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The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The Pronto V4 extraction catheter (Pronto) is a dual lumen rapid exchange catheter that has a working length of approximately 138 cm and is packaged with related accessories. The smaller wire lumen of the catheter is able to accommodate guidewires ≤0.014 inches in diameter. The larger extraction lumen allows for the removal of thrombus by use of the included 30 mL syringes through the extension line and stopcock. The catheter has a stiff proximal region and a flexible distal region. The catheter has a rounded distal tip with a protected, sloped opening of the extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen. The catheter contains a radiopaque marker band located approximately 2 mm from the distal tip. The distal 18 cm of the catheter has a hydrophilic coating to enhance deliverability to the target vasculature. The device has positioning marks located at 95 cm and 105 cm from the distal tip, respectively. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of catheter to the included extension line, stopcock, and 30 mL syringes. A filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis of any thrombus.

The provided text does not describe a study involving "acceptance criteria" and "reported device performance" in the typical sense of a clinical or comparative effectiveness study. Instead, it describes a medical device, the Pronto V4 extraction catheter, that has undergone verification testing against specified acceptance criteria to demonstrate substantial equivalence to a predicate device for FDA clearance.

Therefore, many of the requested fields cannot be directly answered from the provided text because they pertain to clinical study methodologies that are not present.

However, I can extract information related to the device verification and the "acceptance criteria" as described in the document.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

The document states: "Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions."

While specific numerical acceptance criteria (e.g., "tensile strength > X N") and the exact reported values for each test are not provided, the document lists the categories of tests performed. The "reported device performance" is implicitly stated as "met the specified acceptance criteria" for all tests.

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

• Sample Size: Not specified for any of the verification tests.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical data.

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)

• Not Applicable. The "ground truth" for these engineering/biomaterial tests would be the established scientific and engineering principles and standards against which the device performance is measured, not expert clinical consensus as might be the case for diagnostic imaging.

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

• Not Applicable. This concept applies to human expert review in diagnostic assessments, not to bench testing of a device's physical properties or biocompatibility. The tests would be performed and evaluated according to predefined protocols.

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

• No. This document describes the clearance of a mechanical medical device (extraction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

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

• Not Applicable. This device is a physical catheter, not an algorithm.

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

• The "ground truth" in this context refers to established engineering standards, material science principles, and biological safety guidelines (e.g., ISO standards for biocompatibility) that define acceptable performance for each test. For example, for "Tensile," the ground truth would be a minimum tensile strength required for safe operation, likely derived from clinical use cases and engineering specifications.

8. The sample size for the training set

• Not Applicable. This document describes verification testing for a physical medical device, not a machine learning model. There is no "training set."

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

• Not Applicable. See response to #8.

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