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The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.

The provided text describes bench testing and biocompatibility testing for the Trevo Trak™ 21 Microcatheter. It does not contain information about studies involving AI, human readers, or image analysis, thus many of the requested fields cannot be filled from the given text.

Here is the information that can be extracted from the provided FDA 510(k) summary regarding the acceptance criteria and the studies performed for the Trevo Trak™ 21 Microcatheter:

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

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

• The document mentions "All test samples met acceptance criteria" for the In-vitro Simulated Use Study, but the specific sample size for each bench test is not provided in this summary.
• Data Provenance: The studies are described as "design verification and design validation testing conducted on the Trevo Trak 21 Microcatheter," "bench testing," and "biocompatibility testing." The methods refer to international standards (EN ISO, ASTM), suggesting the tests were conducted according to established laboratory protocols. No information is provided about data provenance in terms of country of origin or if it's retrospective/prospective, as these are bench and biocompatibility tests, not clinical studies.

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

• For the bench testing and biocompatibility testing, "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy are not applicable. The 'In-vitro Simulated Use Study' mentions evaluation by "multiple physician users" for device delivery, durability, and integrity, but the specific number and qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable for bench testing and biocompatibility. The tests have predefined pass/fail criteria based on physical measurements, chemical analyses, or visual inspections against a standard.

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 MRMC comparative effectiveness study was done. This is a medical device (microcatheter), not an AI-powered diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the performance data (bench testing), the "ground truth" is defined by pre-established specifications and international standards (e.g., ISO, EN). The device's performance is measured against these quantitative and qualitative criteria.
• For biocompatibility, the "ground truth" is established by biocompatibility testing results against predefined thresholds for biological response according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. No training set was used.

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