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The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

The provided document, K072509, is a 510(k) premarket notification for a medical device, the PRO-PICC™ CT catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical trials with specific acceptance criteria in the manner of a new drug or a highly innovative device.

Therefore, the study design and acceptance criteria outlined would be for in vitro (bench) testing designed to show the device performs similarly to or within acceptable limits compared to the predicate device, or to established industry standards (ISO). There are no clinical studies described, nor are there any AI components involved.

Here's a breakdown of the requested information based on the provided text, with a recognition that many items are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was performed to "assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol." It does not provide specific numerical acceptance criteria or results, but rather a statement of compliance.

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

• Sample Size for Test Set: Not explicitly stated for specific in vitro tests. Typically, in vitro testing for device performance involves a specified number of samples (e.g., 5-10 devices per test condition) to demonstrate consistency and compliance with standards.
• Data Provenance: The document refers to "in vitro testing" and internal engineering protocols. This indicates the testing was conducted prospectively in a laboratory setting by the manufacturer (Medcomp®). There is no mention of country of origin for the data as it's not patient data.

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

• Not applicable. This device submission relies on in vitro engineering testing against established standards, not expert-derived ground truth based on patient data. There are no experts reviewing test images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this is an in vitro device performance study, not a study involving human interpretation of data requiring adjudication.

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 device is a physical medical catheter, not an AI or imaging analysis tool. No MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by international standards (ISO 10555-1, 10555-3, 10993) and the manufacturer's internal engineering protocols. These standards specify acceptable limits for various physical and material properties (e.g., burst pressure, flow rates, biocompatibility), which form the basis of the "ground truth" for demonstrating device safety and reliable performance.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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