(29 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
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.
§ 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).