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The MicroScan Dried Gram-Negative 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 anaerobic gram-negative bacilli. 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 cefepime at concentrations of 0.12-64 µg/mL to the test panel. Testing is indicated for Enterobacterales, Pseudomonas aeruginosa and Aeromonas spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter koseri, (formerly Citrobacter diversus), Citrobacter freundii complex (Citrobacter freudnii, Citrobacter werkmanii and Citrobacter youngae), Klebsiella oxytoca, Morganella morganii, Proteus vulgaris, Providencia stuartii, Providencia rettgeri, Serratia marcescens)

Pseudomonas aeruginosa

Aeromonas spp.

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

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.

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

Device Performance Acceptance Criteria and Study Details for MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime

Based on the provided FDA 510(k) Clearance Letter, the device in question is the MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL), which is an Antimicrobial Susceptibility Test (AST) System. The study described focuses on demonstrating the substantial equivalence of this new configuration (with Cefepime) to a predicate device.

Given the nature of the device (an AST System), the "acceptance criteria" are typically related to the accuracy of determining Minimum Inhibitory Concentration (MIC) and the resulting categorical agreement (Susceptible, Intermediate, Resistant) compared to a reference method. The "study that proves the device meets the acceptance criteria" refers to the performance evaluation conducted for the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

For AST systems, the key performance metrics are Essential Agreement (EA) and Categorical Agreement (CA) when compared to a CLSI (Clinical and Laboratory Standards Institute) frozen reference panel. The FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009, likely outlines the specific acceptance criteria thresholds for EA and CA. While the exact numerical acceptance criteria are not explicitly stated in the provided text, the performance "demonstrated acceptable performance" implies meeting these pre-defined thresholds.

Important Note: The document highlights some instances where the performance was "outside of essential agreement" for Enterobacterales with Prompt inoculation and "below 90%" for Aeromonas spp. with turbidity inoculation and WalkAway read method. These discrepancies are "mitigated with a limitation" in the product labeling, suggesting that while initial performance in those specific conditions did not meet implicit criteria, the overall robust performance with other methods/organisms, coupled with labeling limitations, made the device acceptable for clearance.

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

• Sample Size: The document does not explicitly provide a total number for the test set sample size (e.g., number of isolates tested). It refers to "contemporary and stock Efficacy isolates and stock Challenge strains" used for external evaluations.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "external evaluations," which generally implies testing conducted at clinical sites or contract research organizations. The study appears to be retrospective in the sense that it uses "stock Efficacy isolates and stock Challenge strains" which are pre-existing collections of bacterial isolates. It also mentions "contemporary" isolates, suggesting some recent collection. It implies a laboratory-based performance study rather than a clinical trial with patient outcomes.

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

This type of device (AST System) does not typically rely on human expert interpretation for establishing the "ground truth" of the test set. The ground truth for antimicrobial susceptibility testing is established by a reference method, which for this device is stated as a "CLSI frozen Reference Panel."

Therefore:

• Number of Experts: Not applicable in the context of creating the ground truth for AST.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

As the ground truth is established by a reference method (CLSI frozen Reference Panel), there is no human adjudication method like 2+1 or 3+1 typically used for image-based diagnostics. The device's results are directly compared to the quantitatively or qualitatively determined results from the CLSI 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

There is no indication that an MRMC comparative effectiveness study was performed. This type of study is not relevant for this device, which is an automated or manually read laboratory diagnostic for antimicrobial susceptibility, not an AI-assisted diagnostic tool that aids human readers in interpretation. The device itself performs the susceptibility test.

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

Yes, the performance data presented is effectively standalone performance of the device (MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime). The device "read either visually or with MicroScan instrumentation" and its performance (Essential Agreement, Categorical Agreement) is directly compared to the reference standard. The "human-in-the-loop" would be the laboratory professional reading the results, and the study evaluates the accuracy of the device itself in producing those results. Where visual reads are mentioned, it's about the device's ability to produce clear inhibition patterns for visual interpretation, not a human independently interpreting raw data without the device.

