ASTM F1717 Static and Dynamic Testing

[Mazata]

I need some help obtaining test results for a posterior cervical fusion device. Specifically ASTM F1717 static and dynamic testing. I need for my 510(k) submission. Where can I get a competitve company's test results?

 

[indubioush]

Where can I get a competitve company's test results?

Why do you need another company's test results for YOUR submission?

 

[QM_123]

I need some help obtaining test results for a posterior cervical fusion device. Specifically ASTM F1717 static and dynamic testing. I need for my 510(k) submission. Where can I get a competitve company's test results?

I have no experience in FDA but I think you need your competitor's results to compare with your device's results, most probably standard does not provide acceptable value for test results, right? Searching literature published on the equivalent devices, especially biomechanical studies performed through ASTM F1717, may help you to find some results.