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The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.

The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller. The catheter body is radiopaque with a distinguishable marker at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.

The provided text describes the Prowler Plus Infusion Catheter and its summary of safety and effectiveness, including a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria with numerical targets, nor does it detail a study with reported device performance against such criteria in the format typically used for medical device efficacy or AI performance evaluation. The information provided is for a traditional medical device (catheter), not an AI/ML-enabled device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from the given document, as these pertain to studies typically conducted for AI/ML device validation.

Based on the provided text, here's what can be extracted:

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

The document does not explicitly state numerical acceptance criteria. Instead, it states that "Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or better than the predicate devices tested." This implies an equivalence or non-inferiority standard, but specific numerical targets are not provided. The performance is described qualitatively as meeting this standard.

The design verification tests included:

• Pull Strength Test
• Trackability Test
• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)
• Static Burst Pressure Test
• Alternative Flow Rate Calculation
• Air Aspiration
• Linear Stiffness Test (Boink)
• Shapeability Test

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

This information is not provided in the document. The "Summary of Studies" only lists the types of tests performed.

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 information is not applicable and not provided. The device is a physical catheter, and its performance is evaluated through engineering design verification tests, not clinical studies requiring expert ground truth or AI/ML model evaluation.

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

This information is not applicable and not provided. It relates to studies typically conducted for AI/ML device validation.

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

An MRMC study was not done, as this is a physical medical device (catheter), not an AI/ML system.

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

A standalone performance study a it is a physical medical device (catheter), not an AI/ML system.

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

Not applicable. The "ground truth" for a physical device like a catheter is the engineering specification and performance standards derived from predicate devices, verified through physical and mechanical testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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