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MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose nonfermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S7 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Gatifloxacin on the Synergies plus" Gram-Negative MIC/Combo Panels.

The Gram-Negative organisms which may be used for Gatifloxacin susceptibility testing in this panel are:

Escherichia coli Klebsiella pneumoniae Proteus mirabilis Acinetobacter lwoffii Citrobacter koseri Proteus vulgaris

Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii

MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels are read on the WalkAway SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus ™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

The provided text describes the 510(k) summary for the MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Gatifloxacin (0.004 - 16 ug/ml). This device is used to determine the susceptibility of Gram-Negative bacilli to antimicrobial agents. The information below is extracted from the provided text to answer your questions.

1. A table of acceptance criteria and the reported device performance

The provided summary mentions the device's performance compared to an NCCLS frozen Reference Panel. While explicit "acceptance criteria" are not numerically stated as such, the "acceptable performance" is defined by the following agreement percentages:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Essential Agreement: 404 isolates tested (presumably 404 comparisons).
  • Categorical Agreement: 317 isolates tested (presumably 317 comparisons).
• Data Provenance: The document states "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." This suggests a combination of prospective (fresh isolates) and retrospective (stock isolates/strains) data. The country of origin is not specified, but the submission is to the U.S. FDA.

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 given text. The ground truth was established by an "NCCLS frozen Reference panel," but details about the experts or their qualifications for establishing this reference are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text. The comparison was made against an NCCLS frozen Reference panel, but how that panel's results were adjudicated is not detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated system for determining antimicrobial susceptibility, not an AI-assisted diagnostic tool for human readers.
• Effect Size: Not applicable, as no MRMC study was performed involving human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The "MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Gatifloxacin" is an automated system that provides the Minimum Inhibitory Concentration (MIC) for test organisms. The evaluation compared the device's results directly against an "NCCLS frozen Reference panel" to assess its accuracy. The text describes the device's performance as an algorithm/system generating results directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was the results obtained from an NCCLS frozen Reference Panel. This panel represents a standardized and accepted method for determining antimicrobial susceptibility, likely established through rigorous laboratory procedures and potentially expert consensus on those methods.

8. The sample size for the training set

The text does not specify a separate "training set" or its sample size. The description focuses on the external evaluation (test set) and quality control. For such an automated system relying on established biochemical reactions, the "training" might be inherent in the manufacturing and calibration processes rather than a distinct machine learning-style training set of data.

9. How the ground truth for the training set was established

As no specific training set is mentioned, information on how its ground truth was established is not provided in the text.

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