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The Pressure Injectable PICC with Chlorag+ard Antithrombogenic Technology is indicated for shortterm or long-term peripheral 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 injection equipment used with the pressure injectable PICC may not exceed 300 psi.

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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test nethods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess 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 VPS System guidance indicator shows a Blue Bullseye, the catherer tip is in the desired location.

The VPS System is indicated for use as 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 Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in patients 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 purpose of this premarket notification is to propose design and material modifications to the subject device: the Arrow Vascular Positioning System (VPS) stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS . The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS already loaded into a central catheter. (The Arrow VPS Stylet PLUS and the Arrow VPS Stylet PLUS included in the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS are exactly the same stylet.)

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

• 6 ft overall length

This document describes the premarket notification (K153487) for the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS. It details modifications made to the device and the nonclinical testing performed to demonstrate substantial equivalence to a predicate device (K141618).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists the nonclinical tests performed and their results, which were all "PASS". The implicit acceptance criterion for each test is that the device must pass it.

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

The document describes nonclinical testing (bench testing and biocompatibility) rather than a clinical study with a "test set" from patients. Therefore, information about patient sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided. The tests were performed on the device itself.

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

Not applicable. This was nonclinical testing, not a study involving human interpretation of data where expert consensus would establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was nonclinical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. This document describes nonclinical, bench, and biocompatibility testing to demonstrate substantial equivalence of a modified medical device to a predicate device. It is not an MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.

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

No. This document pertains to a physical medical device (catheter and stylet), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established by adherence to specified international standards and guidances (e.g., ISO 10555-1, BS EN ISO 11070, ASTM F640-07, ISO 10993-1, IEC 60601 series). These standards define the test methods and criteria for acceptable functional and safety performance (e.g., tensile strength, corrosion resistance, biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm study requiring a training set. The modifications are to a physical medical device.

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

Not applicable. This is not an AI/algorithm study requiring a training set.

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The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction.

The CG+ Arrow PICC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the cather , intravascular capability for ECG delection and intravascular ultrasound for catheter guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catherer in location information by using the patient's physiological (cardiae electrical activity and blood flow) 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 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 Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraincied situations for this technique are in patients where allerations of cardias the presentation of the P-waye as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. 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 Pressure Intectable PICC with Chlorag+ard Aniithombogenic Technology is indicated for short-lerm or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of pressure of pressure injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.

Chlorag+ard Technology treatment on the external surface of the entire fluid patiway of the catheler has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheler surfaces. Antimicrobial and antitlersmoogenic effectiveness were evaluated using in viro and in vive test methods and no correlation between these test methods and clinical outcome has currently been asseriained. It is not intented of existing infections or vein thrombosis.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the catheter, intravascular capability for ECG detection and intravascular ultrasound for catherer guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catheter ip location information by using the patient's physiological (cardial activity and blood flow) 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 allemative 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 patientions of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachyeardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. 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 Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.)

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

• 6 ft overall length .

This document describes a 510(k) submission for the Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. It is a submission for substantial equivalence to previously cleared devices, meaning the focus of the study is to demonstrate that the new device performs as well as the predicate device(s), rather than establishing new clinical effectiveness. Therefore, the information provided below is extracted based on the nature of this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence for a medical device that has minor changes from existing predicate devices, the "acceptance criteria" are typically defined by demonstrating that the modified device performs comparably to the predicate device and meets established engineering and biocompatibility standards. Clinical performance is generally not evaluated with new efficacy endpoints unless the changes introduce new risks or intended uses. In this case, the acceptance criteria are largely implied by the PASS results in the nonclinical testing, indicating the device meets the set standards for each test.

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

Since this is a 510(k) submission for substantial equivalence based on nonclinical testing, there is no "test set" of clinical data in the typical sense (i.e., a set of patient data used to evaluate clinical accuracy or performance metrics against a ground truth). The testing conducted was primarily bench testing and laboratory testing on the device itself.

• Sample Size: The document does not specify exact sample sizes for each nonclinical test (e.g., how many stylets were tested for tensile strength). These are typically determined by engineering and quality control standards.
• Data Provenance: The data is generated from laboratory and bench testing performed on the Arrow VPS Stylet PLUS and the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. The origin of the data is the manufacturer's internal testing. It is not patient or country-specific. The testing was performed after preconditioning with Et.O sterilization, ISTA simulated environmental conditions, and one year of accelerated aging.

