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Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

Non Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices.

This document is a 510(k) Premarket Notification for a medical device (Velano Vascular Q2 Extension Set), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria through a rigorous study. Therefore, the information typically required to answer your prompt about AI acceptance criteria and study details (such as sample size for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) for an AI/ML device is not present in this document.

This document describes a traditional medical device (an intravascular administration set) and performs mechanical and functional testing to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

However, I can extract the relevant information regarding the device's functional and safety testing, despite it not being an AI-driven device.

Here's a breakdown of the acceptance criteria and study information provided in the document:

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

The document doesn't explicitly present a table of "acceptance criteria" against "reported performance" in a quantitative manner for each test. Instead, it lists the types of functional and safety tests performed and states that these tests ensured the device design meets its functional and performance requirements. The conclusion explicitly states that "Velano Vascular considers the Velano Vascular Q2® Extension Set device to be substantially equivalent to the predicate device listed above. This conclusion is based upon the intended use, design specifications, patient contacting materials, manufacturing and sterilization processes." This implies that the device met the implicit acceptance criteria for each test to achieve substantial equivalence.

Implicit Acceptance Criteria and Demonstrated Performance (Inferred from the document):

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

• Sample Size: The document repeatedly refers to "representative samples" being used for mechanical testing (Page 7). However, it does not specify the exact number of samples (sample size) used for each test.
• Data Provenance: Not applicable in the context of "data" for an AI/ML device. For a physical device, the data provenance is the location where the manufacturing and testing occurred. This information is not detailed beyond the manufacturer's address (San Francisco, CA). The tests are presumably performed in a controlled laboratory environment. The testing is prospective in the sense that it's performed as part of the submission process for the new device.

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

• This is not applicable as this is not an AI/ML device requiring human expert ground truth for classification or interpretation. The performance is assessed through objective physical and functional tests.

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

• This is not applicable as this is not an AI/ML device requiring human expert adjudication. The test results are based on objective measurements and established 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 is not applicable as this is not an AI/ML device.

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

• This is not applicable as this is not an AI/ML device. The device's "standalone" performance is its physical and functional performance during the mechanical tests.

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

• For physical/mechanical devices, "ground truth" is established by engineering specifications, industry standards (e.g., ISO), and physical measurements against known values and benchmarks (like the predicate device's performance). For example, a leak test's "ground truth" is "no leak detected under specified pressure." This is not based on expert consensus in the diagnostic sense, but rather adherence to predefined engineering limits and physical laws.

8. The sample size for the training set:

• This is not applicable as this is not an AI/ML device.

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

• This is not applicable as this is not an AI/ML device.

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