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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. After inoculation, panels are incubated for 20 - 24 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 particular submission is for the addition of the antimicrobial Daptomycin at concentrations of 0.25 to 8 µg/ml to the test panel.

The organisms which may be used for Daptomycin susceptibility testing in this panel are:

Streptococcus pyogenes Streptoccocus agalactiae Streptococcus dysglactiae subsp.equisimilis

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. 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. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAwav System.

Here's a breakdown of the acceptance criteria and the study details for the MicroScan® MICroSTREP plus® Panels with Daptomycin, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains."
   • Data Provenance: Not explicitly stated (e.g., country of origin). It was an "external evaluation." The study appears to be retrospective, using "stock" isolates and challenge strains.

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

   • This information is not provided in the given text.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided in the given text. The comparison was made against "Expected Results determined prior to the evaluation" for challenge strains, and a "CLSI frozen Reference panel" for general performance. This implies a predefined ground truth rather than a live adjudication process.

4. 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. This was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is an Antimicrobial Susceptibility Test (AST) system, not an AI-powered diagnostic tool. The "read methods" mentioned are manual visual reading or the MicroScan® WalkAway System, which is an automated instrument, not an AI system in the modern sense of medical imaging or diagnostic AI.

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

   • The device itself (MicroScan® MICroSTREP plus® Panel) determines the MIC. The performance comparison was done against a CLSI reference panel. While there's an option for the MicroScan® WalkAway System to read the panels, the core evaluation is on the panel's ability to accurately reflect MIC, which can be interpreted manually or by the instrument. Thus, the performance of the "panel" itself (the algorithm being the chemical reactions resulting in MIC) was assessed in a standalone manner against the reference.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For general performance, the ground truth was a CLSI frozen Reference Panel.
   • For challenge strains, the ground truth was "Expected Results determined prior to the evaluation." This likely refers to results from established reference methods or known MICs for those specific strains.

7. The sample size for the training set:

   • This information is not provided in the given text, as this is not a machine learning or AI-based device that typically has a "training set." The development of such a test involves chemical and biological optimization rather than data-driven machine learning training.

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

   • Not applicable, as there is no "training set" in the context of this device's development.

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To determine bacterial antimicrobial agent susceptibility. 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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefuroxime at concentrations of 0.12 to 8 mcg/ml to the test panel. The organisms which may be used for Cefuroxime susceptibility testing in this panel are: Streptococcus pneumoniae.

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. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation 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.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance Study

The MicroScan® MICroSTREP plus™ Panel with Cefuroxime is designed to determine the minimum inhibitory concentration (MIC) of Cefuroxime for Streptococcus pneumoniae. The primary study to demonstrate substantial equivalence compared the device's performance to an NCCLS frozen Reference Panel.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria for essential agreement, reproducibility, and quality control are not detailed in the provided text. The document states "acceptable performance" and "acceptable reproducibility/results" without numerical thresholds other than the Essential Agreement percentage.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • The document refers to "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the specific number of isolates/strains used is not provided in the summary.
• Data Provenance: The document does not explicitly state the country of origin. The test isolates included "fresh and stock Efficacy isolates and stock Challenge strains." It is implied that these were clinical isolates and standardized challenge strains, respectively. The study design was a prospective comparison against a reference standard.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth (reference MIC values) was established using an NCCLS frozen Reference Panel. This implies that the reference panel itself underwent rigorous characterization, likely involving expert consensus and standardized protocols, but the details are not described in this submission. The device is read "visually" by a human, but this is the device's output, not the ground truth establishment.