7. The Type of Ground Truth Used

The ground truth used was established by a CLSI frozen Reference Panel. This is a recognized and standardized method for determining antimicrobial susceptibility, often involving broth microdilution or agar dilution methods where organisms are tested against known concentrations of antimicrobials. It is a highly controlled and quantitative method to determine the true MIC value against which the device's performance is compared.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about its sample size. This is consistent with the nature of the device. AST systems are generally rule-based or empirically derived systems based on established microbiological principles, rather than machine learning models that require distinct training sets. The development of such panels involves extensive empirical testing during the R&D phase to ensure the correct concentrations and formulations, but this isn't typically referred to as a "training set" in the context of an AI/ML model.

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

As no training set (in the AI/ML sense) is indicated, this point is not applicable.

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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-Negative 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 anaerobic gram-negative bacilli. 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 aztreonam at concentrations of 0.5-64 µg/mL to the test panel. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Yersinia enterocolitica)

Pseudomonas aeruginosa

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

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 FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test (AST) system, specifically the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam. It is not an AI/ML medical device. Therefore, many of the requested criteria regarding AI-specific study design (like MRMC studies, number of experts for AI ground truth, training set details) are not applicable to this type of device and study.

However, I can extract the relevant acceptance criteria and performance data for this AST device based on the provided document.

Acceptance Criteria and Device Performance (for an AST System)

The study proves the device's performance through comparison with a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel. The criteria primarily revolve around "Essential Agreement (EA)" and "Categorical Agreement (CA)" between the new device and the reference method.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly refers to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. This guidance typically defines the statistical acceptance criteria for EA and CA for AST systems. The document states the device "demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document..." meeting "acceptable performance."

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

• The document mentions "external evaluations were conducted with contemporary and stock Efficacy isolates and stock Challenge strains."
• Specific numerical sample sizes for the test set (number of isolates/strains) are not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin. It indicates the use of "contemporary and stock Efficacy isolates and stock Challenge strains," which suggests a mix of clinical and laboratory strains. The study appears to be prospective in nature, as new data was generated for this specific submission to demonstrate performance against a reference standard.

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

• This is an AST system, not an AI/ML device requiring expert radiological annotation.
• Ground Truth Establishment: The ground truth (reference MIC values and categorical interpretations) for the test set was established by a CLSI frozen Reference panel. This is a recognized standard method for AST device validation. The "experts" in this context are the established CLSI methodologies and laboratories that produce these reference panels, not individual human readers or annotators in the typical AI/ML sense.

4. Adjudication Method for the Test Set

• Adjudication, as typically described (e.g., 2+1, 3+1), is not applicable here because the ground truth is established by a standardized laboratory method (CLSI frozen Reference panel), not by consensus among human experts annotating medical images. The comparison is objective, based on measured MIC values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
• This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test system, where the output is a MIC value and a categorical interpretation for a bacterial isolate, not an image interpretation by a human observer.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• This question is framed for AI/ML algorithms. While the device automation ("MicroScan instrumentation," "WalkAway instrument") is a component, the "standalone performance" here refers to the device's ability to accurately determine MIC and categorize susceptibility when compared to the CLSI reference method.
• The study did evaluate the device's performance independently of human interpretation, as it explicitly states panels can be "read either visually or with MicroScan instrumentation." The reported EA and CA numbers reflect the system's performance, including automated reading where applicable.

7. The Type of Ground Truth Used

• Reference Standard: The ground truth used was a CLSI frozen Reference Panel. This is considered the gold standard for comparing the performance of new antimicrobial susceptibility test devices. It provides "true" Minimum Inhibitory Concentration (MIC) values for the bacterial isolates against the antimicrobial agent.

8. The Sample Size for the Training Set

• This is an IVD device, not an AI/ML system that undergoes a separate "training" phase with a large dataset in the sense of machine learning. The device's underlying "knowledge" is built into its design, chemistry, and reading algorithms (for automated methods).
• Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this device.

