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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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The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.

The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.

1. Acceptance Criteria and Device Performance:

The provided document describes a 510(k) submission for a non-AI medical device (Arrow GlideThru Peel-Away Sheath/Dilator Introducer). Therefore, the concept of "acceptance criteria" and "reported device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) is not directly applicable here.

Instead, the device's performance is demonstrated through a set of nonclinical bench tests, and the acceptance criterion is "substantially equivalent functionality to the predicate device."

• Tensile strength |
  | - Biocompatibility | Testing completed. While specific quantitative results aren't provided, the conclusion states "substantially equivalent functionality," implying successful completion and acceptable results for biocompatibility. |
  | - Sheath surface free from extraneous matter | Testing completed. Implied to meet acceptance criteria as "substantially equivalent functionality" is concluded. |
  | - Radiodetectability | The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in:
• Radiopacity |
  | - Luer testing | Testing completed. Implied to meet acceptance criteria. |
  | - Simulated Use testing | Testing completed. Implied to meet acceptance criteria. |
  | - Penetration/Insertion force | The results of comparison testing demonstrated that the GlideThru is comparable to the predicate device in:
• Penetration/Insertion force |
  | - No new safety or effectiveness issues compared to predicate device | The FDA's conclusion explicitly states: "Any differences between the subject and predicate sheath introducers do not raise new issues of safety or effectiveness. The Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath." This confirms the device met the overarching acceptance criteria for 510(k) clearance. |

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

Not applicable. This is a medical device, not an AI model, and the testing involved bench tests on the device itself, not a 'test set' of data in the AI sense. The document does not specify exact sample sizes for each bench test, but it confirms that these nonclinical tests were performed.
The data provenance is from nonclinical bench testing performed by Arrow International, Inc.

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

Not applicable. This device does not use an AI model, so there is no "ground truth" established by experts in the context of AI model evaluation. The "ground truth" for the device's performance is derived from physical measurements and observations during bench testing against predefined specifications or comparison with the predicate device.

4. Adjudication method for the test set:

Not applicable. There is no human adjudication process for a "test set" in the context of this device. The evaluation is based on objective measurements from bench 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 is not an AI-assisted device, so no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the device's performance is established through objective physical measurements and observations from nonclinical bench testing comparing the subject device to a legally marketed predicate device (Xentek Medical, Inc. Tearaway Introducer Sheath K000313). This includes:

• Tensile strength measurements
• Evaluation of biocompatibility (as per relevant standards, though specific details are not provided in this summary)
• Visual inspection for extraneous matter
• Radiodetection tests
• Luer connection tests
• Simulated use scenarios
• Penetration/Insertion force measurements

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no AI model and thus no training set, this question is not relevant.

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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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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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The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable PICC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection.

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 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 Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

• . 4 Fr, 1-Lumen, 40-55 cm catheter preloaded with VPS Stylet
• 5 Fr, 2-Lumen 40-55 cm catheter preloaded with VPS Stylet ●
• 6 Fr, 3-Lumen 40-55 cm catheter preloaded with VPS Stylet .

The Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable 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 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 Arrow PICC powered by Arrow VPS Stylet in which the Arrow PICC is provided pre-loaded with the Arrow VPS Stylet.

The provided text, K121941, describes a 510(k) premarket notification for a medical device (Arrow PICC powered by Arrow VPS Stylet). It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with acceptance criteria and performance data for a new device's efficacy or accuracy.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new AI/software-driven diagnostic or treatment device.

Here's why and what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence. The "performance" discussed relates to physical characteristics like tensile strength and burst pressure for the catheter and stylet, not a clinical performance metric.

2. Sample size used for the test set and the data provenance: Not applicable for clinical performance. The nonclinical testing mentioned (tensile strength, burst, etc.) would have its own sample sizes, but these are not provided. There's no "test set" of clinical data for AI performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for AI performance.

