(75 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 Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.
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The provided text is a 510(k) clearance letter from the FDA for a susceptibility testing device. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device, a Sensititre 18-24 Hour Susceptibility Plate with Meropenem, has been found substantially equivalent to a legally marketed predicate device.
Therefore, many of your questions cannot be answered from the provided text.
Here's what can be inferred or stated based on the text:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) clearance letter states that the device is "substantially equivalent" to predicate devices, but it does not detail the specific performance metrics or acceptance criteria used to make that determination.
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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 present in the provided document.
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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 present in the provided document. For susceptibility testing, the "ground truth" would typically be established by a reference method (e.g., agar dilution or broth microdilution performed according to CLSI guidelines), not necessarily by human experts in the same way as imaging analysis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided document.
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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 present in the provided document. MRMC studies are typically associated with diagnostic imaging AI, not susceptibility testing.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Susceptibility Test Panel" (in vitro diagnostic product) which determines the susceptibility of organisms to an antibiotic. It is inherently a standalone analytical test, not an AI algorithm requiring human-in-the-loop performance. Its performance would be evaluated on its ability to accurately determine susceptibility based on growth patterns in the presence of various antibiotic concentrations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for an in vitro diagnostic susceptibility test, the ground truth would almost certainly be established by a reference method (e.g., standard broth microdilution or agar dilution) performed by a qualified laboratory, following recognized standards (like those from CLSI - Clinical and Laboratory Standards Institute). It would not be expert consensus, pathology, or outcomes data.
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The sample size for the training set: This information is not present in the provided document. For an in vitro diagnostic device like this, there wouldn't typically be a "training set" in the machine learning sense. Instead, performance is evaluated against known bacterial isolates with established susceptibility profiles.
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How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI sense is not applicable here. The ground truth for the performance evaluation of such a device would be established using a gold standard reference method (e.g., CLSI-defined methods like broth microdilution) to determine the true Minimum Inhibitory Concentration (MIC) for tested organisms against the antibiotic Meropenem.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.