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The Medline Integrated Arterial Catheter permits access to the peripheral arterial circulation system for short-term access (less than 30 days).

The Medline Integrated Arterial Catheter is a single-use device supplied sterile and nonpyrogenic; it will be packaged inside convenience kits alongside various components outside the scope of this 510(k) submission. The proposed device is a single lumen peripherally inserted catheter device designed to permit short-term access to the peripheral arterial circulatory for less than 30 days. The device assembly comprises a 20-Gauge catheter, 22-Gauge introducer needle, and a 0.018" guidewire with slide advancer. The catheter is made of radiopaque polyurethane tubing, echogenic needle, and removable stainless steel guidewire with slide advancer. The subject device has a kink-resistant catheter design. The device features dual flash with two distinct points of visualization, one with the clear introducer needle proximal hub and the second point at the notch cutout in the needle shaft. The final finished device is packaged with a suture wing (ALCS004). The suture wing is a Class I, 510(k) exempt device.

I'm sorry, but the provided text describes a medical device submission (a 510(k) for the Medline Integrated Arterial Catheter) to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance and technological characteristics, rather than clinical studies with acceptance criteria for an AI/CADe device.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/CADe system.
• MRMC studies, standalone AI performance, or effect sizes for human reader improvement with AI assistance.
• Details on training set sample size or how ground truth for the training set was established for an AI/CADe system.

The document discusses non-clinical functional performance testing (e.g., stress cracking, leakage, kink resistance) and biocompatibility testing for a physical medical catheter, along with a comparison to predicate catheter devices. It explicitly states: "Summary of Clinical Testing: Not applicable. No clinical testing was conducted on the proposed device."

Without information about an AI/CADe device's clinical performance or a corresponding study, I cannot provide the details you've requested.

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The Arterial Catheter permits access to the peripheral arterial circulation.

The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arterial Catheter, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "flow rate must be > X mL/min"). Instead, it lists the types of performance tests conducted and generally states that the device "comply with" standards and that "performance is acceptable."

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

The document does not specify the sample sizes used for any of the non-clinical performance tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these tests, as they appear to be laboratory-based engineering performance evaluations rather than clinical data involving human subjects.

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

This information is not applicable and not provided. The "ground truth" for these tests would be established by the physical and chemical properties of the device and its direct performance against defined engineering standards, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of results or image assessment, not for direct engineering performance tests.

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 MRMC comparative effectiveness study was mentioned. The device is an arterial catheter, a physical medical device, not an AI-powered diagnostic tool. Therefore, human reader improvement with/without AI assistance is not relevant or applicable.

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

This is not applicable, as the device is a physical medical instrument and not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical performance tests (e.g., flow rate, tensile strength, leakage) is established by adherence to recognized engineering standards (e.g., ISO 10555-1, ISO 10993-1, ISO 11607-1, ISO 11135) and the physical properties and measured performance of the device against predefined specifications derived from those standards. For biocompatibility, it's based on the material's interaction with biological systems as assessed by specific tests.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device like this catheter.

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The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The Merit RadialFlo Arterial Catheter is an intravascular catheter designed to access the vasculature to sample blood and monitor blood pressure. The device is equipped with a Floswitch to limit blood spill or control flow as needed. The needle includes a unique notch to provide instant blood return upon vessel entry. The radiopaque catheter provides visibility under X-ray and fluoroscopy.

The arterial catheter is intended to be in contact with the circulating blood for a prolonged (24 hours to 30 days) duration. The steel needle is in contact with circulating blood for a limited (

The provided text describes the Merit RadialFlo Arterial Catheter, which is an intravascular catheter for short-term use (less than 30 days) to sample blood and monitor blood pressure. The document focuses on regulatory approval (510(k) submission) and demonstration of substantial equivalence to predicate devices, rather than a study proving the device meets explicit clinical outcome acceptance criteria in an AI context.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this documentation, as it pertains to a medical device's physical and biological performance rather than an AI/ML diagnostic or prognostic system.

