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The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The Subject Device includes (1) Aspire Aspirator and (1) MAX 7F - 11F Catheter. Subject Device and the Predicate are single-use, sterile, and short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The Subject Device's Intended Use and Fundamental Scientific Principle are the same as the Predicate. The Predicate and Subject Device are the same in the way they are inserted into the body over a guidewire and advanced to the target arterial or venous peripheral vascular anatomy. The Subject Device and Predicate share the same core Aspirator to create thrombectomy force. MAX 7 - 11F Catheters may be connected to basic syringes and other aspiration pumps. Aspire Mechanical Aspirators may be connected to other catheters. The Subject Device does not add any new materials or manufacturing processes to the manufacturing process.

The provided FDA 510(k) summary for the Aspire MAX 7-11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not required for this determination. Therefore, a study demonstrating the device meets acceptance criteria through clinical performance (like an MRMC study or standalone AI performance) and an associated table of acceptance criteria with reported performance are not present in this document.

The document discusses non-clinical testing which confirmed the device meets specifications and intended use. However, it does not provide specific acceptance criteria or detailed performance metrics from these non-clinical tests in a format that lends itself to the requested table. The summary states:

"Non-clinical testing in this Submission confirms the Subject Device passes simulated use tracking. simulated aspiration, and simulated thrombectomy in the peripheral vasculature with test units accelerated aged up to 3-years. Accordingly, non-clinical testing confirms the Subject Device meets specifications, intended use, demonstration of claims, and equivalence to Predicate."

Based on the provided document, here's what can be extracted regarding acceptance criteria and the study:

Since the document explicitly states "Clinical testing is not required for the determination of substantial equivalence," and focuses on non-clinical testing, much of the requested information (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone AI performance) is not applicable or detailed in this submission.

Regarding the requested information:

1. A table of acceptance criteria and the reported device performance:

The document mentions that non-clinical testing confirmed the device "meets specifications, intended use, demonstration of claims, and equivalence to Predicate." However, specific quantitative acceptance criteria and their corresponding reported performance values from these non-clinical tests are not provided in this public summary. For example, it doesn't state "Aspiration force must be > X N; achieved Y N."

2. Sample size used for the test set and the data provenance:

• Test set: Not explicitly stated for non-clinical tests in terms of specific numbers of devices or simulated scenarios. It refers to "test units accelerated aged up to 3-years."
• Data Provenance: Not applicable as this is non-clinical/simulated data, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for non-clinical, simulated tests would be based on engineering specifications and physical measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for non-clinical testing.

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:

• No. The document explicitly states "Clinical testing is not required for the determination of substantial equivalence." MRMC studies are associated with clinical performance evaluation, particularly for imaging devices involving human interpretation, which is not the case here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a mechanical thrombectomy system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical tests, the "ground truth" would be the engineering specifications, physical principles, and laboratory measurements confirming the device's mechanical capabilities (e.g., aspiration force, tracking ability, thrombectomy effectiveness in simulated environments).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

In summary, the provided document is a 510(k) summary for a mechanical device, not an AI/imaging device. As such, the detailed information typically requested for AI performance studies (like MRMC, standalone AI, training/test sets, expert adjudication) is not found here because it's not relevant to this type of submission. The primary "proof" of meeting acceptance criteria for this device, as presented, is through successful completion of non-clinical, simulated performance tests demonstrating its equivalence to a predicate device and adherence to engineering specifications.

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