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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the evaluation of antimicrobi vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S ≤ 2, I = 4 -8, R ≥ 16).

The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:

Enterococcus spp. (e.g., Enterococcus faecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis

MicroScan Dried Gram-Positive 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-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and the study details for the MicroScan Dried Gram-Positive MIC/Combo Panels, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

• The document mentions "stock and fresh isolates (Efficacy phase)" and "challenge strains (Challenge phase)."
• Sample Size:
  • The exact sample size for the "stock and fresh isolates" and "challenge strains" is not explicitly stated in the provided text.
  • The document does say the data was collected from "external validation of vancomycin."
• Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated. The phrase "external validation" suggests it was not solely internal testing. The study design comparing against a CLSI frozen Reference Panel implies specific methodological rigor.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth. Ground truth for the reference panel is typically established through standardized laboratory methods (e.g., CLSI guidelines).

4. Adjudication method for the test set:

• The document does not describe an adjudication method involving multiple human readers for the test set. The comparison is between the device's results and a "CLSI frozen Reference Panel," which represents the established ground truth.

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:

• No MRMC comparative effectiveness study was done. This device is an automated antimicrobial susceptibility test (AST) system, not an AI-assisted diagnostic device for human interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

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

• Yes, this study represents a standalone evaluation of the device. The "MicroScan Dried Gram-Positive MIC/Combo Panels" are designed to determine susceptibility by reading the minimum inhibitory concentration (MIC) after incubation, either visually or with MicroScan instrumentation. The evaluation compares this system's performance against a reference method without human interpretation as part of the primary outcome measure.

7. The type of ground truth used:

• The ground truth used was a CLSI frozen Reference Panel, and for challenge strains, "Expected Results determined prior to the evaluation." This implies a reference standard method (broth microdilution according to Clinical and Laboratory Standards Institute guidelines) as the ground truth.

8. The sample size for the training set:

• The document does not mention a distinct "training set" or its sample size. This is a premarket notification for a device modification, and the evaluation focuses on performance against a reference standard, not on training a machine learning algorithm.

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

• This question is not applicable as the document does not describe a training set in the context of machine learning, nor does it detail how initial ground truth for general panel development (beyond this specific validation) was established. The focus is on validation against an existing, established reference standard for antimicrobial susceptibility testing.

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