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The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.

The Applied Medical Dual Lumen Graft Cleaning Catheter is a single-use catheter intended for removal of thromboemboli from vascular grafts.

The provided text describes a 510(k) submission for the Applied Medical latis™ Dual Lumen Graft Cleaning Catheter. This regulatory submission process is focused on demonstrating substantial equivalence to a previously marketed device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device might.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone performance with AI, training set details) are not applicable to this type of medical device submission as described in the provided document. The "study" here is primarily a set of mechanical and biocompatibility tests to show the device is safe and performs comparably to its predicates.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Detailed Information (Not all applicable to this type of device submission):

1. Sample Size Used for the Test Set and the Data Provenance:

   • Sample Size: Not specified for clinical or performance data as this submission relies on demonstrating substantial equivalence through mechanical safety and biocompatibility tests, not a clinical trial with a "test set" of patients in the context of AI/ML evaluation.
   • Data Provenance: Not applicable in the context of human data. The tests were likely conducted in a lab setting by the manufacturer.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • Not Applicable. The "ground truth" for this device's submission is primarily established through engineering tests (mechanical, functional, biocompatibility) and comparison to predicate devices, not through expert consensus on diagnostic images or patient outcomes.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2.

4. 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 is not an AI/ML device, nor is it a device that is intended to assist human readers in interpretation. It's a physical medical catheter.

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

   • Not Applicable. This is not an algorithm or AI system.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the successful completion of mechanical safety tests and biocompatibility tests, and the demonstration of comparability to the predicate devices. This is based on engineering specifications and established test methodologies for medical devices.

7. The Sample Size for the Training Set:

   • Not Applicable. This device does not use a "training set" in the context of machine learning.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. See point 7.

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