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The OmniPICCPI Peripherally Inserted Central Catheter is indicated for use in attaining short and long term vascular access for administration of medications, parenteral nutrition, IV fluids, blood products or blood withdrawal. The OmniPICCPI is indicated for power injection of contrast media at a maximum recommended infusion rate of 3ml/sec and maximum pressure or pounds per square inch (psi) of 300 psi.

The Peripherally Inserted Central Catheter (OmmiPICC P.I.) kit includes a catheter and introduction components. The catheter is a percutaneous central venous catheter inserted peripherally. The catheter is comprised of radiopaque polyurethane tubing. The catheter is attached to an injection molded polyurethane hub with extension leg(s) for access via a luer lock device. Each product is packaged in a sterile tray with appropriately sized introducer components. This PICC product line includes externally communicating central venous catheters of 60 cm that is trimmable from the distal end with a single 4 Fr single and 5 Fr dual lumen configurations. These are tested to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec at a maximum power injection setting of 300 psi.

The provided document is a 510(k) premarket notification for the OmniPICC P.I. (Peripherally Inserted Central Catheter). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC), and detailed ground truth establishment for AI/algorithm-based devices is not present in this document because it pertains to a different type of device (a physical medical catheter) and regulatory pathway.

The document describes the device, its intended use, and its indications for use, highlighting its capability for power injection. The primary "study" involved is a comparison to a predicate device (Bard PowerPICC™ Catheter) to demonstrate substantial equivalence, rather than a clinical trial assessing performance against specific acceptance criteria in the way an AI diagnostic device would.

However, I can extract the relevant information that is present in the document. The "device performance" in this context refers to its physical capabilities for power injection, which are stated parameters rather than measured outcomes from a clinical study with a test set.

Here's the closest representation of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the physical capabilities and new features of the OmniPICC P.I. to justify its substantial equivalence to predicate devices, particularly for power injection. The "acceptance criteria" for the device, in this context, are the specified physical performance limits it is designed to meet for safe and effective use during power injection procedures.

Study Details (Based on Substantial Equivalence Justification)

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

• Sample Size: Not applicable in the context of a clinical test set for AI. The "test" for this device involved comparing its physical and material characteristics, intended use, and indications for use against predicate devices. The document does not describe a clinical trial with a "test set" of patients or data.
• Data Provenance: Not applicable. The justification is based on design specifications and material properties, rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. Ground truth as typically understood for AI algorithms (e.g., expert consensus on an image) is not relevant for this medical device submission. The "ground truth" for a substantial equivalence determination is the performance and safety profile of the predicate device and the engineering specifications of the new device.

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

• Not applicable. No clinical test set requiring adjudication of findings is described.

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/software device, therefore MRMC studies are irrelevant to this submission.

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

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

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

• For the purpose of a 510(k) for a physical medical catheter, the "ground truth" is established by a combination of:
  • Predicate Device Performance: The safety and effectiveness data and established performance of legally marketed predicate devices (OmniPICC PI™ Catheter, PowerPICC™ Catheter).
  • Engineering Specifications and Material Testing: The inherent physical properties, design, and manufacturing standards of the OmniPICC P.I. catheter, including its ability to withstand specified pressures and flow rates for power injection.
  • Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.5970).

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is described.

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

• Not applicable. No training set for an algorithm is described.

Summary of the "Study" (510(k) Substantial Equivalence):

The document serves as a premarket notification (510(k)) to the FDA. The "study" described is a demonstration of substantial equivalence to previously cleared predicate devices (K051102 for OmniPICC PITM Catheter and K033389, K050931, K051672, & K051991 for PowerPICCTM Catheter by Bard Access Systems, Inc.).

Key points of this "study" are:

• Intended Use and Fundamental Scientific Technology: The OmniPICC P.I. is stated to be identical to its predicate device (Bard PowerPICC™) in these aspects.
• Configuration, Dimensions, and Materials: The two devices are stated to be substantially similar in these aspects. The 510(k) specifically aims to add new product codes in 4 French single and 5 French dual lumen sizes, which are within the scope of predicate devices' capabilities.
• Performance Claim: The device has been tested (implicitly, through engineering and design validation) to withstand power injection of 3ml/sec (4 Fr Single) to 5 ml/sec (5 Fr dual lumen) at a maximum power injection setting of 300 psi. This is a design specification intended to demonstrate equivalency or improvement upon predicate devices for similar power injection capabilities.

This type of submission does not involve clinical trials with human subjects or a statistical analysis of diagnostic accuracy that would be typical for an AI-powered device. Instead, it relies on a comparison of technical specifications, intended use, and materials to establish that the new device is as safe and effective as a device already on the market.

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