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HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.

The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.

This document is a 510(k) K193015 Premarket Notification for the HydroPICC (Model 142) intravascular catheter, asserting its substantial equivalence to a previously cleared predicate device, HydroPICC (Model 141, K172885).

The submission focuses heavily on demonstrating equivalence and does NOT include a study involving AI assistance for human readers, nor a standalone AI algorithm performance study. Therefore, most of the requested information regarding AI study design, ground truth establishment for AI, expert involvement, and MRMC studies is not present in this document.

The document describes performance testing for a medical device (intravascular catheter), not an AI algorithm. The acceptance criteria and performance data described relate to physical and mechanical properties of the catheter, as distinct from the performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML medical devices.

Here's the breakdown of the information that CAN be extracted, followed by a clear statement of what is NOT in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols," but it does not provide a specific table with numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and the standards followed.

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

The document does not specify the sample size used for the test set for each individual test. It merely states that "The subject devices met all predetermined acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for this engineering/performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This document describes the testing of a medical device (catheter), not the performance of an AI algorithm based on expert-labeled data.

4. Adjudication Method for the Test Set

Not applicable. This is for medical device performance (physical, mechanical, safety), not for AI algorithm evaluation requiring expert consensus/adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done because this submission is not for an AI/ML medical device and does not involve human readers interpreting images with or without AI assistance.

6. Standalone Algorithm Performance

No standalone algorithm performance study was done relevant to AI/ML, as this is not an AI/ML device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., ISO, ASTM standards, FDA guidance documents, and internal protocols) for physical and mechanical properties, not expert consensus on medical images, pathology, or outcomes data in the context of an AI study.

8. Sample Size for the Training Set

Not applicable. This document describes testing for a manufactured medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

Summary of what is NOT in the document regarding acceptance criteria and studies for an AI/ML device:

The provided document is a 510(k) premarket notification for a physical medical device (intravascular catheter). It details the substantial equivalence to a predicate device and describes the various engineering and performance tests conducted to ensure the device meets safety and performance standards. It does not contain any information about an AI/ML device, its acceptance criteria, expert consensus, ground truth establishment, or any studies related to its performance (standalone or human-in-the-loop). Therefore, the specific requirements of the prompt regarding AI are not addressed by this document.

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