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Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.

The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer sheath and a dilator. The Emcee Infusion Introducer Sheath Set may also contain a guidewire. Design features have been added to the Emcee Introducer Set (K980504) to enhance the facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. These design features include the addition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.

The provided text describes a 510(k) summary for the Emcee™ Infusion Introducer Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices and includes information about non-clinical performance testing, specifically biocompatibility. However, it does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed questions about sample sizes, ground truth, expert involvement, or multi-reader multi-case studies typically associated with AI/algorithm performance evaluations.

Therefore, I cannot populate the table or answer most of the specific questions as the provided document pertains to a medical device's 510(k) submission, not an AI/algorithm study.

Here's what can be extracted from the provided text:

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

The document mentions "non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." Specifically, it states:

Missing Information:

The document does not provide details for the following:

• Sample sized used for the test set and the data provenance: Not applicable as this is a physical medical device, not an AI/algorithm.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

The 510(k) summary primarily focuses on demonstrating the substantial equivalence of the Emcee Infusion Introducer Sheath Set to existing predicate devices (Emcee™ Introducer Set and LocalMed™ InfusaSleeve™ II). The performance testing mentioned is non-clinical, with biocompatibility being the only specifically detailed test, based on ISO 10993-1. The document does not describe any studies involving algorithms, human readers, or performance metrics typically associated with AI device evaluations.

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