(230 days)
The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.
The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.
It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device: the Fogarty Thru-Lumen Embolectomy Catheter.
This document is not about an AI/software-as-medical-device (SaMD) or a device that relies on complex algorithms requiring a study to prove its performance against acceptance criteria like sensitivity, specificity, or AUC based on a test set, ground truth, or expert readers.
Instead, this device is a physical catheter used to remove emboli and thrombi. The "acceptance criteria" and "study" proving its performance in this context relate to engineering and biocompatibility testing, not to AI model performance or interpretation of medical images.
Here's why the questions about AI/software-related study methodologies are not applicable to the provided document:
- No mention of AI, algorithms, or software: The document describes a physical medical device. There is no indication that it incorporates AI, software, or image analysis to function.
- "Study that proves the device meets the acceptance criteria" refers to bench testing: The document explicitly states under "Device Testing": "Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria." This refers to mechanical, material, and sterilization performance, not diagnostic accuracy or AI performance.
- Comparison to a predicate device: The basis for clearance is "substantial equivalence" to a predicate device (Fogarty Thru-Lumen Embolectomy Catheter cleared in K892410). The comparative analysis states, "The subject device is identical to the predicate device in terms of the intended use, indications for use, and technological characteristics (including design, material, chemical composition, principle of operation)." This reinforces that it's a physical device, not an AI system that would typically undergo MRMC studies or performance validation against a ground truth dataset of patient images.
Therefore, I cannot provide the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided FDA document pertains to a physical medical device and does not involve AI or software development with the type of validation methodology you are asking about.
To summarize, the document is about the FDA clearance of a conventional medical device, not an AI-powered one. The "acceptance criteria" and "study" refer to engineering and biological safety tests, not the performance metrics of an AI model.
§ 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).