(14 days)
The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
The subject MRI PowerPort™ device with 9.6 Fr silicone catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a plastic port and silicone catheter that is attached to the port with a cathlock compression fitting. The subject device is distinguishable as a member of BAS's power injectable port series by the triangular body shape, unique purple coloring, and three palpation bumps on the septum. PowerPort™ implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion set to create a power injectable system.
The provided text is a 510(k) Summary for the MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter. It indicates that the device's safety and performance were established through design verification testing and risk management, which showed the device met predetermined acceptance criteria for its intended use and was substantially equivalent to predicate devices. However, the document does not contain explicit details about specific acceptance criteria values, reported device performance metrics tied to those criteria, the sample sizes for test or training sets, data provenance, the number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.
The document states:
"No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, design verification testing was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria listed therein."
Given the information provided, it's not possible to populate the requested table and details comprehensively as the document explicitly states that specific performance standards have not been established by the FDA, and while internal testing was done, the specifics of "predetermined acceptance criteria listed therein" are not included in this summary.
Therefore, the table and answers below will reflect the lack of specific information in the provided text regarding these points.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set or the data provenance. It only states that "design verification testing was performed." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The device is an implanted port, not an imaging or diagnostic device that typically requires expert interpretation for ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. -
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:
No MRMC comparative effectiveness study was mentioned. The device is a medical implant, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was mentioned. The device is a medical implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically understood in AI/diagnostic studies does not directly apply here. The document refers to "design verification testing" and meeting "predetermined acceptance criteria" related to the safety and efficacy of the physical device and its intended use (e.g., flow rates, material compatibility). -
The sample size for the training set:
Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.