(83 days)
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for daptomycin in the dilution range of 0.03-64 µg/mL for testing non-fastidious gram-positive isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System.
Daptomycin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Enterococcus faecalis (vancomycin-susceptible isolates only)
Staphylococcus aureus (including methicillin-resistant isolates)
Daptomycin has been shown to be active in vitro only against the following organisms according to the FDA drug label: Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium (including vancomycin-resistant isolates)
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This document is a 510(k) clearance letter for an in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML specific criteria (such as AI assistance, standalone algorithm performance, number of experts, and training set information) are not applicable.
The document discusses the regulatory clearance of "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL." This system is for antimicrobial susceptibility testing.
Here's an attempt to answer the relevant questions based on the provided text, while noting the inapplicability of AI/ML specific questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria and reported device performance. It is a clearance letter, assuming these details were part of the 510(k) submission that led to this clearance. The clearance confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards for antimicrobial susceptibility testing.
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 clearance letter. Such details would typically be found in the 510(k) submission itself.
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 question is not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" in antimicrobial susceptibility testing would typically involve a reference method (e.g., broth microdilution or agar dilution) against which the device's results are compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not an AI/ML device involving human adjudication of results. The "adjudication" in this context would be the comparison of the device's MIC results against the reference method's MIC results, followed by categorical agreement calculations (e.g., Essential Agreement, Categorical Agreement).
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 automated in vitro diagnostic system, not an AI-assisted tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is framed for AI algorithms. For this device, "standalone performance" would refer to the device's ability to accurately determine MIC values without manual intervention, which is its primary function. The clearance implies that its standalone performance (without human interpretation beyond reading the results) is acceptable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For antimicrobial susceptibility testing devices, the "ground truth" is typically established by reference dilution methods, such as broth microdilution or agar dilution, which are considered the gold standard for determining the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against a microorganism. The results obtained from the Sensititre system would be compared against these reference method results.
8. The sample size for the training set
Not applicable. This is an in vitro diagnostic device, not an AI/ML model that undergoes a "training" process in the dataset sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the AI/ML context for this type of 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).