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The 5 Fr Dual Lumen Groshong® NXT PICC Catheter is designed for use in short term or long term intravenous therapy and any other therapies requiring long term central venous access (e.g. blood sampling). It is used for administration of hyperalimentation, chemotherapy and other I.V. fluids. The dual lumen feature permits simultaneous infusion of incompatible solutions and/or aspiration of blood samples. Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information.

The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

The 5 Fr Dual Lumen silicone Groshong® NXT PICC Catheters feature a reverse-taper catheter design. They are 45 or 55 cm in length. The catheters have two equal-sized lumens and a closed, rounded, atraumatic, radiopaque, distal tip with the 3-position, pressure-sensitive Groshong® valve in each lumen. Valves are staggered for simultaneous infusion of incompatible solutions and/or aspiration of blood samples.

The proximal end of the catheter has a bifurcation with integral Statlock compatible suture wings. There are red and white plastic luer lock connectors on the extension legs. Extension legs are insert molded into the proximal end of the bifurcation. Catheters are provided sterile with a preloaded hydrophilic stiffening stylet.

The provided text describes the 510(k) submission for the 5 Fr Dual Lumen Groshong® NXT PICC Catheter, focusing on its substantial equivalence to a predicate device. It contains the general information requested by the FDA for such submissions, including nonclinical performance testing. However, it does NOT include a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or a detailed statistical analysis against specific acceptance criteria. The document states that "performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (design)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific sample sizes, ground truth information, or details about expert involvement in a clinical evaluation. The information provided is primarily related to nonclinical engineering and material testing for regulatory submission.

Below is a summary of the information that can be extracted from the provided text, primarily focusing on the nonclinical performance testing and the regulatory process, as well as indicating what information is not available in the provided text for a clinical "study."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria with corresponding performance results in a table format for a clinical study. Instead, it lists the types of nonclinical performance testing conducted to demonstrate substantial equivalence to the predicate device. The conclusion states that "Performance data demonstrate equivalence," implying that the results of these tests met the necessary standards for regulatory approval.

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

• Test Set Sample Size: Not specified for any clinical or nonclinical study. The nonclinical performance testing was conducted according to protocols based on FDA guidance and additional standards, but the number of units tested is not detailed.
• Data Provenance: The data is from "design verification testing" conducted by Bard Access Systems, Inc. (BAS) for regulatory submission to the FDA. No information on country of origin of data or retrospective/prospective nature is given, as it pertains to engineering performance testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The testing described is nonclinical performance testing of a medical device's physical and functional characteristics, not an evaluation against a clinical ground truth established by experts.

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

• This information is not applicable and not provided. This relates to clinical evaluation and expert consensus, which is not described in the document.

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

• No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or described. This document pertains to the regulatory clearance of a physical medical device (PICC catheter), not an AI-powered diagnostic tool.

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

• No standalone algorithm performance or human-in-the-loop performance studies were conducted or described. This document pertains to the regulatory clearance of a physical medical device (PICC catheter).

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

• For the nonclinical performance testing, the "ground truth" was established by engineering specifications, accepted scientific methods, and compliance with FDA Guidance on Premarket Notification for Intravascular Catheters (dated 3/16/95), as well as ISO-10993 for biocompatibility. There is no clinical ground truth (expert consensus, pathology, outcomes data) mentioned in the provided text.

8. The sample size for the training set

• Not applicable and not provided. This device is not an AI algorithm; therefore, there is no "training set."

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

• Not applicable and not provided. This device is not an AI algorithm; therefore, there is no "training set" or corresponding ground truth establishment process.

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