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The Trellis™ Infusion System is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The Trellis Infusion Catheter enables the physician to isolate a treatment region, infuse a physician-specified fluid, and disperse the fluid by means of oscillation of a Dispersion Wire. The Isolation/Infusion component is a multi-lumen catheter with two compliant balloons at the distal end and infusion holes located between these balloons. When inflated, the compliant balloons isolate a treatment zone to maintain concentration of the infused fluid. The device also has a central through-lumen that is compatible with a 0.035" guidewire. The Dispersion Wire component is a sheathed, shape-set Nitinol cable that provides oscillation when activated. The Dispersion Wire is connected to an integral Oscillation Drive Unit which oscillates the Dispersion Wire up to 25 Hertz within the isolated region to further disperse the infused fluid.

The provided text is related to a 510(k) premarket notification for the Trellis Infusion System. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or detailed results of a study that prove the device meets precise acceptance criteria in the format required for a typical AI/ML device submission.

The document pre-dates many of the modern requirements for AI/ML device submissions, which typically involve detailed performance metrics like sensitivity, specificity, AUC, and their associated confidence intervals against established ground truth.

Given the information available, I can extract and infer some aspects, but I cannot fulfill all parts of your request as the document doesn't provide the level of detail seen in a modern AI/ML device submission.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

Device Name: Trellis Infusion System

Acceptance Criteria and Device Performance (Based on provided text):

The document lists various tests conducted to ensure the Trellis met "all specifications" and reports a general conclusion of safety and effectiveness without numerical performance metrics or explicit acceptance thresholds.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for each test. For the pre-clinical in vivo testing, it mentions "animal arteries" but doesn't quantify the number of animals or vessels.
   • Data Provenance: Not specified (e.g., country of origin). The in vivo testing was "pre-clinical," implying animal studies rather than human clinical data. The description of testing does not specify retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The testing described primarily involves engineering performance tests and anatomical/histological assessments in animal models, not human expert interpretation in the way AI/ML ground truth is established.

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

   • Not applicable as the tests described are primarily objective engineering and in vivo animal studies, not human interpretation-based assessments requiring adjudication.

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:

   • No. This is a traditional medical device submission for an infusion system, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

   • No. This device is a physical catheter system, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the engineering tests, the ground truth would be the defined specifications for each test (e.g., a specific tensile strength value).
   • For the in vivo testing, the "ground truth" was established by direct observation during the procedure (e.g., visualization under fluoroscopy) and subsequent "histological examination of treated vessels" by presumably qualified pathologists/veterinary pathologists, though their details are not provided.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable.

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