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The Pronto .035" extraction catheter is indicated for:

• The removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system.
• The removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system.
• To infuse/deliver diagnostic or therapeutic agents.

The Pronto .035" extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire. The larger lumen allows for the removal of thrombus by use of the included syringe through the extension line and stopcock. The catheter has a rounded distal tip with a protected, extraction lumen to facilitate advancement of the catheter into the blood vessel and maximize extraction of thrombus through the extraction lumen.
The catheter has a radiopaque marker band located approximately 4mm from the distal tip. The proximal end of the catheter incorporates a hemostatic Y-junction that allows for the attachment of the catheter to the included extension line, stopcock and syringe; and can be tightened down on the guidewire to prevent blood leakage.

This document is a 510(k) summary for the Pronto™ .035" Extraction Catheter. It describes the device, its intended use, and a summary of non-clinical and clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes a series of "Device Verification Testing" performed to support equivalency to predicate devices. The performance is generally stated as "met all specified design and performance requirements."

Here's a breakdown based on the provided text:

2. 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 sample sizes used for each individual performance test within the "Device Verification Testing." It only generally states that testing was performed. The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device aiming for substantial equivalence, these tests are typically conducted in a laboratory setting by the manufacturer.

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 section is not applicable as the provided document describes non-clinical performance testing for a medical device (catheter), not a diagnostic or AI-based device that would require expert-established ground truth. The tests are mechanical and functional in nature.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human interpretation or subjective assessment, which is not the case for the described "Device Verification Testing."

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

There is no MRMC comparative effectiveness study mentioned. This document pertains to the market clearance of a physical medical device (catheter), not an AI diagnostic tool.

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

This section is not applicable. The device is a physical catheter, not an algorithm.

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

For the "Device Verification Testing," the "ground truth" refers to pre-defined engineering specifications, material standards, and functional requirements for a medical device. For example, for "catheter bond strength," the ground truth would be a minimum acceptable force value. For "biocompatibility," the ground truth is adherence to ISO 10993 standards. It's not a ground truth derived from expert consensus, pathology, or outcomes data as seen in diagnostic studies.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device, not a machine learning model, therefore there is no training set.

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

This section is not applicable for the same reasons as point 8.

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