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The WOLF Thrombectorny SmartClaw Catheter, in conjunction with the WOLF Thrombectomy Aspiration Sheath, 14F, is indicated for:

• · the non-surgical removal of thrombi and emboli from arterial and venous blood vessels in the peripheral vasculature.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The WOLF Thrombectomy SmartClaw Catheter is a thrombectomy catheter designed to work solely with the currently marketed WOLF Thrombectomy Sheath (K210911). The device consists of an inner catheter shaft, outer catheter shaft, heat set nitinol braid, and an actuation handle assembly connected to the proximal ends of the shafts. There are two device configurations that only differ in length of the expandable nitinol braided basket. The two configurations are identified by the max diameter of the expanded basket (20mm, 32mm).

The WOLF Thrombectomy SmartClaw Catheter is introduced through the WOLF Sheath and delivered to the targeted vessel location under fluoroscopy and standard endovascular techniques using a commercially available guidewire. The distal nitinol basket is expanded by moving the handle slider proximally and the clot may then be pulled proximally towards and aspirated through the WOLF Sheath.

The provided text is a 510(k) Summary for the WOLF Thrombectomy SmartClaw Catheter. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or a study that directly proves the device meets those criteria in a quantifiable manner (e.g., sensitivity, specificity, or improvement in human reader performance).

The "Performance Data" section lists various types of tests performed (biocompatibility, in-vitro performance, and an animal study) to support substantial equivalence. It states that "results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and "No new safety or performance issues were raised during the testing." However, detailed results, numerical acceptance criteria, or a description of how these tests prove the device meets specific acceptance criteria relevant to an AI/ML device's performance evaluation (which seem to be the focus of the request) are not provided.

Therefore, for the information requested, I can only provide what is available, which is very limited for an AI/ML context.

1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria and reported device performance in a quantitative manner that would be typical for an AI/ML device (e.g., sensitivity, specificity thresholds). It only broadly states that the device was tested to assure conformance to its intended use and raised no new safety or performance issues.

2. Sample size used for the test set and the data provenance
Not applicable. The document discusses bench testing, biocompatibility testing, and an animal study, not a clinical test set with human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a process for establishing ground truth using experts for a test set, as would be relevant for an AI/ML device.

4. Adjudication method for the test set
Not applicable.

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. The WOLF Thrombectomy SmartClaw Catheter is a medical device for thrombectomy, not an AI/ML diagnostic or assistive tool for human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the performance data listed (bench, animal, biocompatibility), the "ground truth" would be the direct measurement of physical properties, biological responses, or clinical outcomes in the animal study, which are not detailed.

8. The sample size for the training set
Not applicable. This device is not an AI/ML product that undergoes training.

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

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