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The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The PVS "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PVS "Pivot™" Steerable Delivery System® Microcatheter:

Acceptance Criteria and Device Performance

The submission does not explicitly list quantitative "acceptance criteria" in the format of a requirement and a corresponding measured value for the individual performance tests. Instead, it states that the tests "yielded acceptable results" or were "verified in accordance with" standards. The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting established industry standards.

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify the exact sample sizes (number of devices) used for each individual performance test (e.g., dimensional inspection, burst strength, tensile strength). The data provenance is not mentioned, as these are in vitro engineering tests rather than clinical data from patients. The tests are prospective in the sense that they were conducted specifically for this submission.

2. 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 is not applicable as the studies described are in vitro performance and biocompatibility tests on the device itself, not clinical studies involving "ground truth" derived from expert consensus on patient cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as there were no patient cases or expert readings 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 MRMC study was performed. This document describes a medical device (a microcatheter), not an AI algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. The "ground truth" for the device's performance is derived from established engineering test methods and their defined pass/fail criteria according to ISO standards and internal specifications, rather than clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:
   Not applicable, as this is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

8. How the ground truth for the training set was established:
   Not applicable, for the same reason as point 7.

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