(184 days)
The subject device is intended for intravenous fluid, blood and blood products, and for delivery of short-term epidural administration not exceeding 96 hours, in the hospital and home care environment.
Not Found
This looks like a 510(k) premarket notification letter from 1997 for an infusion pump, which is a medical device. This type of document typically approves a device for market based on substantial equivalence to a predicate device, rather than presenting a detailed study proving acceptance criteria.
The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) is characteristic of a performance study report, often found in premarket approval (PMA) submissions or detailed clinical trial reports. These are generally much more extensive documents than a 510(k) approval letter.
Therefore, the provided text does not contain the specific information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what we can infer:
- 510(k) Process: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. It often relies on a comparison of design, materials, performance specifications, and intended use, rather than a full-blown clinical trial with detailed efficacy and safety endpoints like those requested in your prompt.
- Lack of Performance Data: The letter mentions the "Abbott Lifecare Standard Tubing Infusion Pump" and its intended use for intravenous fluid, blood, blood products, and short-term epidural administration. However, it does not provide any specific performance metrics (e.g., flow rate accuracy, alarm sensitivity, failure rates) or the results of a study designed to test these against pre-defined acceptance criteria.
- No Study Details: There's no mention of a particular study, sample sizes, experts, adjudication methods, or multi-reader multi-case studies. These are all elements of a robust clinical or performance evaluation study.
- Ground Truth: For an infusion pump, "ground truth" would typically relate to the accuracy of fluid delivery, the reliability of safety mechanisms (e.g., occlusion detection, air-in-line detection), and the pump's ability to maintain a set flow rate. This document doesn't delve into how these were established or tested in a study.
In summary, based solely on the provided text, I cannot complete the table or answer the questions because the document is an FDA approval letter for substantial equivalence, not a performance study report.
§ 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).