(90 days)
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for meropenem in the dilution range of 0.015 - 32 ug/ml for testing fastidious isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.
Meropenem has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Streptococcus spp. Viridians group Haemophilus influenzae
Not Found
The provided text is a 510(k) clearance letter from the FDA for an Antimicrobial Susceptibility Test Powder. It does not contain the details of acceptance criteria or a study proving that a device meets such criteria, as it relates to an AI/ML-driven medical device. The document is an administrative letter confirming the substantial equivalence of a new version of an in vitro diagnostic product (Sensititre) used for antimicrobial susceptibility testing, specifically for meropenem against certain bacterial isolates.
Therefore, I cannot extract the information requested about acceptance criteria, device performance, test set details (sample size, provenance, expert adjudication, MRMC study, standalone performance), ground truth, or training set details. This information would typically be found in a detailed study report or premarket submission for an AI/ML device, not in a 510(k) clearance letter for an in vitro diagnostic for antimicrobial susceptibility.
In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving device performance 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).