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The BardPort®, SlimPort®, and X-Port® 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.

BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation. BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine vascular access using a non-coring access needle.

The provided text is a 510(k) Pre-Market Notification for BardPort®, SlimPort®, and X-Port® Implanted Ports. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing. It does not describe an AI/ML device or its acceptance criteria and study data in the typical sense of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, effect size of human improvement) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (implanted infusion ports).

However, I can extract information related to the performance tests conducted to demonstrate the substantial equivalence of the device, which serves as the "study" proving the device meets its "acceptance criteria" in the context of this 510(k) submission.

Here's the closest interpretation of your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of medical device are typically defined by engineering specifications and recognized standards, which are evaluated through physical performance tests. The "reported device performance" is the successful completion of these tests.

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

• Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each performance test. It only lists the types of tests conducted.
• Data Provenance: Not applicable in the context of a physical device's engineering and performance testing. The "data" comes from in-house laboratory testing.

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

• This is not applicable as the "ground truth" for a physical device like an implanted port is determined by objective engineering measurements and adherence to specified performance standards, not expert interpretation of diagnostic images or clinical outcomes. The "experts" in this context would be the engineers and quality control personnel performing and evaluating the tests.

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

• Not applicable. Performance tests for physical devices typically rely on objective measurements against pre-defined thresholds, rather than subjective 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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• In the context of this device, the "ground truth" is established through objective physical and chemical properties testing against defined engineering specifications and recognized standards. Examples include measurements of tensile strength, burst pressure, leak rates, material composition, and dimensional accuracy, as outlined by standards like ISO 10555-1, ISO 10555-3, and ASTM F2503-13.

8. The sample size for the training set

• Not applicable. There is no AI/ML model being "trained" for this device. The development process for the device involved design controls and risk analysis, with modifications based on prior cleared devices (predicates).

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

• Not applicable. There is no AI/ML model for which a "training set" ground truth would be established. The "ground truth" for the device's design and performance validation relies on established engineering principles, material science, and adherence to medical device standards.

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