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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.

The provided document describes the 510(k) summary for Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, a device used to determine antimicrobial agent susceptibility.

Here's an analysis of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

The device demonstrated acceptable performance by meeting the (unstated, but implied typical) thresholds for Essential Agreement and Categorical Agreement, as well as showing acceptable reproducibility and quality control.

2. Sample Size and Data Provenance

The document does not explicitly state the exact sample sizes for the test set. However, it indicates:

• "The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: The document does not specify the country of origin. The study was retrospective as it used "stock Efficacy isolates and stock Challenge strains" implying pre-existing samples. "Fresh, recent" isolates suggest some prospective collection, but the overall context of "external evaluations designed to confirm" typically refers to testing against a well-characterized panel.

3. Number of Experts and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method

The document does not specify an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on comparing the device's performance against a CLSI frozen Reference Panel, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was conducted. The "Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance" compared to the CLSI frozen Reference Panel. This describes the performance of the device (algorithm/system) itself without human interpretation as the primary endpoint beyond the initial setup.

7. Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This is a standardized and well-characterized panel typically used for evaluating antimicrobial susceptibility test systems, representing a robust and accepted form of ground truth in this field.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for a training set. This is typical for submissions focused on the validation of an in-vitro diagnostic device against a reference method, rather than the development of a novel algorithm through machine learning, where training sets are usually discussed.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established. The focus is solely on the performance against the CLSI frozen Reference Panel during evaluation.

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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-neqative 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 acceptance criteria and study detailed in the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the device demonstrated "substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', dated August 28, 2009." This FDA guidance document would contain the explicit, quantitative acceptance criteria for Essential Agreement, which the 96.8% met.

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

• Sample Size: The exact number of isolates used in the external evaluations is not explicitly stated. However, the text mentions "fresh, recent and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: The data was collected from "external evaluations." The country of origin is not specified, nor is whether the data was retrospective or prospective. Given the nature of an antimicrobial susceptibility test, it's highly likely to involve prospective testing of isolates.

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

• Number of Experts: This information is not provided in the document for the establishment of the ground truth.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for establishing the ground truth. The comparison is made against a "CLSI frozen Reference Panel," which inherently serves as the reference standard. This suggests that the reference panel itself is the gold standard, rather than a process of expert adjudication for each test.

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the automated device (MicroScan Dried Gram-Negative MIC/Combo Panels) against a reference standard (CLSI frozen Reference Panel), not on comparing human readers with and without AI assistance. The text explicitly refers to "MicroScan Dried Gram-Negative MIC/Combo Panels" as the "proposed" device, indicating it's an automated system.

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

• Yes, a standalone study was performed. The study assessed the performance of the "MicroScan Dried Gram-Negative MIC/Combo Panels" in determining Minimum Inhibitory Concentrations (MICs). This panel is an automated device designed to yield results without human intervention in the interpretation of the MICs. The comparison is against a CLSI reference panel, which is the standard for standalone device evaluation.

7. The Type of Ground Truth Used:

• CLSI Frozen Reference Panel. The ground truth was established by a "CLSI frozen Reference Panel." The Clinical and Laboratory Standards Institute (CLSI) sets the gold standard for antimicrobial susceptibility testing, and their reference panels are widely accepted as reliable ground truth in this field.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. The document describes a performance evaluation of a device, not the development or training of an AI algorithm in the traditional sense. Therefore, there is no mention of a "training set" for an AI model. This device is a pre-programmed diagnostic tool, not a machine learning model that requires a training phase.

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

• Not Applicable / Not Provided. As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not relevant to this document.

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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 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 ceftolozane/tazobactam at concentrations of 0.25/4 to 16/4 ug/mL to the test panel.

Ceftolozane/azobactam has been shown to be active both clinically and in vitro against the following organisms: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

In vitro data is available for the following organisms, but their clinical significance is unknown: Citrobacter koseri, Morganii, Proteus vulgaris, Providencia retteeri, Providencia stuartii, Serratia liquefaciens, 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 premarket notification (510(k)) for the MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MicroScan Dried Gram-Negative MIC/Combo Panel with Ceftolozane/Tazobactam are based on "Essential Agreement" (EA) with a CLSI frozen Reference Panel. While a specific numerical threshold for "acceptable performance" from the guidance document is not explicitly stated in this summary, it's implied that the achieved 92.8% EA is considered acceptable.

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

The exact sample size (number of isolates) for the test set is not explicitly stated in the provided summary. However, it mentions:

• Data Provenance: The external evaluations were conducted with:
  • "fresh, recent and stock Efficacy isolates"
  • "stock Challenge strains"
  • This suggests a mix of clinical (retrospective or prospective depending on "recent") and curated laboratory strains.
  • The country of origin is not specified, but typically, these studies are conducted in the country where the device is being submitted for approval (e.g., USA for FDA submission).

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 document. For antimicrobial susceptibility testing, the "ground truth" is typically established by the CLSI frozen Reference Panel, which is itself a standardized and highly quality-controlled method. The "experts" in this context are the trained laboratory personnel performing the reference method, rather than "experts" in specific specialties like radiologists.

