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The Attain 6216A/6218A Product Family is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The modified Attain 6216A and 6218A Left Heart Delivery Systems contain one or two guide catheters, one guide catheter dilator, one guidewire, one valve and one slitter. They are designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.

The modified Attain 6216A and 6218A Left Heart Delivery Systems are available in two models:
Attain LDS 6216A Left Heart Delivery System
Attain Access 6218A Left Heart Delivery System
All components with the exception of the guide catheter (shape, length and quantity) and dilator (length) are identical in both models.

The modified Attain 6216A/6218A Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. They are also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.

The modified Attain 6216A and 6218A Guide Catheters are available in seven models as follows:
Attain 6216A-MB2 Guide Catheter for Left Heart Delivery
Attain 6216A-MP Guide Catheter for Left Heart Delivery
Attain 6218A-AM Guide Catheter for Left Heart Delivery
Attain 6218A-45S Guide Catheter for Left Heart Delivery
Attain 6218A-EH Guide Catheter for Left Heart Delivery
Attain 6218A-50S Guide Catheter for Left Heart Delivery
Attain 6218A-57S Guide Catheter for Left Heart Delivery
Each model is different with respect to guide catheter shape and length and the dilator length.

The provided text is a 510(k) summary for the Medtronic Attain LDS 6216A Left Heart Delivery System and Attain Access 6218A Left Heart Delivery System. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The "Summary of Studies" section explicitly states: "The modified Attain 6216A and 6218A Product Family met all specified design and performance requirements." However, the specific acceptance criteria and the details of the studies conducted to meet these requirements are not provided in this document.

Furthermore, the "Summary of Clinical Data" explicitly states: "No clinical investigation has been performed for this device." This confirms that there was no clinical study involving human patients to assess the device's performance in a clinical setting.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only generally states that "design and performance requirements" were met.
2. Sample size used for the test set and the data provenance: Not available, as specific studies for performance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external "ground truth" establishment is mentioned for performance studies.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical or AI-assisted study is described.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The studies mentioned are related to design and performance requirements (likely bench and lab testing) and biocompatibility (consistent with ISO10993-1:2003). The conclusion of the submission relies on the device's substantial equivalence to previously cleared predicate devices, meaning it shares similar technological characteristics, intended use, function, materials, and method of operation.

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