(179 days)
The Digi-Injector is indicated for use as a general purpose injector of fluids It is to be used with single-use, disposable needles of any gauge size. It is to be used wherever precise control of injection rate or volume is required. The Digi-Injector is also indicated for use for injection of fluids (high or low viscosity) during ophthalmic surgery.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, any specific study, sample sizes, expert involvement, or ground truth establishment.
The document is a FDA 510(k) clearance letter for a device called "Digi-Injector." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also includes the "Indications for Use" for the device.
However, a 510(k) clearance typically involves a demonstration of substantial equivalence, which often relies on comparison to a predicate device rather than presenting detailed performance data from a standalone study with specific acceptance criteria as requested in your prompt. The letter itself does not contain the specifics of any performance study that would establish acceptance criteria.
Therefore, I cannot fill out the requested table or answer any of the questions related to the study design, sample size, or ground truth.
§ 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).