Search Results

The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.

The provided text is a 510(k) premarket notification summary for the LBI Embolectomy System. It does not describe an AI/ML medical device, nor does it contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or comparative effectiveness with human readers.

Therefore, I cannot fulfill your request for this specific document.

The document discusses the substantial equivalence of the LBI Embolectomy System to legally marketed predicate devices, focusing on:

• Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
• Device Description: A 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly and a fiber element on a 0.014" guidewire with an attachable actuator tool, along with accessories.
• Safety & Performance: Demonstrated through comparison to predicate devices, biocompatibility testing, in vitro testing, and animal testing.

No information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is present.

Ask a specific question about this device