the devices are minor and do not raise new issues of safety and effectiveness." This "performance" statement is high-level and does not provide specific quantitative metrics.

2. Sample Size for Test Set and Data Provenance:
* Not applicable/Not mentioned. The document describes a medical instrument, not an AI/ML system that uses a "test set" of data in the common sense. Performance testing would typically involve bench testing, perhaps animal models, or cadaver studies, but no details on sample sizes or data provenance for such studies are provided.

3. Number of Experts and Qualifications for Ground Truth:
* Not applicable/Not mentioned. "Ground truth" in the context of expert consensus on data is not relevant for this type of device submission.

4. Adjudication Method:
* Not applicable/Not mentioned.

5. MRMC Comparative Effectiveness Study:
* Not applicable/Not mentioned. This is not an AI-assisted device.

6. Standalone Performance Study:
* Not applicable/Not mentioned in the context of an AI algorithm. Device performance would be evaluated in a standalone manner (without human-in-the-loop "AI assistance") for its intended functions, but the specific studies and results are not detailed in this summary.

7. Type of Ground Truth Used:
* Not applicable/Not mentioned in the context of AI/ML. For this device, "ground truth" would relate to the successful and safe performance of its mechanical and electrical functions in a surgical setting, compared to established predicate devices. This would likely be assessed through engineering tests, pre-clinical evaluations, and clinical experience with similar devices, rather than labeled data.

8. Sample Size for Training Set:
* Not applicable/Not mentioned. This is not an AI/ML device requiring a training set.

9. How Ground Truth for Training Set Was Established:
* Not applicable/Not mentioned.

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