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BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure or administer fluids. This device 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. This device is suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.

BD Nexiva™ Diffusics™ Closed IV Catheter Systems (Nexiva Diffusics) and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (Nexiva Diffusics with Max Zero) are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ Catheter Material with three side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge-specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package.

A BD MaxZero™ device with protective cover is provided in the unit package for BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector kit. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needle stick injury.

These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. The stabilization platform and Luer connector are color coded to indicate 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).

The provided FDA 510(k) clearance letter and summary for the BD Nexiva™ Diffusics™ Closed IV Catheter System does not contain information related to software, artificial intelligence, or diagnostic imaging. Therefore, it is impossible to describe acceptance criteria and study details related to a device using AI, ground truth, expert readers, or sample sizes for training/test sets as requested in the prompt.

The document pertains to a physical medical device (an IV catheter system) and its substantial equivalence to predicate devices, focusing on:

• Indications for Use: Changes to include "blood pressure monitoring indication" for one of the devices.
• Physical Characteristics: Materials, dimensions, sterilization, and packaging components.
• Performance Testing: Mechanical and functional tests relevant to IV catheters (frequency response, kink resistance, blood fill time, luer lock performance, packaging integrity).

There is no mention of:

• A device that uses AI.
• Any form of image analysis, signal processing, or diagnostic output that would require a "test set," "ground truth," "expert consensus," "human-in-the-loop performance," or "MRMC comparative effectiveness study."
• Specific acceptance criteria percentages for sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device performance.
• Training or test data sets, data provenance, or the number/qualifications of experts for labeling or adjudication.

The questions in the prompt are designed for a different type of medical device submission, specifically those involving software as a medical device (SaMD) or AI/machine learning components for diagnostic or prognostic purposes.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information.

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The BD Nexiva™ Diffusics™ Closed IV Catheter System is intended to be inserted into a patient's vascular system for short term use to sample blood 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) when access ports not suitable for use with power injectors are removed.

BD Nexiva™ Diffusics™ Closed IV Catheter Systems are over-the-needle, intravascular (IV) catheters. These devices have a radiopaque BD Vialon™ catheter material with three side holes located near the tip of the catheter which are designed to optimize power injection procedures. These devices also have a needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, Luer connector, and vent plug. The Luer connector displays gauge specific maximum flow rate and the maximum power injector pressure limit setting. The needle and catheter are protected by a needle cover. An end cap with protective cover is provided in the unit package. A BD MaxZero™ device with protective cover is provided in the unit package.

This document is a 510(k) Premarket Notification from the FDA regarding the BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector. It determines that the device is substantially equivalent to a legally marketed predicate device.

The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically related to an AI/Machine Learning device. However, this document does not describe an AI/Machine Learning device or any AI/ML performance studies. It pertains to a physical medical device (an IV catheter system).

Therefore, I cannot provide the requested information for acceptance criteria and study proving device meets criteria in the context of an AI/ML device from this document.

The document primarily focuses on demonstrating substantial equivalence of the new catheter system to a previously cleared predicate device (K173354) by comparing technological characteristics and outlining performance tests conducted on the physical device.

Here's what can be extracted, specific to the physical device, but it's important to reiterate that this is NOT about an AI/ML system's performance.

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

The document broadly states that "the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device." However, it does not provide specific numerical acceptance criteria or detailed reported performance values for each test. Instead, it lists the types of tests conducted:

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

The document states, "When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device." This implies that new testing was primarily conducted for the modified aspects (e.g., the longer length catheter configurations and the addition of the MaxZero™ Needle-free Connector). Specific sample sizes for these tests are not provided in this document. The data provenance would be from manufacturing and testing labs of Becton Dickinson. It's a regulatory submission for a physical device, so the data is likely prospective testing conducted to demonstrate product safety and performance. No country of origin of data is specified beyond "Becton Dickinson Infusion Therapy Systems Inc. Sandy, Utah 84070 USA."

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

This question is not applicable as this is a submission for a physical device, not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" for a physical device would be its measurable physical properties and performance under specific test conditions, established by engineering and quality control procedures, adhering to relevant ISO and ASTM standards.

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

Not applicable. Adjudication methods are typically relevant for human interpretation of imaging or other medical data in AI/ML validation studies. For physical device testing, the "adjudication" is compliance with documented, objective test procedures and acceptance criteria.

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/ML device or an MRMC study.

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

Not applicable. This is not an AI/ML device.

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

For this physical device, the "ground truth" is based on:

• Engineering specifications and design requirements: How the device is designed to perform.
• Measurement and testing against recognized standards: Compliance with ISO (e.g., 10993 for biocompatibility, 10555 for catheters, 11607 for packaging) and ASTM standards (e.g., F2096, F88/F88M-15, D4169-16).
• Internal BD requirements: Specific performance parameters defined by the manufacturer (e.g., open flow pressure, power injection peak pressure, catheter stability).

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

Not applicable. This is a physical device, not an AI/ML model.

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