(18 days)
The Medtronice ZumaTM Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system
The Medtronic® Zuma™ Guiding Catheters will be available in 6F, 7F and 8F outer diameters. The 6F catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 7F and 8F catheters are manufactured with a braided proximal and segmented shaft with an inner liner and a soft distal tip. The inner lumen of the 22ma™ catheter (6F-8F) has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft than its predicate devices.
The provided text refers to a 510(k) summary for a medical device called the Medtronic® Zuma™ Guiding Catheter, not a study evaluating an AI-powered device. Therefore, information regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, or training sets is not available in the provided document.
However, I can extract the general acceptance criteria for this medical device and how it was shown to meet them based on the provided text.
Here's the information parsed from the provided text:
Acceptance Criteria and Device Performance for Medtronic® Zuma™ Guiding Catheter
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All appropriate Biocompatibility tests were successfully performed on the materials used. |
| Functional Specifications | Test results verified that the device meets all applicable specifications and is deemed adequate for the intended use. |
| Substantial Equivalence to Predicate Devices | The Zuma™ guide catheter is considered to be substantially equivalent to: Medtronic® 6F Zuma™ Guiding Catheter, Medtronic® Vector™ Guiding Catheter, Cordis® Brite Tip® Guiding Catheter. |
| Intended Use | Designed to provide a pathway for therapeutic devices in the coronary or peripheral vascular system. |
| Sizes and Design | Available in 6F, 7F, and 8F outer diameters. 6F: braided proximal shaft, inner liner, soft distal tip. 7F/8F: braided proximal and segmented shaft, inner liner, soft distal tip. Inner lumen has a thin lubricious coating. Larger inner lumen diameter and stiffer shaft than predicate devices. |
Study Details (as inferable from a 510(k) submission for a non-AI device):
- Sample size for the test set and the data provenance: Not applicable in the context of an AI device. For this traditional medical device, testing would involve in-vitro (bench) testing, and potentially animal studies, to demonstrate performance and safety, but not human "test set" data in the AI sense. The provenance would be the laboratory where testing was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a guiding catheter, "ground truth" relates to physical and performance specifications verified through engineering and biocompatibility testing, not expert interpretation of data.
- Adjudication method for the test set: Not applicable. Performance is based on objective, quantifiable measurements against pre-defined specifications for physical properties, functionality, and biocompatibility.
- 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 is not an AI-powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" would be established by engineering specifications, material science standards (for biocompatibility), and established medical device performance criteria.
- The sample size for the training set: Not applicable. This is not an AI-powered device and therefore does not have a training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.
§ 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).