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The BardPort® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

The Titanium Implanted Port is the largest of the BardPort® single lumen titanium port family. The port body consists of titanium base and top with a round shape design. The port has four suture slots and two suture holes that are silicone encapsulated. The Titanium Low Profile Implanted Port is a modified, slightly smaller version of the Titanium Implanted Port. The port body consists of titanium base and top with a round shape design. The port has six unfilled suture holes. The Titanium Implanted Port is available with attachable or pre-attached 6.6 and 9.6 Fr open-ended silicone intravascular catheters. The Titanium Low Profile Port is available with attachable or pre-attached 6.6 Fr open-ended silicone intravascular catheter. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone septum. Fluid communication to the vascular system is provided through a catheter attached to the port. The port system serves as a conduit for fluids into, and out of, the central venous system.

Here's a breakdown of the acceptance criteria and study information for the BardPort® Single Lumen Titanium Implanted Ports, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Verification testing was performed according to protocols," but does not specify the number of units or data points in the test set.
• Data Provenance: Not explicitly stated. The study seems to have been conducted by Bard Access Systems as "in-house protocols" and "Verification testing was performed according to protocols based on the above referenced international standard, as well as in-house protocols." It does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Not applicable. The document describes performance testing against international standards and in-house protocols, not a clinical trial with human experts establishing ground truth for a test set.

4. Adjudication Method (Test Set)

• Not applicable. This was a device performance study against pre-defined technical criteria, not a study requiring adjudication of expert opinions.

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

• No. The provided text does not mention an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. This document describes a traditional 510(k) submission for a physical medical device.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone algorithm" performance is not applicable.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance was established by predetermined performance acceptance criteria based on:
  • International standard ISO 10555-3:1997 (Sterile, Single-Use Intravascular Catheters, Central venous catheters).
  • Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 and FDA Modified ISO 10993 Test Profile.
  • In-house protocols for performance testing.
  • FMEA for risk assessment.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant and does not involve AI or machine learning models that require a "training set."

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

• Not applicable, as there is no training set for this type of device.

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