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The steerable catheter set is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.

The Attain Prevail™ 6228CTH80 Steerable Catheter Set contains one 80cm Steerable catheter, one guidewire, one Y-connector with valve, one extension set, 3-way stopcock, one guidewire clip and two guidewire torque tools.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Medtronic Attain Prevail™ 6228CTH80 Steerable Catheter Set:

This submission is for a medical device (catheter), not an AI/ML-driven diagnostic or image analysis system. Therefore, many of the typical acceptance criteria and study components related to ML models (like statistical performance metrics, ground truth experts, MRMC studies, or training/test sets) are not applicable in this context. The evaluation focuses on device integrity, biocompatibility, and sterility as compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not contain specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML device. Instead, acceptance is based on meeting design and performance requirements through various engineering and biological tests, demonstrating substantial equivalence to a predicate device.

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The "testing" referred to here is engineering and biological validation on device prototypes or manufactured units. The sample sizes for these specific tests (e.g., number of catheters tested for tensile strength, torque, steerability, etc.) are not detailed in this summary.
• Data Provenance: Not applicable. The "data" comes from physical testing of the device and its components, not from patient data or imaging.

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 concept of "ground truth experts" for establishing diagnostic accuracy in this type of device submission. The "ground truth" for device performance is defined by engineering specifications and international standards.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication Method: Not applicable. Adjudication methods are used to resolve disagreements among human readers or experts in diagnostic studies, which is not relevant for this device.

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

• MRMC Study: No. This is a medical catheter and not an AI/ML diagnostic or image analysis system. An MRMC study is not relevant.

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

• Standalone Study: No. This is a medical catheter and not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For a medical device like this catheter, the "ground truth" for performance is based on engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility), and established test methodologies to evaluate physical properties, functionality, sterility, and material safety. There is no diagnostic "ground truth" from patient data or pathology.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning and therefore has no "training set."

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not involve machine learning and therefore has no "training set" or associated ground truth.

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