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The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term (

The Cook® Spectrum® 2 MRC Central Venous Catheter is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The Cook® Spectrum® 2 MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The Cook® Spectrum® 2 MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces. The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the Cook® Spectrum® 2 MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injectionmolded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.

The provided text is a 510(k) summary for the Cook® Spectrum® 2 MRC Central Venous Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, nor does it contain the requested detailed information regarding test set size, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on demonstrating the substantial equivalence of a medical device (a central venous catheter) to a previously cleared predicate device. This is typically done through non-clinical performance testing (e.g., tensile strength, flow rate, biocompatibility) and a comparison of technological characteristics, rather than clinical studies with human readers or AI algorithms.

Therefore, I cannot extract the information required to answer your specific questions related to acceptance criteria and a study proving device performance as if it were an AI/ML device. The document does not contain this type of data or study design.

Here's what I can infer from the document regarding the acceptance criteria and performance, keeping in mind it's for a traditional medical device, not an AI/ML one:

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Testing):

The "acceptance criteria" here are implicitly tied to demonstrating the Cook® Spectrum® 2 MRC Central Venous Catheter is as safe and effective as the predicate device. This is achieved by showing that the new device meets relevant industry standards and performs similarly to the predicate in key technical areas.

Since the requested information pertains to AI/ML device studies, and this document is for a traditional catheter, the following points cannot be addressed from the provided text:

• Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" refers to physical, chemical, and biological tests on the device itself.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device involves expert annotations of data (e.g., images), which is not relevant here.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is not an AI/ML device, and no human reader studies are described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for image interpretation or diagnosis is being established.
• The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
• How the ground truth for the training set was established: Not applicable.

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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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