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Extra Large Check-Flo introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

Cook Incorporated's Extra Large Check-Flo® Introducer is a single-use, sterile, disposable product that is used to introduce therapeutic or diagnostic devices into the vasculature. The Extra Large Check-Flo® Introducer consists of an introducer sheath, Check-Flo® hemostatic valve assembly, and dilator. The sheath is constructed with a hemostatic valve that accepts a large range of French sizes while preventing blood reflux and air aspiration. The subject device, the Extra Large Check-Flo® Introducer, is manufactured in diameters of 20.0, 22.0 and 24.0 French with sheath lengths of 25, 40, or 65 centimeters. The dilator is manufactured in lengths 16 centimeters longer than the sheath (41, 56, and 81 centimeters, respectively). The diameter of the distal endhole of the dilator measures 0.035 inch. The introducer sheath and dilator are matched as a unit to provide a smooth transition.

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called the "Extra Large Check-Flo® Introducer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.

Therefore, the information typically requested in your prompt regarding acceptance criteria for AI/ML device performance (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. This document describes the acceptance criteria and study that proves a physical medical device (a catheter introducer) meets performance specifications, not an AI/ML-based diagnostic or therapeutic device.

However, I can extract the acceptance criteria and the performance results for the physical device as described in the provided text.

Here's the relevant information from the document:

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

The document lists various tests performed and states that the "Test results met predetermined criteria" or "The predetermined acceptance criterion was met." Specific numerical acceptance criteria values are generally not provided in this summary, but the success of meeting them is stated.

Regarding the other points of your prompt (2-9), these are not applicable to the information provided in this 510(k) summary for a physical medical device:

• 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to a physical device, not an AI/ML model with test data. The number of physical units tested per criterion is not specified.
• 3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant here. Device performance is measured by physical tests according to standards.
• 4. Adjudication method: Not applicable. Device performance is determined by adherence to engineering specifications and international standards, not expert adjudication of diagnostic outcomes.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This is for AI/ML diagnostic or assistive devices, not for a catheter introducer.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
• 7. The type of ground truth used: Not applicable. Device performance is measured against engineering specifications and test standards (e.g., tensile strength, dimensions, biocompatibility), not clinical "ground truth" derived from patient outcomes or expert consensus in the diagnostic sense.
• 8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that undergoes training.
• 9. How the ground truth for the training set was established: Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a physical medical device. It demonstrates performance by stating that the device passed a series of engineering and biocompatibility tests in accordance with established industry standards and internal specifications, thus supporting its substantial equivalence to a predicate device. It does not contain information related to AI/ML model performance or associated clinical study designs.

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