Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device