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Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

B. Braun Medical's Introcan Safety IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions.

This document is a 510(k) summary for the Introcan® Safety™ IV Catheter and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/CAD/imaging device.

The provided text describes a medical device (an IV catheter) and its regulatory clearance process, focusing on substantial equivalence to predicate devices rather than a performance study with defined acceptance criteria and statistical analysis to demonstrate novel efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is missing:

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

This information is not provided in the document. The document focuses on regulatory clearance based on substantial equivalence for a medical device (intravenous catheter), not an AI/CAD/imaging device with specific performance metrics like sensitivity, specificity, or F1-score.

2. Sample sized 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. The document states "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for the Introcan® Safety™ IV Catheter." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

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 provided. As this is a physical medical device (IV catheter), the concept of "ground truth" and "experts" for establishing it in the context of an AI/CAD/imaging device's performance study does not directly apply here. The "functional testing" mentioned would typically involve engineering and biocompatibility tests, not expert interpretation of outputs.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not described for this 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/provided. An MRMC study is relevant for AI/CAD systems that assist human readers (e.g., radiologists). This document describes an IV catheter, which is a physical medical device, not an AI system.

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

This information is not applicable/provided. This document describes an IV catheter, which is a physical medical device, not an algorithm.

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

This information is not provided. For physical devices like an IV catheter, "ground truth" would relate to meeting engineering specifications, biocompatibility, and functional requirements (e.g., flow rate, pressure resistance, needle stick prevention efficacy). The document refers to "functional testing" but does not detail the specific ground truth metrics or how they were established.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for AI/machine learning models. This document describes a physical medical device.

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

This information is not applicable/provided. As above, this concept applies to AI/ML model development, not the regulatory submission for a physical IV catheter.

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