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The VASOVIEW 6 PRO 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, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The VASOSHIELD Pressure Controlling Syringe is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.

The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System consists of the VASOVIEW 6 PRO Harvesting Cannula which is designed for use in conjunction with the 7mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring wire, endoscope washer tube and Bipolar BiSector for ligation and division of vessel branched. The system includes the following accessories- (1) The 7mm Extended Length Endoscope and Dissection Tip for blunt dissection of tissue and isolation of structures in the cavity. (2) Shortport Blunt Tip Trocar (BTT) to provide a port for insertion of endoscoic instruments into an incision site. (3) VASOSHIELD Pressure Controlling Syringe is a fully assembled 60 mL syringe with a pressure relief valve that is controlled by a pressure setting ring.

The Maquet Cardiovascular LLC VasoView 6 Pro Endoscopic Vessel Harvesting System is a medical device that received 510(k) clearance (K091733) on August 28, 2009. The submission indicates that the device's performance meets established acceptance criteria and is substantially equivalent to predicate devices. However, the provided document is a 510(k) summary and does not contain detailed information about specific acceptance criteria or a dedicated study report comparing the device's performance against these criteria.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states generally that: "The results of the verification testing demonstrate that the VASOVIEW 6 PRO Performance meet the established acceptance criteria and performs in a manner equivalent to the predicate device." And similarly for the VASOSHIELD Pressure Controlling Syringe: "The results of the verification testing for the VASOSHIELD Pressure Controlling Syringe also demonstrate that the syringe meets established acceptance criteria and performs in a manner equivalent to its predicate device."

However, specific acceptance criteria (e.g., in terms of precision, accuracy, failure rates, etc.) and quantified performance results are not provided in this 510(k) summary. The summary only makes a general statement of compliance.

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

• The 510(k) summary does not specify the sample size used for any test set.
• The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned. The verification testing generally implies that these tests were conducted by the manufacturer as part of their design control process.

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

• This information is not provided in the 510(k) summary. The context suggests general engineering and product performance testing rather than clinical studies requiring expert ground truth for image or diagnostic interpretation.

4. Adjudication method for the test set:

• This information is not provided in the 510(k) summary. Given the nature of the device (endoscopic vessel harvesting system) and the general statements about verification testing, it's unlikely that "adjudication" in the sense of expert review for diagnostic accuracy would be applicable to the primary performance testing 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:

• This information is not applicable and not provided. The VasoView 6 PRO is an endoscopic surgical device, not an AI or diagnostic imaging device that would typically undergo an MRMC study with human readers.

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

• This information is not applicable and not provided. The device is an endoscopic harvesting system used by surgeons, not a standalone algorithm.

7. The type of ground truth used:

• The document describes "verification testing," which typically involves engineering and functional performance testing against predefined specifications (e.g., device dimensions, material properties, sterilization efficacy, electrical safety, mechanical strength, fluid flow rates, coagulation effectiveness). The "ground truth" would be established by measuring these physical or functional parameters. No pathology, outcomes data, or expert consensus in a diagnostic sense is mentioned.

8. The sample size for the training set:

• This information is not applicable and not provided. The VasoView 6 PRO Endoscopic Vessel Harvesting System is a mechanical and electrical surgical device, not a machine learning or AI-driven system that would require a "training set."

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

• This information is not applicable and not provided as there is no mention of a training set for this type of device.

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