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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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Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.

The provided document is a 510(k) summary for the Emcee™ Introducer Set, a medical device. It describes the device, its intended use, and states that performance testing was done, but it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

Instead, it states: "The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." It also mentions "Biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E..." and concludes the device "is considered to be biocompatible."

Therefore, based only on the provided text, I cannot fill in most of the requested information. The document focuses on regulatory approval (510(k) process) based on substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.

However, I can extract the following:

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)

• Sample size for test set: Not specified.
• Data provenance: Not specified (implied to be from non-clinical testing, likely in a lab setting).
• Retrospective or prospective: Not specified.

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)

• Not applicable/Not specified. This information would typically be relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the nature of the described "non-clinical performance testing" for an introducer set.

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

• Not applicable/Not specified, for the same reasons as point 3.

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. This is a physical medical device (catheter introducer), not an AI/imaging diagnostic device.

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

• Not applicable. This is a physical medical device.

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

• For biocompatibility, the ground truth was "International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests"."
• For other "non-clinical performance testing," the specific ground truth is not detailed but would likely involve established engineering standards, material science properties, and functional benchmarks relevant to introducer sheaths (e.g., insertion force, hemostasis, flow rates, structural integrity).

8. The sample size for the training set

• Not applicable. As a physical device undergoing non-clinical testing, there isn't a "training set" in the machine learning sense.

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

• Not applicable.

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