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The AngioXpand Introducer Catheter is intended to facilitate placement of other devices such as guidewires or catheters through the skin into the vascular system.

The AngioXpand Introducer Catheter is a medical device composed of a disposable needle and catheter. The device is equivalent in intended use to current legally marketed introducer catheter devices, and utilizes the same catheter-over-needle form as other legally marketed devices.

The AngioXpand Introducer Catheter decreases the range of introducing needle sizes required during patient cannulation. The system is expected to provide a patient the benefit realized by decreasing the size of the introducing needle required of larger gauge introducers.

An appropriate sized guidewire or dilator becomes the means of expanding the introducer's tip, allowing passage of a catheter or guidewire into the blood vessel. This action permits the initial size of the needle to be smaller than the desired placed catheter size.

The provided text describes the AngioXpand Introducer Catheter and its substantial equivalence claim to a predicate device but does not contain information about specific acceptance criteria, study details, or performance metrics beyond a general statement of equivalency. Therefore, much of the requested information cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only broadly mentions "testing" and "data provided."

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 type of information is usually relevant for studies involving human interpretation or clinical endpoints, which are not detailed here. The study focuses on material properties, design, and intended use as compared to a predicate device.

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

• Not applicable/Not specified. The document does not describe a process involving expert adjudication for a test set.

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 is not a study involving AI or human reader interpretation. The device is a physical introducer catheter.

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

• No. This is not an algorithm or AI-based device.

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

• Not explicitly stated for specific performance criteria. The "ground truth" for demonstrating substantial equivalence appears to be based on established performance characteristics and safety profiles of the predicate device and relevant industry standards for introducer catheters.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Summary of Study (Based on available information):

The provided text indicates that A.B. Korkor Medical, Inc. conducted a study to demonstrate the substantial equivalence of the AngioXpand Introducer Catheter to a legally marketed predicate device, the BD Introsyte Precision Introducer Catheter (K020834). This study involved a comparison of device features, materials, intended use, and performance. While specific test results or quantitative performance metrics are not detailed, the FDA's 510(k) clearance (K092097) confirms that the device was deemed substantially equivalent for its stated indications for use. The nature of the device (an introducer catheter) suggests that the "testing in accordance with applicable standards" likely included mechanical, material, and biocompatibility testing to ensure safety and functionality comparable to the predicate device. However, the document does not provide the specifics of these tests or their results.

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