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The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

The provided text is a 510(k) summary for the "Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. It does not describe a study to prove a device meets acceptance criteria for an AI/algorithm-based medical device.

Instead, this document details the substantial equivalence of a physical medical device (a catheter) to existing predicate devices based on design characteristics, materials, and non-clinical performance testing. The "Chlorag+ard Technology" mentioned refers to a coating on the catheter that has antimicrobial and antithrombogenic properties, which were evaluated using in vitro and in vivo test methods. This is not an AI or algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input document is for a physical medical device, not an AI/algorithm-based one.

If you can provide a different document that describes an AI/algorithm-based medical device, I would be happy to then attempt to answer the questions you've posed.

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The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC™ may not exceed 300 psi. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term or long-term access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with usable lengths of 20, 25, and 30 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The catheters will be packaged sterile in kits that will include components to facilitate insertion.

This is a 510(k) summary for a medical device (Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology), not an AI/ML medical device. Therefore, the information typically expected for AI/ML device studies (such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not applicable or provided in this document.

The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (K112896 and K071538). The "study" mentioned refers to nonclinical (bench) testing performed to demonstrate that the device meets performance, safety, and efficacy requirements, largely by referencing tests performed on its predicate device, K112896, and some additional tests specific to the new device's length.

However, I can extract information related to the device's performance based on the nonclinical testing mentioned.

Here's a summary of the relevant sections, re-framing traditional "acceptance criteria" and "reported performance" based on the provided text, recognizing this is for a physical medical device and not an AI model.

Device: Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Type of Device: Percutaneous, implanted, long-term intravascular catheter (physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" is typically met by demonstrating compliance with established performance standards for medical devices and showing substantial equivalence to a legally marketed predicate device. The document lists performance tests conducted or referenced from the predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for each bench test. For physical device testing, sample size is typically determined by statistical methods for specific tests, but these details are not provided in this summary.
• Data Provenance: The tests are "bench testing," meaning they were conducted in a laboratory setting. No country of origin for the data is mentioned, but typically such testing would be done by the manufacturer (Arrow International, Inc., based in Reading, PA, USA) or a qualified contract lab. The tests are prospective in the sense that they were designed and executed to support the submission.

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

Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML devices interpreting medical images or data. For physical device performance testing, the "ground truth" is established by direct measurement of physical properties against engineering specifications and regulatory standards. The "experts" would be the engineers and technicians conducting the bench tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers/experts, typically in the context of diagnostic interpretation for AI/ML devices. For physical device testing, results are typically objective measurements.

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

Not applicable. MRMC studies are for evaluating diagnostic performance of AI/ML systems, often with human readers. This document describes a physical medical device.

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

Not applicable. There is no AI algorithm in this device.

7. The Type of Ground Truth Used

The "ground truth" for these physical device tests would be the established engineering specifications, regulatory standards, and comparative performance against predicate devices as measured by objective physical and chemical methods (e.g., pressure resistance, flow rates, antimicrobial activity measured in agar cultures or animal models, physical integrity tests).

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm to train. The "training" for a physical device involves designing and manufacturing processes to meet specifications, but not in the AI sense.

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

Not applicable. There is no AI algorithm to train in this context.

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