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The MicroScan Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes. 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 particular submission is for the addition of the antimicrobial daptomycin at concentrations of 0.06-32 µg/mL to the test panel. Testing is indicated for Enterococcus faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) has demonstrated acceptable performance with the following organisms:

• Enterococcus faecium
• Enterococcus spp. other than E. faecium (Enterococcus faecalis, Enterococcus avium, Enterococcus raffinosus, Enterococcus casseliflavus and Enterococcus durans)
• Staphylococcus spp. (Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus capitis, Staphylococcus haemolyticus, Staphylococcus lugdunensis, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus simulans, Staphylococcus saprophyticus, Staphylococcus intermedius, and Staphylococcus sciuri)

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 bacteria.

The principle of MicroScan panels with 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.

This product is single-use and intended for laboratory professional use.

The provided text specifies the performance validation of the MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics against a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel. The primary metrics are Essential Agreement (EA) and Categorical Agreement (CA).

Note: The document states "acceptable performance" without defining specific numerical thresholds for EA and CA as explicit "acceptance criteria." However, the reported values are presented as meeting this "acceptable performance." In antimicrobial susceptibility testing, typical FDA guidance for acceptable EA is generally $\geq$90% and for CA is general $\geq$90% to 95%, depending on the organism/drug combination and resistance rates.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "external evaluations" conducted with:

• Fresh and stock Efficacy isolates
• Stock Challenge strains

It does not explicitly state the numerical sample size (number of isolates/strains) used for the test set.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the mention of "external evaluations," it implies that the testing was performed, but the location and study design (retrospective/prospective) are not detailed. Standard AST studies typically involve prospective collection of clinical isolates and/or the use of well-characterized reference strains.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the test set was established by comparison with a CLSI frozen Reference Panel. This implies that the reference standard, and thus the "ground truth," is determined by a highly standardized and validated laboratory method (broth microdilution or similar CLSI-recognized standard).

The document does not mention human experts being used directly to establish the ground truth for individual cases in the test set. Instead, the CLSI frozen Reference Panel itself serves as the gold standard.

4. Adjudication Method for the Test Set

No human adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the ground truth is established by the CLSI frozen Reference Panel, not by human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable to this device. This device is an Antimicrobial Susceptibility Test (AST) panel, which determines the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against bacteria. It does not involve human readers interpreting images, and therefore, an MRMC study is not relevant. The device measures a quantitative result (MIC) which is then interpreted categorically (susceptible, intermediate, resistant) based on established breakpoints.

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

Yes, this study represents a standalone performance evaluation of the device. The "MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin" is a diagnostic test system. Its performance is evaluated against a recognized reference method (CLSI frozen Reference Panel) to determine its accuracy in reporting MIC values and categorical interpretations. While human operators inoculate and read the panels (either visually or with MicroScan instrumentation), the "performance" being assessed here is the device's ability to produce accurate results compared to the reference standard, not an AI algorithm's ability to interpret data without human input.

7. The type of Ground Truth Used

The ground truth used was comparison to a CLSI frozen Reference Panel. This is a laboratory-based gold standard for antimicrobial susceptibility testing, representing the accepted accurate measurement of MIC. It is a highly controlled and standardized method.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is an AST panel, not an AI/ML diagnostic algorithm that requires a training set. The performance validation is based on a comparison to a reference standard using a test set of bacterial isolates/strains.

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

As there is no concept of a training set for this type of device (AST panel based on traditional microbiological principles), this question is not applicable.

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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 bacteria. 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 particular submission is for the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 ug/ml to the test panel.

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

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)

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 bacteria.

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 study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" and "Reproducibility isolates." Specific numerical sample sizes for each of these categories are not provided.
  • The Essential Agreement figures are reported for Enterococcus spp. but the total number of isolates tested to achieve these percentages is not given.
• Data Provenance: The text does not specify the country of origin of the data. The study involved a reevaluation of clinical evaluation data. It is a retrospective analysis of existing data combined with new testing for reproducibility and quality control.

3. Number of Experts and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document refers to "CLSI frozen Reference Panel" as a comparator, implying that the ground truth was established using standard clinical laboratory methods, likely by trained microbiologists, but explicit details are missing.

