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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 the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature. The device consists of a plastic housing containing an Introducer Wheel, Advancing Wheels, 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 a compatible 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 they engage the introducer wheel.

The SonoStik Guide Wire Introducer is compatible with and intended to be used with the MedSource Labs VeroTrue Conventional IV Catheter (K193278 catheter and needle set in 18-, 20-, and 22-gauge sizes.

The provided text is a 510(k) summary for the SonoStik Guide Wire Introducer. It describes a medical device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

However, the questions you asked are largely related to software as a medical device (SaMD) or AI/ML-enabled medical devices, specifically in the context of diagnostic performance evaluation using methodologies like MRMC studies, ground truth establishment by experts, and analysis of metrics like sensitivity, specificity, or AUC.

The SonoStik Guide Wire Introducer is a physical medical device, not software or AI. Therefore, the information typically requested for AI/ML device acceptance criteria and performance studies (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, effect size of human reader improvement with AI assistance, standalone algorithm performance, type of ground truth like pathology or outcomes data) is not relevant and not present in this document.

The document focuses on the physical and functional aspects of the device.

Here's what can be extracted from the document regarding the device's evaluation, though it won't directly answer most of your detailed questions about AI/ML device performance:

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

The document broadly states: "Testing found the SonoStik Guide Wire Introducer met all applicable acceptance criteria associated with the introduction of a guide wire and catheter through the skin into a vein or artery of the peripheral vasculature."

The specific acceptance criteria are not detailed in a table, but the types of tests performed indicate the areas of evaluation:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "worst-case non-clinical testing." For physical device performance, this usually means testing a sufficient number of units to demonstrate statistical confidence or to meet engineering specification requirements, but exact numbers are not provided.
• Data Provenance: Not applicable in the context of clinical data for AI/ML devices. The testing was laboratory-based non-clinical performance and safety testing.

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

• Not applicable. This is for a physical device, not an AI/ML diagnostic algorithm that requires expert interpretation for ground truth. Performance was assessed mechanically and through established laboratory methods.

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

• Not applicable. This concept is relevant for establishing a reference standard from multiple expert opinions in diagnostic studies, not for the physical performance testing of a 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:

• No. This is a physical device, not an AI or imaging device where MRMC studies are performed to evaluate diagnostic accuracy and reader performance.

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

• Not applicable. There is no algorithm.

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

• Not applicable in the AI/ML sense. "Ground truth" for this device would be its ability to physically perform its intended function (e.g., smoothly advance a guidewire, maintain integrity) as measured by engineering specifications and industry standards, and demonstrating biocompatibility. This is determined by validated test methods and comparison to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set for an algorithm.

In summary: The provided document is a 510(k) summary for a physical catheter introducer device. It describes its components, intended use, and the non-clinical (laboratory) testing performed to demonstrate its substantial equivalence to a previously cleared device. The detailed questions you've posed are designed for evaluating AI/ML-enabled medical devices, which have very different performance validation requirements than the SonoStik Guide Wire Introducer.

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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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