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JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology 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.

JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The JOVUS Eagle Eye™ F/X catheters contain a catheter-tip ultrasound device that applies ultrasound energy dir ctly into the interior vessel wall of the patient to obtain an image of the vessel. This device is not currently indicated for use in cerebral vessels. The JOVUS Eagle Eye F/X catheter accommodates a 0.014" guide wire.

The JOVUS Eagle Eye™ F/X catheter utilizes an integral guide wire lumen in which the catheter tracks over the guide wire at the distal tip. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip.

The JOVUS Eagle Eye™ F/% catheter is introduced percutaneously or via surgical cutdown into the vascular sy:tem. A linear array ultrasonic transducer situated circumferentially near the tip of the catheter produces real time cross-sectional images of coronary and peripheral vessels.

The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.

The provided document is a 510(k) summary for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, seeking substantial equivalence to a predicate device. It's important to note that this type of submission typically focuses on comparison to a predicate device and does not involve the kind of detailed clinical study data often seen for novel devices that require extensive performance data to establish their safety and effectiveness.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the JOVUS Eagle Eye™ F/X 2.9F Intravascular Ultrasound Imaging Catheter in a table format. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance.

The key statement regarding performance is:
"Applicable testing is being performed in accordance with the Master Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results will be found to be comparable to those of the predicate device, Avanar™ F/X 2.9F Iritravascular Ultrasound Imaging Catheter. The new backing material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."

Therefore, the implicit acceptance criterion for overall device performance is "comparable to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set in the context of clinical performance evaluation directly. The evaluation focuses on engineering and biocompatibility testing. There is no mention of patient data (retrospective or prospective) or country of origin for such data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the document does not describe a clinical study involving a test set that requires expert-established ground truth for image interpretation or diagnosis. The testing mentioned is primarily related to device performance, manufacturing, and biocompatibility.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in the document. The submission focuses on device modifications and substantial equivalence, not a comparative clinical trial with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The device is an intravascular ultrasound catheter, which is a physical diagnostic tool operated by a human, not an AI algorithm.

7. The Type of Ground Truth Used

For the biocompatibility testing, the ground truth used was established by compliance with ISO 10993-1, a recognized international standard for biological evaluation of medical devices.

For the claim of "comparable" device performance, the ground truth is implicitly the performance of the predicate device, Avanar™ F/X 2.9F Intravascular Ultrasound Imaging Catheter, as measured through engineering and functional testing. No pathology, expert consensus, or outcomes data is mentioned as ground truth.

8. The Sample Size for the Training Set

This is not applicable. The document describes a medical device, not a machine learning or artificial intelligence system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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