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The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.

The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.

The provided text describes a 510(k) premarket notification for the Medtronic 6F Sherpa NX Balanced Guide Catheter and 7F Sherpa NX Balanced Guide Catheter. It outlines the regulatory review and the company's summary of performance/non-clinical testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about studies involving acceptance criteria related to a device with AI/algorithm performance.

The acceptance criteria mentioned are for the physical and biological properties of a medical catheter, not for an AI model's performance metrics (like accuracy, sensitivity, specificity, etc., with human-in-the-loop or standalone performance, MRMC studies, or ground truth establishment relevant to AI).

Therefore, based only on the provided text, I cannot complete a table or provide details for most of the requested points related to AI/algorithm acceptance criteria and performance studies.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study for an AI-Powered Device (Information MISSING from provided text)

Since the provided document is for a physical medical device (a guide catheter) and not an AI/algorithm, the following sections will indicate "Not Applicable" or "Information Not Found" as the requested information pertains specifically to AI/algorithm performance studies.

1. Table of Acceptance Criteria and Reported Device Performance (for AI/Algorithm)

Note: The provided document details acceptance criteria for the physical properties and biocompatibility of the catheter (e.g., inner/outer diameters, leak resistance, tensile load, cytotoxicity). These are not AI/algorithm performance metrics.

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

• Test Set Sample Size: Information Not Found (Not applicable for a physical catheter).
• Data Provenance: Information Not Found (Not applicable for a physical catheter). The document only states that "no clinical testing data was required for this special 510k submission."

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

• Information Not Found (Not applicable for a physical catheter, as ground truth in the context of AI relates to diagnostic accuracy, not physical device integrity).

4. Adjudication Method for the Test Set

• Information Not Found (Not applicable for a physical catheter).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was it done?: No, an MRMC study was not done, as this submission is for a physical medical device, not an AI/algorithm. The document states "No clinical testing data was required for this special 510k submission."
• Effect size of human reader improvement with AI vs. without AI assistance: Not Applicable (No AI component).

6. Standalone (Algorithm Only) Performance Study

• Was it done?: No, a standalone algorithm performance study was not done. The submission is for a physical medical device.

7. Type of Ground Truth Used

• Information Not Found (Not applicable for a physical catheter, which doesn't involve "ground truth" in the AI diagnostic sense).

8. Sample Size for the Training Set

• Information Not Found (Not applicable, as this is a physical device, not an AI model requiring a training set).

9. How Ground Truth for the Training Set Was Established

• Information Not Found (Not applicable for a physical device).

Summary of what was actually performed and reported in the document:

The provided 510(k) summary describes non-clinical performance testing and biocompatibility assessment for the catheter:

• Biocompatibility Assessment:
  • Conducted according to ISO 10993-1.
  • Evaluated: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Hemocompatibility, Acute Systemic Toxicity.
• Product Performance Evaluation (Dimensional & Performance):
  • Tests included: Inner/Outer Diameters, Total/Effective/Exposed Tip Length, Luer Connector Performance, Leak Resistance, Draw-through stiffness, Shaft/Arch bending stiffness & kink resistance, Crush resistance, Torsional Stiffness, Rotational Kink Angle, Rotations to Separation, Curve retention, Soft tip stiffness, Peak shaft/segment/soft tip/hub-shaft tensile load, Internal lubricity.
  • Specific standards cited for some tests: ISO 594-1, ISO 594-2, EN ISO 80369-7 (for Luer Connector Performance); ISO 10555-1 (for Leak Resistance and Peak Hub/Shaft Tensile Load).
• Conclusion: "The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns." and "The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device."
• Clinical Data: "No clinical testing data was required for this special 510k submission."

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The Medtronic 7F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 7F Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.

The 7F Sherpa NX guide catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary (transition) segment, a primary segment, tungsten marker band, a segment sleeve and a soft tip. The 7F Sherpa NX Guide Catheter design is based on a four layer design with an inner linner of polyethylene.

This 510(k) summary describes a medical device, the Medtronic 7F Sherpa NX Guiding Catheter, and its substantial equivalence to a predicate device. However, it does not contain information related to acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects of a study regarding algorithm performance, ground truth, or expert involvement as requested in the prompt.

The document is a premarket notification for a medical device (a catheter) and focuses on demonstrating its similarity to an already approved device (the 6F Sherpa NX Guiding Catheter). It mentions "performance testing" was conducted, but provides no details about the acceptance criteria or the results of this testing.

Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the necessary information.

Here's how I would present the information if it were available, along with a note that it's not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "performance testing" but provides no details about the data used for this testing.

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

• Not applicable. The document describes a physical medical device (catheter) and its "performance testing." It does not involve an algorithm or a test set requiring expert-established ground truth in the way an AI/ML device would.

4. Adjudication method for the test set

• Not applicable. (See explanation for #3).

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 document is for a physical catheter, not an AI/ML device.

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

• Not applicable. This document is for a physical catheter, not an AI/ML device.

7. The type of ground truth used

• Not applicable. (See explanation for #3). The "performance testing" likely refers to bench testing of the catheter's physical properties (e.g., tensile strength, flexibility, material compatibility) rather than diagnostic accuracy.

8. The sample size for the training set

• Not applicable. (See explanation for #3 and #6).

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

• Not applicable. (See explanation for #3 and #6).

Explanation for lack of data:

The provided document is a 510(k) premarket notification for a physical medical device (a catheter). The focus of such a submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily through engineering specifications, material compatibility, and benchtop performance testing of the device's physical attributes, and potentially some animal or limited human use data if very different from the predicate.

The questions in the prompt (regarding "acceptance criteria based on algorithm performance," "test and training sets," "ground truth," "expert adjudication," "MRMC studies," and "standalone algorithm performance") are highly relevant for the evaluation of Artificial Intelligence (AI) or Machine Learning (ML) enabled medical devices. This document, however, describes a conventional, non-AI medical device, and therefore these types of studies and details are not present or applicable. The "performance testing" mentioned likely refers to physical and mechanical property testing of the catheter, not the diagnostic performance of an AI algorithm.

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