(75 days)
The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimiorobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The Ceftazidime-avibactam MTS at concentrations of 0.016/4- 2564 ug/mL should be interpreted at 16-20 hours of incubation.
Ceftazidime-avibactam has been shown to be active both clinically and in viro against the non-fastidious bacteria listed below
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available but their clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Providencia stuartii
MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent
The provided text describes the Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 μg/mL, which is a quantitative method for in vitro determination of antimicrobial susceptibility of bacteria. The document is a 510(k) clearance letter from the FDA, and it outlines the indications for use and general regulatory information. However, it does not contain the specific detailed information for acceptance criteria and the study that proves the device meets those criteria, such as specific performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or adjudication methods.
Therefore, many of the requested details cannot be extracted directly from this document. I will provide what can be inferred or stated as "not found" based on the given text.
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a specific table of acceptance criteria and reported device performance metrics (e.g., categorical agreement, essential agreement, accuracy, sensitivity, specificity values). The document indicates that the device has been found substantially equivalent to predicate devices, implying that it meets regulatory expectations for antimicrobial susceptibility testing, but the numerical performance data are not included.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Implied: Demonstrate substantial equivalence to predicate devices for antimicrobial susceptibility determination. | Device is cleared for marketing, suggesting performance is acceptable to FDA. |
| Implied: Accurate determination of MICs for listed bacteria. | Device determines MIC in μg/mL against specified bacteria (Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, etc.). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not found in the provided text. The document refers to "in vitro data" but doesn't specify the details of the test set, sample size, or provenance.
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)
This information is not found in the provided text. As this is an in-vitro diagnostic device for antimicrobial susceptibility, the "ground truth" would typically be established by a reference method (e.g., broth microdilution or agar dilution) rather than human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not found in the provided text. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation is involved. For an antimicrobial susceptibility test, the "adjudication" would involve comparing the MTS results to a reference method according to predefined criteria.
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
This information is not found in the provided text. The device described is an in-vitro diagnostic test strip that is manually read, not an AI-assisted diagnostic system involving human readers. Therefore, an MRMC study or AI assistance effect size is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "MIC Test Strip" which is "used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures." This indicates that human-in-the-loop performance is a fundamental part of the device's intended use. A standalone algorithm performance would not be relevant or possible for this type of manual test strip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the ground truth method. However, for antimicrobial susceptibility testing, the ground truth is typically established by a recognized reference method, such as:
- CLSI (Clinical and Laboratory Standards Institute) recommended reference broth microdilution or agar dilution methods.
8. The sample size for the training set
This information is not found in the provided text. This document is a 510(k) clearance letter, which typically summarizes the regulatory decision rather than detailed study protocols or training set specifics.
9. How the ground truth for the training set was established
This information is not found in the provided text. Similar to point 8, the detailed methodology for establishing ground truth for any presumed training set (if applicable for test strip development) is not included in this regulatory letter. It's likely that if a "training set" in a machine learning sense were applicable, the ground truth would be established by reference methods as described in point 7.
§ 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).