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

• As the concept of a "training set" as in AI/ML does not apply here, this point is not applicable. The device's development involved standard microbiological and analytical chemistry principles, validated against established reference methods.

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To determine antimicrobial agent susceptibility

MicroScan Dried Gram-Negative 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-negative bacilli.

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 an analysis of the provided text, focusing on the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implicit Acceptance Criteria: The document references the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. While the specific numerical acceptance thresholds are not directly stated in this summary, guidance documents for AST devices typically require high percentages (e.g., >90%) for Essential Agreement and Categorical Agreement to demonstrate substantial equivalence to a reference method. The "acceptable" findings for reproducibility and quality control imply that they met predefined internal or regulatory thresholds.

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

• Sample Size: Not explicitly stated in terms of the total number of isolates. However, the study mentions conducting "external evaluations with fresh, recent and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: Not specified, but the use of "fresh, recent and stock Efficacy isolates and stock Challenge strains" suggests a mix, likely from various clinical and curated collections. The country of origin is not mentioned. The study is retrospective in nature as it uses existing isolates.

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 summary. The ground truth is established by the "CLSI frozen Reference panel," which implies a standardized, well-defined method rather than interpretation by individual experts for each case.

4. Adjudication Method for the Test Set

This information is not provided. Since the comparison is against a "CLSI frozen Reference panel," it's a direct comparison against a gold standard method, not typically involving expert adjudication of discrepancies between multiple readers for a single case.

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, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated AST device (MicroScan Dried Gram-Negative MIC/Combo Panel) against a reference method, not the impact of AI on human reader performance.

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

Yes, a standalone performance evaluation was done. The device's performance (MicroScan Dried Gram-Negative MIC/Combo Panel) was compared directly to a "CLSI frozen Reference panel" without human intervention for result interpretation within the device's output. The device itself automatically determines the MIC and categorized susceptibility.

7. The Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference panel. This represents a gold standard method for antimicrobial susceptibility testing, based on established Clinical and Laboratory Standards Institute (CLSI) guidelines. It's essentially a highly standardized and validated laboratory method for determining the true MIC for each organism-antimicrobial combination.

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 device is an AST system, which typically relies on established biochemical and growth principles, not a machine learning model that undergoes explicit training on a large dataset in the conventional sense. Therefore, this question is not applicable to the described device.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable. The device's functionality is based on established microbiology principles for determining MICs.

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To determine antimicrobial agent susceptibility

MicroScan Dried Gram-Negative 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-negative bacilli. 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.

This document describes a Special 510(k) submission for a medical device called the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, specifically for an additional indication for use with Acinetobacter spp. The information provided allows us to extract the acceptance criteria and study details.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: While specific percentage thresholds for EA and CA acceptance are not explicitly stated in the provided text, for Antimicrobial Susceptibility Test (AST) systems, FDA guidance typically expects Essential Agreement and Categorical Agreement to be at least 90% for new indications.

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

The document mentions "combined efficacy and challenge data" and "external evaluations" conducted with "fresh and stock Efficacy and Challenge isolates." However, the specific sample size (number of isolates/strains) used for the test set is NOT explicitly provided in the text.

The provenance of the data is not specified in terms of country of origin. The study appears to be prospective as it involves "external evaluations" and testing with "fresh and stock" isolates and comparison to a CLSI frozen Reference panel, implying new data generation for this submission.

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

The document states that the device performance was compared "with a CLSI frozen Reference Panel." A CLSI (Clinical and Laboratory Standards Institute) reference panel implies a well-established and validated method for determining antimicrobial susceptibility, which serves as the gold standard.

The document does NOT explicitly state the number of experts or their qualifications involved in establishing the ground truth using the CLSI frozen Reference Panel. The CLSI method itself is the 'expert' in this context, representing a consensus-driven standard.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the sense of multiple human readers independently assessing results and then resolving discrepancies. Instead, the study's design involves:

• Comparing the MicroScan Dried Gram-Negative MIC/Combo Panels with a CLSI frozen Reference panel. This reference panel serves as the definitive gold standard.
• The agreement metrics (Essential Agreement and Categorical Agreement) are calculated by comparing the results from the device to the results from the CLSI reference panel.