4. Adjudication Method

• Adjudication Method: Not specified. The comparison is made against a "CLSI frozen Reference Panel," which acts as the reference standard. There is no mention of multiple experts independently reading and then adjudicating discrepancies.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test (AST) system, not a diagnostic imaging device that typically involves human readers. The comparison is between the device's performance and a reference standard.
• Effect Size of Human Readers Improvement: Not applicable, as this was not an MRMC study.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: Yes, the study evaluates the standalone performance of the MicroScan Dried Gram-Positive MIC/Combo Panel. It compares the panel's results (read either visually or with MicroScan instrumentation) against a CLSI frozen Reference Panel. The "MicroScan instrumentation" represents the automated component of the device's performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by a CLSI frozen Reference Panel. This is a recognized reference method for antimicrobial susceptibility testing, providing a reliable standard against which the device's performance can be measured.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly mention a "training set" or its size. The study described is a validation study comparing the modified panel's performance against a reference standard. If machine learning or AI was used in the panel's development, information about its training set would typically be separate from this validation study. However, the core technology described (microdilution MIC panels) is a biochemical testing method, not typically an AI/machine learning application requiring an explicit "training set" in the sense of AI models.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable/not provided. As noted above, the document doesn't detail a separate training set for an AI/machine learning model. For traditional AST panels like this, the "ground truth" for developing and calibrating the panel's concentrations and reading parameters would have been established through extensive microbiological research and correlation with clinical outcomes, usually against reference methods like broth microdilution, which is foundational to CLSI standards.

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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 bacteria. 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 particular submission is for the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 ug/ml to the test panel.

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

Enterococci (e.g., Enterococcus faecalis)

Staphylococci. including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)

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 bacteria.

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. For accurate detection of vancomycin resistance with enterococcus species, panels were incubated to 24 hours.

The provided text describes the acceptance criteria and study for the MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation, and "Efficacy, Challenge and Reproducibility isolates" for reproducibility testing. However, the exact number of isolates (sample size) for the test set is not explicitly stated.
• Data Provenance: The text does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, though the description of the "external evaluation" and "Challenge strains" suggests a prospective testing methodology.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The ground truth was established by comparison with a "CLSI frozen Reference Panel," but there's no mention of human experts defining this ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The comparison was made against a CLSI frozen Reference Panel, implying a direct comparison rather than an adjudication process involving multiple human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is an in vitro diagnostic for antimicrobial susceptibility testing, not an AI-assisted diagnostic device for human readers. Therefore, the concept of human reader improvement with or without AI assistance is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The device (MicroScan Dried Gram-Positive MIC/Combo Panel) "demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel." This comparison assesses the algorithm/device's performance in determining MIC values independently. The panel can be read visually or with MicroScan instrumentation, indicating both a potential human-in-the-loop and a standalone (instrument-read) performance. The performance metric of 99.4% Essential Agreement relates to the panel's direct performance.

7. The Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This panel's results are considered the gold standard for comparison in antimicrobial susceptibility testing for the purpose of this submission.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document describes the testing and comparison with a reference panel, but does not detail a separate "training set" for the device, as it is a panel design for inherent chemical and biological interactions, not a machine learning algorithm that requires explicit training data in the same way.

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

Since a training set (in the context of machine learning) is not explicitly mentioned or clearly applicable to this type of device (a chemical/biological testing panel), the method for establishing its ground truth is not provided. The "ground truth" reference (CLSI frozen Reference Panel) is used for evaluation of the device's performance.

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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 bacteria. 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 particular submission is for the addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

methicillin-susceptible and methicillin-resistant isolates - skin isolates only ●

• methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -

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 bacteria.

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 study information for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

• Expected Results: For challenge strains. |
  | 8. Sample size for training set | Not applicable. This device is a diagnostic panel with pre-determined concentrations, not a machine learning algorithm that requires a training set in the conventional sense. The "training" would be the initial development and optimization of the panel's chemistry and design, which is not detailed here. |
  | 9. How ground truth for training set was established | Not applicable in the context of machine learning. The "ground truth" for the development of the panel would be based on established microbiology principles and CLSI guidelines for antimicrobial susceptibility testing, which dictate the acceptable range of concentrations and expected results for known organisms. |

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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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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 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

The MicroScan Cefoxitin Screen is intended to determine the susceptibility of staphylococci to the penicillinase stable beta-lactams.

