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The Centurion® Pressure Injectable Extension set intended for the delivery and /or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

The Centurion® Pressure Injectable Extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 mL/second.

Centurion® Pressure Injectable Extension Sets consist of polyvinyl chloride (PVC) tubing with non-DEHP plasticizer. They are configured with female luer locks on the proximal and distal ends, respectively, and are available in straight, Y, and T configurations. A slide or snap clamp may be positioned over the tubing to obstruct the fluid flow when needed.

The Centurion® Pressure Injectable Extension Set is available in configurations with and without a needlefree valve. These valves are separately marketed devices and the applicable 510(k)'s are maintained by the respective manufacturers.

The Centurion® Pressure Injectable Extension Sets are prescription devices provided sterile and nonpyrogenic for single use only and may be packaged individually or in medical convenience kits.

The provided text describes a medical device, the Centurion® Pressure Injectable Extension Set, and its 510(k) submission to the FDA. It details the device's intended use, technological characteristics, and performance data from various tests. However, the document does not present acceptance criteria in a table format nor does it directly describe a study that proves the device meets specific acceptance criteria in terms of quantifiable performance metrics (like sensitivity, specificity, accuracy, etc.) for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Ensuring the materials are safe for biological contact.
• Sterilization validation: Confirming the device is sterile and non-pyrogenic.
• Packaging validation: Ensuring the packaging maintains sterility and shelf life.
• Functional testing: Implied by the statement "the functionality, integrity, and safety and effectiveness... are sufficient for its intended use." This likely includes pressure and flow rate capabilities as per the intended use, but specific quantifiable acceptance criteria and the results directly against those are not explicitly presented.

Therefore, many of the requested elements for an AI/diagnostic device study (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (an extension set) and not a diagnostic algorithm or image analysis system.

Here's an attempt to fill in the table and address the questions based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified for any of the tests (biocompatibility, sterilization, packaging, or functional). The data provenance is also not specified (e.g., country of origin, retrospective/prospective). These are typically found in detailed test reports, not summarized 510(k) documents.

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 (an extension set), not a diagnostic device or AI algorithm requiring expert-established ground truth for performance evaluation in the clinical sense. Biocompatibility, sterility, and functional tests are performed by laboratory technicians and engineers against established standards.

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

• Not Applicable. See point 3.

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. This is not an AI or diagnostic imaging device.

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

• Not Applicable. See point 5.

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

• Standardized Test Methods and Industry Standards: The "ground truth" for this device's performance is established by adherence to recognized international and national standards and guidelines for medical devices:
  • ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices) for biocompatibility.
  • ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products – Ethylene oxide) for sterilization.
  • ISO 11607-1 (Packaging for terminally sterilized medical devices) for packaging.
  • Functional requirements (e.g., pressure and flow rate capabilities) are likely tested against internal specifications derived from the intended use and predicate device characteristics.

8. The sample size for the training set

• Not Applicable. This is not a device that involves machine learning or AI models with training sets.

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

• Not Applicable. See point 8.

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