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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.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the sample sizes for each performance test. It mentions "Testing was performed on the worse case configuration of the system" for biocompatibility. The tests are general device performance and biocompatibility tests, not clinical studies with patient data.

• Sample Size for Test Set: Not explicitly stated for each individual test. It mentions "worse case configuration" for biocompatibility testing. These are laboratory/bench tests, not studies on patient data.
• Data Provenance: Not applicable in the context of patient data for a test set. This refers to laboratory and bench testing performed by the manufacturer, Terumo Medical Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcomes. The performance tests are objective engineering and biological evaluations, not dependent on expert interpretation of clinical data for a test set.

4. Adjudication method for the test set

This is not applicable. The performance tests are objective measurements against predefined specifications, not subject to adjudication by multiple experts in the way clinical diagnostic interpretations would be.

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

This is not applicable. The device is a medical instrument (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For the performance tests, the "ground truth" refers to established engineering standards, material specifications, and biological testing protocols (e.g., ISO, USP, ASTM standards for biocompatibility and physical properties). For example, for "Needle OD," the ground truth would be the specified diameter range from the design documents. For biocompatibility tests, the ground truth is defined by the limits and criteria set forth in the referenced ISO and ASTM standards.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI model requiring a training set.

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

This is not applicable. The device is a physical medical instrument, not an AI model.

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