This particular submission is for the addition of the antimicrobial test the Cefoxitin Screen, at a concentration of 4 mcg/ml, to the test panel.

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

Staphylococcus aureus Staphylococcus lugdunensis

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 study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the device's performance metrics but implies the acceptance criteria by stating that the "Cefoxitin Screen demonstrated acceptable performance" when compared to the reference methods and that its performance was "substantially equivalent" as defined by FDA guidance documents. Exact numerical acceptance thresholds are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "external design validation (Clinical Trial) was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the specific sample size for the test set is not provided.

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: The use of "fresh and stock Efficacy isolates and stock Challenge strains" suggests a combination. "Fresh" isolates could imply prospective collection, while "stock" isolates typically refer to retrospective or archived samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the summary. The ground truth was established by comparing the device's performance against two reference methods (CLSI cefoxitin disk diffusion and mecA PCR) and to "Expected Results" for challenge strains, but it doesn't mention expert review of the test set itself.

4. Adjudication Method for the Test Set

This information is not provided in the summary. The ground truth was established by reference methods and expected results, not through an explicit adjudication process described in the text.

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

A MRMC comparative effectiveness study was not performed according to this summary. The study is evaluating the performance of an automated susceptibility test system against reference methods, not human readers.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Yes, a standalone study was performed. The "MicroScan® Dried Gram-Positive MIC/Combo Panels" is an automated system designed for determining antimicrobial susceptibility. Its performance was evaluated directly against reference standards (CLSI cefoxitin disk diffusion and mecA PCR) and against "Expected Results" for challenge strains, indicating an algorithm-only evaluation without human-in-the-loop performance being part of this PAI.

7. Type of Ground Truth Used

The ground truth was established primarily using:

• Reference Methods: CLSI cefoxitin disk diffusion test.
• Molecular Test: mecA PCR.
• Expected Results: For stock Challenge strains, determined prior to evaluation.

8. Sample Size for the Training Set

The sample size for the training set is not explicitly provided in the summary. The summary describes the test set and evaluation but does not detail the training process or dataset.

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

This information is not provided in the summary. As the training set size isn't mentioned, the method for establishing its ground truth is also absent.

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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 - 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.

The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The ICd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate.

This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.

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 antiryicrobial 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 with the Inducible Clindamycin test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number. The study mentions "fresh and stock Efficacy isolates and stock Challenge strains."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study was an "external design validation (Clinical Trial)". It's a prospective evaluation for efficacy isolates and stock 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 document. The ground truth method, CLSI D-zone disk diffusion test, is a standardized laboratory test, not an expert consensus for each case.

3. Adjudication method for the test set:

   • This information is not provided. Given that the comparative method is the CLSI D-zone disk diffusion test, it's unlikely that a human adjudication method in the typical sense (like 2+1, 3+1 for imaging) was used. The CLSI D-zone disk diffusion test itself serves as the reference standard.

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, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test for antimicrobial susceptibility, not an imaging AI device that assists human readers.

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

   • Yes, the study assesses the "standalone" performance of the MicroScan Inducible Clindamycin test against the CLSI D-zone disk diffusion test. While the test involves laboratory procedures performed by humans, the performance metrics (Categorical Agreement, Sensitivity, Specificity) are for the device's output itself, not its assistance to a human interpreter. The text mentions it can be "read either visually or with MicroScan instrumentation."

6. The type of ground truth used:

   • The ground truth used was the CLSI D-zone disk diffusion test. This is a recognized standard laboratory method for detecting inducible clindamycin resistance. For challenge strains, "Expected Results determined prior to the evaluation" also served as ground truth.

7. The sample size for the training set:

   • This information is not provided. The document describes a validation study, not the development process. Given this is an IVD microbiology test, there might not be a "training set" in the machine learning sense, but rather development and internal validation data that isn't detailed in this summary.

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

   • Since the training set sample size is not provided, the method for establishing its ground truth is also not provided.

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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

Not Found

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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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 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator. Results are read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to the test panel.

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 16-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

This solicitation is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to MicroScan® Dried Gram-Positive MIC/Combo Panels.

