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The Prelude® Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Merit Medical System's Prelude Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The device is marketed with and without an appropriately sized guide wire and/or needle. The subject sheath introducers have a radiopaque marker tip.

The provided text describes a medical device, the Prelude® Sheath Introducer, and its 510(k) submission. However, it does not contain the detailed information requested regarding acceptance criteria, specific device performance metrics in a study, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The text only generally states:

• "Verification and Validation Studies, conducted to demonstrate control of hazards identified in Merit's Clinical Risk Assessment, demonstrate that the modified devices met all of their pre-determined acceptance criteria and acceptably control the identified hazards."

This statement confirms that some studies were done and that some acceptance criteria were met, but it does not provide the specifics of those criteria or the actual performance results.

Therefore, I cannot populate the table or provide specific answers to most of the questions based on the input text.

Information not available in the provided text:

1. A table of acceptance criteria and the reported device performance: The text only generally states that "pre-determined acceptance criteria" were met, but does not list the criteria or the specific performance results.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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