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The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec.

The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the ORION™ III CT CVC.

The ORION™ II CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies, The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The ORION™ II CT CVC product line has catheters in 16 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All ORION™ II CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes the 510(k) Premarket Notification Submission for the ORION™ II CT CVC. It details the device, its intended use, a technological comparison to a predicate device, and the conclusion regarding its safety and effectiveness.

However, the document does not contain specific acceptance criteria in a tabular format, nor does it provide a detailed study report with performance metrics like sensitivity, specificity, or AUC, or information about sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC study results (which are typically relevant for AI/radiology devices).

The document is for a Central Venous Catheter (CVC), which is a medical device for infusion, not an AI or imaging device with performance metrics related to diagnostic accuracy. Therefore, many of the requested points, particularly those related to a multi-reader multi-case study, ground truth establishment for AI, and advanced performance metrics, are not applicable to this type of submission.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "The ORION™ II CT CVC met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria are not detailed in the provided text. The performance reported is in terms of the device's ability to withstand certain conditions.

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

• Sample size: Not specified in the provided text. The document refers to "Verification testing" and "design verification testing" being performed but does not state the number of devices tested.
• Data provenance: Not applicable in the context of clinical data for a diagnostic device. The testing conducted would be bench testing/engineering verification, not clinical data from patients.

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 catheter, not a diagnostic imaging device that requires expert-established ground truth for a test set. Ground truth would relate to physical and chemical properties and performance under stress, established by engineering and quality assurance standards.

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

• Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for performance testing of a catheter.

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-assisted diagnostic device.

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

• Not applicable. This is not an algorithm.

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

• For this device, "ground truth" would be established by objective measurements and scientific standards in engineering and materials testing. For example, pressure measurements, flow rates, material composition analysis, and sterility testing according to established international standards (ISO). The document references:
  • FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
  • ISO 11135-1:2007 for Sterilization.
  • ISO-10993, Part 1 for Biocompatibility.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-based device that requires a training set.

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

• Not applicable.

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