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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

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