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The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Bard Access Systems, Inc.'s PowerPICC Provena Catheters with SOLO² Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for long or short-term use, as clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate device. The subject devices include a silicone valve on the proximal end. The subject devices included in this notification are of varying French size and catheter configuration types, as summarized in the table below.

Summary of Subject Devices
Catheter Configuration | French size (Number of Lumens)
PowerPICC Provena Catheters with SOLO² Valve Technology | 3 French Single Lumen (SL)
PowerPICC Provena Catheters with SOLO² Valve Technology | 4 French Dual Lumen (DL)

The following device descriptors apply to all French sizes and configurations of the subject catheters:
● Catheters are open-ended, radiopaque polyurethane;
● Catheters incorporate a silicone valve on the proximal end;
● Catheters have a reverse taper design;
● Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
● Purple colorant is included in the catheter material to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters;
● Catheter extension legs, luer hubs, and junction are printed with markings to identify the catheter as PowerPICC Provena Catheters with SOLO² Valve Technology, and include information to facilitate proper use of the device.

The subject devices are provided sterile in basic interventional radiology (IR) kits, as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.

The provided text describes specific performance tests conducted for the PowerPICC Provena Catheters with SOLO² Valve Technology to demonstrate substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information provided does not align with the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria.

However, based on the provided text, I can infer the "acceptance criteria" from the "Risk Acceptability Criteria (Acceptance Criteria of Test)" column and the reported performance from the "Verification / Validation Method" column. The study described is a series of in-house and standard-based performance tests, not an MRMC or standalone AI study.

Here's an interpretation based on the provided content, acknowledging its limitations regarding AI/ML:

This document describes the testing and verification of a medical catheter, not an AI/ML-driven device. Therefore, many of the requested criteria specific to AI/ML systems (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, effect size, standalone performance) are not applicable or cannot be extracted from the provided text.

However, I can extract the acceptance criteria and stated performance for the catheter device as presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantial equivalence as compared to the cited predicate device."

AI/ML Specific Questions (Cannot be answered from the provided text as it's not an AI/ML device)

2. Sample sizes used for the test set and data provenance: Not applicable. This is a physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device is established through physical and mechanical testing against standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established through meeting material, mechanical, and functional performance specifications defined by internal standards, ISO standards (e.g., ISO 10555-1:2013), and FDA guidance documents.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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