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The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology is indicated for short-term (30 days) 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 Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa), 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 pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were evaluated using 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 treating infections.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology has the following characteristics:

• . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet
• 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet
• 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet

The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy.

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide 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 can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag+ard technology. There are no modifications subject to this premarket notification related to the geometric or material design of the devices modified in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The provided text is a 510(k) summary for Arrow International, Inc.'s CG+ Arrow JACC devices. It aims to demonstrate substantial equivalence to a predicate device, focusing on a modification to the recommended procedural technique (catheter trimming instructions).

Here's an analysis of the acceptance criteria and supporting study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for performance metrics in the way one might expect for a formal clinical trial or algorithm validation. Instead, the focus is on demonstrating substantial equivalence to a predicate device after a modification to a procedural technique. The "performance" being evaluated is essentially the continued safety and functional equivalence of the modified device.

Important Note: The document explicitly states that "no correlation between these testing methods and clinical outcome has currently been ascertained" for the antimicrobial efficacy. This means while the device has shown antimicrobial activity in lab/animal settings, there isn't clinical evidence in this document proving it translates to reduced infections in humans.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for test sets in a traditional sense. The "testing" mentioned is primarily design verification testing and risk analysis related to the modification (catheter trimming). There is no mention of a patient-based test set with specific sample sizes.

• Data Provenance: The testing mentioned ("internal method", "in vitro and in vivo test methods") points to internal laboratory or animal studies, likely conducted by the manufacturer (Arrow International, Inc./Teleflex Inc.). There is no mention of country of origin for data or whether it's retrospective or prospective clinical data.

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

This information is not provided. Given the nature of the submission (510(k) for a procedural modification to an existing device), the "ground truth" for the verification testing would be based on engineering specifications, material science, and established safety standards rather than expert clinical consensus on a patient test set.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no mention of a test set that would require expert adjudication in the context of this submission. The "adjudication" would be performed by the manufacturer's internal quality and regulatory teams, and subsequently by the FDA reviewers, applying regulatory standards to the provided test results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This submission is for a medical device (catheter) with guidance (VPS Stylet), not an AI-powered diagnostic imaging system that would typically involve human "readers" and AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The "VPS Stylet" is a guidance system used by a human operator during a medical procedure, not a standalone AI algorithm.

7. The Type of Ground Truth Used

For the aspects evaluated:

• Catheter Trimming Compatibility & Functional Performance: The "ground truth" would be engineering specifications, established mechanical/material properties, and successful demonstration of absence of adverse effects from trimming through design verification testing.
• Antimicrobial & Antithrombogenic Efficacy: The "ground truth" was established through in vitro and in vivo test methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of an "AI algorithm" or a "training set" in this 510(k) submission.

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

This information is not applicable/not provided as there is no "training set" mentioned.

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The Arrow® Pessure Injectable Jugalarian Central Catherer™ with Chlorag+ard Antimicrobial and Antithrombagenc Technology is indicated for short-tern access to the central venous system for intrasenous therapy. blood sampling, infusion, pressure injection of contrast media and allows for contrasion The maximum pressure of pressure injector quipment used with the Arrow Pressure Injectable 1900 psi. The marimum pressure injection 110ve rate for the specific lumen heing used for pressure injection is printed on the extension line hub.

Chionageurd Technology treatment on the cathere of the cathere body as well as the entire fibid pathway of the catherer has been shown to be citective in reducing microbial colonization on cathers. Antimierobial cities were evaluated using in ritre and in rive and in rive and in rive and in rive and in rive methods and no correlation between these esting methods and clinical outcome has currently been assertained. It is not intended to be used for the treatment of existing infections.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheress for use in placement of the cather. intravascular espability for ECG devection and intravascular ultrasound for eatherer guiding and passioning. The VPS Stylet, when used with the VPS Console, provides real-time catherer information by using the patient's physiological (curdize clectrical activity and blow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as an sherative method to Internation venus cather up placement confirmation in add patients when a steady Blue Bullseye is obtained, NOTE: IT's steady Blue Bullained, standard haspital proctive should be followed to confirm catherer tip location.

Limiting but not contraindiented situations for this receivers where alterations of cardiae thythm change the presentation of the fwave as in atial fibrillation, arrial flutter severe achycardia and pacental venous catherization procedures performed through femoral or suphenous vein access which of the P-vave. In such patients, who are easily identifiable prior to central venous catheter insertion. the use of an additional method is required to confirm catherer tip location.

