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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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The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T. The Port is normally included in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.

The Rhapsody CT is supplied as a sterile device, and is intended for single patient use only. The port is available as a single model and is manufactured of the highest quality titanium. It also incorporates a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. The Port is normally inclused in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.

Let's break down the information provided in the K081889 510(k) summary regarding the GrantAdler Rhapsody CT.

It's important to note that this 510(k) submission is for a medical device (implantable port and catheter), not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (like sample sizes for test/training sets, ground truth establishment methods, expert adjudication, MRMC studies, and standalone AI performance) are not applicable here.

The "acceptance criteria" for this type of device are primarily compliance with design specifications, material properties, and functional performance, often benchmarked against predicate devices and relevant industry standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided table in the document is a "Grant Adler Rhapsody CT Table of Comparison," which compares the Rhapsody CT device to its predicate devices (Grant Adler Rhapsody K043178 and Bard Power Port K060812). This table effectively serves as a summary of the device's performance against relevant design and functional criteria, demonstrating substantial equivalence to predicates.

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

For a medical device like this, there isn't a traditional "test set" with "data provenance" in the way one would describe an AI/ML algorithm. Instead, verification and validation testing is performed on the physical device.

• Sample Size: The document does not specify the exact number of physical devices tested for each criterion (e.g., how many ports were tested for leaks, or how many underwent material biocompatibility assessments). This information is typically detailed in the full testing reports submitted to the FDA, but not usually in the 510(k) summary. We can infer that enough samples were tested to provide statistical confidence for the claimed performance.
• Data Provenance: Not applicable in the context of AI/ML data. The "data" here comes from laboratory testing of manufactured devices.

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

This concept is not applicable to this device. There is no "ground truth" established by experts in the context of image interpretation or diagnosis. Instead, the performance criteria (e.g., "no leaks," "pass biocompatibility," "5 ml/s flow rate at <300 psi") are established through engineering specifications, regulatory standards, and comparison to predicate devices, and then verified through objective physical and chemical testing.

4. Adjudication Method

Not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in diagnostic tasks, which is not relevant for an implantable port.

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

Not applicable. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on human reader performance. This device is an implantable port, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by:

• Engineering Specifications: Design limits for pressure, flow rates, dimensions.
• Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other device properties.
• Predicate Device Performance: The performance of legally marketed predicate devices forms a baseline against which the new device is compared to establish substantial equivalence.
• Objective Physical and Chemical Testing: Lab tests demonstrating "no leaks," "pass biocompatibility," "max pressure/flow capabilities," and "MRI safety."

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.

In summary, the K081889 document is a 510(k) premarket notification for a physical medical device (an implantable port and catheter). The "acceptance criteria" and "study" described are focused on demonstrating the device's safety and effectiveness through engineering design, material compatibility, functional performance testing, and substantial equivalence to predicate devices, rather than the statistical performance metrics typical for AI/ML diagnostic software.

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