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The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.

MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the coronary sinus in a retrograde manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature manual and auto inflating cuffs, and contain an aid in verification of cannula placement. The removable malleable stylet is used to provide stiffness and shape to the cannula body during insertion and features additional deflectability and rotation at the distal cannula tip to aid in placement into the coronary sinus. These cannulae have features that make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thorocotomy).

This document describes the 510(k) summary for the Medtronic MiRCSP (Minimally Invasive Retrograde Coronary Sinus Perfusion) Auto and Manual Inflate Cannula. This is a premarket notification for a medical device seeking substantial equivalence to already marketed devices, rather than a study proving performance against new acceptance criteria. Such 510(k) submissions typically rely on performance data demonstrating that the new device is as safe and effective as existing, legally marketed predicate devices, without requiring extensive new clinical trials.

Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, are not directly applicable or available within this 510(k) summary in the comprehensive format you requested. The submission focuses on demonstrating substantial equivalence through bench and animal testing, and comparison of technological characteristics to predicate devices.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, there isn't a table of new acceptance criteria established for this specific device. Instead, the performance characteristics were compared to existing cleared Medtronic RCSP models. The "acceptance criteria" are implicitly that the MiRCSP Cannulae perform equivalently to the predicate devices in the tested areas.

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

• Test Set: Not explicitly stated. The document mentions "Bench and animal testing" but does not provide specific numbers for these tests or the origins of data (e.g., country).
• Data Provenance: The tests were conducted internally by Medtronic ("Medtronic has demonstrated..."). The nature of the testing (bench and animal) suggests controlled laboratory environments.

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

• This information is not provided. Since clinical testing was "not required," there wouldn't have been a panel of clinical experts establishing ground truth in the traditional sense for this submission. Performance was likely evaluated against engineering specifications and comparisons to predicate device performance.

4. Adjudication Method for the Test Set:

• Not applicable/Not described. This typically relates to expert review of clinical data, which was not the primary basis of this 510(k) submission.

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 device is a physical medical instrument (cannula), not an AI-powered diagnostic or decision-support system. Therefore, MRMC studies and "human readers with/without AI assistance" are not relevant to this submission.

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

• Not applicable. This device does not involve algorithms in the sense of AI or image analysis.

7. The type of ground truth used:

• For the performance tests:
  • Flow Rate Versus Pressure Drop: Likely engineering specifications and comparison to predicate device performance data.
  • Visibility Under Ultrasound and Fluoroscopic Visualization Techniques: Visual assessment by trained personnel (possibly engineers or technicians) in a controlled environment, likely compared to known visibility characteristics of predicate devices.
  • Structural Integrity: Engineering tests (e.g., tensile strength, burst pressure) against predetermined specifications.
  • Biocompatibility Testing: Adherence to established ISO standards for medical device biocompatibility.
• The "ground truth" here is primarily based on engineering specifications, regulatory standards, and comparative performance data of predicate devices, rather than clinical outcomes or expert consensus on patient cases.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The device's design was likely informed by existing Medtronic RCSP models and engineering principles.

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

• Not applicable, as there is no training set for an algorithm. The "ground truth" for the design of the device is implicitly based on established surgical practices, the clinical needs for minimally invasive procedures, and the proven performance of predicate devices.

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