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MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Netilmicin (0.12 - 32 ug/ml) 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 bac!II (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

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

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

Acintobacter spp Citrobacter koseri (diversus) Citrobacter freundii Escherichia coli Enterobacter spp Klebsiella pneumoniae Proteus vulgaris Pseudomonas aeruginosa Serratia spp Shigella spp Salmonella spp

The MicroScan® Synergies plus™ Gram-Negative with Netilmicin is not intended for use with:

Proteus mirabilis

MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determing 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 ® Cramgrowing aeroon and racullanter and 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 I le allumic oblar susceptions broth to concentrations bridging the range of clinical interest and are occar unders in Macher Innoin arout form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SY System or equivalent Standardized Suspension of the organism and ancentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

The provided text describes the MicroScan® Synergies plus™ (initially rapID/S plus™) Gram-Negative MIC/Combo Panels with Netilmicin for determining antimicrobial agent susceptibility. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document references "FDA criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000. While the specific numerical acceptance criteria for Essential Agreement and Category Agreement are not explicitly stated as distinct acceptance criteria in the provided text, the performance is reported against this standard.

2. Sample size used for the test set and the data provenance

• Sample Size:
  • The test set consisted of "fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates or strains used is not specified in the provided text.
• Data Provenance:
  • The evaluation was conducted as an "external evaluation." The country of origin of the data is not specified.
  • The study utilized both "fresh and stock Efficacy isolates and stock Challenge strains," indicating a mix of retrospective (stock strains) and potentially prospective (fresh isolates) data collection, though the specifics are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth was established by comparing the device's performance to an "NCCLS frozen Reference Panel" and "Expected Results" for challenge strains. This implies a standardized reference method rather than direct expert interpretation of each case for ground truth. Therefore:

• Number of experts: Not applicable in the context of individual case reads. The NCCLS panel and "Expected Results" define the ground truth based on established methods.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

The text describes a comparison against an "NCCLS frozen Reference Panel" and "Expected Results" for challenge strains. This is a reference method comparison, not an adjudication process involving multiple human readers. Therefore, an adjudication method (like 2+1, 3+1) is not applicable here.

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 done. This device is an automated antimicrobial susceptibility testing panel, not a diagnostic imaging AI system designed to assist human readers.
• Effect size of human reader improvement: Not applicable.

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

Yes, a standalone performance evaluation was done. The device (MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Netilmicin read on the WalkAway® SI System or equivalent) functions as an automated system to determine Minimum Inhibitory Concentration (MIC) without direct human interpretation for each individual result once inoculated. The performance reported (95.1% Essential Agreement) is a standalone performance metric of the combined device and automated reading system against a reference standard.

7. The type of ground truth used

The ground truth used was:

• Reference Standard Comparison: Performance was compared to an "NCCLS frozen Reference Panel."
• Expected Results: For challenge strains, performance was compared to "Expected Results determined prior to the evaluation."

This represents a laboratory reference method ground truth, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The provided text does not specify a separate training set or its sample size. The description focuses on the evaluation/test set. For an in-vitro diagnostic device of this nature, the "training" aspect is more about the scientific and engineering development and optimization of the panel and reading system, rather than a distinct machine learning training set with labeled data as seen in AI algorithms.

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

Since a distinct training set with established ground truth as commonly understood in AI/ML contexts is not mentioned, this information is not applicable based on the provided text. The development of the device itself would have relied on established microbiological principles, reference methods, and quality control procedures to ensure its performance characteristics.

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