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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 a single lumen, 18 gauge configuration with usable length of 8 cm (3.15").

This document is a 510(k) summary for the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, seeking substantial equivalence to a predicate device. As such, it focuses on demonstrating equivalence through comparison of technological characteristics and nonclinical bench testing. It does not describe acceptance criteria and a study that proves the device meets those criteria in the context of an AI-powered medical device.

The information provided confirms that the device is a physical intravascular catheter, not an AI/software device. Therefore, the specific requirements listed in the prompt (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The document highlights:

• Acceptance Criteria (Implied by equivalence): The "acceptance criteria" here are implicitly that the new device performs equivalently to the predicate device in relevant physical and functional characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: This is demonstrated through a detailed comparison table (Section 7) and a list of "Nonclinical Testing" (Section 8).

Here's a breakdown of what is available and what is not relevant from your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical targets as would be seen for an AI device. Instead, it presents a comparison to a predicate device. The "acceptance" is based on demonstrating that the subject device is "substantially equivalent" to the predicate, meaning it performs similarly and does not introduce new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance:

• This is not an AI/software device, so there isn't a "test set" in the sense of a dataset for algorithm evaluation.
• The performance is evaluated through bench testing (listed in Section 8). Details on the specific sample sizes for these physical and material tests are not provided in this summary.
• Data provenance: Not applicable as it's not clinical data. The tests are laboratory-based, performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not an AI/software device requiring expert labeling of data.
• The "ground truth" for a physical device is established through engineering specifications, material science, and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This concept is for resolving disagreements in expert annotations for AI datasets, not for physical device testing.

5. 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 device is a catheter, not an AI software intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI algorithm. Its performance is inherent in its physical properties and design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For physical devices like this, the "ground truth" for validating performance is typically derived from:
  • Engineering specifications and design requirements: Does it meet the intended physical dimensions, material properties, and functional outputs (e.g., flow rate, pressure limits)?
  • Recognized consensus standards: Compliance with ISO standards related to biocompatibility, sterilization, and general medical device safety.
  • Bench testing results: Data from rigorous laboratory tests simulating various use conditions.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable. This is not a machine learning model.

In summary, this 510(k) pertains to a physical medical device (catheter), not an AI/software product. Therefore, most of the requested information regarding AI device evaluation (test/training sets, expert ground truth, MRMC studies) is not relevant to this document. The "study" proving the device meets acceptance criteria is the comprehensive nonclinical bench testing outlined in Section 8, which demonstrates that the device performs functionally and safely, and is substantially equivalent to its predicate.

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