However, I can provide information on the device's acceptance criteria based on the regulatory standards it meets and its reported performance against those technical standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes a series of bench tests and biocompatibility tests to demonstrate that the Merit RadialFlo Arterial Catheter meets established safety and performance standards for its intended use. This is a traditional medical device approval process, not an AI/ML software validation.

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

• Sample size: Not explicitly stated as a single "test set" in the context of an AI/ML study. The studies refer to "a battery of tests" and "results of the testing" which typically involve specific numbers of devices or test samples for each individual test (e.g., a certain number of catheters for tensile strength, a certain number of samples for cytotoxicity testing). These numbers are not provided in the summary.
• Data provenance: The tests are conducted according to internationally recognized consensus standards (ISO, ASTM, IEC, USP). This implies controlled laboratory settings and standardized methodology, rather than patient data from a specific country or retrospective/prospective clinical data.

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

• Not applicable. Ground truth in this context refers to the defined acceptance criteria of the technical and biological standards, not expert medical opinion on a specific condition.

4. Adjudication method for the test set:

• Not applicable, as this refers to a medical device's physical and biological performance against predefined technical standards, not interpretation of data by human readers.

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 device is a physical intravascular catheter, not an AI/ML diagnostic or assistance tool.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used:

• Technical Standards and Specifications: The ground truth for performance is established by the acceptance criteria defined within the referenced international standards (ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 9626, IEC 62366-1, ISO 2233, ISO 11607-1, ISO 11607-2, ASTM D4169-16, ASTM F1980-16, ISO 11135, AAMI TIR 28, AAMI/ANSI ST72).
• Biological Compatibility Principles: The ground truth for biocompatibility is established by the acceptance criteria defined within the referenced international standards (ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-7) and the United States Pharmacopeia 41.

8. The sample size for the training set:

• Not applicable. This type of device approval does not involve a "training set" in the context of AI/ML.

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

• Not applicable.

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The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is used to gain access to the vascular (e.g. arterial) system to sample blood, administer fluids, and monitor blood pressure intravascularly.

The ARTERIAL WAND™ Safety Introducer with Arterial Catheter made of ChronoFlex C® with BioGUARD™ Technology is an all-in-one preassembled device that combines the functionality of a catheter introducer system with an arterial catheter. The ARTERIAL WAND™ is used to gain access to the vascular (e.g. arterial) system to insert the arterial catheter. The arterial catheter may then be left in place for a period of

I am sorry but this document does not contain the information required to answer your request. This document is related to a Medical Device Application for a catheter, and the questions are related to AI/ML device testing.

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The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

The subject Arrow Seldinger Arterial Catheterization Devices consist of either an introducer needle or catheter-over-needle assembly, spring wire guide, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a luer hub with dust cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique.

The provided text describes a 510(k) summary for the Arrow Seldinger Arterial Catheterization Device, which is a medical device and not an AI/ML powered device. Therefore, the information requested regarding acceptance criteria and study details for an AI-powered device (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (K093050) through nonclinical bench testing, rather than proving performance against specific acceptance criteria for an AI/ML algorithm.

Here's a summary of the nonclinical testing performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI medical device and the document describes nonclinical bench testing for substantial equivalence rather than an AI performance study, there isn't a direct "acceptance criteria" table with numerical performance metrics for an algorithm. Instead, the "acceptance criteria" can be inferred from the "applicable requirements" of the referenced ISO standards, and the "reported device performance" is that the device met these requirements, thus supporting substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing for a physical medical device, not a test set for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" for a physical device would be compliance with engineering specifications and ISO standards, which is evaluated through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to establishing ground truth for AI model evaluation, which is not being done here.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. For the device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1, ISO 10555-1, ISO 11070) and internal design specifications.

8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.

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

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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 catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.

This document describes a medical device, the Versa-Cath Arterial Catheter, for which a 510(k) premarket notification was filed (K961883). The provided text is a summary of the device description and its substantial equivalence argument, not a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details because the input does not contain information about acceptance criteria or a study that evaluated the device's performance against specific criteria. The document focuses on describing the device, its intended use, and materials to establish substantial equivalence to predicate devices, which is a regulatory pathway, not a performance study.

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