(22 days)
The Medtronic Export® AP Catheter is indicated for:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To subselectively infuse/deliver diagnostics or therapeutic agents with or without vessel occlusion
The Medtronic Export® AP Aspiration Catheter is a dual lumen catheter used for aspiration of thrombus and/or debris from a vascular site. The Medtronic Export® AP may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
The provided text is a 510(k) summary for the Medtronic Export® AP Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and typically does not include the detailed performance studies or acceptance criteria that a standalone AI/software medical device submission would. The document focuses on demonstrating equivalence to a prior device rather than proving novel performance.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/software, ground truth, expert review, sample sizes for training/test sets, and comparative effectiveness studies) are not applicable and cannot be found in this document.
This device is an embolectomy catheter, a physical medical device, not a software or AI product. The "performance" assessment here refers to its physical characteristics and functionality, not diagnostic accuracy or efficacy in an AI context.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or detailed performance metrics (like sensitivity, specificity, accuracy) are reported in the provided text. The "performance" is implicitly demonstrated through the device passing "all design verification and validation testing" and its substantial equivalence to a predicate device.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not explicitly listed as numerical criteria. The underlying criteria are that the device performs as intended and is substantially equivalent to the predicate device. | "The proposed Medtronic Export® AP Aspiration Catheter has successfully passed all design verification and validation testing." |
| "Medtronic has demonstrated that the Export® AP Aspiration Catheter is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "all design verification and validation testing," but does not detail the number of units tested or specific test cases.
- Data Provenance: Not applicable in the context of clinical data for AI. Physical device testing typically involves laboratory settings, mechanical testing, and potentially animal or benchtop models, but the specifics are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical catheter, not an AI or diagnostic imaging device that requires expert ground truth for performance assessment. Its "ground truth" would be objective measurements of its physical and functional properties.
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of diagnostic outcomes.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device used by a human.
7. The type of ground truth used:
The "ground truth" for a physical device like a catheter would typically be objective physical measurements (e.g., burst pressure, tensile strength, flow rates, flexibility) and functional tests, along with a review of its design and materials. The document states it passed "design verification and validation testing," which implies these types of tests were conducted against established engineering specifications. Specific details are not provided.
8. The sample size for the training set:
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning device.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).