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The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Cefepime, at concentrations of 0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefepime susceptibility testing on this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Lancefield's Group A streptococci), Streptococcus agalactiae (Lancefield's Group B streptococci), Viridans group streptococci

Device Description

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

AI/ML Overview

The information provided is centered around the 510(k) submission for the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Cefepime, specifically for the instrument read method. This submission does not pertain to an AI device or a comparative effectiveness study involving human readers with and without AI assistance. Therefore, some of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only) performance," are not directly applicable or cannot be extracted from the given text.

Based on the provided text, here is a summary of the acceptance criteria and the study details:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Overall Essential Agreement	Defined in FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. (Specific percentage not explicitly stated in document, but generally high for AST systems to assure clinical relevance.)	95.7% for Cefepime instrument read results compared with Expected Result.
Instrument Reproducibility	Acceptable reproducibility and precision for Cefepime and the WalkAway® instrument.	Demonstrated acceptable reproducibility and precision.
Quality Control	Acceptable results for Cefepime.	Demonstrated acceptable results.

Study Details

Study Parameter	Description
1. Sample size used for the test set	Not explicitly stated as a numerical value. The evaluation was conducted with "stock and CDC Challenge strains."
2. Data provenance (e.g. country of origin of the data, retrospective or prospective)	Not explicitly stated regarding country of origin. The study was an "evaluation" designed to confirm acceptability, suggesting it was prospective for the purpose of the 510(k) submission. "Stock and CDC Challenge strains" imply controlled, laboratory-based isolates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts	Not applicable. Ground truth was established by "Expected Results determined before the evaluation" based on a "CLSI frozen Reference Panel." This suggests a standardized methodology rather than individual expert consensus from a specified number of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set	Not applicable. Ground truth was based on a "CLSI frozen Reference Panel" (Expected Results), and comparison was made against this reference, not adjudicated by human experts in the context of interpretation discrepancies.
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	Not applicable. This submission is for an instrument-read method of an antimicrobial susceptibility panel, not an AI or human-in-the-loop diagnostic system. The focus is on the performance of the instrument reading compared to a reference standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done	This is a standalone performance assessment of the instrument-read method. The "algorithm" here refers to the instrument's capability to read the MICroSTREP plus® Panel with Cefepime, without human intervention for the reading process itself. Manual reading is mentioned as an alternative method in the product description.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)	"Expected Results determined before the evaluation" based on a "CLSI frozen Reference Panel." This represents a standardized, laboratory-based reference method, which is the established "ground truth" for antimicrobial susceptibility testing.
8. The sample size for the training set	Not applicable. This document describes a validation study for an existing instrument's capability, not the development of a novel machine learning algorithm that requires a "training set." The instrument's underlying reading mechanism would have been developed and "trained" separately.
9. How the ground truth for the training set was established	Not applicable, as no training set for a new algorithm is discussed.

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