There aren't set criteria. For devices, preliminary bench data...

There aren't set criteria. For devices, preliminary bench data (which we have a ton of) and even literature on the device along with clinical data can help support the submission. It's much more holistic determination than with drugs, which is what I'm much more familiar with and which are overwhelmingly based on trial data.

FDA believes it is appropriate to consider whether there
is a reasonable expectation that a device could provide for more effective treatment or diagnosis
relative to the current standard of care (SOC) in the U.S. A complete set of clinical data is not
required for designation. Instead, a sponsor should demonstrate a reasonable expectation that the
device could provide for more effective treatment or diagnosis of the disease or condition
identified in the proposed indications for use. This includes a reasonable expectation that the
device could function as intended (technical success) and that a functioning device could more
effectively treat or diagnose the identified disease or condition (clinical success). Mechanisms
for demonstrating a reasonable expectation of technical and clinical success could include
literature or preliminary data (bench, animal, or clinical). For example, a sponsor might provide
preliminary bench data to support the potential for technical success and literature to support that
a given principle of operation could more effectively treat or diagnose the identified disease or
condition.

And the criteria for submission we would fall under is:

a product intended to treat or diagnose a life-threatening or irreversible disease or
condition that results in more efficient or safer clinical operation.

This info is from the FDA's Breakthrough Device guidelines linked below:

FDA Guidelines on Breakthrough Devices