(61 days)
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.
Susceptibility Test Panel
This document is a 510(k) clearance letter for a medical device and thus does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.
However, I can extract information related to the device, its intended use, and the type of information that was likely considered for its clearance.
Device Name: Sensititre 18-24 Hour Susceptibility Plates (specifically, the addition of Cefdinir to the Sensititre 18-24 hour MIC panel).
Regulatory Class: II
Product Code: JWY
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided as typical performance metrics (e.g., sensitivity, specificity, accuracy) are not included in this document.
- The acceptance criteria for substantial equivalence are generally that the device is as safe and effective as a legally marketed predicate device.
- The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core finding, implying the performance met the FDA's criteria for equivalence based on the submitted data.
- The "reported device performance" is summarized as the ability of the Sensititre 18-24 hour MIC panel to test for Cefdinir susceptibility in specific non-fastidious gram-negative isolates (Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis) in a dilution range of 0.06 - 64 ug/ml.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The letter mentions "In vitro data" was provided. Details about the sample size (number of isolates tested), country of origin, or study design (retrospective/prospective) are not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not explicitly stated in the provided text. For susceptibility testing, ground truth is typically established by a reference method (e.g., agar dilution or broth microdilution following CLSI guidelines), not by human expert consensus in the way it might be for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not stated. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where consensus among experts is needed. For an in vitro diagnostic device measuring antimicrobial susceptibility, the ground truth is usually an objective measurement from a reference method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, which is a laboratory assay. It does not involve "human readers" interpreting images or other complex data that would necessitate an MRMC study or AI assistance in the way described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the AI sense. The Sensititre system is a standalone automated/semi-automated system for determining Minimum Inhibitory Concentration (MIC). Its performance is evaluated independently of human interpretation of complex patterns, but a laboratory technologist would still perform the test and interpret the numerical MIC results against breakpoints. So, while it's an "algorithm only" in the sense it provides a direct result, it's not "AI" in the modern sense of machine learning for complex pattern recognition. The "standalone performance" would refer to its accuracy compared to a reference method, which is implied by the substantial equivalence determination.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as the Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution or agar dilution methods. The device's results (MIC values) would have been compared to these reference method results for accuracy.
8. The sample size for the training set
- Not explicitly stated in the provided text. This is not typically disclosed in a 510(k) clearance letter. For an IVD like this, there isn't a "training set" in the machine learning sense. Instead, there are validation studies performed with a sufficient number of bacterial isolates to demonstrate the device's accuracy and reproducibility.
9. How the ground truth for the training set was established
- Not applicable for a "training set" in the AI sense. As mentioned above, ground truth for such IVDs is established by comparing results to a recognized reference method for antimicrobial susceptibility testing (e.g., CLSI guidelines).
§ 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).