(38 days)
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 Gemifloxacin (0.03 -0.5 ug/mL), Linezolid (0.5-4 ug/mL), Levolloxacin (0.5-16 ug/mL) for use with the Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plate. This device is an in vitro diagnostic product for clinical susceptibility testing of specific bacterial strains against antimicrobial agents.
Therefore, the requested information about acceptance criteria for a medical imaging AI device or an AI model, ground truth, expert consensus, and MRMC studies is not applicable to this document.
The document discusses the regulatory approval of a microbiology testing plate based on substantial equivalence to legally marketed predicate devices, not on performance criteria that would involve AI or human reader studies.
Here's why the requested information cannot be extracted from the provided text:
- This is not an AI device. The device is a microbiology susceptibility plate, a lab consumable for determining how effective an antibiotic is against a specific bacterium. It's a chemical/biological assay, not an AI or imaging device.
- No AI performance metrics are discussed. The document deals with regulatory matters for an in vitro diagnostic product. It doesn't mention sensitivity, specificity, AUC, or any other performance metrics typically associated with AI.
- No human reader studies are mentioned. There's no indication of radiologists, experts, or their performance with or without AI assistance.
- No ground truth establishment for AI is present. The "ground truth" for a microbiology susceptibility plate would typically be the minimum inhibitory concentration (MIC) determined by a reference method, which is a standardized laboratory procedure, not expert consensus or pathology in the context of AI.
- Training or test set sample sizes for an AI algorithm are not relevant.
In summary, the provided text does not contain any of the information requested for AI device acceptance criteria or studies.
§ 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).