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The Wildcat 5F Guidewire Support Catheter is intended to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.

Device Description

The Wildcat 5F Guidewire Support Catheter is a 5F sheath and 0.014" guidewire compatible over-thewire device. It consists of a catheter shaft with handle assembly at the proximal end an atraumatic distal tip. The catheter has a working length of 140 cm. A locking luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.

AI/ML Overview

The provided text describes the nonclinical performance data for the Avinger Wildcat 5F Guidewire Support Catheter. It focuses on demonstrating equivalence to a previously cleared device (Wildcat 7F Guidewire Support Catheter) rather than establishing specific acceptance criteria with numerical targets.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of predetermined numerical acceptance criteria against which device performance is measured. Instead, it states that:

Acceptance Criterion (Implicit)	Reported Device Performance
Conformance to "Sterile, single-use intravascular catheters – Part 1 – General Requirements" (ISO 10555-1) for tensile, torque strength, and coating integrity.	"All data fell well within pre-determined product specifications and external standard requirements." (This indicates that the device met the requirements of ISO 10555-1 for these parameters.)
Conformance to "Biological Evaluation of Medical Devices" (EN ISO 10993-1) for biocompatibility.	Device compatibility testing "was conducted according to EN ISO 10993-1" and "All data fell well within pre-determined product specifications and external standard requirements." (This indicates the device met biocompatibility requirements.)
Successful evaluation in a porcine animal model.	"device performance was successfully evaluated in a porcine animal model. The test model represented a discrete vascular bed in the coronary arteries under GLP-like conditions." (This indicates the device performed as intended in an in-vivo setting, though specific quantitative acceptance metrics for this performance are not provided.)
Substantial Equivalence to Wildcat 7F Guidewire Support Catheter.	"Based upon the product technical information, intended use, performance and biocompatibility data provided in this premarket notification, the Avinger 5F catheter has been shown to be equivalent to the currently marketed Avinger 7F catheter."

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:
- For laboratory testing (tensile, torque, coating integrity, compatibility): Not specified.
- For porcine animal model: Not specified.
Data Provenance: The document does not specify the country of origin of the data for either the laboratory tests or the animal study.
Retrospective or Prospective: Not specified, but given the context of design verification testing and animal studies, it is implied to be prospective testing.

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. This device is a medical instrument (catheter), and its performance evaluation does not involve establishing ground truth from expert interpretation in the way an AI diagnostic device would. The "ground truth" here is the physical and biological performance against established standards and in-vivo functionality.

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

Not applicable. Adjudication methods are typically associated with human-read studies, particularly in the context of diagnostic AI, to resolve discrepancies in expert interpretations. This document describes physical and biological performance tests.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This document describes the nonclinical performance of a guidewire support catheter, not a diagnostic AI system.

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

This question refers to AI algorithm performance. This document describes the performance of a physical medical device. The "standalone performance" of the device is described as its ability to meet specifications in laboratory tests and perform successfully in an animal model.

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

The "ground truth" for this device's evaluation is primarily:

Engineering Specifications: Pre-determined product specifications for tensile, torque strength, and coating integrity, derived from ISO 10555-1.
Biocompatibility Standards: Requirements set forth in EN ISO 10993-1.
In-vivo Functionality: Successful performance in a well-defined porcine animal model representing a discrete vascular bed.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; it's a physical medical instrument. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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