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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices.

The provided text describes a medical device, the Medtronic Multi-Stage Venous Cannula, and summarizes performance and biological testing to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or a study proving the device meets specific performance targets in the format requested.

The document states: "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." While this confirms tests were done and criteria were met, the specific quantitative acceptance criteria and the results are not provided in the summary.

Therefore, for section 1 (Table of acceptance criteria and reported device performance), I can only list the types of tests performed, as the actual quantitative criteria and results are absent.

Here's the information based on the provided text, with limitations noted where data is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." However, the specific quantitative values for these acceptance criteria and the detailed results of the device's performance against them are not provided in this summary.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This type of information is generally relevant for AI/software-based medical devices or diagnostic tools. The Medtronic Multi-Stage Venous Cannula is a physical medical device. Therefore, no experts were used to establish ground truth in this context, as the "ground truth" would be the physical properties and performance of the device under testing conditions.

4. Adjudication method for the test set

• Not applicable, as this is a physical device subject to engineering and biological performance testing, not diagnostic performance evaluation involving human observers.

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

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• The "ground truth" in this context would be the objective measurements and standards defined for the physical and biological performance of the cannula. For example, a "kink/bend" test would have a defined failure threshold (ground truth for failure), and the device is tested against it. Similarly, biocompatibility is evaluated against established ISO standards.

8. The sample size for the training set

• Not applicable. This is a physical device undergoing performance testing, not a machine learning model requiring a training set.

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

• Not applicable. This is a physical device undergoing performance testing, not a machine learning model.

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