What does performance specification include?

[gsubas]

Hello all,
I am trying to understand what parameters are included in performance specification besides the ones mentioned in FDA guidance document. FDA Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device lists performance specification as performance characteristics of a device as listed in device labeling or in finished product release specifications. Some examples of performance specifications are measurement accuracy, output accuracy, energy output level, and stability criteria.
Does performance specification include output voltage and output currents as well? Can you call specification of a device performance specification?
I tried searching the web but did not get a satisfactory answer. If you could point me to the right direction it will be highly appreciated.
Thank you.

 

[John Broomfield]

Performance specs are basic inputs to the design of services and products.

They answer fundamental questions such as:

A. What will the service enable its customers to achieve?
B. What will the product be capable of?
C. Under what conditions?

Until the design process has these inputs it is unlikely to deliver quality services and products.

Performance specs may also include basic health and safety requirements or leave these inputs to competent designers.

As you can see these inputs may also come from market research, regulators, users and customers.