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The BOBBY Balloon Guide Catheter is intended: For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the BOBBY Balloon Guide Catheter. It's important to note that this is a medical device (catheter), not an AI/algorithm-based device, so the usual metrics for AI performance (like sensitivity, specificity, MRMC studies, training/test sets for AI) are not applicable here.

The "acceptance criteria" for this device are established through various performance and biocompatibility tests designed to ensure its safety and effectiveness for its intended use. The "study that proves the device meets the acceptance criteria" refers to the results of these performance and biocompatibility tests.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table under "Performance Testing Summary" and "Biocompatibility Testing Summary." The "Acceptance Criteria" for each test are implied by the "Reference Standard" and the "Results" section confirming that "All samples met the pre-determined acceptance criteria" or similar statements of compliance.

Key:

• Acceptance Criteria (Implied): Meeting the requirements of the stated reference standard or pre-determined specifications.
• Reported Device Performance: "Pass" indicating that all samples tested met the criteria.

Biocompatibility Tests:

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

The document states "All samples met the pre-determined acceptance criteria" implying multiple samples were tested for each performance test. However, the specific sample sizes for each test are not explicitly provided in this summary.

Data Provenance: The tests are described as in vitro (benchtop testing) and in vitro biocompatibility tests, some conducted in a "cerebral vascular model." It is retrospective in the sense that the results are being reported after the tests were conducted. The country of origin for the data is not specified but would typically be where MicroVention, Inc. conducts its R&D and testing, likely in the USA given their address is Tustin, California.

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

This question is not applicable to this type of device submission. The "ground truth" for this medical device is established by physical and chemical properties and performance characteristics measured against recognized international standards (e.g., ISO, ASTM, USP) and internal specifications, rather than by human expert review of images or data.

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

This question is not applicable as there is no human-in-the-loop assessment requiring adjudication for this device's performance testing. The tests are objective measurements against set standards.

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 question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The BOBBY Balloon Guide Catheter is a physical medical device, not an AI or imaging device, and does not involve human readers interpreting data assisted by AI.

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

This question is not applicable. This is not an algorithm-only or AI device.

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

The "ground truth" for this device's performance and biocompatibility is based on established engineering and material science standards (ISO, ASTM, USP), verified physical/chemical measurements, and the device's ability to consistently meet predefined specifications for functionality and safety in a laboratory setting. For comparison, the predicate device's characteristics also serve as a comparative ground.

8. The sample size for the training set

This question is not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

This question is not applicable, as there is no AI training set.

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