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Introcan Salety® 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 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 septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed 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 325 psi with a luer lock connection only.

This document is a 510(k) Pre-market Notification for the Introcan Safety® 2 IV Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets novel acceptance criteria through a standalone study structured like a diagnostic AI performance evaluation. Therefore, many of the requested elements (like MRMC studies, number of experts, training set details) are not applicable or provided in the context of this regulatory submission for a physical medical device.

However, based on the provided text, I can extract information related to the device's performance and the non-clinical testing conducted to support its substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established based on international standards (e.g., ISO 10555-1, ISO 10555-5) and internal specifications. The reported performance is presented as the device successfully passing or meeting these criteria, particularly highlighting the changes from the predicate device.

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

The document describes non-clinical bench testing rather than clinical studies with human data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable.

• Sample Size: Not explicitly stated as a single number across all tests. The testing section lists various tests performed (e.g., ISO standards, internal specifications). For each test, an appropriate number of device samples would have been used to demonstrate compliance, but specific counts are not provided in this summary.
• Data Provenance: N/A, as this is bench testing of physical devices, not clinical data provenance (country of origin, retrospective/prospective). The tests were conducted internally by B. Braun Medical Inc.

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

N/A. This is a physical device, and the "ground truth" for its performance is established through adherence to engineering standards and protocols, not through expert human interpretation of clinical data as would be done for a diagnostic AI.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for bench testing of a physical 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

N/A. This is a physical medical device, not an AI diagnostic tool. No MRMC study was performed, nor would it be relevant for this type of device.

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

N/A. This is a physical medical device. It does not involve an algorithm, so "standalone performance" in the AI sense is not applicable.

7. The type of ground truth used

The "ground truth" for this device's performance is compliance with established international consensus standards (ISO 10555-1, ISO 10555-5) and internal engineering specifications and test protocols. These standards define measurable performance characteristics (e.g., flow rate, burst pressure, air tightness) that the device must meet.

8. The sample size for the training set

N/A. This device is not an AI algorithm and therefore does not have a "training set."

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

N/A. Not applicable, as there is no training set for a physical medical device.

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The Introcan Safety® 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids and blood intravascularly. The catheters may be 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 that controls the flow of blood during and after cannulation, 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, the needle is withdrawn 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 needleshielding 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 devices will be available in 18, 20, 22, and 24-gauge versions with and without a stabilization platform.

The document does not describe the acceptance criteria and study for an AI/ML powered medical device. Instead, it is a 510(k) summary for the Introcan Safety® 2 IV Catheter, a physical medical device. Therefore, the requested information about acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training is not present in the provided text.

The document discusses non-clinical bench testing to demonstrate the device performs as intended and is substantially equivalent to a predicate device. This testing includes:

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

The document does not explicitly present a table of acceptance criteria for a device performance metric in the context of an AI/ML algorithm. However, it does list specific performance characteristics and indicates "Same per size" for gravity flow rate when compared to the predicate device, implying that the acceptance criterion for flow rate is to match the predicate's performance for equivalent sizes.

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 mentions "Bench testing performed" and "verification testing" but does not specify sample sizes for these tests. It also does not provide information on data provenance as it refers to laboratory/bench testing of a physical device, not data for an algorithm.

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 present in the document because the device is a physical medical device, not an AI/ML software. Ground truth for an AI algorithm is not relevant here.

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

This information is not applicable and not present in the document.

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 present in the document. The device is a physical IV catheter, not an AI-assisted diagnostic or clinical decision support tool.

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

This information is not applicable and not present in the document.

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

Not applicable as this is a physical device. Performance is assessed against established engineering standards and internal specifications for physical properties and functionality.

8. The sample size for the training set:

Not applicable as this is a physical device and does not involve AI/ML training data.

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

Not applicable as this is a physical device and does not involve AI/ML training data.

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