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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 non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S/ System or equivalent Ichnemore: "This "how and WalkAway" 96) according to the Package Insert.

This particular submission is for the antimicrobial Meropenem on the rapID/S plus " Gram-Negative MIC/Combo Panels.

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

Acinetobacter spp Aeromonas hydrophila Citrobacter koseri (diversus) Citrobacter freundii Escherichia coli Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Pasteurella multocida Proteus mirabilis Proteus vulgaris Serratia marcescens Shigella spp Salmonella spp Yersinia enterolitica

The MicroScan® rapID/S plus "Gram-Negative with Meropenem is not intended for use with:

Pseudomonas aeruginosa

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® SY 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® SV 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.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: MicroScan® plus™ Gram-Negative MIC/Combo Panels with Meropenem (0.12-32 µg/ml)

1. Table of Acceptance Criteria and Reported Device Performance

Additional context: The "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000, is mentioned, suggesting that the criteria followed this FDA DRAFT document. While a specific numerical threshold for "Essential Agreement" isn't provided as a literal "acceptance criteria" in the text, the statement of "greater than 97.3%" being acceptable implies it met the internal or FDA's expected threshold.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: "fresh and stock Efficacy isolates and stock Challenge strains."
• Sample Size: Not explicitly stated. The text only mentions "external evaluation was conducted."
• Data Provenance: Not explicitly stated. There's no information about the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for the comparative study was established using an NCCLS frozen Reference Panel and Expected Results determined prior to the evaluation for Challenge strains, not by individual experts or a consensus panel in the traditional sense of human readers interpreting images or data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on an NCCLS frozen Reference Panel and pre-determined Expected Results, not a process requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an antimicrobial susceptibility device, not a medical imaging device. The study design described is a comparative study against a reference method (NCCLS frozen panel), not an MRMC study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes. The study focused on the performance of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel when read on the WalkAway® SY System (or equivalent), comparing its results directly to the NCCLS frozen Reference Panel. This represents the standalone performance of the device and its automated reading system.

7. The Type of Ground Truth Used

• For the "Efficacy isolates": NCCLS frozen Reference Panel. The NCCLS (now CLSI - Clinical and Laboratory Standards Institute) provides standardized methods and reference materials for antimicrobial susceptibility testing, so their frozen panels serve as a recognized ground truth for comparison.
• For "Challenge strains": "Expected Results determined prior to the evaluation." These expected results would likely be established through rigorous laboratory testing using a gold standard method.

8. The Sample Size for the Training Set

Not applicable. The text describes a comparative performance study of an in vitro diagnostic device, not a machine learning model that requires a "training set" in the conventional sense. The device's underlying principles are based on established microbiology techniques, not trained on a distinct dataset like an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for a machine learning model.

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