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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

The EZ-IO System previously cleared with K14117 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.

Study Details

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

   • Sample Size (Test Set): 121 evaluable subjects.
     • 79 healthy volunteers
     • 39 with diabetes only
     • 3 with diabetes and renal insufficiency
   • Data Provenance: US single-site, prospective clinical IDE trial.

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

   • Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.

3. Adjudication method for the test set:

   • Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.

4. 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. This is not an AI/imaging device. It is a medical device for vascular access.

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

   • N/A. This is not an AI/algorithm device.

6. The type of ground truth used:

   • Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.

7. The sample size for the training set:

   • N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.

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

   • N/A. As above, no training set in the AI sense was used.

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The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

The Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.

The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems.

Instead, the document is a 510(k) summary for a medical device (Arrow Quickflash Arterial Catheterization Device) and focuses on demonstrating substantial equivalence to a predicate device. The information provided pertains to:

• Substantial Equivalence: The primary goal is to show the new device is substantially equivalent to an older, legally marketed predicate device (Arrow Radial Artery Catheterization Set K810675). This is achieved through comparisons of indications for use, technological characteristics, and non-clinical testing.
• Technological Characteristics Comparison: A table compares design features of the predicate and subject device (e.g., catheter body OD and length, material, blood flashback visualization, integrated guidewire, sterilization method).
• Nonclinical Testing: A list of bench tests performed for design verification (e.g., biocompatibility, corrosion resistance, leakage, tensile testing, luer testing, simulated use, penetration/insertion force, kink resistance, dimensional verification, needle flexing, spring wire guide flexing, catheter resistance to collapse).

Therefore, I cannot provide the requested information about acceptance criteria and device performance as this document does not contain such details relevant to AI/ML or comparative effectiveness studies.

Here's why the requested information cannot be extracted from the provided text:

1. AI/ML Context: The device is an "Arterial Catheterization Device" and appears to be a physical medical instrument, not an AI/ML software device.
2. Acceptance Criteria & Performance Metrics: The document lists nonclinical testing to demonstrate safety and performance relative to the predicate, but these are not the "acceptance criteria" and "reported device performance" in the sense of accuracy, sensitivity, specificity, or other statistical measures typically associated with AI/ML model evaluation.
3. Study Details (Sample Size, Ground Truth, Experts): Since it's not an AI/ML product study, there is no mention of training sets, test sets, data provenance, expert ground truth, adjudication methods, or MRMC studies.

In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specifics required to answer your prompt, which seems to imply an AI/ML driven device evaluation.

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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 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 device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.

The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC) is a short-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in a 12 Fr. triple-lumen configuration with usable lengths of 16-25 cm. The catheters can be used for the injection of contrast media. The maximum recommended pressure injection flow rate is 6 mL/sec.

The catheters are packaged sterile with various components to facilitate insertion.

This document is a 510(k) summary for a medical device called the "Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions," not a study describing AI algorithm. It details the device's indications for use, its substantial equivalence to predicate devices, and non-clinical testing performed.

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance because the provided text is about a physical medical device (a catheter) and does not mention any AI component or algorithm.

Specifically, there is no mention of:

• Acceptance criteria table and reported device performance for an AI algorithm.
• Sample size for a test set, data provenance, ground truth establishment, or expert qualifications for an AI study.
• Adjudication methods for an AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance of an AI algorithm.
• Ground truth types for an AI algorithm.
• Training set sample size or ground truth establishment for an AI algorithm.

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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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