(49 days)
The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.
The Veinnovations Infiltration System consists of the Infiltration Pump and proprietary, sterile, single use Veinnovations Y Infiltration Set.
The provided document is a 510(k) premarket notification determination letter for the "Veiinnovations Infiltration System." This type of document establishes substantial equivalence to a predicate device for marketing purposes and does not contain detailed study results or acceptance criteria in the manner requested for AI/ML device performance.
Therefore, I cannot provide the requested information as the document does not describe acceptance criteria or a study proving device conformance to such criteria. The document focuses on regulatory approval based on substantial equivalence, not detailed performance studies with acceptance criteria, sample sizes for test sets or training sets, ground truth establishment, or expert evaluations.
Here's why each point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only mentions that the device is "substantially equivalent" to a predicate device based on indications for use, design, materials, and operational characteristics. No specific performance metrics or acceptance criteria are listed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided. This is typical for a 510(k) summary focused on substantial equivalence rather than a clinical trial report.
- 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): Not applicable, as no test set or ground truth establishment by experts is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is described.
- 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. The device is an "infiltration pump system," a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, MRMC studies or AI assistance are irrelevant to this product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical pump system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is discussed for this type of device.
- The sample size for the training set: Not applicable, as no AI/ML model or training set is involved.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval letter for a medical device (an infiltration pump) based on substantial equivalence, not a scientific publication detailing performance studies for an AI/ML product.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).