Table 4.

California Technology Assessment Forum Assessment Criteria

Number	Description	Comments
TA 1	The technology must have final approval from the appropriate government regulatory bodies	Approval via 510(k) process is streamlined for new devices that are similar to older devices
TA 2	The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes	Range: Levels 1–5, e.g., level 1, randomized, controlled trials powered to demonstrate clinically significant outcomes; level 5, case series without controls
TA 3	The technology must improve net health outcomes	Diagnostic tests must change management in ways that benefit patients
TA 4	The technology must be as beneficial as any established alternatives	It remains unclear how to evaluate diagnostic/prognostic tests lacking a gold-standard reference
TA 5	The improvement must be attainable outside the investigational setting	By definition, trials are conducted within an investigational setting, and therefore this criterion implies a speculation about potential, and not actually studied, applications