(113 days)
The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires 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 text is a 510(k) premarket notification for a medical device called the "speX Support Catheter." This document is a regulatory submission to the FDA for market clearance, arguing that the new device is substantially equivalent to a previously cleared predicate device.
Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, not on proving that an AI/ML powered device meets specific performance criteria through a clinical study where AI assists human readers or performs standalone analysis.
Therefore, most of the requested information regarding acceptance criteria, study design (sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone AI performance), and training set details for an AI-powered device is not applicable to this document.
The document discusses performance data in general terms for a physical medical device (catheter), not a digital health/AI product. The "performance data" mentioned (Simulated Use Testing, Particulate Testing) are engineering and biocompatibility tests typical for physical medical devices, not clinical performance studies for an AI algorithm.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for a medical device approval): The device must demonstrate a safety and effectiveness profile similar to the predicate device and meet "specified criteria" in performance testing. The text states: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
- Reported Device Performance:
- "Simulated Use Testing" was performed.
- "Particulate Testing" was performed.
- Result: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
- Conclusion: "Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device." And "The design testing performed for the speX Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."
2. Sample sizes used for the test set and the data provenance:
- Not applicable. This document describes testing for a physical medical device (catheter), not an AI algorithm. The "test set" concept in the context of AI (i.e., a dataset of images/cases for algorithm evaluation) is not relevant to this submission. The "Simulated Use Testing" likely involved a certain number of tests on physical prototypes, but specific sample sizes and data provenance (country of origin, retrospective/prospective) are not detailed because they are not required for this type of submission for a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of medical images or diagnostic AI systems is not relevant for this physical device.
4. Adjudication method for the test set:
- Not applicable. No adjudication method for a test set is mentioned, as it's not an AI study.
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. No MRMC study was done, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No standalone AI algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Ground truth for diagnostic accuracy is not relevant for this physical device. The "ground truth" for a physical device's performance would be engineering specifications and safety standards, which are implicitly met.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of AI for this physical device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "ground truth for the training set" for this physical device.
In summary, the provided document is a regulatory filing for a physical medical device (a catheter) demonstrating substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the specific details requested about AI model validation and performance criteria are not present in this document.
§ 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).