The CG+ Arrow JACC powered by Arrow VPS Stylet has the following characteristics:

• . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
• . 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
• . 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet

The CG+ Arrow JACC powered by Arrow VPS Stylet is a CG+ Arrow JACC pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The CG+ Arrow JACC devices will also be provided in sterile kit configurations without the Arrow VPS Stylet preloaded in the catheter.

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide 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 can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based coating technology.

The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet is designed to be compatible with any catheter with an inner luminal diameter of at least 0.021 inch.

The provided text is a 510(k) summary for the "CG+ Arrow JACC powered by Arrow VPS Stylet." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with defined metrics for the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI/algorithm performance, cannot be fully extracted from this document in the way it would for a software device with performance claims. The document is primarily a comparison against existing hardware devices.

However, I can provide the information available that most closely aligns with your request, focusing on the verification testing performed.

Summary of Device and its Purpose:

The "CG+ Arrow JACC powered by Arrow VPS Stylet" combines a Central Venous Catheter (CG+ Arrow JACC) with a Vascular Positioning System (VPS) Stylet. The VPS Stylet, used with a console, guides the catheter to the desired location (lower third of the SVC or cavo-atrial junction) using Doppler and intravascular electrocardiogram (ivECG) signals.

1. Table of Acceptance Criteria and Reported Device Performance

As this document is a 510(k) for substantial equivalence of a hardware device (catheter and stylet), it does not present acceptance criteria in the typical format of a standalone performance study for an AI/algorithm, with metrics like AUC, sensitivity, or specificity. Instead, it describes verification testing performed to ensure the device meets engineering and safety specifications, demonstrating equivalence to predicate devices.

The "acceptance criteria" can be inferred from the need for the device to perform "the same" or comparably to its predicates in various tests. The "reported device performance" is a statement that these tests were performed and the device passed, leading to the conclusion of substantial equivalence.

• Testing performed for content. |
  | - Chlorhexidine coating efficacy (Antimicrobial, Antithrombogenic) | - "SAME" as predicate device ("Effective in reducing microbial colonization," "Antithrombogenic Efficacy").
• Testing performed for efficacy. |
  | - Chlorhexidine release rate (elution) | - Testing performed. |
  | - Mechanical Hemolysis | - Testing performed. |
  | - Solvent Residual | - Testing performed. |
  | - Chemical Degradation | - Testing performed. |
  | Catheter Performance Testing: | |
  | - Tensile strength | - Testing performed. |
  | - Catheter body kink resistance | - Testing performed. |
  | - Flow rate (Max infusion rate, Pressure injection capabilities) | - Max infusion rate: 1-Lumen: 5 mL/sec; 2-Lumen: 5 mL/sec; 3-Lumen: 6 mL/sec.
• Pressure Injection: 1-Lumen Distal: 5 mL/sec (SAME); 2-Lumen Distal: 5 mL/sec (SAME), Proximal: 4 mL/sec; 3-Lumen Distal: 6 mL/sec, Proximal/Medial: No Pressure Injection. Testing performed. |
  | - Static burst pressure | - Testing performed. |
  | - Air and liquid leakage | - Testing performed. |
  | - Flex cycling | - Testing performed. |
  | - Catheter whip | - Testing performed. |
  | - Catheter tip compression stiffness | - Testing performed. |
  | - Luer hub testing | - Testing performed. |
  | - Collapse resistance | - Testing performed. |
  | - Central venous pressure monitoring | - Testing performed. |
  | Combined Device Performance Testing (Catheter + VPS Stylet): | |
  | - Stylet tensile strength | - Testing performed. |
  | - Simulated use insertion/removal (Force to remove stylet from catheter) | - Testing performed. |
  | - Post-insertion/removal catheter air and liquid leakage | - Testing performed. |
  | - Stylet electrical testing | - Testing performed. |
  | Overall (from "Conclusions" section): | The results of the risk assessment and resultant testing performed have demonstrated that the proposed design and specification changes do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices. This implies all tests were passed to demonstrate no new safety/effectiveness concerns. |

No information is provided for the following points as they are generally related to AI/algorithm performance studies, which this document does not contain:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only states that "Antimicrobial efficacies were evaluated using in vitro and in vivo methods" for the Chlorag+ard technology on the catheter, but does not provide details on sample sizes, ground truth, or expert involvement for these specific tests. The VPS Stylet's function is described as providing "real-time catheter information by using the patient's physiological (cardiac electrical activity and blood) information," leading to a "Blue Bullseye" indicator, but no performance metrics for this guidance system itself are provided beyond acknowledging its indication and an alternative method for tip placement confirmation.

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