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The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system.
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein.

Each Smiths Medical Peel-Away Sheath Introducer consists of a dilator and a peelable sheath. Both the dilator and the sheath have a hub at the proximal end. The dilator slides inside the sheath and the hubs are engaged so that sheath and dilator may be manipulated as a single unit. One version of the Smiths Medical Peel-Away Sheath Introducer has a valve on the proximal end of the hub.

The introducers are available in French sizes ranging from 6 to 11. Interior diameters of the sheath range from .085 to .147 inches. Outside diameters range from .116 to .182 inches. The length of the dilator for the non-valved introducer is nominally 8 inches from hub to tip with a 6 inch sheath. The dilator for the valved introducer is 7 inches long with a 5 inch sheath.

The Peel-Away Sheath Introducer is used to facilitate the insertion of a catheter into the vascular system by dilating a vessel and introducing the sheath. The hubs are then disengaged and the dilator is removed leaving the sheath through which a catheter may be inserted. The sheath hubs are then broken and the sheath is peeled away and removed from the catheter.

The provided document is a 510(k) premarket notification for a medical device (Smiths Medical Peel-Away Sheath Introducers). It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm or clinical performance measures.

This document describes a regulatory submission for a physical medical device, focusing on substantial equivalence to predicate devices, non-clinical testing (physical properties, biocompatibility), and indications for use. It explicitly states that "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Smiths Medical Peel-Away Sheath Introducer."

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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