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The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy

The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.

The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

The provided text describes the Terumo Medical Corporation's Pinnacle Precision Access System and its premarket notification (510(k) summary) to the FDA. This document is for a medical device (catheter introducer) and therefore does not involve AI or machine learning. As such, many of the requested categories related to AI model evaluation are not applicable.

Here's the information that can be extracted or deduced from the provided text, along with an explanation for categories that are not applicable:

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

The acceptance criteria are generally implied by the successful passing of the listed performance tests. The reported device performance is that it "successfully passed all of the following performance tests." Specific quantitative thresholds for "acceptance" are not explicitly detailed in the summary but are inherent in the "pass" result for each test.

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