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The SonoStik Guide Wire Introducer is used to facilitate the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The SonoStik Guide Wire Introducer is not intended for use in the coronary arteries or neurovasculature.

The SonoStik Guide Wire Introducer is intended to facilitate placing a catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, an Advancing Wheel and a guide wire. The mechanism of action of the SonoStik Guide Wire Introducer is accomplished by the Introducer Wheel and the two Advancing Wheels inside the plastic housing. The SonoStik Guide Wire Introducer housing has a "male end" connector capable of mating with the back end of the needle introducer and accurately positions the guide wire through the plastic housing and into the back end of the needle. Once mated, the Introducer and cannula/needle are used to insert the needle into the tissue or vessel. The Introducer Wheel is turned, advancing the guide wire into the vessel lumen. The device has a transparent tube at the proximal end of the device which enables the user to visualize guide wire advancement as he/she engages the introducer wheel.

The provided text describes the SonoStik Guide Wire Introducer, a device used to facilitate the introduction of a guide wire and catheter into a peripheral vein or artery. It does not describe a device that uses AI or machine learning, nor does it conduct studies that would typically require experts for ground truth, MRMC studies, or training sets for algorithms. The device is a physical medical instrument. Therefore, most of the requested information regarding acceptance criteria and studies (points 2-9) is not applicable in the context of AI/ML devices.

However, I can extract the acceptance criteria and performance data for the physical device as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states: "All devices tested passed all tests. Therefore, data and results from the above tests demonstrate that the SonoStik Guide Wire Introducer meets its performance requirements, and can be found substantially equivalent to the performance of the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each test performed. It generally states "All devices tested passed all tests." The data provenance (country of origin, retrospective/prospective) is not mentioned, as these were lab-based performance studies and not clinical trials with patient data.

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. This is a physical device, and the ground truth for its performance is established through standardized engineering and biocompatibility tests, not clinical expert consensus on images or diagnoses.

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

Not applicable. This pertains to clinical image interpretation in AI/ML studies, not the performance testing for a physical medical device.

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

Not applicable. This is not an AI-assisted 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, not an algorithm.

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

The "ground truth" for this device's performance is derived from the results of standardized laboratory and simulated use tests as per recognized international (ISO) and national (ANSI/AAMI) standards for biocompatibility, sterility, and mechanical performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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