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

This section is not applicable to this submission. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy or clinical outcomes where human experts interpret data. This 510(k) submission focuses on demonstrating the device's technical specifications and safety through nonclinical testing, not on clinical interpretation or an AI algorithm's performance against human experts.

4. Adjudication Method for the Test Set

This section is not applicable as there was no clinical test set requiring adjudication by experts. The "adjudication" in this context would be the successful completion of each nonclinical test according to predefined engineering and safety standards, as indicated by the PASS results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI system on human reader performance, which is not the focus of this 510(k) submission for mechanical and electrical device changes.

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

The device described (Arrow VPS Stylet PLUS) is a physical medical instrument used to guide catheters and provides real-time information to a "VPS Console." While the VPS Console likely contains algorithms to process the ivECG and Doppler signals, this submission focuses on the stylet itself. Therefore, a "standalone algorithm performance" study in the context of AI models is not relevant or described in this document. The electrical performance tests (Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity, Sensitivity stability) assess the functionality of the device's signal-sensing components, which are essential for the console's operation.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical testing performed can be defined as:

• Engineering Specifications and Standards: Each test (e.g., tensile strength, electrical performance, biocompatibility) has predefined, objective acceptance criteria (e.g., a minimum tensile strength, a specific range for electrical resistance, absence of cytotoxic effects) based on international standards (e.g., ISO, ASTM, IEC) and the manufacturer's own design specifications.
• Predicate Device Performance: A key aspect of "substantial equivalence" in a 510(k) is demonstrating that the new device performs "as well as" the predicate device(s). Therefore, the performance characteristics of the legally marketed predicate devices serve as an implicit "ground truth" or benchmark for comparison in the nonclinical testing.

8. The Sample Size for the Training Set

This section is not applicable. This submission describes a physical medical device and its nonclinical testing to demonstrate substantial equivalence, not the development or training of an AI algorithm. Therefore, there is no "training set."

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

This section is not applicable as there is no training set for an AI algorithm.

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The Pressure Injectable PICC with Chierobial and Antitrombogenic Technology is indicated for short-erm or long-erm peripheral 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 injection equipment used with the pressure injectable PCC cathere may not exceed 300 psi.

Chlorageard Technology treament on the cather of the cather fluid pathway of the cather ins been shown to be effective in reducing microbial colonization on cather surfaces. Antimicrobial and antitrombial and antithrombogenic effectiveness were evaluated using in viro test methods and no correlation between these est methods and clinical outcome has currently been ascerained. It is not intended to be used for the treatment of existing intections or vein thrombosis.

The VPS Stylet and Console are indicated for guidening for central venous cathers. The Stylet provides stiffiess for use in placement of the catherer, intravascular conding and intravascular ultrasond for cathere guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time cather in lormation by using the patient's physiological (cardias electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Dullseye, 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 contraction of in adult patients when a steady Blue Bullsey. If a stedy Blue Bullseye is not oblained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique of earlier there allerations of cardiac the presentation of the Pwave as in attial fibrillation, arial flutter, severe achyandian driven rhythm, and in central venous catherization procedures performed through femoral or saphenous vein access which change the presents, who are easily identifiable prior to central venous catherer insertion, the use of an additional method is required to confirm catherer tip location.

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

• 6 Fr, 3-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet
  The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow CG+ PICC 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 6 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based coating technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

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 was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.

The number of lumens has increased from 2 to 3 and as a result the subject device is French size has increased from 5.5 to 6 French. In order to identify the third lumen, an additional colorant and ink were used. Additionally, the internal lumen configuration of the predicate (K123759) has changed from a "Round-Crescent" to a "Round-Split-Crescent". The "Round-Split-Crescent" internal lumen design modification resulted in an increased flowrate in the distal lumen from a maximum of 5 ml/sec. (The proximal and medial lumen are not pressure injectable on the subject device.) The increased surface area on the subject device's 6 French 3-L catheter design resulted in a 3.8 mg increase in the maximum allowable chlorhexidine content as compared to the predicate device (the content per surface area remains unchanged).

The provided text is a 510(k) summary for the "CG+ Arrow PICC powered by Arrow VPS Stylet." It describes the device, its intended use, technological characteristics, and nonclinical testing performed. However, it does not detail specific acceptance criteria or the study that explicitly proves the device meets those criteria in the format requested.

The document states that the new device (6 French, 3-Lumen) is "substantially equivalent" to a predicate device (K123759, 5.5 French, 2-Lumen) due to minor modifications that do not raise new safety or effectiveness concerns. The nonclinical testing performed primarily verified that these modifications (increased lumen count, size, and associated chlorhexidine content increase) did not negatively impact performance or safety.

