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The Medtronic Attain Select™ II model 6248DEL delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left heart venous anatomy. The delivery catheter system is indicated for use with outer catheters.

The Attain Select™ II 6248DEL Delivery Catheter System contains a delivery catheter and an inner catheter. The Delivery Catheter System is used in conjunction with a commercially available Medtronic Attain outer guide catheter. The outer guide catheter is used to gain coronary sinus access. Together, all three catheters function as a telescoping system that can provide additional sub-selecting capabilities. The 6248DEL Delivery Catheter System is available in two models each containing a straight inner catheter and a delivery catheter with either a 90° or 130° curved tip. The inner catheter in both kits is identical

This document is a 510(k) summary for the Medtronic Attain Select™ II 6248DEL Delivery Catheter System. It describes the device, its intended use, and substantial equivalence to predicate devices. It also briefly mentions testing performed.

However, the provided text does not contain detailed information about specific acceptance criteria or the results of a study that quantifies compliance with those criteria for an AI/ML device.

The document states:

• "Device integrity testing was performed to support the equivalency of the Attain Select™ II 6248DEL Delivery Catheter System to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The Attain Select™ II 6248DEL Delivery Catheter System met all specified design and performance requirements."

This is a general statement that the device met its design and performance requirements, but it does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria in a quantitative manner.
3. Details on sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any study results directly applicable to acceptance criteria.
4. Any mention of AI, machine learning, or algorithms, let alone standalone performance or MRMC studies.

Therefore, I cannot provide the requested information from the given text because it is a submission for a delivery catheter system, not an AI/ML diagnostic device, and it does not detail specific acceptance criteria or performance study results in the manner you've requested. The document focuses on demonstrating substantial equivalence to predicate physical medical devices rather than the performance metrics of an algorithm.

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