Therefore, an explicit human adjudication process is not applicable or described for this type of test, as the ground truth is established by a standardized laboratory method (CLSI).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human readers evaluate images or data, and AI assists or replaces them. This submission is for an in-vitro diagnostic (IVD) device that determines antimicrobial susceptibility, not for image interpretation or diagnosis by human readers in the classical sense of an MRMC study.

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

Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The "MicroScan Dried Gram-Negative MIC/Combo Panels" and associated instruments (WalkAway instrument) determine the MIC, which is then directly compared to the CLSI reference panel. While human operators are involved in setting up the test and reading the final MIC (which is then used to determine susceptibility), the comparison metrics (EA and CA) directly assess the output of the device relative to the reference method, not the human interpretation of that output.

7. The Type of Ground Truth Used

The type of ground truth used is a CLSI frozen Reference Panel. This represents a highly standardized and validated laboratory method for determining antimicrobial susceptibility, considered the gold standard for AST devices.

8. The Sample Size for the Training Set

The document does NOT specify the sample size for the training set. This submission is a Special 510(k) for an additional indication for an existing device. It focuses on the performance data for the specific indication requested (Acinetobacter spp. with Meropenem). Information regarding the original training set for the broader device development is not provided.

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

Since the training set sample size is not provided, how its ground truth was established is also not described in this document. For AST devices, the ground truth for training (if an AI/ML component were heavily involved in the core susceptibility determination, which doesn't appear to be the case here as it's an assay system) would typically also be established using CLSI reference methods or other well-accepted laboratory standards for bacterial identification and susceptibility.

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The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic gram-negative bacilli. 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 updated susceptibility test interpretative criteria for Enterobacteriaceae and Pseudomonas aeruginosa, as well as expanding Salmonella ser. Typhi interpretative criteria to all Salmonella spp. for the antimicrobial ciprofloxacin (Cp) at concentrations of 0.004 to 8 µg/mL to the test panel.

Ciprofloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

Active in vitro and in clinical infections against:

Citrobacter koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella ser.Typhi Serratia marcescens Shigella flexneri Shigella sonnei Active in vitro but clinical significance unknown: Enterobacter aerogenes, Klebsiella oxytoca, Salmonella enteritidis

MicroScan Dried Gram-Negative 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-negative bacilli.

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.

This document describes the validation of the Beckman Coulter MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin (Cp) for updated susceptibility test interpretative criteria for Enterobacteriaceae and Pseudomonas aeruginosa, and expanding Salmonella ser. Typhi interpretative criteria to all Salmonella spp. for ciprofloxacin.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The device is assessed based on two primary metrics: Essential Agreement (EA) and Categorical Agreement (CA), when compared to a CLSI frozen Reference Panel.

Note: While specific numerical acceptance criteria for EA and CA are not explicitly given in the provided text, the statement "acceptable performance" and the context of FDA guidance for Antimicrobial Susceptibility Test (AST) Systems implies that the reported percentages met pre-defined thresholds, typically very high for these types of devices (e.g., >90% or >95%). The FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems" would contain the precise acceptance criteria.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact number of isolates for each organism group (Enterobacteriaceae, Salmonella spp., Pseudomonas aeruginosa) is not explicitly stated as a numerical count in the provided text. However, the study "conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains" implies a sufficient number of samples were used to achieve the reported agreement percentages. For AST devices, these involve hundreds, if not thousands, of unique isolates.
• Data Provenance: The text states "The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains." This suggests a combination of retrospective (stock strains) and prospective (fresh, recent isolates) data. The country of origin is not specified, but given the company (Beckman Coulter, Inc., West Sacramento, California) and the FDA submission, it is highly likely the data includes isolates from the United States and potentially other regions relevant to the target clinical population.

3. Number of Experts and Qualifications

This information is not provided in the given document. For AST device validation, ground truth is typically established by laboratory methods, not expert human readers.

