(88 days)
The InThrill™ Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft.
The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions.
The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature.
The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.
The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately:
- InThrill Sheath (8 Fr)
- InThrill Thrombectomy Catheter (8 Fr)
The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.
I'm sorry, but based on the provided FDA 510(k) clearance letter for the InThrill™ Thrombectomy System, there is no information available about acceptance criteria and a study that proves the device meets specific performance criteria for AI/ML-based medical devices.
This document describes a medical device (thrombectomy system) which is a physical, mechanical device, not an AI/ML-based software device. The entire document focuses on the substantial equivalence of the InThrill™ Thrombectomy System to a predicate device, based on non-clinical performance and biocompatibility testing.
Therefore, I cannot fulfill your request for the specific points related to AI/ML device testing, such as:
- A table of acceptance criteria and reported device performance related to AI/ML metrics.
- Sample size and data provenance for an AI/ML test set.
- Number of experts and their qualifications for AI/ML ground truth.
- Adjudication method for AI/ML test set.
- MRMC comparative effectiveness study for AI assistance.
- Standalone (algorithm only) performance for AI.
- Type of ground truth used for AI/ML.
- Sample size for training set and how ground truth was established for AI/ML.
The "Performance Tests" section in the document refers to engineering and functional performance tests for the physical device (e.g., tensile strength, luer connections, clot burden removal efficacy of the mechanical device), not the performance of an AI algorithm in interpreting medical images or data.
If you have a document pertaining to an AI/ML medical device, I would be happy to analyze it for the criteria you've outlined.
§ 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).