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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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