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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.

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