What is the minimum sample required for Performance Evaluation for IVD ?

B

belemsanchez

#1
please, I have a doubt, when you make a performance evaluation, whats is the minimun number of samples? are 20 samples in IVD?

Thanks a lot
 
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rangani_rj

Involved In Discussions
#2
Hi

Though I am not expert in Statistic, I have some idea based on my research work in post-graduation that there is not like ?minimum sample size in statistic?.

You have to first define which test is appropriate for your study (ANNOVA, Dunn?s test etc). Sample size depends on multiple factor. First It depends on which power of statistical significance you want for your particular test (like p<0.001(99% positive outcome and one negative), P<0.005(95%)).
Further it will also depend on which type of test your device is performing. Whether it is detecting rare disease parameter or common parameter. For rare disease parameter your sample will be limited.

What I was doing to determine minimum sample required, I was putting some rough value of sample size and expected positive outcome in statistic software (Biostat) for particular test (Two Way Annova). It shows the acceptance of result with confidence interval (P value). Another software is Graphic pad Prism. Another simple way ? first define test and then using Excel and rough data determine minimum size of sample with positive result.

This is my research experience, I dont know whether it is applicable for such IVD related regulatory work or not.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
As someone who does this a living - there is no minimum sample size. It all depends on your (desired) label claim for Sensitivity and Specificity, the significance and power desired, whether or not your test will use different types of samples (whole blood, plasma, serum, tissue, fecal, urine etc.) and the need for diversity of disease variants (such as geographic stratification).

It will also depend on the type of analysis your regulatory reviewer prefers...latent class, baysian, clopper-pearson...
 

rangani_rj

Involved In Discussions
#4
Hi,

I was reading regulation on IVD and found that common technical specification (CTS) directive for IVD (2002/364/EC) have already mentioned some requirements for performance evaluation (specificity, sensitivity, population selection, specimen type etc) in table 1 to table 10 according to IVD devices (Blood groupin, Virus, Genotype).

Have a look on this directive if you are still searching for sample size.
 
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