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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 the regulatory filing for the Trevo Trak 21 Microcatheter (K211594), which is a device intended for selective placement of devices and/or fluids in vasculature. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192122), particularly concerning a change in the recommended minimum inner diameter of the guide catheter.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria specified are primarily related to general device performance and safety rather than a specific algorithmic output, as this is a physical medical device (microcatheter) and not an AI/ML powered device. The "reported device performance" refers to the results of bench testing.

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

The document does not explicitly state the numerical sample sizes for each bench test conducted on the Trevo Trak 21 Microcatheter (K211594). It mentions that the testing was performed to assess compatibility with a 0.046 inch inner diameter (ID) guide catheter.

• Test Set Sample Size: Not explicitly stated for K211594's current submission. The wording "User will assess Trevo Trak™ 21 Microcatheter with a worst case compatible guide catheter" suggests a focus on representative scenarios but not a specific 'n' number.
• Data Provenance: The bench testing appears to be prospective and conducted by Stryker Neurovascular themselves, as part of their submission for K211594. The location of the testing is not specified, but the manufacturer is based in Fremont, California, USA. The shelf-life, sterilization, and biocompatibility data referenced previous testing in K192122, suggesting retrospective use of that data for the current submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring expert interpretation of results for ground truth establishment. The "ground truth" for the performance tests relies on established engineering and materials science principles and validated test methods.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. The assessment of bench test results involves direct measurements, visual inspections, and adherence to predefined engineering specifications, not expert consensus or adjudication.

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

This is not applicable. The Trevo Trak 21 Microcatheter is a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

This is not applicable as the device is a physical medical device and does not involve any algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications, recognized national/international standards (e.g., ISO 14971 for risk assessment, ISO 10993-1 for biocompatibility), and validated test methods. The successful meeting of these criteria serves as the basis for claiming safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This is not applicable for the same reasons as point 8.

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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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