(81 days)
A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling.
The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.
The provided document is a 510(k) summary for the PORT-A-CATH® Low-Profile™ Implantable Access Systems, dated December 29, 1997. It describes a medical device and its intended use but does not include any acceptance criteria or a study proving its performance against such criteria for AI/ML device evaluation.
The document explicitly states:
- "Functional testing was not deemed necessary, since no changes were made to the product."
- "Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product..."
Therefore, I cannot provide the information requested in your prompt because the 510(k) submission for this device did not involve performance studies against acceptance criteria in the context of AI/ML or even general functional/clinical studies, as it was deemed substantially equivalent to existing devices.
To directly answer your numbered points based on the absence of such information in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or reported device performance data are present as no functional or clinical studies were deemed necessary.
- Sample size used for the test set and the data provenance: Not applicable. No test set was used as no studies were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an implanted port system, not an AI/ML diagnostic tool, and no such study was performed or mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.