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The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.

The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.

The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance" Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15").

The provided text is a 510(k) Summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, detailing its substantial equivalence to a predicate device. This document focuses on the physical and functional aspects of a medical device (intravascular catheter) and its comparison to a similar existing device. It does not contain information related to an AI/ML powered medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or details about ground truth establishment for a diagnostic algorithm.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies for an AI/ML device performance, as this information is not present in the provided document. The nonclinical testing listed relates to the physical performance and safety of the catheter itself, not to the diagnostic accuracy of an AI.

To elaborate on why the requested information cannot be found:

• Acceptance Criteria & Reported Device Performance (Table): The document provides a comparison of features, materials, and functional aspects of the subject device against a predicate device. It indicates "Same" or "Different" for many features and then lists various nonclinical bench tests in Section 8. However, it does not present quantitative acceptance criteria or reported performance for an AI/ML output. For example, it doesn't state "AI sensitivity > X%" or "AI accuracy > Y%" with corresponding actual performance.
• Sample Size (Test Set) & Data Provenance: This would be relevant for an AI study involving patient data. The document describes bench testing of a physical catheter, which does not typically involve a "test set" of patient data in the context of AI.
• Number of Experts, Qualifications & Adjudication Method: These points are critical for establishing ground truth in AI studies. Since this device is a physical catheter, there is no AI algorithm generating diagnostic outputs that would require expert adjudication for a ground truth.
• MRMC Comparative Effectiveness Study: This type of study assesses how AI affects human reader performance. As the device is not an AI, this study type is not applicable.
• Standalone Performance: This refers to the AI algorithm's performance without human intervention. Again, not applicable to a physical catheter.
• Type of Ground Truth: For an AI device, ground truth might be pathology, long-term outcomes, or expert consensus. For this physical catheter, "ground truth" is established through engineering specifications, material properties, and physical performance benchmarks.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: These are fundamental elements of AI model development. Since this is not an AI device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

In summary, the provided document describes the regulatory clearance for a physical medical device (intravascular catheter) through a substantial equivalence pathway, not an AI/ML-powered diagnostic or assistive device. Therefore, the information requested in your prompt is not available within this text.

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