4. Adjudication Method

This information is not applicable as the ground truth is based on a reference laboratory method (CLSI frozen Reference Panel), not on human expert reads requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human interpretation of images is a key component, and AI assists in that interpretation. For Antimicrobial Susceptibility Testing (AST) devices, the focus is on the device's ability to produce accurate Minimum Inhibitory Concentration (MIC) values and categorical interpretations (Susceptible, Intermediate, Resistant) compared to a gold standard laboratory method.

6. Standalone (Algorithm Only) Performance

The study primarily evaluates the standalone performance of the MicroScan Dried Gram-Negative MIC/Combo Panels. The device determines MIC values and susceptibility categories. While it can be "read either visually or with MicroScan instrumentation," the core performance metrics (EA and CA) are for the device's output, not for human-in-the-loop performance. The comparison is against a CLSI frozen Reference Panel, which is a laboratory standard, making this a standalone performance assessment.

7. Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This is considered a gold standard in microbiology for determining antimicrobial susceptibility, based on established Clinical and Laboratory Standards Institute (CLSI) guidelines. It represents the accepted accurate determination of MICs.

8. Sample Size for the Training Set

The document does not provide information regarding the training set sample size. This submission focuses on the validation or test performance of the device. The development and training details of the underlying system (e.g., if any machine learning models were used for automated reading) are not disclosed in this summary.

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

Since the document does not provide information on a training set, it does not elaborate on how ground truth for a training set was established. For AST devices, development typically involves extensive testing against reference methods in a continuous improvement process, which implicitly trains the system to accurately determine MICs.

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To determine antimicrobial agent susceptibility

MicroScan Dried Gram-Negative 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-negative bacilli.

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.

This document describes the premarket notification (510(k)) for Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) for determining antimicrobial agent susceptibility.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA" typically specifies numerical acceptance criteria for Essential Agreement and Categorical Agreement (e.g., typically ≥ 90% for EA and CA), but these specific numerical thresholds are not explicitly detailed in this provided text. The text only states that the performance was "acceptable" as defined in that guidance document.

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

The document mentions "external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains." However, the exact sample size (number of isolates/strains) for the test set is not provided in the given text.

The data provenance is not explicitly stated in terms of country of origin. It is a retrospective study design since it used "stock Efficacy isolates and stock Challenge strains" and compared the device's performance to a CLSI frozen Reference Panel.

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

This information is not provided in the document. For antimicrobial susceptibility testing, the "ground truth" is typically established by recognized reference methods, such as the broth microdilution method as outlined by CLSI (Clinical and Laboratory Standards Institute), which inherently does not involve human expert consensus in the same way imaging or clinical diagnosis studies might. The CLSI frozen Reference Panel served as the gold standard for comparison.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of antimicrobial susceptibility testing. The comparison is made against a CLSI frozen Reference Panel, which itself is a standardized method, not subject to individual interpretation requiring adjudication.

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 study is for an antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the study describes the standalone performance of the MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin. The performance metrics (EA, CA) are reported for the device ("Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument") compared to the CLSI frozen Reference Panel. There is no human interpretation or intervention in the measurement process described beyond the initial setup/inoculation and reading by the automated WalkAway instrument.

7. The Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This represents a standardized, reference method for determining antimicrobial susceptibility, widely accepted as the gold standard in microbiology.

8. The Sample Size for the Training Set

Not applicable/provided. The document describes a performance evaluation study comparing a new device to a reference standard; it does not mention a "training set" in the context of machine learning or AI models. This device is not an AI algorithm that learns from data.

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

Not applicable/provided as there is no training set mentioned for this type of device.

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MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8 micrograms/mL)

MicroScan Dried Gram-Neqative 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-negative bacilli.

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 an analysis of the provided text, focusing on the acceptance criteria and study data for the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam:

The document describes the Beckman Coulter MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8µg/mL), a device intended for determining antimicrobial agent susceptibility. The device is classified as Class II and operates by rehydrating dried antimicrobial agent dilutions with a standardized suspension of the organism, incubating for 16-20 hours, and then reading the minimum inhibitory concentration (MIC).

