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The Chase Blood Vessel Shunt is intended to be used to internally shunt blood vessels during anastomosis. The shunt bulbs allow a dry field to be maintained during a vessel anastomosis procedure. The shunt also allows blood to be delivered distally past the anastomosis during vessel repair. The blood vessel shunt is easily removed prior to the final sutures being tied. Select the blood vessel shunt which is appropriate for the internal diameter of the blood vessel.

The Chase Blood Vessel Shunt is a stcrile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. A tab on a tether is attached to the mid-point of the flexible shaft forming a "T" configuration. The shunt is radiopaque.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Chase Blood Vessel Shunt:

Based on the provided documents, the Chase Blood Vessel Shunt was cleared via a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with predefined acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, and ground truth establishment in a traditional clinical study context is not explicitly available or described in these documents.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The "study" described is a declaration of substantial equivalence, material testing, and functional comparison to a predicate, not a clinical trial with a defined test set of patients or cases.
• Data Provenance: Not applicable in the context of a clinical test set. The data presented relates to engineering tests (biocompatibility, sterilization, packaging, shipping) and a qualitative comparison to a predicate device. Data provenance for these tests would typically be from in-house labs or certified testing facilities.

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

• Number of Experts: Not applicable. There is no mention of a clinical test set requiring expert-established ground truth. The "ground truth" for functional equivalence was based on direct comparison to the predicate device and established engineering standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence and non-clinical performance data.

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

• Standalone Performance Study: Not applicable. This device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context is not relevant. The closest equivalent is the "functional testing" which states all characteristics are "non-differentiable" from the predicate.

7. The Type of Ground Truth Used

• Ground Truth Type: For this 510(k) submission, the "ground truth" is established through:
  • Predicate Device Equivalence: The existence and performance of the legally marketed Research Medical Inc. Intravascular Shunt.
  • Industry Standards: ISO standards for biocompatibility and ASTM standards for package integrity.
  • Validated Methods: Ethylene Oxide sterilization validation and national shipping test protocols.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/algorithm device that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable.

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