Therefore, many of the requested sections (e.g., specific acceptance criteria, reported performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance details, and ground truth establishment) cannot be directly extracted from this document as it focuses on demonstrating substantial equivalence based on nonclinical testing rather than clinical efficacy against defined acceptance criteria.

Missing Information:

• Specific quantitative acceptance criteria for device performance.
• A comparative study demonstrating the device meets explicit acceptance criteria.
• Sample sizes for test sets where clinical performance is evaluated.
• Data provenance for such clinical tests.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Details of any MRMC comparative effectiveness study, including effect size.
• Details of any standalone algorithm performance study.
• Type of ground truth used (clinical outcomes, pathology, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

Information Extracted from the Document (where applicable to the questions):

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with specific quantitative targets and reported performance against them in the context of clinical efficacy or accuracy. Instead, it relies on demonstrating that modifications to the predicate device did not negatively impact existing performance characteristics based on nonclinical testing.

Nonclinical Testing Performed & Verification:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is "Nonclinical Testing," implying laboratory-based or bench testing, not clinical studies with human subjects or patient data.

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)

This information is not applicable as the document describes nonclinical, laboratory-based testing rather than studies requiring expert ground truth for clinical diagnostic performance.

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

This information is not applicable as the document describes nonclinical, laboratory-based 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

This information is not applicable. The device is a physical medical device (PICC catheter and stylet system) and not an AI-powered diagnostic or assistive tool for human readers in the context of image interpretation. The VPS Stylet aids in guidance during catheter placement using physiological signals, not in reading or interpreting clinical cases.

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

This information is not applicable in the context of an algorithm's diagnostic performance. The VPS Stylet and Console system does provide "real-time catheter tip information" and a "guidance indicator (Blue Bullseye)" based on "physiological (cardiac electrical activity and blood flow) information." This can be seen as standalone guidance performance, where the system provides an indicator of desired tip location without human interpretation of raw physiological signals. However, the document does not present a formal study of its standalone "accuracy" against a gold standard for tip placement in terms of a specific performance metric. Instead, it states the VPS System is "indicated for use as an alternative method to fluoroscopy or chest x-ray for confirmation... when a steady Blue Bullseye" is obtained, inferring its standalone guidance capability.

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

For the nonclinical testing, the "ground truth" or reference was likely defined by engineering specifications, material standards, and validated laboratory test methodologies. For the VPS Stylet's function of guiding catheter tip placement, the implicit ground truth for its "Blue Bullseye" indication would be the actual anatomical location of the catheter tip (e.g., lower third of SVC or cavo-atrial junction), which can be confirmed by "standard hospital practice" such as fluoroscopy or chest x-ray. However, the document does not detail studies comparing the Blue Bullseye to such gold standards, but rather states its indication as an alternative method.

8. The sample size for the training set

This information is not provided and is likely not applicable as this is not an AI/ML-based device that would typically have a separate "training set" in the conventional sense. The "training" for such a system would involve engineering development and calibration of the physiological sensing and analysis algorithms.

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

This information is not applicable for the reasons stated in point 8.

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The Pressure Injectable PICC with Chlorag+ard Antithrombogeaic Technology is indicated for short-term or long-term peripheral 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 injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catherer has been shown to be effective in reducing microbial colonization and thrombus accumulation on cather surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascenained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheres. The Stylet provides stiffess 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 Coasole, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) 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 alternative method to fluoroscopy or chest x-ray for central venous catherer 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 patients where alterations of cardias 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 or saphenous 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 catherer tip location.

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

• 5.5 Fr, 2-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
  The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow CG+ PICC 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. The external catheter body and the 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 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 was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.

For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet. To accommodate the VPS stylet, the internal lumen configuration of the predicate Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) has changed from a "Double-D" design to a "Round-Crescent". As a result of the internal lumen design change, the flow rate of the proximal lumen has changed from a maximum rate of 5 ml/sec to 4 ml/sec. The distal lumen flow rate remains the same as the predicate PICC (K112896).

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a comprehensive clinical study to establish new performance metrics. Therefore, some of the requested information (like specific acceptance criteria for a novel performance claim, MRMC studies, or detailed ground truth establishment for a large training set) may not be explicitly present or fully detailed as it would be in a clinical trial report.

