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The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.

This document is a 510(k) summary for the Solera™ Plus Thrombectomy Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in a clinical setting.

Therefore, the information requested in your prompt regarding acceptance criteria and performance study details (e.g., sample size, ground truth, MRMC studies) is not present in the provided text.

Based on the provided text, here's what can be extracted and what cannot:

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

• Not Available: The document states that "All components, subassemblies, and/or full Maginan The required specifications for the completed tests," and that mechanical tests were done in the same manner as the predicate device. However, it does not explicitly list specific acceptance criteria (e.g., specific thresholds for thrombus removal percentage, flow rates, or device integrity parameters) nor does it provide a table of reported device performance against such clinical or bench-testing criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available: The document mentions "Testing Summary" but does not specify any sample sizes for tests, nor does it refer to clinical test sets or data provenance in the context of performance proof. The testing appears to be primarily bench or in-vitro, comparing it to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Available: This type of information is relevant for studies involving human interpretation or clinical outcomes. The provided document relates to a medical device's technical specifications and substantial equivalence, not a study evaluating diagnostic or treatment efficacy with expert adjudication.

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

• Not Applicable/Not Available: As with point 3, this is not relevant to the type of information presented in this 510(k) summary.

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/Not Available: MRMC studies are typically for diagnostic AI systems or those involving human interpretation. This document describes a mechanical thrombectomy catheter, not an AI or diagnostic tool.

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

• Not Applicable/Not Available: This refers to AI algorithm performance. The device is a mechanical catheter.

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

• Not Available: The document vaguely refers to "required specifications" for mechanical tests, implying engineered benchmarks rather than clinical "ground truth" as typically defined in diagnostic studies.

8. The sample size for the training set

• Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

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

• Not Applicable/Not Available: This refers to AI model training data. The device is a mechanical catheter.

In summary, the provided 510(k) summary is for a mechanical thrombectomy catheter and focuses on establishing substantial equivalence to previously cleared devices through material suitability and a testing summary that asserts compliance with specifications, rather than a clinical performance study with detailed acceptance criteria and human expert evaluation.

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