Search Results

The AngioJet Solent Omni Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:

• . upper and lower extremity peripheral arteries > 3.0mm in diameter,
• . upper extremity peripheral veins > 3.0mm in diameter,
• . ileofemoral and lower extremity veins > 3.0mm in diameter,
• A-V access conduits > 3.0mm in diameter and .
• for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Solent Omni Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Solent Omni Thrombectomy Set is used with the AngioJet Ultra Console.

The provided text describes a 510(k) premarket notification for the AngioJet Solent Omni Thrombectomy Set, which is a medical device. The document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, rather than establishing acceptance criteria or reporting specific device performance metrics against predefined thresholds.

Therefore, the requested information, which typically pertains to the establishment of performance criteria for new or substantially modified devices, a clinical study proving the device meets those criteria, and details about a training set, is not available in the provided text.

The document does list the types of tests performed to support substantial equivalence. These are primarily bench and laboratory tests demonstrating the device's characteristics and safety, rather than performance against efficacy endpoints or diagnostic accuracy.

Here's an analysis of why the requested information cannot be extracted, referencing the specific points:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Performance Data" which includes various types of testing, but it does not specify quantitative acceptance criteria (e.g., "clot removal efficiency > X%") nor does it report specific numerical results against such criteria. It generally states that "Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use" without detailing those results.

2. Sample size used for the test set and the data provenance: This is not available. The testing described consists of bench and laboratory tests (e.g., biocompatibility, mechanical integrity, clot removal, hemolysis). These are not clinical studies with "test sets" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Since there are no clinical test sets with patient data, there's no need for expert ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a thrombectomy set, not an AI diagnostic/imaging device. The description of tests does not indicate any MRMC study or AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there are no clinical test sets. The "ground truth" for the bench tests would be defined by the testing standards and specifications themselves (e.g., a certain material property, a specific amount of clot removed under controlled conditions).

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The tests are for device performance and safety.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document for the AngioJet Solent Omni Thrombectomy Set describes a premarket notification for a medical device based on showing substantial equivalence to existing predicate devices. The information focuses on safety and performance testing for the physical device, not on clinical efficacy endpoints, diagnostic accuracy, or AI-driven performance metrics against a defined ground truth derived from expert consensus or pathology.

Ask a specific question about this device