(47 days)
The Sensititre 18 - 24 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 elimination of limitations in the sensititre technical insert. The limitation to be removed are as follows: 2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillin/clavulanic acid with Enterococcus sp., and gentamicin (500 ug/mL) with Enterococcus faccium is unknown because too few resistant strains were available at the time of comparative testing. The addition of the following limitation in the Sensititre technical insert: The autoreader system should not be used Nitrofurantoin with Enterococcus species. Nitrofurantoin should be read manually. The ability to detect resistance with nitrofuantoin is unknown because too few resistant strains were available at the time of comparative testing.
Not Found
This document is a 510(k) premarket notification acceptance letter from the FDA for a Susceptibility Test Panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. However, it does not include detailed study information, acceptance criteria tables, or performance data typically found in a clinical study report or a summary of safety and effectiveness.
Therefore,Based on the provided document, I cannot fulfill all components of your request, as the document is an FDA acceptance letter and not a detailed study report. It states what limitations are being removed and added to the device's technical insert, implying that certain studies were done to support these changes, but it does not provide the study details requested.
Here's what I can extract or infer from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document is an FDA clearance letter, not a scientific study report. It mentions the "elimination of limitations" and "addition of a limitation" for the Sensititre system, implying that testing was conducted to support these changes, but the specific acceptance criteria and performance results are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "lack of performance data on emerging resistant Enterococcus sp." and "too few resistant strains were available at the time of comparative testing" for specific drug-organism combinations, suggesting that the initial testing datasets had limitations, but it does not detail the sample sizes or provenance of the data used for the re-evaluation.
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 provided in the document. For antimicrobial susceptibility testing, the "ground truth" is typically established by reference methods and expert interpretation of results, but the specifics are not included here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 is not applicable to this device. The device is an "Antimicrobial Susceptibility Test" system (Susceptibility Test Panel), not an AI-assisted diagnostic imaging device that involves human readers interpreting images. The mention of "AutoReader system" refers to an automated instrument for reading the susceptibility tests, not an AI for human augmentation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is the "Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System." The document mentions the "AutoReader system" and limitations regarding its use for certain organisms (e.g., Enterococcus sp.) and drugs (Nitrofurantoin), suggesting there is an automated component. The statement "The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually" implies that a standalone (automated) assessment for Enterococcus sp. was initially not sufficient. The subsequent removal of this limitation suggests improved standalone performance was demonstrated. However, specific standalone performance metrics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For antimicrobial susceptibility testing, the ground truth is typically established by reference methods, such as broth microdilution or agar dilution as defined by CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state the ground truth method but implies the use of comparative testing against established methods.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document. As mentioned for the test set, it would likely be established using reference antimicrobial susceptibility testing methods.
In summary, this FDA letter confirms the clearance of a device based on its substantial equivalence and the resolution of previous limitations. It does not contain the detailed study results, methodologies, or specific performance metrics that would answer most of your questions. Such information would typically be found in the 510(k) submission itself or a summary of safety and effectiveness, neither of which is part of these provided pages.
§ 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).