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Alvision™ Interventional Cardiology Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the coronary vascular system.

Alvicath™ Endovascular Diagnostic Catheters are intended for use in the delivery of radio-opaque media to selected sites in the peripheral vascular system.

The Alvision™ Interventional Cardiology Diagnostic Catheter ("Alvision™") and the Alvicath™ Endovascular Diagnostic Catheter ("Alvicath™") are sterile, nonpyrogenic, single lumen catheters with a soft distal tip and a proximal strain relief and luer hub. The tri-layer catheter body construction is constructed of a first extrusion layer, a stainless steel wire braid middle layer, and a radiopaque outer layer of Nylon 12. The catheters are for single-use only.

The Alvision™ and Alvicath™ Diagnostic Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 4, 5, 6 and 7. Alvision Diagnostic Catheters are provided in useable lengths of 80, 100 and 110cm. Alvicath Endovascular Diagnostic Catheters are provided in useable lengths of 45, 60, 65, 80 and 100cm.

This document describes a 510(k) premarket notification for the Alvision Interventional Cardiology Diagnostic Catheter and Alvicath Endovascular Diagnostic Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against predefined clinical criteria in a standalone study.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The collective results of the nonclinical testing demonstrate that the materials chosen and design of the Alvision and Alvicath Diagnostic Catheters meet the established specifications necessary for consistent performance during its intended use." The specific numerical acceptance criteria are not detailed in this summary, but the successful completion of these tests indicates the device met the pre-defined internal specifications.

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

The document explicitly states: "No clinical testing was performed in support of this premarket notification." Therefore, there is no clinical "test set" in the traditional sense for evaluating device performance against a clinical ground truth. The "test set" here refers to the samples used for the non-clinical, benchtop, and biocompatibility tests. The sample sizes for these individual tests are not specified in the document.

• Data Provenance: The testing was non-clinical (benchtop and lab-based biocompatibility). No geographical or retrospective/prospective data provenance applies to these types of tests.

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

Not applicable. As no clinical testing was performed, there was no clinical ground truth established by experts for a test set. The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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. The submission explicitly states "No clinical testing was performed."

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

Not applicable. This device is a diagnostic catheter, a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was based on:

• Pre-defined engineering specifications for mechanical properties (e.g., tensile strength, flow rate, kink resistance).
• International standards for biocompatibility (e.g., ISO 10993-1) and sterilization.
• Industry standards for packaging integrity.

8. The Sample Size for the Training Set

Not applicable. As no clinical testing or machine learning model training was involved, there is no "training set." The device's design and materials were developed and refined through engineering processes, not by training against a dataset.

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

Not applicable. There was no training set.

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The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.

The Alguide™ Endovascular Guiding Catheter is intended for use in the intravascular introduction of interventional/ diagnostic devices into the peripheral vascular system.

The Alviguide™ Blue+ and Alguide™ Guide Catheters are sterile, non-pyrogenic, single lumen catheters with a tri-layer catheter body construction consisting of a polymer inner layer and a radiopaque outer layer surrounding a stainless steel wire braid, and a soft tip at the distal end. The catheters are for single-use only.

The Alviguide™ Blue+ and Alguide™ Guide Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 5, 6, 7 and 8 and lengths of 45, 60, 65 and 80cm (Alguide™), and 100cm (Alviguide™ Blue+ and Alguide™).

The provided text describes the 510(k) premarket notification for two guiding catheters and lists the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain information about the acceptance criteria for a device's performance in a study, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document focuses on:

• Device Description: Alviguide™ Blue+ Interventional Cardiology Guiding Catheter and Alguide™ Endovascular Guiding Catheter.
• Intended Use: Intravascular introduction of interventional/diagnostic devices into the coronary/peripheral vascular system.
• Substantial Equivalence: Comparison to predicate devices based on similar indications for use, design, materials, and nonclinical (bench) and biocompatibility testing.

The "testing in support of substantial equivalence determination" section lists various bench tests and biocompatibility tests, but these are focused on the physical and biological properties of the catheter itself, not on the performance of a diagnostic algorithm or AI system. There is no mention of "acceptance criteria" for a study in the sense of accuracy, sensitivity, specificity, or performance thresholds for an AI.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about an AI-driven study from the provided text. The document pertains to a physical medical device (catheter), not an AI/software-as-a-medical-device (SaMD).

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