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The Quest Vessel Catheter is intended for use in cardiovascular surgical procedures to test the integrity of vein grafts prior to attachment to coronary arteries, and to facilitate antegrade cardioplegia administration directly down the vein graft following completion of the distal anastomosis.

Saphenous vein cannulae are used during cardiopulmonary bypass to test the integrity of vein grafts prior to attachment to the coronary arteries and to facilitate antegrade cardioplegia administration directly down the vein graft following completion of the distal anastomosis.

The harvested vein graft must be tested for leaks or weakened areas prior to attachment to the coronaries to assure a competent conduit. To accomplish this, a small vessel cannula with a tapered shaft is inserted into one end of the graft and secured with a suture. Barbs or bulbous tips on the shaft of the cannula prevent the tied vein from slipping off. The opposite end has a female luer fitting for attachment to a saline-filled syringe. The graft may then be inflated with the saline at low pressures to test for leaks.

The surgeon cuts the graft to a suitable length and proceeds with attachment of the distal anastomosis. When indicated, the surgeon may decide to perfuse cardioplegia through the cannula-graft to the heart using a vein graft perfusion set attached to the cardioplegia delivery line. This allows nourishment to reach those areas of the heart that may not have been well perfused previously due to the arterial occlusion. Furthermore, the surgeon may use the cannula to assess the quality of the distal anastomosis by visual examination under pressure.

Materials:
• Cannula body: Clear ABS
• Duckbill valve: Silicone

Dimensions:
• Length: 2.00"
• I.D.: .06"
• O.D. 2nd barb: .16"

Connections: Female luer with taper per ISO 594/1

This document describes the Quest Vessel Catheter, intended for cardiovascular surgical procedures to test vein graft integrity and facilitate antegrade cardioplegia administration. The filing is a 510(k) summary demonstrating substantial equivalence to a predicate device, the DLP Vessel Cannula (K791832).

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

The document does not explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it describes a comparative testing approach, aiming to demonstrate "substantially equivalent performance" to the predicate device. The performance sections primarily list the types of tests conducted:

2. Sample sizes used for the test set and the data provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of catheters tested for pressure drop, leaks, etc.). It only states that tests were conducted on "both the Quest device and the DLP device."

The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. Given that this is a 510(k) premarket notification for a medical device designed for cardiovascular surgery, the tests would be performed in a laboratory setting by the manufacturer (Quest Medical, Inc. based in Allen, TX, USA) to support the regulatory submission. Therefore, the data would be considered prospective for the purpose of the submission.

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

This section is not applicable to this type of device and study. The "ground truth" for performance testing of a physical medical device like a catheter typically involves objective measurements and scientific standards rather than expert clinical judgment or consensus on, for example, image interpretation. The performance tests described (pressure drop, leak testing, bond strength, etc.) rely on quantifiable physical properties and engineering principles, not an expert panel to establish a clinical ground truth.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessments, such as evaluating medical images, where there might be disagreement between reviewers. For physical performance tests of a medical device, the results are generally objective measurements that do not require clinical adjudication.

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 section is not applicable. An MRMC study is relevant to imaging diagnostics or other areas where algorithms assist human "readers" (e.g., radiologists interpreting images). The Quest Vessel Catheter is a physical medical device used in surgery, not a diagnostic tool where human 'readers' interact with AI.

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

This section is not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for evaluating the performance of this device is based on objective physical and engineering measurements against established standards and comparison to a legally marketed predicate device. This includes:

• Quantitative measurements: such as pressure drop, leak detection, bond strength, and cracking pressure, which can be objectively measured using laboratory equipment.
• Material standards: Conformance to ISO 10993 for biocompatibility.
• Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is demonstrating that the new device performs comparably to the predicate device across all relevant safety and effectiveness parameters.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This section is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

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