4. Adjudication Method for the Test Set

This information is not provided in the document. For AST, adjudication as described (e.g., 2+1) is typically not applicable as the reference method (CLSI frozen panel) is considered the gold standard, and the device's results are compared directly to it. Discrepant results would likely be retested rather than adjudicated by multiple expert readers.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not done for this device. This device is an automated in vitro diagnostic for determining antimicrobial susceptibility, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.

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

Yes, a standalone performance evaluation was completed. The device, MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam, is an automated system (though it can also be read visually) that performs the susceptibility test independent of human interpretation for the primary results. The performance is assessed by comparing its output (MIC values) directly to the CLSI frozen Reference Panel.

7. The Type of Ground Truth Used

The type of ground truth used is a CLSI frozen Reference Panel. This is a recognized gold standard method for antimicrobial susceptibility testing, providing quantitative Minimum Inhibitory Concentration (MIC) values.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" as this is not a machine learning or AI-based diagnostic device in the contemporary sense. The "training" of such a device generally refers to the initial development and optimization of the reagent formulations and reading algorithms (if applicable) against known strains, but the specific sample sizes for such internal development are not typically reported in regulatory summaries like this. The data presented here ("external evaluations") would be considered the validation or test set.

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

As no explicit "training set" is mentioned in the context of machine learning, this question is not directly applicable. However, the foundational methods for establishing ground truth in AST (whether for development or validation) rely on established microbiological techniques, primarily the broth microdilution method as standardized by the Clinical and Laboratory Standards Institute (CLSI). This involves precise preparation of antimicrobial dilutions and bacterial inoculums, followed by incubation and visual determination of the lowest concentration inhibiting visible growth.

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The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichia coli, Klebsiella spp. and Proteus mirabilis.

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 use of cefotaxime (2, 16 µg/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 µg/ml), ceftazidime (1, 8 µg/ml) and ceftazidime/clavulanic acid (0.25/4, 2/4 µg/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods.

The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:

Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis

MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp. and P. mirabilis.

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 at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

The provided 510(k) summary focuses on the MicroScan® Dried Gram Negative MIC/Combo Panels for confirming Extended-Spectrum Beta-Lactamase (ESBL) production. The study details are specific to this device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a precise numerical sample size for the "test set" (referred to as "stock challenge strains" within "Design Validation studies"). It mentions "ESBL and non-ESBL-producing strains." Without a specific number, it is impossible to definitively detail the sample size.
• Data Provenance: The data appears to be prospective as it's generated from "Challenge studies" and "Design Validation studies" specifically conducted to confirm the acceptability of the streamlined dilutions. The country of origin of the data is not specified, but given the manufacturer (Dade Behring Inc.) and the FDA submission, it's likely primarily US-based or international data submitted to the FDA for US market clearance.

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

• The ground truth for the test set was established by "molecular characterization." This implies laboratory-based genetic or biochemical testing, not human expert interpretation of images or clinical findings. Therefore, the concept of "number of experts" and their "qualifications" in the traditional sense (e.g., radiologists) is not applicable here. The ground truth relies on the accuracy and established validity of the molecular characterization methods themselves.

4. Adjudication Method for the Test Set:

• Since the ground truth was established by "molecular characterization," the concept of an "adjudication method" involving multiple human readers (like 2+1, 3+1) is not applicable. The molecular characterization itself serves as the definitive reference, and the device's results are compared directly against it.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context typically seen for diagnostic imaging tools involving human readers. This device is an in-vitro diagnostic (IVD) for bacterial susceptibility testing, where the "reader" can be manual or an automated instrument. The study did assess "reproducibility" across "manual, WalkAway® and autoSCAN®-4 instruments," which addresses variation in reading methods but not human diagnostic improvement with AI assistance.
• Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable here because it's not an AI-assisted diagnostic task for visual interpretation by humans.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance study was conducted. The "Overall Agreement of > 93% with ESBL and non-ESBL-producing strains" was determined by comparing the "panel confirmation result" (the device's output) directly against the "molecular characterization result" (the ground truth). This is a standalone assessment of the device's accuracy without human intervention influencing the final classification, other than the initial setup and reading of the panel, which can be automated.

7. Type of Ground Truth Used:

• The ground truth used was molecular characterization (described as "molecular characterization result"). This refers to laboratory techniques (e.g., PCR, sequencing, enzyme assays) that identify the presence or absence of ESBL-producing genes or enzymes, providing a definitive biological determination.

8. Sample Size for the Training Set:

• The document does not explicitly state a sample size for a "training set." This type of device (microdilution panels) is typically developed and validated based on established microbiological principles and chemical formulations rather than machine learning models that require distinct training and test sets. The studies described are validation and challenge studies, which assess the performance of the final device, not the iterative training of an algorithm.

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

• As there's no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The development of such panels relies on a priori chemical and biological knowledge, and subsequent validation against well-characterized reference strains and clinical isolates. The "molecular characterization" served as the gold standard for the validation/test set.

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The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. coli, Klebsiella spp and P. mirabilis.

The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.