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the device's performance is "Essential Agreement" when compared to a CLSI frozen Reference Panel. While a specific numerical target for Essential Agreement is not explicitly stated as an "acceptance criterion" in a table format, the document clearly states that the device "demonstrated substantially equivalent performance" and "acceptable performance with an overall Essential Agreement of 98.3%." This implies that the observed 98.3% Essential Agreement met the internal or regulatory threshold for acceptability.

Note: The document also mentions "acceptable reproducibility and precision" for inoculum and instrument testing (using Turbidity or Prompt® inoculum methods and autoSCAN-4 or WalkAway systems), and "acceptable results" for Quality Control testing for meropenem/vaborbactam. While these are important aspects of device performance, the primary comparative performance metric explicitly stated against a reference panel is Essential Agreement.

Study Details

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

   • Test Set Description: The external evaluations were conducted with "fresh, recent and stock Efficacy isolates and stock Challenge strains."
   • Sample Size: The exact sample size for the test set (number of isolates or strains) is not explicitly stated in the provided text.
   • Data Provenance: The document does not specify the country of origin of the data. The data appears to be prospective in the sense that the evaluations were designed to confirm acceptability of the proposed panel, rather than analyzing existing archived data.

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 text. The ground truth is established by a "CLSI frozen Reference panel," which implies a standardized laboratory method, not expert interpretation.

3. Adjudication method for the test set:

   • This information is not applicable/provided. The method relies on a single, standardized reference panel (CLSI frozen Reference Panel) for comparison, not a multi-reader 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, an MRMC comparative effectiveness study was not done. This device is an Antimicrobial Susceptibility Test (AST) system, which determines the MIC of an antibiotic against bacteria, not an AI-powered diagnostic imaging or interpretation tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

   • This device essentially functions as a standalone algorithm/system in its primary determination of MICs. While human operators are involved in setting up the test and reading the results (or loading into an automated reader), the "performance" described (Essential Agreement) is that of the device itself in comparison to a reference standard, not a human-in-the-loop scenario. There's no AI component mentioned as an 'algorithm'.

6. The type of ground truth used:

   • The ground truth used for comparison is a CLSI frozen Reference Panel. This represents a standardized, established laboratory method for determining antimicrobial susceptibility, considered the gold standard for comparison in AST device evaluations.

7. The sample size for the training set:

   • This information is not provided in the text. The concept of a "training set" typically applies to machine learning or AI models. This document describes a traditional in-vitro diagnostic device, and while there would have been internal development data, it's not described in terms of "training sets" as it would be for an AI device.

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

   • This information is not provided and is likely not applicable in the context of this type of device and its evaluation as described. The ground truth for comparative evaluation was the CLSI frozen Reference Panel.

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The MicroScan Dried Gram-Negative 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-negative bacilli. 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 antimicrobial ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.

The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:

Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens

MicroScan Dried Gram-Neqative 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-negative bacilli.

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.

This document describes the validation of Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam for determining antimicrobial susceptibility.

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

The document uses "Essential Agreement" as the primary performance metric. While specific numerical acceptance criteria (e.g., "must be at least X%") are not explicitly stated as a separate line item, the reported values are presented as demonstrating "acceptable performance" compared to an FDA guidance document.

Note: The document states the performance was compared with CLSI frozen Reference Panel, as defined in an FDA guidance document. This implies the acceptable thresholds are those outlined in that guidance, though they are not explicitly listed in this summary.

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

• Sample Size (Test Set): Not explicitly stated with a single numerical value. The "external evaluations" were conducted with "fresh and stock Efficacy isolates and stock Challenge strains." However, the number of these isolates is not provided in this summary.
• Data Provenance: Not explicitly stated. The document refers to "external evaluations," but does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission, it's highly likely to be prospective clinical and/or simulated data, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth is established by a "CLSI frozen Reference panel," which is a laboratory standard rather than human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a "CLSI frozen Reference panel" and not through human experts requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a study for an in vitro diagnostic device, not an imaging device requiring human reader interpretation. The device is designed to determine antimicrobial susceptibility, which is a direct measurement against a reference, not an interpretation task where human readers would improve with AI assistance.

