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These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The Select 3D™ Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). The new sizes are 18 and 20 Fr. The Cannulae are available uncoated or with a Carmeda® Coating.

The provided text is a 510(k) summary for the Medtronic Select 3D™ Arterial Cannula. It describes a medical device, its intended use, and a comparison to predicate devices, along with a summary of performance data.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size for the "in vitro dimensional and functional testing," "accelerated aged dimensional and functional testing," "flow and hemolysis characterization," or the "Carmeda® Coating ability" tests. It only states that these tests were performed and "All testing passed."
• Data Provenance: The studies were in vitro (laboratory-based) tests. The country of origin for the data is not explicitly stated but implies the studies were conducted by Medtronic Perfusion Systems in the USA, as they are the submitter located in Minnesota. The studies were prospective as they were conducted to validate the new device sizes.

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

This type of information is not applicable to this submission. The "ground truth" for this device validation is based on engineering specifications, material properties, and performance standards for in vitro testing, not expert interpretation of medical images or clinical outcomes. The tests evaluate physical and functional characteristics against predetermined engineering benchmarks.

4. Adjudication Method for the Test Set

This is not applicable as the validation did not involve subjective interpretation or a need for reconciliation of expert opinions. The tests were objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The submission is for a medical device (cannula) and focuses on its physical and functional performance, not on diagnostic accuracy requiring human reader judgment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical cannula, not an algorithm or AI system. The validation focuses on the device's intrinsic physical properties and performance in an in vitro setting.

7. The Type of Ground Truth Used

The "ground truth" for this device validation involved engineering specifications, material specifications, and established performance benchmarks for flow characteristics, hemolysis, dimensional accuracy, and durability (accelerated aging). It is based on objective, measurable physical and functional properties, rather than pathology, outcomes data, or expert consensus in a medical diagnostic context.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI or machine learning model that requires a training set. The "training" in this context refers to the manufacturing and design processes, which are guided by established engineering principles and prior device knowledge, rather than a data-driven training set.

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

This question is not applicable for the same reasons as point 8. The "ground truth" is inherent in the established engineering and design principles, and the performance of the predicate devices. The new cannulae were developed based on the known successful design and performance of the predicate devices, simply differing in diameter.

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These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The Select 3D™ and Select CAP™ Arterial Cannulae both have clear flexible, thin w.ill wire-wound PVC bodies with angled, beveled tips. The proximal end of each cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line.

The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicate direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). It is available in 22 and 24 Fr sizes.

The Select CAP™ Arterial Cannula tips have an integrated pressure monitoring port. The pressure monitoring port on the tip of the cannulae provides the real time capability of accurately measuring central arterial pressure within the aorta. Overall cannula length is 12" (30.5 cm). It is available in 18, 20, 22, and 24 Fr. sizes.

The devices may include a Carmeda® BioActive Surface.

This submission describes device modifications, specifically adding a Carmeda® BioActive Surface coating to existing Select 3D™ and Select CAP™ Arterial Cannulae. Therefore, the "study" is focused on demonstrating that the coated devices maintain the performance characteristics of the uncoated predicate devices and that the coating itself is safe and effective.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document does not explicitly present a table of quantitative acceptance criteria (e.g., minimum flow rates, burst pressures, specific leach limits) that were met. Instead, it refers to "functional testing," "coverage, bioactivity, and leach testing" as having been performed and the results supporting substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The description mentions "in vitro visual and functional testing" and "coverage, bioactivity, and leach testing" performed on "Carmeda® coated devices," implying a sample of such devices, but the exact number is not provided.
• Data Provenance: The testing was "in vitro," meaning laboratory-based testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.

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

This is not applicable as the study did not involve human subjects or expert assessment for ground truth establishment. The testing described is entirely in vitro (laboratory-based chemical and physical performance testing).

4. Adjudication Method for the Test Set:

This is not applicable as the study did not involve human subjects, diagnostic assessments, or a need for adjudication among experts.

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 is not applicable. This submission is for a medical device (arterial cannulae), not an AI/imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

This is not applicable as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

• In vitro measurements and observations: This includes visual inspections, functional tests (e.g., flow characteristics, mechanical integrity), and chemical analyses (e.g., coverage, bioactivity, leach testing) conducted in a laboratory setting.
• Comparison to predicate devices: The "ground truth" for performance is effectively defined by the established performance characteristics of the prior, uncoated, predicate devices, which the new coated devices must match or exceed.

8. The Sample Size for the Training Set:

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set."

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

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set" or ground truth establishment for it.

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