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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038-inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Pedal Access Set is intended to introduce up to an 0.038" wire guide into the peripheral vasculature. It is also used to introduce diagnostic and/or interventional devices able to pass through the ID of the introducer.

The Micropuncture® Introducer Sets and Micropuncture® Pedal Access Sets are utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are composed of either a 4.0 French or a 5.0 French outer sheath and a 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, a 0.018 inch mandrel with a distal coil tip, and (optionally) a Check-Flo® Hemostasis valve, a Tuohy-Borst Sidearm Adapter, and a wire guide inserter. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

The provided document is a 510(k) summary for the Micropuncture® Introducer Sets and Micropuncture® Pedal Access Sets. It details the device description, indications for use, and a comparison to predicate devices, focusing on materials, methods of construction, principles of operation, and basic technological characteristics.

However, the questions you've asked pertain to acceptance criteria and study data for a software or AI-powered medical device. The document describes a physical medical device (catheter introducer) and its performance testing (tensile strength, liquid leakage, Luer performance, etc.), but it does not include any information about a study proving the device meets acceptance criteria related to a software or AI-driven diagnostic or assistive function, nor does it mention anything related to human readers, experts establishing ground truth, or adjudication methods for diagnostic output.

Therefore, I cannot answer most of your specific questions based on the provided text. The document refers to the acceptance criteria being met for various physical and mechanical tests, but these are not related to AI or diagnostic accuracy studies.

Here's a breakdown of what I can glean from the document in relation to your questions, and what I cannot:

What I Can Answer (Limited to the scope of this hardware device):

• 1. A table of acceptance criteria and the reported device performance:
  • The document states that for all listed tests ("Tensile," "Liquid Leakage," "Luer Performance Testing," "Non-Rotating Hub Cap Summative Evaluation"), the "predetermined acceptance criteria for all studies were met."
  • It does not provide the specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) or the exact reported performance values. It only states that the products passed.

What I Cannot Answer / Is Not Applicable (as it pertains to AI/Software studies):

• 2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device testing. The "test set" here refers to physical units of the device being tested, not a dataset for an AI model.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device is based on physical/mechanical engineering standards and validation. The "Expert Review" mentioned under "Validation" for the "Non-Rotating Hub Cap Summative Evaluation" is likely an engineering or usability review, not a diagnostic image review by radiologists.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 was not done as it's a physical device, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, ground truth is based on engineering specifications, material properties, and performance standards (e.g., ISO 11070, ISO 80369-7).
• 8. The sample size for the training set: Not applicable, as this is not an AI model.
• 9. How the ground truth for the training set was established: Not applicable, as this is not an AI model.

In summary, the provided document details the regulatory clearance for a physical medical device. It successfully demonstrates that the device meets its design input requirements through various engineering and performance tests, but it does not contain the kind of information about AI model validation or human-in-the-loop studies that your questions are looking for.

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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The device is utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, and a 0.018 inch mandrel wire guide with a distal coil tip. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

Here's a breakdown of the acceptance criteria and study information for the Micropuncture Introducer Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual test. It only states that "Testing verified..." and "The predetermined acceptance criteria were met."

The data provenance is from benchtop testing conducted by Cook Incorporated. The country of origin for the data is not explicitly stated, but Cook Incorporated is located in Bloomington, Indiana, USA, suggesting the testing likely occurred in the US or under the company's direct supervision. The studies are retrospective in the sense that they are laboratory tests performed on finalized device designs rather than prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical evaluations requiring expert interpretation of ground truth in the same way an AI diagnostic device would. The "ground truth" for these tests is based on established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective physical and material performance tests, not subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (introducer set), not an AI diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards). For example, for biocompatibility, the ground truth is conformance with ANSI AAMI ISO 10993-1. For leakage, it's conformance with BS EN ISO 11070:2014.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML product and does not involve a "training set" in the computational sense. The testing described is verification and validation for a manufactured product.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

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The Micropuncture Introducer Set is intended for the placement of wire guides up to .038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture Introducer Sets contains a coaxial catheter, a wire guide, and a needle. The device is utilized to gain access to the vasculature using the Seldinger technique.

Here's an analysis of the provided document regarding the acceptance criteria and supporting studies for the Micropuncture® Introducer Set:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a general statement that "The predetermined acceptance criteria were met" for each test. Specific numerical acceptance criteria were not detailed in this summary.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide information on the sample sizes used for any of the tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the document describes performance testing for a medical device (introducer set), not a diagnostic algorithm or image analysis tool requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document describes laboratory-based performance testing, not studies involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device described is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. The tests performed are laboratory-based engineering and material science tests. The "ground truth" would be the direct measurement of physical properties (e.g., force, rotation, tensile strength) or biological responses (e.g., cytotoxicity).

8. The Sample Size for the Training Set

Not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

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