(80 days)
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for ceftobiprole in the dilution range of 0.008-16 ug/mL for testidious gram-positive isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Ceftobiprole has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Staphylococcus aureus (including methicillin-resistant isolates)
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The provided document is a 510(k) premarket notification letter from the FDA regarding a Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
It is important to note that this document does not contain information about acceptance criteria or a study proving device performance in the context of an Artificial Intelligence (AI) or machine learning device. The details requested in points 1-9 of your prompt are typically relevant to the performance evaluation of AI/ML-driven medical devices, especially those involving image analysis or diagnostic predictions.
The document is about an Antimicrobial Susceptibility Test Powder system, which evaluates the minimum inhibitory concentration (MIC) or breakpoint susceptibility of bacteria to an antibiotic (Ceftobiprole). The "performance" of such a device is typically assessed through analytical and clinical studies to ensure its accuracy in determining antibiotic susceptibility, often compared against a reference method (e.g., broth microdilution).
Since the document does not relate to an AI/ML device, I cannot provide the specific details requested in your prompt regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or expert involvement in a multi-reader study.
If you are looking for an example of how an AI/ML medical device's performance is demonstrated to the FDA, you would need to refer to a different type of 510(k) summary or premarket approval (PMA) document for an AI/ML device.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).