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This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.

The tubing consists of biocompatible polyvinyl chloride tubing in various lengths. This tubing will be used in the extracorporeal circuit during cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment. The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices. Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).

The provided text describes a 510(k) submission for "Tubing and Connectors with Trillium™ Biopassive Surface." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria in the way a new drug or novel medical device might.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not applicable or available within this document, as the submission relies on demonstrating comparable technological characteristics and safety/effectiveness data through bench testing, not clinical performance studies with defined endpoints against acceptance criteria.

However, I can extract the relevant information regarding the types of testing performed to demonstrate that the device does not raise new safety or effectiveness questions compared to its predicate:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a 510(k) for a modified device (coating) and relies on substantial equivalence to a predicate, there aren't explicit, quantified "acceptance criteria" in the traditional sense that would be seen in a clinical trial. Instead, the "performance data" demonstrates that the new device's characteristics do not significantly affect safety and effectiveness when compared to the predicate. The "reported device performance" is essentially that the device performed comparably to the predicate in these tests.

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

• Sample Size: Not specified in the document. The testing described is bench testing (in vitro), not human or animal studies with a "test set" in the clinical trial sense.
• Data Provenance: The data provenance is from in vitro bench testing. The country of origin of this data is not specified, but it would have been generated by Medtronic Perfusion Systems or a contracted lab. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to evaluate the modified device.

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

• Not Applicable: This type of testing (bench testing for material properties and performance) does not typically involve human experts establishing "ground truth" in the way a clinical image analysis study would. The "ground truth" is established by the standardized methods for measuring coating leaching, pressure integrity, etc., and comparison against the predicate device.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical data interpretation. Bench tests rely on objective measurements and established protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: No MRMC study was performed. This device is tubing and connectors for cardiopulmonary bypass, not an imaging or diagnostic device that would involve human readers.

6. Standalone Performance (Algorithm Only):

• Not Applicable: This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

• For the bench testing, the "ground truth" is based on objective measurements of physical and chemical properties (e.g., coating leaching, pressure decay, pull strength) as defined by established test methods and comparison to the performance characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are evaluated through standard engineering and biocompatibility testing.

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

• Not Applicable: As there is no training set.

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