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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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The St. Jude Medical Slittable Direct™ Outer Guide Catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical devices, including implantable left heart leads and delivery tools, and support of fluids where minimizing blood loss is essential. In addition, the outer guide catheters can work with inner catheters as a system.

The outer catheter is an introducer that is used to cannulate the Coronary Sinus (CS). The CPS Direct SL outer catheter will have 7 different curves configurations. The catheters will be available in 47 and 54cm working lengths and are radiopaque. The inner diameter of the sheath shall be PTFE lined and to ensure additional lubricity the inside and outside surfaces of the sheath shall be coated with a lubricious coating. The sheath shall have a proximal split away hub which interfaces with the hemostasis valve. The catheter functions as an outer catheter and can work with an inner guide catheter as a system.

This document describes a 510(k) premarket notification for the "CPS Direct™ SL Outer Catheter," a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through extensive studies involving human subjects or AI algorithms. As such, many of the requested categories for AI-driven device studies are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted, acknowledging the limitations for a traditional medical device submission:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Device comparison testing" and "Verification... which included mechanical, functional and biocompatibility testing." However, it does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). These would typically be detailed in underlying test reports, not usually summarized in a 510(k) notification in this manner unless it's a clinical study. This is a medical device, not an AI or software device that processes data in the typical sense this question implies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the type of device and submission described. The "ground truth" for this catheter's performance is established through engineering and biological testing (mechanical, functional, biocompatibility) against established specifications and predicate device equivalence, not through expert review of data like in an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations where expert consensus on outcomes or interpretations is required, typically for diagnostic or prognostic devices. This submission involves technical device testing.

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

This question is not applicable. This is a physical medical device (catheter), not an AI system. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be performed or reported for this device.

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

This question is not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance, in the context of the described studies, would be based on:

• Engineering specifications and standards: For mechanical and functional testing.
• Established biocompatibility standards: For biocompatibility testing.
• Validated sterilization methods: For sterilization validation.
• Performance of predicate devices: As a benchmark for "substantial equivalence."

It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-driven devices.

8. The sample size for the training set

This question is not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.

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

This question is not applicable. As there is no training set, there is no ground truth, as defined for AI models, that needs to be established for it.

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