4. Adjudication method: Not applicable. No clinical ground truth was established for AI performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it was not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, it was not. The VPS Stylet provides "real-time catheter tip location information" using physiological data, but this is a real-time guidance system, not an "algorithm only" diagnostic.

7. The type of ground truth used: For the "guidance and tip positioning" aspect, the VPS System uses "patient's physiological (cardiac electrical activity and blood flow) information" to indicate "desired location." The "ground truth" for confirming tip placement after using the device is still external verification (e.g., fluoroscopy or chest x-ray if a steady Blue Bullseye is not obtained). The submission claims the VPS System is an alternative method to fluoroscopy or chest x-ray when a steady Blue Bullseye is obtained. This implies that the 'Blue Bullseye' indicator is the surrogate for correct placement, but the document doesn't detail the validation of this 'Blue Bullseye' against an independent gold standard in a study context.

8. The sample size for the training set: Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be.

9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The submission K121941 is for a combination device: the "Arrow PICC powered by Arrow VPS Stylet." The core of the submission relies on demonstrating substantial equivalence to existing, already cleared devices:

• K103255: Vascular Positioning System (VPS System) Stylet
• K113277: Arrow ADVANTAGE Pressure Injectable Peripherally Inserted Central Catheter (PICC)
• K080604: Pressure Injectable PICC

The argument is that combining these two previously cleared devices "does not raise new issues of safety or effectiveness."

Nonclinical Testing:
The document states that "Nonclinical Testing" was performed for:

• Catheter performance: tensile strength, and burst tests.
• Stylet performance: tensile, Hi-pot, continuity, and removal testing.

The results of these tests "demonstrate that the Arrow PICC powered by Arrow VPS Stylet is as safe, as effective and performs comparably to the predicate VPS stylet and Pressure Injectable PICC." However, specific acceptance criteria or detailed numerical results from these tests are not provided in this summary.

In conclusion, this 510(k) summary focuses on demonstrating that a combination of two already-cleared physical devices is substantially equivalent to those individual devices, without presenting new clinical performance data or acceptance criteria for a novel AI/software component as requested.

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The ArrowEVOLUTION™ 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 injector equipment used with the ArrowEVOLUTION™ 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 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 or vein thrombosis.

The ArrowEVOLUTIONTM 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 is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 5 5 em. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 rnL/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 catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.

This is a 510(k) premarket notification for a medical device (PICC). It does not appear to describe a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on non-clinical testing (in vitro and in vivo animal studies) for antithrombogenic effectiveness, and antimicrobial properties.

Therefore, I cannot provide the specific information requested in points 1 through 9 because the provided text does not contain details of a clinical study with acceptance criteria and reported device performance in terms of metrics like sensitivity, specificity, or reader improvement with AI.

The document states:

• Nonclinical Testing: "In vitro and in vivo testing was performed to assess the antithrombogenic effectiveness of the proposed device. Testing included in vitro thrombogenicity (platelet adhesion) and patency and in vivo animal studies comparing the proposed device and the predicate Zeus device. The ArrowEVOLUTION™ catheter performed as well as or better than the Zeus predicate device in both in vitro testing making the proposed device substantially equivalent to the Zeus predicate in terms of technological performance."
• No Correlation to Clinical Outcome: "Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained."

This indicates that the evaluation was primarily based on laboratory and animal studies, not a human clinical trial that would typically define acceptance criteria based on performance metrics against a ground truth established by experts.

Summary of available information relevant to your request, but not meeting all points:

• Study described: Non-clinical (in vitro and in vivo animal studies) comparing the proposed device to a predicate device (Zeus™ CT PICC, K083763).
• Purpose of study: To assess antithrombogenic effectiveness and support substantial equivalence.
• Outcome: The proposed device performed "as well as or better than" the predicate device in in vitro testing.
• Ground Truth: In this context, the "ground truth" would be the direct measurement of thrombogenicity (platelet adhesion) or patency in the laboratory/animal models, rather than a clinical outcome or expert consensus on images.
• No human-in-the-loop or standalone AI: This is a physical medical device, not an AI/software device.

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