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The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

The OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.

This is a 510(k) premarket notification for a medical device (Q50® PLUS Stent Graft Balloon Catheter), not an AI/ML device. Therefore, the typical "acceptance criteria" and "study" information regarding device performance in an AI/ML context (such as accuracy, sensitivity, specificity, sample size, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.

Instead, for a medical device like this, acceptance criteria typically refer to the specifications that the device must meet through various engineering, mechanical, and biological tests to demonstrate safety and effectiveness for its intended use, and substantial equivalence to a predicate device.

Here's how to interpret the provided information in the context of a 510(k) submission for a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are the specifications that each mechanical, performance, and biocompatibility test must meet. The "reported device performance" is that "All tests met specifications."

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

• Sample Size: The document does not explicitly state the sample sizes for each mechanical, performance, or biocompatibility test. Regulatory submissions for medical devices typically involve testing a statistically representative number of units for each test, but the exact numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI/ML algorithm's test set. The data provenance here would refer to the source of the physical devices tested (e.g., manufactured at QXMédical's facility). The testing is prospective for the submission, meaning tests were performed specifically for this device and submission.

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

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by engineering and laboratory measurements against predefined specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading for AI/ML validation). The performance of this device is assessed directly through physical and chemical testing.

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. MRMC studies are specifically designed to assess the impact of AI on human reader performance, which is not relevant for a physical catheter.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this medical device is the adherence to established engineering specifications, material properties, and performance benchmarks as defined by relevant industry standards and internal design requirements. This is verified through:

• Direct physical measurement (e.g., dimensions, compliance, tensile strength).
• Functional testing (e.g., inflation, deflation, occlusion, compatibility).
• Biocompatibility assessments (following ISO standards, often involving chemical analysis and biological assays).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

In summary, the provided information details a traditional medical device 510(k) submission, not an AI/ML device. The "study" proving the device meets acceptance criteria is the comprehensive non-clinical testing program described, which demonstrated that all aspects of the device's mechanical function, performance, and biocompatibility met the defined specifications and showed substantial equivalence to the predicate device.

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