4. Adjudication Method

• The document does not describe an adjudication method (e.g., 2+1, 3+1). The performance was compared directly to an NCCLS frozen Reference Panel, which serves as the established ground truth. Discrepancies between the device and the reference panel would traditionally be analyzed, but no specific adjudication process for these discrepancies is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done comparing human reader performance with and without AI assistance (or device assistance in this context). This device is a diagnostic panel that is read visually by a human. The study focuses on the accuracy of the panel itself in providing the MIC value compared to a reference method, not on the improvement of a human reader's diagnostic accuracy with the panel's assistance.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The "MicroScan® MICroSTREP plus™ Panel" itself, when read visually according to instructions, constitutes the "device" whose performance was evaluated in comparison to the NCCLS frozen Reference Panel. While a human performs the visual reading, the performance evaluation is centered on the panel's ability to accurately present the MIC, not on the human's interpretation skills in isolation or with assistance. The comparison of the panel's results to a reference standard is a standalone assessment of the device's diagnostic output.

7. Type of Ground Truth Used

• The ground truth used was comparison to an NCCLS frozen Reference Panel. This type of ground truth represents a highly standardized and recognized reference method for antimicrobial susceptibility testing, considered the "gold standard" in the field at the time.

8. Sample Size for the Training Set

• The document does not explicitly describe a separate "training set" for the MicroScan® MICroSTREP plus™ Panel. As a diagnostic device for antimicrobial susceptibility, it is typically developed through extensive R&D and internal testing with various isolates. The provided submission describes the validation/testing of the market-ready device. Therefore, a specific "training set" sample size for an AI/algorithm context is not applicable or provided.

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

• Since a separate "training set" is not explicitly mentioned in the context of an AI/algorithm development and validation, the method for establishing its ground truth is not applicable or detailed. The device's underlying principles are based on established broth dilution susceptibility testing. Any internal development or calibration would have used similar laboratory reference methods to establish the 'true' MIC values for those internal isolates.

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To determine bacterial antimicrobial agent susceptibility. 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. This particular submission is for the addition of the antimicrobial Vancomvcin at concentrations of 0.06 to 8 mcg/ml to the test panel. The organisms which may be used for Vancomycin susceptibility testing in this panel are: Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, the viridans group, Streptococcus bovis.

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. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation 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 (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and the study details for the MicroScan® MICroSTREP plus™ Panel with Vancomycin, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated as a number. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation.
   • Data Provenance: Not explicitly stated (e.g., country of origin). It's a "Premarket Notification (510/k])" which implies internal company evaluation and then submission to the FDA. The nature of the isolates (fresh, stock, challenge) suggests a mix, potentially collected over time or specifically prepared.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

3. Adjudication method for the test set:

   • Not applicable/Not described. The ground truth appears to be based on an "NCCLS frozen Reference Panel," which acts as the comparator, rather than a human consensus adjudication process for the test results. The device results are compared against this reference, not human expert reads of the device itself.

4. 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 in vitro diagnostic (IVD) panel for determining antimicrobial susceptibility, not an AI-assisted diagnostic tool for human readers. The "reading" is visual observation of growth inhibition from the panel, not an interpretation of medical images or complex data by human readers.

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

   • This is an in vitro diagnostic (IVD) panel. The "algorithm" is the biochemical process within the panel and the visual interpretation rules. The performance reported (Essential Agreement, Reproducibility, Quality Control) is inherently the device's performance in generating results that are then visually read by a human. While the final interpretation is human-dependent, the device itself is designed to produce a quantitative result (MIC), and the reported performance reflects its accuracy in doing so compared to a reference standard. Therefore, in a sense, the "standalone" or intrinsic performance of the panel's ability to produce the correct MIC is what was evaluated against the reference.

6. The type of ground truth used:

   • NCCLS frozen Reference Panel. This is a recognized standard for antimicrobial susceptibility testing, considered a gold standard (or a very high-quality reference standard) for comparing new susceptibility testing methods.

7. The sample size for the training set:

   • Not applicable/Not described. This device is a biochemical in vitro diagnostic panel, not a machine learning algorithm that requires a training set.

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

   • Not applicable. As this is not a machine learning algorithm, there is no training set or associated ground truth establishment method.

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