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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 Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.

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I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, and ground truth establishment for a medical device.

The document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin." This letter indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. While it mentions the "indications for use" and the product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the type of study conducted to demonstrate performance (e.g., test set, training set, retrospective/prospective).
• Information about experts used for ground truth, adjudication methods, or the type of ground truth.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The letter is a regulatory document confirming clearance, not a scientific study report with performance metrics.

To answer your questions, I would need access to the actual 510(k) submission document or a scientific paper detailing the validation study for this device.

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