(21 days)
The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
The provided document is a 510(k) summary for the speX Support Catheter, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI-driven device meets specific acceptance criteria.
As such, the information requested in the prompt, which is typically relevant for AI/ML medical devices, is largely absent from this document. The document describes a physical medical device (a support catheter), and the "performance data" refers to physical and mechanical tests of the catheter, not the performance of an algorithm.
Therefore, I cannot provide most of the requested information based on the provided text.
Here is what I can extract:
1. A table of acceptance criteria and the reported device performance:
Based on the document, specific numerical acceptance criteria and reported device performance are not explicitly detailed in a table format. The document states:
- "The modified speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
- "Based on the performance testing the modified speX Support Catheter was found to be substantially equivalent to the predicate device."
The types of tests performed were:
- Simulated Use Testing
- Component/Assembly Integrity Testing
- Corrosion Resistance Testing
- Lubricity Testing
2. Sample sized used for the test set and the data provenance:
- This information is not available in the provided text, as the study involves physical device testing, not AI data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/not available, as the study pertains to physical device performance and not diagnostic or interpretive tasks requiring expert ground truth in the context of AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/not available for this type of physical device testing.
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:
- This information is not applicable. This document describes a physical medical device, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- This information is not applicable. For physical device testing, "ground truth" would typically refer to established engineering specifications, mechanical properties, and functional requirements, as opposed to medical diagnoses.
8. The sample size for the training set:
- This information is not applicable/not available as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- This information is not applicable/not available as this is a physical medical device, not an AI model.
§ 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).