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The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This is a medical device submission, specifically a 510(k) premarket notification for a reprocessed intravascular ultrasound (IVUS) catheter. The document details the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria for a study or the results of such a study proving the device meets those criteria in a way that allows for the extraction of the requested information regarding AI device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

The document focuses on demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices, a requirement for 510(k) clearance. The testing mentioned in this document (biocompatibility, cleaning validation, sterilization validation, functional testing, etc.) are standard tests for reprocessed medical devices to ensure they are safe and effective after reprocessing, not necessarily a clinical study to evaluate diagnostic performance against a specific set of acceptance criteria for an AI algorithm.

Therefore, for most of your specific questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Not Available in the Provided Text:

• A table of acceptance criteria and the reported device performance (in the context of an AI device or a diagnostic performance study): The document lists functional and safety testing for a reprocessed physical device, not an AI or diagnostic performance study with specific criteria like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable as no diagnostic performance study of an AI device is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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. This is not an AI device submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for a diagnostic performance study.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be partially inferred or is directly stated (though not in the context of an AI study):

• Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
• Device Type: Intravascular Ultrasound (IVUS) Catheter (a physical medical device, not an AI algorithm)
• Purpose: Evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image.
• Testing Conducted (Functional and Safety, not diagnostic performance):
  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing (Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility)
  • Drying Validation
  • Packaging Validation
• Conclusion from the document: Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein, based on the functional and safety testing for a reprocessed device.

In summary, this document is a 510(k) submission for a reprocessed medical device (an IVUS catheter) and does not describe the evaluation of an AI-powered diagnostic device or a study with "acceptance criteria" in the sense of diagnostic performance metrics for an algorithm.

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