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BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the cather direction.

These devices are available with or without wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.

The provided document is a 510(k) summary for the BD Cathena Safety IV Catheter. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it describes a medical device (an IV catheter) and outlines its substantial equivalence to a predicate device based on technological characteristics and performance testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device from this document. The document primarily focuses on regulatory approval for the BD Cathena Safety IV Catheter, which is a physical medical device, not an AI/ML product.

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BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.

These devices are available with or without multi-access BD Multiguard™ Technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction.

These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.

The provided document is a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to specifically answer questions about acceptance criteria and comprehensive study details like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for AI/human performance studies.

The document focuses on demonstrating substantial equivalence to a predicate device (K192443) for minor modifications, primarily the introduction of 16 GA configurations and updates to specifications and instructions for use. It primarily relies on leveraging data from the predicate device and internal BD studies for specific performance tests.

Here's what can be extracted and what information is missing:

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

The document states: "Per design control requirements specified in 21 CFR 820.30, the subject devices met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices."

However, the specific "predetermined acceptance criteria" and the "reported device performance" are not explicitly listed in a table format in the provided text. The tests performed are:

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

This information is not provided in the document. The document mentions "BD Internal Studies" for some tests, but details about sample size or data provenance (retrospective/prospective, country of origin) are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a physical medical device (intravascular catheter), not an AI-powered diagnostic or decision support system that typically requires expert-established ground truth for its performance evaluation (e.g., in reading medical images). The testing involves physical properties and performance characteristics of the catheter.

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

This information is not applicable and not provided. As mentioned above, this type of testing is not relevant for the evaluation of a physical medical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This device is a physical invasive medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

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

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

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

For the performance tests conducted, the "ground truth" would be defined by engineering specifications, industry standards (e.g., ISO), and known physical properties of materials. For example, the "ground truth" for "force to break adhesion" would be a specific measurable force value derived from engineering design and safety requirements. Biocompatibility relies on well-established testing protocols and standards.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical product, not an AI system that requires a "training set" in the machine learning sense. The term "training set" is not relevant here.

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

This information is not applicable and not provided. As stated above, the concept of a "training set" and its "ground truth" is not relevant to the evaluation of this physical medical device.

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BD Cathena Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

BD Cathena™ Safety IV Catheters are over-the-needle, intravascular catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green, 16GA (1.7 mm)=Grey). These devices are not made with natural rubber latex.

This document describes a 510(k) premarket notification for the BD Cathena™ Safety IV Catheter, demonstrating its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or comparative effectiveness against human readers, as it is a physical medical device. The acceptance criteria and "study" described refer to various design verification tests and compliance with recognized standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests and standards compliance that serve as the acceptance criteria. The reported device performance is that it met all predetermined acceptance criteria.

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

The document does not explicitly state the sample sizes used for each of the performance or standards tests. It generically states "Performance tests completed on the subject device were those tests required to support a determination of substantial equivalence to the predicate devices. Design verification tests were performed based on the risk analysis." It also does not specify the origin of any data (e.g., country of origin, retrospective/prospective), as these are laboratory and simulated use tests rather than clinical data from human subjects.

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 human interpretation of medical images or data requiring expert ground truth in that sense. The "ground truth" for these tests would be derived from physical measurements and adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective physical or material property measurements, and standards compliance. There is no mention of adjudication among multiple evaluators.

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 a physical medical device (intravenous catheter and safety mechanism), not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the tests mentioned are:

• Engineering Specifications: The design specifications for the device, including dimensions, forces, pressures, and other physical properties.
• International Standards: Adherence to recognized international standards such as ISO 594, ISO 10555, ISO 23908, and ISO 10993 for various aspects like gauging, leakage, mechanical strength, sharps injury protection, and biocompatibility.
• Risk Analysis Outcomes: The design verification tests were performed based on a risk analysis, meaning acceptance criteria were likely set to mitigate identified risks.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of physical medical device design verification described here. The development of the device involves engineering design, prototyping, and iterative testing, not machine learning training.

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

Not applicable. See point 8.

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