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The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria related to AI/algorithm performance.

Instead, the document is a 510(k) summary for a medical catheter (Versus™ Catheter (VS110-8B)), comparing it to predicate devices to establish substantial equivalence.

The performance testing section (Section VII) outlines several non-clinical tests performed, including:

• Sterilization and Shelf Life: Validated per ISO 11135:2014, with a sterility assurance level of 10^-6 and a shelf life of 3 months established through accelerated aging studies.
• Biocompatibility: Evaluated against ISO 10993 and FDA Draft Guidance, including tests for acute systemic toxicity, complement activation, cytotoxicity, hemolysis, heparinized blood platelet and leukocyte count, intracutaneous irritation, material-mediated pyrogenicity, maximization sensitization, partial thromboplastin time (PTT), and particulate infrared spectroscopy.
• Human Factors Testing (Usability): Conducted per IEC 62366-1:2015 and FDA Guidance, demonstrating that intended users could perform critical tasks in a simulated environment. The results met predefined acceptance criteria, but the specific criteria and performance metrics are not detailed in this document.
• Performance Testing - Bench: Included tests for kink radius, trackability, advancement force, retraction force, infusion uniformity, pressure lumen measurement, dimensional and visual verification, luer hub compatibility, balloon inflation and integrity, corrosion resistance, and radiopacity.
• Performance Testing – Animal: A GLP porcine study comparing the Versus™ Catheter to the primary predicate device. The study met all success criteria established.

Crucially, there is no mention of:

• AI/algorithm performance: The device is a physical catheter, not an AI software.
• Test set sample size and data provenance for AI: Not applicable as it's not an AI device.
• Number of experts and their qualifications for ground truth: Not applicable for device testing of this nature.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth (e.g., expert consensus, pathology, outcomes data): Not applicable in the context of AI. The ground truth for biocompatibility and bench testing is established through standardized testing methodologies and material properties. For the animal study, the ground truth would be the physiological and pathological outcomes observed in the animals.
• Training set sample size and how ground truth was established for the training set: Not applicable as it's not an AI/machine learning device.

Therefore, I cannot populate the table or answer the questions related to AI/algorithm performance as the provided text pertains to a physical medical device (catheter) and its substantial equivalence testing, not an AI or software as a medical device.

The only "acceptance criteria" mentioned are that the human factors testing and animal study "met the predefined acceptance/success criteria," but the specific numerical or qualitative details of those criteria are not provided in this summary.

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