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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Tetracycline (0.5 -8 ug/mL), Trimethoprim/Sulphamethoxazole (0.5/9.5-4/76 ug/mL), Vancomycin (0.5-4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

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The provided text is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. It mentions that the device is substantially equivalent to a predicate and that the company provided a submission document, but the letter itself does not contain the detailed study results, acceptance criteria, or performance data.

Therefore, I cannot extract the specific information requested in your prompt based solely on the provided FDA letter. The letter refers to a "premarket notification of intent to market the device" which would contain such information, but that document is not provided here.

To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the study performed to demonstrate substantial equivalence, including acceptance criteria and performance data.

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