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The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.

The catheter features an outer shaft and is comprised of three: an inflow lumen to supply saline to the catheter tip, an outflow lumen for removal of thrombotic material and a guidewire lumen to accommodate an 0.018 inch guidewire. The catheter is 6F in diameter and is available in soft and braided configurations.

The provided text describes a 510(k) premarket notification for the Oasis Thrombectomy System. This type of submission generally establishes substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria in the same way a PMA or de novo submission might. While a clinical trial is mentioned, the text does not detail specific acceptance criteria or performance metrics in a quantitative manner.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance Study

The document states that a study was conducted to demonstrate substantial equivalence, focusing on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with quantitative performance metrics for the Oasis Thrombectomy System. Instead, it makes a general statement about safety and effectiveness.

Note: The definition of "safe" and "effective" in this context is implicitly linked to being comparable to the predicate device and the alternative treatment (pulsed spray thrombolytic therapy).

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size used in the randomized, prospective clinical trial.
• Data Provenance: The study was a "randomized, prospective clinical trial," indicating that the data was collected specifically for this study, likely in a controlled clinical environment. The country of origin is not explicitly stated, but given the submission to the FDA, it's reasonable to infer a US-based or international study conforming to FDA guidelines.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish a ground truth for a test set in the context of image analysis or similar diagnostic device evaluation. The study was a clinical trial comparing the device's performance directly against an alternative treatment. Therefore, the "ground truth" would be the observed clinical outcomes in patients.

4. Adjudication Method for the Test Set:

Given that this was a clinical trial evaluating a thrombectomy device's performance rather than an interpretation of data by multiple readers, there is no mention of an adjudication method (e.g., 2+1, 3+1) for a test set in the context of image or data interpretation. Adjudication in a clinical trial would typically refer to independent review committees for adverse events or specific endpoints, but this information is not provided here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the performance of diagnostic aids, often involving human readers interpreting medical images with and without AI assistance. The Oasis Thrombectomy System is a mechanical device for thrombus removal, not a diagnostic imaging aid.
• Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This device is a physical, mechanical thrombectomy device, and its performance is inherently tied to its use by a clinician in a procedure. There is no "algorithm only" component to evaluate in this context.

7. Type of Ground Truth Used:

The ground truth for the clinical trial would be based on outcomes data related to the removal of thrombus from hemodialysis access grafts and patient safety. This would include direct clinical observations (e.g., successful removal of thrombus, restoration of blood flow), adverse events, and potentially objective measures of graft patency, though these specific details are not provided. The study compared these outcomes against a recognized alternative treatment.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. Training sets are relevant for machine learning algorithms or similar data-driven models. This submission focuses on a mechanical device evaluated through a clinical trial.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as no training set is described.

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