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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for antimicrobial susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical interpretations of the Cefdinir results are limited to Streptococcus pneumoniae (penicillin-susceptible strains only) and Haemophilus influenzae.

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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device. It does not contain the detailed technical information (acceptance criteria, study design, results, etc.) that would allow for a comprehensive description of the device's performance and the study proving it meets acceptance criteria.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance for market. It refers to "indications for use stated in the enclosure" but does not detail a specific study or acceptance criteria within the provided text.

Therefore, I cannot provide the requested information from the given input.

To answer your request, I would need a document that describes:

• The actual study performed (e.g., a clinical trial report, a validation study report).
• The specific acceptance criteria defined for the device's performance.
• The detailed results of that study demonstrating how the device met those criteria.

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