Dear Statisticians and regulatory experts,

Kindly help me to solve this problem for one of the medical device project. I asked many statisticians, but none were able to give convincing answer from the regulatory standpoint as you know FDA is very strict with the evidences and rationals. I found the similar problem on this forum but couldn't find the end answer.

Problem: The manufacturer of medical endoscope device equipment (pretty expensive prototypes) and they are trying to figure out justification for using 5, 7 or 10 samples with sufficient confidence level and reliability to proceed w/ manufacturing.

Testing such as bend cycling and environmental testing etc which they can do in house, for these tests sample sizes need to be determined (for each test). *These sample sizes can be calculated based on confidence and reliability levels, but a precedent should be set for the confidence/reliability that is needed for these devices and testing based on the risk level of the testing and the expense of running these tests.

At least with the examples of similar kind with formula and method!

I have very limited statistical knowledge. Kindly help me to solve this problem with the solutions from the regulatory standpoint.

Thank you!

Kindly help me to solve this problem for one of the medical device project. I asked many statisticians, but none were able to give convincing answer from the regulatory standpoint as you know FDA is very strict with the evidences and rationals. I found the similar problem on this forum but couldn't find the end answer.

Problem: The manufacturer of medical endoscope device equipment (pretty expensive prototypes) and they are trying to figure out justification for using 5, 7 or 10 samples with sufficient confidence level and reliability to proceed w/ manufacturing.

Testing such as bend cycling and environmental testing etc which they can do in house, for these tests sample sizes need to be determined (for each test). *These sample sizes can be calculated based on confidence and reliability levels, but a precedent should be set for the confidence/reliability that is needed for these devices and testing based on the risk level of the testing and the expense of running these tests.

At least with the examples of similar kind with formula and method!

I have very limited statistical knowledge. Kindly help me to solve this problem with the solutions from the regulatory standpoint.

Thank you!

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