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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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This device 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 device is utilized to gain access to the peripheral vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French or 5.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gauge percutaneous entry needle, an 0.018 inch mandril wire guide with a distal coil tip, and a Check-Flo® Hemostasis Valve. These sets are supplied sterile and are intended for one-time use.

The provided text describes the Cook Incorporated Micropuncture® Pedal Access Set (K172980). It details the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to establish its substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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 primarily details non-clinical laboratory testing. For these tests, specific sample sizes are not explicitly stated, but the results indicate that the "predetermined acceptance criteria were met" for all tests. There is no information regarding country of origin or retrospective/prospective nature for these non-clinical tests.

The document does reference clinical literature to support the indications for use, stating:

• "These articles describe successful use of the subject device for pedal access in a total of 220 patients..."
• The articles listed are from the Journal of Endovascular Therapy, Fortschr Röntgenstr, and Annals of Vascular Surgery, suggesting an international (likely multi-country) provenance, and they are retrospective or prospective observational studies/case series rather than controlled trials focused specifically on this device's performance against pre-defined criteria. The specific nature (retrospective/prospective) would need to be gleaned from the individual articles, which are only referenced.

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. The primary evidence presented for substantial equivalence is based on non-clinical performance testing against established engineering standards (e.g., ISO standards), not on expert-adjudicated test sets or ground truth established by experts. The clinical literature cited involves patient outcomes from medical procedures, where the "ground truth" would be the clinical success or complications observed by the treating physicians, but this is used as supportive evidence for the indications for use, not as a test set for device performance itself.

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

Not applicable. This is for non-clinical testing against engineering standards.

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 device is not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (catheter introducer set).

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 consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is defined by the specific performance requirements outlined in the referenced ISO and other engineering standards. For instance, the "ground truth" for the tensile test is "no loosening or separation."

For the clinical literature cited, the "ground truth" is implicitly the outcomes data from the patient cases described in those publications (e.g., successful revascularization, complications, etc.), which support the general utility of pedal access.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require training sets.

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

Not applicable. This is a physical medical device and does not involve AI or machine learning models.

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