(29 days)
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)
| Acceptance Criteria (for AI/Algorithm) | Reported Device Performance (for AI/Algorithm) |
|---|---|
| Specific AI performance metrics (e.g., Sensitivity, Specificity, AUC for disease detection, or improvement in human reader performance) | Information Not Found in the provided text, as this is for a physical medical catheter. |
| Pre-defined thresholds for these metrics. | Information Not Found. |
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."
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).