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The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature. AngioDynamics, Inc. Percutaneous Introducers are designed for use during interventional procedures and are not intended for critical care use.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the AngioDynamics Percutaneous Introducer does not contain the detailed information necessary to answer your request in full.

Here's a breakdown of what can be extracted and what is missing, based on the input:

What can be extracted:

• Device Name: AngioDynamics, Inc. Percutaneous Introducer
• 510(k) Number: K040728
• Intended Use: "The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature."
• Type of Study (Implied): A 510(k) clearance primarily relies on a demonstration of "substantial equivalence" to a legally marketed predicate device, rather than a clinical effects study. The letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This means the submission likely focused on design, materials, and performance characteristics (e.g., mechanical testing) to show it performs as safely and effectively as an existing device, rather than proving novel clinical benefit through a detailed clinical trial.

What is missing from the provided text:

The document is a clearance letter, not the actual 510(k) submission. Therefore, it does not include:

1. Acceptance Criteria Table and Reported Device Performance: This would be found in the performance testing section of the 510(k) submission itself, detailing specific metrics (e.g., tensile strength, burst pressure, lubricity, insertion force, etc.) and the results that met pre-defined criteria. The clearance letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance: This information would be specific to any non-clinical (e.g., benchtop, in vitro) or potentially limited clinical testing performed to support substantial equivalence. The letter does not specify this.
3. Number of Experts Used to Establish Ground Truth and Qualifications: This is typically relevant for studies involving subjective assessments (e.g., imaging interpretation), which is not the primary focus of an introducer substantial equivalence claim.
4. Adjudication method for the test set: Not applicable based on the available information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Highly unlikely for an introducer device seeking 510(k) clearance, as these types of studies are typically for devices claiming improved diagnostic accuracy or clinical outcomes. The letter does not mention any such study.
6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used: For an introducer, "ground truth" would likely relate to objective physical and mechanical properties, not expert consensus on pathology or outcomes data in the way an AI diagnostic device would.
8. Sample Size for the Training Set: Not applicable as this is a physical device, and there is no "training set" in the context of machine learning unless an AI component was involved, which is not indicated.
9. How the Ground Truth for the Training Set was Established: Not applicable.

Conclusion:

The provided FDA clearance letter confirms that the AngioDynamics Percutaneous Introducer was found substantially equivalent to a predicate device based on a 510(k) submission (K040728). However, it does not contain the detailed technical data, study methodologies, or specific performance criteria and results that you are requesting. This information would be within the confidential 510(k) submission document itself, which is not publicly released in its entirety.

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