After inoculation, panels are incubated for a minimum of 16 hours at 35℃ in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 µgml), ceftazidime (0.5-128 µg/ml) and cefotaxime (0.5-128 ug/ml) for ESBL screening, and for the antimicrobics ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 µg/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 µg/ml) for ESBL confirmation.

The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis

The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichia coli
Klebsiella oxvioca
Klebsiella pneumoniae
Proteus mirabilis

MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quanfitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and confirmation of ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

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 at 35 °C for a minimum of 16 hours. the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram Negative MIC/Combo Panels, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "both fresh and stock isolates and stock challenge strains" were used, but does not specify the exact sample size for the test set.

• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective as it compares panel results against established reference methods (CLSI frozen Reference result or molecular characterization result).

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It refers to CLSI document M100-S16 and molecular characterization results as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers. The comparison is between the device's results and a single reference ground truth (CLSI or molecular characterization).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the device's performance against a reference standard, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, the study describes standalone performance of the device. The "dried Test panel antimicrobial agents demonstrated an overall Agreement of > 90% for both screen and confirmation" when compared against reference methods, indicating the device itself was evaluated. There is no mention of a human-in-the-loop component for the performance evaluation described.

7. Type of Ground Truth Used

The ground truth used was:

• CLSI frozen Reference result
• Molecular characterization result (Challenge)

8. Sample Size for the Training Set

The document does not specify a separate training set sample size. The study describes "Efficacy and Challenge studies" and "Design Validation studies," but these appear to be primarily for performance evaluation against the established ground truth rather than a distinct training phase for an algorithm. This device is a pre-formed panel, not a software algorithm that would typically require a training set in the modern sense.

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

As no distinct training set is described for an algorithm, the method for establishing ground truth for a training set is not applicable in this context. The document focuses on demonstrating the device's performance against established reference standards (CLSI and molecular characterization).

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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. 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 to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.

The Gram-Negative organisms which may be used for Amoxicillin/K. Clavulanate susceptibility testing in this panel are:

Enterobacter species
Escherichia coli
Klebsiella species
Proteus mirabilis

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a change to a currently marketed device, specifically the performance evaluation for a reformulated antimicrobial agent (Amoxicillin/K. Clavulanate) on MicroScan® Dried Gram-Negative MIC/Combo Panels.

It describes the FDA's decision to clear the device, but it does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in the manufacturer's submission or a separate study report.

Therefore, I cannot provide the requested information from the text you provided. The document focuses on the regulatory outcome rather than the specifics of the underlying performance study.

To answer your request, I would need access to the actual 510(k) submission document (e.g., the "traditional 510(k)" or "special 510(k)" submission) prepared by Dade MicroScan Inc. This submission would contain the detailed study protocols, results, and analysis.

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For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

This submission requests clearance of the following new Indication for Use:

Panels containing Cefpodoxime, Ceftazidime, Aztreonam Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to screen for Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).

An alternate method is required for confirmation testing.

Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone.

This document describes the acceptance criteria and the study conducted for MicroScan® Dried Gram Negative MIC/Combo Panels with certain antimicrobial agents to detect suspected Extended-Spectrum Beta-Lactamases (ESBLs) in specific bacterial strains.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity/specificity thresholds). However, it implies acceptable performance based on reproducibility and quality control. The efficacy study aimed to confirm acceptability by comparing panel results against molecular characterization data.

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

• Test Set Sample Size: The document states that the efficacy testing was conducted with "ESBL and non-ESBL producing strains and AmpC-type strains." The exact number of strains used in the test set is not specified in the provided text.
• Data Provenance: Not explicitly stated. The document refers to "previously generated molecular characterization data," but the origin (e.g., country, specific labs) is not detailed. The study itself appears to be conducted by Dade MicroScan Inc. (USA). The study is retrospective in the sense that molecular characterization data was "previously generated," and the panel results were compared against this existing data.

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

This information is not provided. The ground truth ("molecular characterization data") was "previously generated," but details on the experts involved in establishing this ground truth are absent.

4. Adjudication Method for the Test Set

This information is not provided. The comparison was against "previously generated molecular characterization data," implying a direct comparison rather than an adjudication process between human readers/interpreters within the scope of the device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study, as typically understood for human readers, was not performed. This study focuses on the in vitro diagnostic device's ability to detect ESBLs by comparing its results to a ground truth (molecular characterization data), not on how human readers perform with or without AI assistance.

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 MicroScan® Dried Gram Negative MIC/Combo Panels. The device itself (the panel and its interpretation via instrument) is being evaluated for its ability to detect ESBLs, independent of human interpretation or assistance beyond the standard operation of the instrument.

7. The Type of Ground Truth Used

The ground truth used was molecular characterization data. The document states, "...comparing the panel susceptibility results against previously generated molecular characterization data." This suggests genetic or biochemical testing to definitively identify ESBL-producing strains.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or detail for algorithm development or machine learning. The study focuses on evaluating the performance of existing panels for a new indication for use. Therefore, no sample size for an algorithm training set is applicable or provided.

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

Since no training set for an algorithm is discussed, this information is not applicable. The "previously generated molecular characterization data" served as the reference standard for the test set evaluation.

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