(102 days)
The InThrill Thrombectomy System is indicated for:
- The non-surgical removal of thrombi and emboli from blood vessels, including 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/graff.
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, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The InThrill™ Thrombectomy System consists of the InThrill Sheath ("Sheath") and the InThrill Thrombectomy Catheter ("Catheter"), each packaged separately.
The Sheath is an introducer sheath with a distal self-expanding funnel, proximal aspiration port, and proximal hub. A Dilator is provided to aid insertion and positioning of the Sheath. Radiopaque markers aid Sheath positioning under fluoroscopic visualization. The Sheath and Dilator tips are radiopaque, and there is a radiopaque marker band at the proximal end of the Sheath funnel.
The provided text describes the 510(k) summary for the InThrill Thrombectomy System (K223613). While it details the device, its intended use, and a comparison to predicate devices, it does not contain information on acceptance criteria or the specifics of a study proving the device meets those criteria in the context of AI/ML performance.
The "Performance Tests" section on page 8 lists several non-clinical tests conducted, and states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide the specific acceptance criteria values, nor the reported device performance values against those criteria. Furthermore, these appear to be engineering/mechanical performance tests, not AI/ML model performance evaluations.
The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This means there was no human clinical study conducted to assess the device's performance in patients, and therefore no data on metrics like sensitivity, specificity, or AUC as would be typical for AI/ML device approval.
Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them in the context of AI/ML performance.
The provided document is a 510(k) premarket notification for a medical device (an embolectomy catheter), which focuses on demonstrating substantial equivalence to predicate devices primarily through engineering and non-clinical testing. It does not describe an AI/ML component or a study with requirements such as ground truth establishment for a test set, expert adjudication, or MRMC studies.
If this was a request to describe the acceptance criteria and study for a different type of device or an AI/ML component that was not detailed in this specific 510(k) summary, then the information would need to come from a different source.
§ 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).