6. Standalone Performance

Yes, standalone performance was done. The study directly compares the MicroScan Dried Gram-Negative MIC/Combo Panels' performance against a CLSI frozen Reference panel. This is effectively the algorithm/device's performance without human-in-the-loop assistance for the susceptibility reading itself, although humans operate the device and interpret the results against clinical breakpoints. The "Essential Agreement" values represent this standalone performance. The document states panels are "read either visually or with MicroScan instrumentation," indicating the device itself generates the MIC values.

7. Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This is a laboratory standard for antimicrobial susceptibility testing, considered the definitive method against which new methods are compared.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This type of device (an antimicrobial susceptibility test panel) is not typically "trained" like a machine learning algorithm for image analysis. Instead, its performance is validated through comparison to a well-established reference method, ensuring it consistently and accurately measures antimicrobial susceptibility.

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

As there is no mention of a training set, this information is not applicable.

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The MicroScan Dried Gram-Negative 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-negative bacilli. 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 antimicrobial ciprofloxacin (Cp-S) at concentrations of 0.004 to 8 µg/ mL to the test panel.

The gram-negative organism which may be used for ciprofloxacin susceptibility testing on this panel is:

Salmonella Typhi

MicroScan Dried Gram-Neqative 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-negative bacilli.

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 summary of the acceptance criteria and the study details for the MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S based on the provided FDA 510(k) summary:

Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 - 8 µg/mL)
Intended Use: To determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. Specifically, this submission is for the antimicrobial ciprofloxacin (Cp-S) at concentrations of 0.004 to 8 µg/mL for the organism Salmonella Typhi.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for "Essential Agreement" in a formal table format with specific thresholds. However, it indicates that the device demonstrated "acceptable performance" and details the "Essential Agreement" obtained.

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

• Test Set Organism: The specific organism mentioned for testing in this submission is Salmonella Typhi. The document refers to "stock Challenge strains" for the external evaluation.
• Sample Size: The document does not specify the exact number of Salmonella Typhi isolates or challenges strains used in the test set. It mentions "external evaluation was conducted with stock Challenge strains."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the use of "stock Challenge strains" implies a controlled laboratory setting, which is typical for in vitro diagnostic device evaluations.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of human experts to establish ground truth for the test set.
• Ground Truth Method: The ground truth for antimicrobial susceptibility testing (in vitro diagnostic devices) is typically established by using a CLSI frozen Reference Panel. This standardized method eliminates the need for human expert consensus on individual results because the reference method itself serves as the gold standard for comparison.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth is established by a standardized reference method (CLSI frozen Reference Panel), not by human expert review requiring adjudication.

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

• No, an MRMC study was not conducted. This type of study (AI assistance for human readers) is not relevant for an in vitro diagnostic device like an antimicrobial susceptibility test panel, which determines susceptibility directly. The device itself is the primary determinant of the result, not an aid to human interpretation of images or complex data as seen in AI imaging applications.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The entire study described is a standalone evaluation of the device's ability to accurately determine antimicrobial susceptibility concentrations when compared against a recognized reference method (CLSI frozen Reference Panel). The "Essential Agreement" reported is a measure of this standalone performance.

7. Type of Ground Truth Used

• CLSI frozen Reference Panel: This is the established "gold standard" reference method for antimicrobial susceptibility testing, providing the ground truth for comparison.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. For in vitro diagnostic devices based on chemical reactions (like MIC panels), there isn't typically a "training set" in the machine learning sense. The device's performance is inherently based on its chemical design and manufacturing, which is validated through performance studies as described.

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

• Not applicable, as there is no mention of a traditional "training set" and its ground truth in the context of this device. The development of such panels relies on established microbiological principles and validated manufacturing processes to ensure the correct antimicrobial concentrations are present in each well.

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