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B. Braun Extension Sets are intended for direct injection, intermittent infusion, continuous infusion or aspiration.

B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.

B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. In clinical practice, extension sets are connected to primary IV sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter. An extension set attached to a catheter hub allows the clinician to perform syringe aspirations and injections away from the patient's catheter site.

Extension Sets are widely used in the clinical setting, are available in various lengths and dimensions, and may be comprised of various generic components that are broadly used throughout the industry. Various components such as stopcocks, clamps, injection sites, connectors, manifolds, filters and needleless connectors, previously cleared in 510(k)s, may be included on an Extension Set. B. Braun Extension Sets offer a range of lengths and a variety of tubing dimensions (ie: microbore, standard bore) that provide flexibility in a variety of clinical settings. B. Braun Extension Sets are configured to ensure the intended use of the device is met.

B. Braun's optional stabilization component is a non-removable component that slides on the tubing and may be firmly positioned on the patient connector, secured at the discretion of the clinician at time of use. The optional stabilization component provides additional stabilization to intravascular catheters while firmly positioned on the patient connector of the Extension Set. The optional stabilization component supports the patient connector of the extension set, reducing its contact with the skin. The geometrical design of the stabilization component supports the patient connector maintaining the catheter insertion angle, minimizing the catheter movement in the vessel and the potential for catheter kinking at the insertion site.

Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second.

B. Braun Extension Sets may be used for any patient population.

Extension Sets comprised of a female luer adapter, extension tubing, slide clamp, stabilization component and a male luer adapter with cap are included in this premarket notification. The following Extension Set configurations are subject of this submission.

• Smallbore Extension Set with stabilization component, Spin-Lock connector, removable slide clamp
• Standard Bore Extension Set with stabilization component, Spin-Lock connector, slide clamp
• Extension Set with stabilization component, Spin-Lock connector, slide clamp

This is a 510(k) premarket notification for an Extension Set by B. Braun Medical Inc. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing. It is not a study proving device meeting acceptance criteria in the sense of an effectiveness or clinical trial, but rather a submission for regulatory clearance based on performance standards.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, ground truth for test/training set, training set size) are not applicable as this document details a regulatory submission for a medical device rather than a clinical study of AI performance.

However, I can extract information related to acceptance criteria and performance testing for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met their acceptance criteria" for the performance tests conducted. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The summary lists the types of tests performed.

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

The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. The data provenance is B. Braun's internal testing facilities (implicit, as they performed the tests for their device). These are retrospective tests performed on manufactured devices for regulatory submission.

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 expert assessment of a test set for ground truth. The "ground truth" here is compliance with established performance standards and biocompatibility requirements.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI algorithm, and no MRMC study was performed or mentioned.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by compliance with recognized international ISO standards for medical devices and performance criteria derived from these standards. For biocompatibility, the ground truth is established by meeting the requirements of the ISO 10993 series.

8. The sample size for the training set

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

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

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

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