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The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. The Rhapsody Port and Catheter are safe to use in an MRI environment.

grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood.

The provided text is for a 510(k) summary for a medical device called "Rhapsody MRI," which is an implanted port and catheter. This document focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its MRI compatibility. Therefore, the "acceptance criteria" and "study" described are related to verifying this compatibility, not the performance of an AI algorithm.

Based on the provided text, here's a breakdown of the requested information, interpreted in the context of a medical device submission rather than an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" for a specific test set in the way one would for an AI/ML study (e.g., number of images or patients). Instead, it refers to "performance testing and design verification testing" related to MRI compatibility. This likely involved a set of physical devices being subjected to various MRI conditions to assess their safety and function.

• Sample Size: Not specified in terms of numerical units like "patients" or "cases." The context suggests a set of physical devices tested.
• Data Provenance: Not specified, but likely refers to internal testing conducted by the manufacturer (GrantAdler Corporation). It is not retrospective or prospective in the clinical study sense; rather, it's product testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept of "experts establishing ground truth" is not directly applicable in the context of this device's submission. The "ground truth" here is the physical interaction of the device with an MRI environment, and its safe and effective function. This would be established through engineering and electromagnetic compatibility testing standards, not expert subjective review.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data, typically in diagnostic imaging studies where there's subjectivity. Here, the assessment is based on objective measurements and adherence to engineering standards for MRI compatibility.

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

No. This is a medical device approval, not an AI/ML algorithm submission. An MRMC study is designed to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for this device.

6. Standalone Performance Study (Algorithm Only)

No. This refers to a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Physical and electronic measurements: Demonstrating the device's behavior in an MRI field (e.g., heating, artifact generation, displacement).
• Adherence to recognized standards: Likely ISO, ASTM, or similar standards for MRI compatibility of implanted devices.
• Functional performance: Ensuring the port and catheter continue to function as intended after exposure to MRI.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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