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The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp. The catheter is intended for short-term use to permit delivery of infusion therapies. infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance Extended Dwell Peripheral Catheter System is available in single lumen, 18 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The provided document is a 510(k) summary for the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K163513). It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but it does not include performance data typically found in clinical studies, nor does it define acceptance criteria in a quantifiable manner for device performance.

Therefore, many of the requested items cannot be answered from the provided text. The document focuses on demonstrating that modifications made to an existing device (guide wire design and catheter release colorant) do not raise new questions of safety or efficacy.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in a quantifiable table format. The document implies acceptance criteria are met if the device performs comparably to the predicate and passes standard tests.
• Reported Device Performance: Not provided in quantifiable metrics. The document states that testing "verified that the changes presented no different questions of safety or efficacy" and that "the results of the risk assessment and resultant testing performed have demonstrated that the proposed guide wire design and catheter release colorant change present no different questions of safety or effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: The testing is "Bench testing," meaning it's performed in a laboratory setting, not with human or animal subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable.

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

• Not applicable. This is not a study involving ground truth established by human experts for a diagnostic or interpretative AI device.

4. Adjudication method for the test set:

• Not applicable. This is not a study involving human adjudication of 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:

• Not applicable. This document describes a medical device (catheter system), not an AI imaging or diagnostic algorithm. No MRMC study 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:

• Not applicable in the context of expert consensus, pathology, or outcomes data, as this is bench testing for a physical device. The "ground truth" for this type of testing is largely based on engineering specifications, material properties, and performance against established industry standards (e.g., ISO 10993-1, ISO 11070).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of what can be extracted/inferred from the document:

• Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System
• Purpose of the Submission: To demonstrate substantial equivalence for a modified version of an already marketed device (K152272 & K151513). The modifications are a guide wire design change (shortening flexible distal portion, removal of stainless steel coil/spring) and a catheter release colorant change.
• Nonclinical Testing Performed: Bench testing, including:
  • Biocompatibility (in accordance with ISO 10993-1)
  • Applicable requirements from ISO 11070 (Surface: Extraneous Matter and Defects, Surface: Lubricant, Guide wire Radio Detectability, Guide wire Fracture, Guide wire Flexure, Guide wire Tensile)
  • Guide wire Stiffness
  • Simulated Use Testing
• Conclusion of Testing: The testing verified that the changes presented no different questions of safety or efficacy, and the device is considered substantially equivalent to the cited predicate devices.

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The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media. The maximum pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). 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 and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic 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 or vein thrombosis.

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 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 a 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. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

The provided text is a 510(k) summary for the "Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. It does not describe a study to prove a device meets acceptance criteria for an AI/algorithm-based medical device.

Instead, this document details the substantial equivalence of a physical medical device (a catheter) to existing predicate devices based on design characteristics, materials, and non-clinical performance testing. The "Chlorag+ard Technology" mentioned refers to a coating on the catheter that has antimicrobial and antithrombogenic properties, which were evaluated using in vitro and in vivo test methods. This is not an AI or algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input document is for a physical medical device, not an AI/algorithm-based one.

If you can provide a different document that describes an AI/algorithm-based medical device, I would be happy to then attempt to answer the questions you've posed.

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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
• < 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene ● (PTFE)
• Intravascular electrocardiogram (ivECG) signal sensing consists of a platinumiridium (Pt/Ir) conductor band assembly
• Doppler transducer connected to coaxial cable at the distal end
• Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in ● to VPS Console or extension cable (that in turn connects to the VPS Console)
• Tuohy-Borst adapter
• . Marking accessory

The Arrow VPS Stylet PLUS is for use in a hospital setting by trained clinicians. The Arrow VPS Stylet PLUS is the stylet portion of a vascular positioning system designed to be used with the VPS Console and a market-available catheter. The Arrow VPS Stylet PLUS body is a polyimide tube with a fluoropolymer (PTFE) coating. The tubing contains a Doppler sensor on a coaxial cable and an intravascular electrocardiogram (ivECG) signal sensing platinum-iridium (Pt/Ir) conductor band with an intermediate stainless steel cannula that is welded to the stainless steel ECG wire. The stainless steel portions of the ECG conductor are encased within the platinum-iridium band. The Doppler sensor and the only exposed portion of the ivECG, i.e. the platinum-iridium band, 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 be plugged into the VPS Console or to an extension cable (that in turn connects to the VPS Console).

The CG+ Arrow PICC Powered by Arrow VPS Stylet PLUS is the Arrow VPS Stylet PLUS preloaded into a 4.5 Fr 1-Lumen, 5.5 Fr 2-Lumen, 40-55 cm pressure injectable Chlorag+ard Peripherally Inserted Central Catheter (PICC).

The CG+ Arrow 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 iniection of contrast media. The external catheter body and the internal fluid path of the device are treated with Chlorag+ard, a Chlorhexidine-based coating technology.

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 Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guidewire into a peripheral vessel. Throughout catheter insertion. blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub, vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device.

The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood.

The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 18, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

Here's a breakdown of the acceptance criteria and study information for the Arrow Endurance™ Extended Dwell Peripheral Catheter System, based on the provided document:

This document describes a 510(k) submission for a product line extension of an already cleared device, not an entirely new device with a standalone performance study in the traditional sense of evaluating an AI or diagnostic algorithm. Therefore, many of the typical questions for AI/algorithm performance (like sample sizes for test sets, ground truth establishment for training sets, MRMC studies, etc.) are not applicable in this context. The core of this submission is demonstrating substantial equivalence to a previously cleared predicate device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting established international standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is essentially the successful completion of these tests.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (as applicable to a 510(k) of this nature)

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

   • The document does not specify a "test set" in the context of an algorithm's performance with a specific number of patient cases. Instead, it refers to bench testing performed on physical samples of the new catheter configurations (18 gauge and 22 gauge, 6cm and 8cm lengths).
   • Data Provenance: The testing was conducted by Arrow International, Inc.
   • The nature of the testing is retrospective in the sense that physical samples were manufactured and then subjected to various engineering and biological tests. It is not patient data.

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

   • Not Applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for these tests is defined by engineering specifications, international standards (ISO, EN), and regulatory guidance (CDRH).

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

   • Not Applicable. As there are no human interpretations or disagreements to resolve, no adjudication method is used.

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:

   • Not Applicable. This device is a peripheral catheter system, a physical medical device, not an AI or diagnostic tool. Therefore, no MRMC study was conducted.

5. 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.

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

   • The "ground truth" for the performance of the catheter is based on engineering specifications, established international standards (ISO, EN), and regulatory guidance (CDRH Sharps Guidance). For example, passing particular flow rate tests, achieving specific tensile strength, or demonstrating a certain level of biocompatibility according to defined protocols and limits.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of machine learning for this physical device.

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

   • Not Applicable. As there is no training set for an algorithm, this question is not relevant.

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