1. Table of Acceptance Criteria & Reported Device Performance:

2. Sample Size & Data Provenance:

• Test Set Sample Size: The document does not specify the exact number of isolates used for the external evaluation. It mentions "fresh and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: Not explicitly stated, but "external evaluation" suggests different sites. The document implies a multicenter evaluation, as it refers to "external evaluation" in plural sense, and thus suggests multicenter data.
• Retrospective/Prospective: Not explicitly stated. The use of "fresh and stock Efficacy isolates" suggests a mix, where "fresh" could imply prospective collection for the study, while "stock" would be retrospective.

3. Number of Experts & Qualifications for Ground Truth (Test Set):

• The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Instead, it refers to a "CLSI (formerly NCCLS) frozen Reference Panel" as the gold standard.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth was established by comparison to a reference standard (CLSI frozen Reference Panel), not through expert adjudication of images/data from the device. "Challenge strains were compared to Expected Results determined prior to the evaluation".

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the standalone performance of the device against a reference method.

6. Standalone Performance Study:

• Yes, a standalone (algorithm only) performance study was conducted. The MicroScan® Dried Gram-Positive MIC/Combo Panel's performance was compared directly to a CLSI frozen Reference Panel.

7. Type of Ground Truth Used:

• Reference Standard: CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS) frozen Reference Panel. This is considered a gold standard for antimicrobial susceptibility testing. For challenge strains, "Expected Results" determined prior to the evaluation were used.

8. Sample Size for the Training Set:

• Not applicable for this type of device and study. Antimicrobial susceptibility test (AST) systems are typically validated against established reference methods (like CLSI) rather than being "trained" in the machine learning sense. The device's underlying principles are based on broth dilution, not a trainable algorithm.

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

• Not applicable (see point 8). The "ground truth" for the development of the AST system itself would be the established scientific principles of antimicrobial activity and bacterial growth inhibition, as defined and standardized by organizations like CLSI.

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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. Panels are incubated for 16 – 20 hours at 35℃ +/- 1℃ 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 Erythromycin at concentrations of 0.25 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

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 (MC) 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 study information for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set:
  • Sample Size: Not explicitly stated in the provided text. The evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." The exact number of isolates/strains used is not provided.
  • Data Provenance: Not explicitly stated. Given it's an "external evaluation" conducted in support of an FDA submission, it's likely multi-center data, but the specific countries of origin are not mentioned. The study was prospective in the sense that it was designed to confirm the acceptability of the proposed panel.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. However, the ground truth was established by an "NCCLS frozen Reference Panel," which implies adherence to standards and expert-derived values, but no specific personnel details are given. The "Expected Results" for Challenge strains would also be based on established expert knowledge or prior testing.

4. Adjudication Method (Test Set)

• Adjudication Method: Not explicitly stated. The comparison was primarily against an "NCCLS frozen Reference Panel" and "Expected Results" for challenge strains, serving as the benchmark. This suggests a direct comparison rather than a human adjudication process between different readers of the device.

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

• Was an MRMC study done? No. This device is an automated in vitro diagnostic (IVD) test for antimicrobial susceptibility. The assessment is against a reference method and established quality control, not against human readers evaluating medical images or similar.

6. Standalone Performance Study

• Was a standalone study done? Yes. The study directly assessed the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (the algorithm/device) against the NCCLS frozen Reference Panel. The reported "Essential Agreement of >96% for Erythromycin" is a measure of its standalone performance compared to the gold standard. Reproducibility and Quality Control testing also evaluate the device's intrinsic performance.

7. Type of Ground Truth Used

• The ground truth used was:
  • Reference Method Comparison: An "NCCLS frozen Reference Panel." This is a standardized, recognized method for determining antimicrobial susceptibility, considered the gold standard for comparison in these types of studies.
  • Expected Results: For "stock Challenge strains," the panels were compared to "Expected Results determined prior to the evaluation." These expected results would be derived from pre-established, verified susceptibility profiles for those specific strains.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This summary describes the validation of a physical diagnostic panel (Microdilution MIC panel), not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves formulation, manufacturing, and internal QC processes to ensure consistency and accuracy, rather than data-driven model training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no "training set" in the context of a machine learning algorithm. The panel's design and manufacturing are based on established microbiological principles for antimicrobial susceptibility testing, with the concentrations of antimicrobial agents diluted in broth to "concentrations bridging the range of clinical interest." The performance of the resulting panel is then validated against reference standards.

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