Search Results

The deflectable catheter delivery system is indicated to provide a pathway though which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The Attain® 6227DEF Deflectable Catheter Delivery System contains 1 deflectable catheter, 1 deflectable catheter dilator, 1 universal slitter, 1 valve, 1 guidewire, 1 needle and 1 syringe. The Attain® 6227DEF Deflectable Catheter Delivery System is designed to access the coronary sinus and the chambers of the heart using the percutaneous needle and syringe to access the venous insertion site, the guidewire to access the vein the introducer valve to reduce blood loss during the implant procedure, the deflectable catheter to introduce a transvenous device, the deflectable catheter dilator to facilitate deflectable catheter passage and the guide catheter slitter to remove the deflectable catheter.

The provided document is a 510(k) summary for the Medtronic Attain® 6227DEF Deflectable Catheter Delivery System. It describes a medical device and its substantial equivalence to a predicate device, as well as testing performed to support this equivalence.

However, this document does not contain information about the acceptance criteria or a study that uses AI/algorithm performance metrics such as sensitivity, specificity, or AUC, nor does it involve human readers, ground truth consensus, or training sets typical of a study proving a device meets acceptance criteria in an AI context.

Instead, this is a regulatory submission for a physical medical catheter delivery system, and the "study" referred to is device integrity testing and biocompatibility testing. The "acceptance criteria" generally refer to the design and performance requirements for the physical device, not a classification or diagnostic performance of an AI algorithm.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/algorithm performance studies based on the provided text. The document describes a traditional medical device clearance process, not one involving an AI component.

Here's an explanation of what the document does describe in terms of "acceptance criteria" and "studies":

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

• Acceptance Criteria (Implied): The device is expected to meet "all specified design and performance requirements" for a catheter delivery system. These would typically include:
  • Mechanical integrity (e.g., tensile strength, resistance to kinking, pushability, torqueability, deflection capabilities).
  • Functional performance (e.g., ability to introduce diagnostic/therapeutic transvenous devices and balloon catheters/leads effectively).
  • Biocompatibility (meeting ISO 10993-1 standards for limited exposure to circulating blood).
  • Sterility (achieving sterility through a validated EtO sterilization process).
• Reported Device Performance:
  • "The Attain® 6227DEF Deflectable Catheter Delivery System met all specified design and performance requirements."
  • "The biocompatibility evaluation... verifies that the Attain® 6227DEF Deflectable Catheter Delivery System is biocompatible."
  • "The Attain® 6227DEF Deflectable Catheter Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process."

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not a data-driven AI test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This relates to expert review of data, not physical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 document is not about AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI sense. For the physical device, the "ground truth" is adherence to engineering specifications and biological safety standards.

8. The sample size for the training set: Not applicable. This is not an AI model.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a medical device's compliance with safety and performance standards for regulatory clearance, not an AI-powered system's performance metrics.

Ask a specific question about this device