Acceptance Criteria and Study Details for K123759

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test beyond "testing was performed." The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices (K103255 and K112896). It refers to the testing as "Nonclinical Testing," which typically involves bench testing, material characterization, and simulated use rather than studies on patient data.
• Data Provenance: The studies mentioned are "Nonclinical Testing" and were likely conducted in a laboratory setting by the manufacturer, Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated). No mention of data from specific countries or whether it was retrospective or prospective clinical data is made, as it appears to be primarily bench/engineering testing.

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

• Not Applicable / Not Stated: This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies) where human experts determine ground truth. The presented tests are non-clinical, mechanical, and performance evaluations. The "ground truth" would be objective measurements against defined engineering specifications or the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable / Not Stated: Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for endpoints requiring human assessment of data. For the non-clinical testing described, results are typically determined by direct measurement, observation, or adherence to test protocols without expert adjudication in the clinical sense.

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: The document describes a medical device (PICC catheter and a stylet for guidance), not an AI system for diagnostic or interpretive purposes. Therefore, an MRMC study or AI assistance effect size is not applicable.

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

• No: The device itself is a physical medical instrument (catheter and stylet), not an algorithm. The VPS Stylet uses physiological information for guidance, but it's part of a human-in-the-loop system (the clinician uses the guidance). There's no AI algorithm operating standalone in the context of this device's submission.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" was established based on:
  • Engineering Specifications: Adherence to predefined mechanical, material, and performance standards.
  • Predicate Device Performance: Demonstrating that the modified device performs equivalently or within acceptable limits compared to the predicate devices (K103255 and K112896).
  • Validated Test Methods: Using established methods to measure parameters like tensile strength, flow rates, leakage, chemical composition, and release rates.

8. The Sample Size for the Training Set

• Not Applicable / Not Stated: This device does not involve a "training set" in the context of machine learning or AI. The testing performed is to validate the physical device's characteristics and performance.

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

• Not Applicable / Not Stated: As there is no training set for an algorithm, this question is not relevant to the described device.

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The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral 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 injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi.

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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

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 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 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 patients 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 or saphenous 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 CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

• 4.5 Fr, 1-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic . catheter preloaded with VPS Stylet
  The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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. The external catheter body and the 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 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 was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.

For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet.

The provided 510(k) summary (K122545) describes a device, the "CG+ Arrow PICC powered by Arrow VPS Stylet," which is a combination of two previously cleared predicate devices: the Vascular Positioning System (VPS System) Stylet (K103255) and the Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896).

Crucially, this submission is for a combination device, not a new AI/software-as-a-medical-device (SaMD) product. The 510(k) summary explicitly states: "The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology; there is no change to the previously cleared devices or their indications for use."

Therefore, the document does not report on a study proving the device meets new acceptance criteria for an AI or SaMD component. Instead, the nonclinical testing performed focused on ensuring that combining the two previously cleared devices did not introduce new safety or effectiveness issues.

Given this context, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/SaMD are not applicable or not present in this document.

However, I can extract the relevant information based on the nature of this 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a combination of pre-approved physical devices, the "acceptance criteria" and "reported device performance" are primarily related to the physical integrity and continued functionality of the combined product. There are no specific performance metrics like sensitivity, specificity, accuracy, or AUC typically associated with AI/SaMD.

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

The document does not specify sample sizes for the "test set" in the context of typical AI/SaMD validation (e.g., number of images or patient cases). The testing described is nonclinical, involving engineering and bench testing.

• Sample Size: Not specified in terms of distinct units or cases. The testing would have involved appropriate numbers of devices/components to satisfy engineering test standards for the mentioned performance categories.
• Data Provenance: Not applicable as it's nonclinical, bench testing.

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

Not applicable. Ground truth for these nonclinical tests would be established by engineering specifications, physical measurements, and adherence to established test protocols. No human expert interpretation of data for ground truthing is described or required for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is not typically part of standard nonclinical engineering bench testing.

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

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission does not involve such an AI component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical catheter and stylet; it is not a standalone algorithm.

7. The Type of Ground Truth Used

For the nonclinical testing, the "ground truth" would be objective engineering measurements and compliance with predetermined physical and mechanical specifications. For example, for air and liquid leakage, the ground truth is "no leakage" beyond an acceptable threshold. For tensile strength, it's maintaining integrity under a specified load.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set for an AI/ML algorithm is involved.

In summary, the K122545 submission is for a combined medical device, not an AI or SaMD product. The testing performed focused on ensuring the physical and functional integrity of the combined components, and therefore, the document does not contain the specific details relevant to AI/SaMD performance validation.

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