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The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated one directional septum, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing. This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used intravascularly with power injectors for which the maximum pressure setting is 300 psi with a luer lock connection only.

The provided text is a 510(k) Summary for the B. Braun Introcan Safety® 2 IV Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about an AI/ML powered device. As such, information typically found in acceptance criteria and study descriptions for AI/ML devices (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present.

However, I can extract the acceptance criteria and the types of studies performed that validate the device's performance based on the provided FDA 510(k) summary.

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

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

The document provides no information regarding sample sizes for test sets. The studies performed were bench tests and biocompatibility evaluations, not clinical studies involving patient data.

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 section is not applicable as the studies conducted were non-clinical bench tests and biocompatibility assessments, which do not typically involve human experts establishing ground truth in the way described for AI/ML performance evaluation.

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

This section is not applicable. Adjudication methods are relevant for studies involving subjective human interpretation, which is not the case for the bench testing described.

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 study was performed. The device is a physical intravascular catheter, not an AI-powered diagnostic or assistive tool. The document explicitly states, "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

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 device, not an algorithm.

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

For the bench tests, the "ground truth" consisted of established engineering and medical device standards (e.g., ISO 10555-1, ISO 10993-1) and internal specifications. For instance, flow rate was measured against an expected flow rate for that catheter size, and burst pressure was tested against a standard definition of failure.

8. The sample size for the training set

This is not applicable as there is no training set for a physical medical device.

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.

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