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The MicroScan® Dried Gram-Positive 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-positive cocci. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This submission is to evaluate the performance of the antimicrobial agent Erythromycin on the MicroScan® Dried Gram-Positive MIC/Combo Panels read on MicroScan® WalkAway and autoSCAN-4 Instruments utilizing the current DMS or LabPro version

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The provided text describes the 510(k) premarket notification for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin. This document is focused on the regulatory approval rather than a detailed study report with all the specific elements requested for acceptance criteria and study design.

However, based on the information provided, we can infer some details and highlight what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:

The document mentions that the submission is "to evaluate the performance of the antimicrobial agent Erythromycin." In the context of antimicrobial susceptibility testing (AST) devices, the primary acceptance criteria typically revolve around the agreement between the new device's readings and a reference method (the "ground truth"). This agreement is often measured in terms of Essential Agreement (EA) and Category Agreement (CA). For AST devices, the ground truth is usually established by a recognized reference method, such as broth microdilution or agar dilution, often performed manually.

While the specific numerical acceptance criteria (e.g., "≥90% EA") and the reported performance (e.g., "95% EA") are not explicitly stated in this regulatory letter, they would have been part of the underlying study submitted to the FDA.

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

• Test Set Organism: The document explicitly states that the organisms used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus.
• Sample Size: The exact number of Staphylococcus aureus isolates used for the test set is not specified in the provided text.
• Data Provenance: The provenance (e.g., country of origin, retrospective or prospective) of the data is not specified in the provided text.

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

• This information is not specified in the provided text. For AST devices, the "experts" are typically the trained microbiologists or laboratory personnel who perform and interpret the reference method.

4. Adjudication method for the test set:

• This information is not specified in the provided text. For AST, adjudication is less about expert consensus on image interpretation and more about resolving discrepancies between the device and the reference method, possibly through re-testing or using an alternative reference method.

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:

• This is not applicable to this device. This is an antimicrobial susceptibility testing device, read either visually or with instrumentation. There is no AI component or human-in-the-loop "reading" in the sense of medical imaging interpretation that would warrant an MRMC study comparing human readers with and without AI assistance. The "readers" here are either the instruments (MicroScan® WalkAway and autoSCAN-4) or a human visually interpreting the panel.

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

• Yes, this is effectively a standalone performance evaluation. The device (MicroScan® Dried Gram-Positive MIC/Combo Panels) in conjunction with the MicroScan® WalkAway and autoSCAN-4 Instruments and associated software (DMS or LabPro version

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