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VITEK® 2 AST-GP Clindamycin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. VITEK 2 AST-GP Clindamycin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Clindamycin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus epidermidis (methicillin-susceptible strains)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

The VITEK® 2 AST - Gram Positive Clindamycin device is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. The study aimed to demonstrate its substantial equivalence to the CLSI broth microdilution reference method.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions an "external evaluation" conducted with:

• Fresh and stock clinical isolates: The exact number is not specified.
• Stock challenge strains: The exact number is not specified.

The provenance of the data (e.g., country of origin) is not explicitly stated, but it is an "external evaluation," suggesting it was not solely internal data from bioMérieux. It also doesn't explicitly state if the data was retrospective or prospective, though clinical isolates generally imply prospective collection or recent isolates.

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

This information is not provided in the given text. The ground truth method is the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not typically established by human experts in the same way imaging or pathology ground truth might be.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. The ground truth is established by a standardized laboratory reference method (CLSI broth microdilution), not through expert consensus requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reading is involved, such as medical imaging. For an antimicrobial susceptibility test system, the comparison is between the automated device and a standardized reference method.

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

Yes, the study describes a standalone performance evaluation. The VITEK® 2 AST system, in both VITEK 2 and VITEK 2 Compact platforms, generates results (MIC value and interpretive category) autonomously. Its performance was compared directly against the CLSI broth microdilution reference method without human intervention in the result determination phase of the device itself.

7. The type of ground truth used

The type of ground truth used was the CLSI broth microdilution reference method. This is a well-established, standardized laboratory methodology for determining antimicrobial susceptibility, considered the gold standard for MIC determination.

8. The sample size for the training set

The sample size for the training set is not specified. The document describes an "external evaluation" which sounds more like a validation or test set rather than a training set. For an AST system, the device's algorithms or measurement principles are developed based on understanding microbial growth kinetics and established breakpoints, rather than explicitly "training" on a large dataset of results in the way machine learning algorithms are. The provided text focuses on the performance comparison of the final device.

9. How the ground truth for the training set was established

As mentioned above, specific information about a "training set" and its ground truth establishment is not provided in the context of typical machine learning training. The VITEK® 2 system's underlying methodology likely relies on established microbiological principles and standardized breakpoints. If internal development involved optimization, the ground truth would similarly be established by reference methods like CLSI broth microdilution for those internal studies.

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VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorqanism listed below, according to the FDA label for this antimicrobial.

Streptococcus pneumoniae (pneumonia and meningitis)

· The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versons of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion cycle, a report is generated that contains the MC value along with the interpretive category result for each antibiotic contained on the card.

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 AST - Gram Positive Penicillin for Streptococcus pneumoniae, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria for Category Agreement, Reproducibility, and Quality Control from the "Class II Special Controls Guidance Document" are not fully detailed in the provided text. The document only references that the study was designed to confirm acceptability based on this guidance.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: An "external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." The exact number of isolates used is not specified in the provided text.
• Data Provenance: The text does not explicitly state the country of origin. It indicates the data came from "external evaluations" and used "fresh and stock clinical isolates and stock challenge strains." This suggests a combination of retrospective (stock isolates) and prospective (fresh clinical isolates) data.

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

• The text does not provide any information about the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

• The text does not provide any information about the adjudication method used for the test set.

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

• No, an MRMC comparative effectiveness study was not done as described in this document. The study compares the device's performance to a reference method (CLSI broth microdilution), not human readers with and without AI assistance.

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

• Yes, a standalone study was performed. The VITEK® 2 AST system, which is an automated system, demonstrates performance by comparing its results directly with the CLSI broth microdilution reference method. The text states: "VITEK 2 Gram Positive Penicillin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method." This indicates the algorithm's performance without human intervention in susceptibility determination.

7. Type of Ground Truth Used

• The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

• The provided text does not specify the sample size for the training set. It only mentions the "external evaluation" for performance assessment.

9. How Ground Truth for the Training Set Was Established

• The provided text does not specify how the ground truth for the training set was established. It only refers to the CLSI broth microdilution reference method for the performance evaluation.

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VITEK® 2 Yeast Voriconazole is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Voriconazole is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Voriconazole has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.

Active in vitro and in clinical infections Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

Active in vitro but their clinical significance is uknown: Candida lusitaniae Candida guilliermondii

The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.

The antifungal presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antifungal medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 36 hours for yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antifungal contained on the card.

This report describes the acceptance criteria and study proving the VITEK® 2 Yeast Voriconazole device meets these criteria.

1. Acceptance Criteria and Reported Device Performance

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

The document states "An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." However, the exact sample size (number of isolates) for the test set is not explicitly provided in the furnished text.

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from an "external evaluation," generally suggesting data collected in a clinical or laboratory setting. The use of "fresh and stock clinical isolates" indicates a mix of prospective (fresh clinical isolates) and retrospective (stock clinical isolates and challenge strains) data.

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

The document does not mention the use of experts to establish ground truth. Instead, the ground truth was established by comparing the device's performance against a "CLSI reference method." This method would involve standardized laboratory procedures rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Since the ground truth was established by the CLSI reference method, there was no adjudication method involving multiple human readers as would be typical in medical imaging or interpretation studies. The comparison was directly against the results generated by the reference method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study typically evaluates human reader performance with and without AI assistance, which is not applicable to an automated antimicrobial susceptibility test (AST) system.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire study described evaluates the VITEK® 2 Yeast Voriconazole device as a standalone algorithm (automated system) without human intervention in the interpretation process once the card is processed. The performance metrics (Essential Agreement and Category Agreement) directly reflect the algorithm's accuracy compared to the reference method.

7. Type of Ground Truth Used

The type of ground truth used was the CLSI reference method (Clinical and Laboratory Standards Institute). This is a standardized laboratory methodology for determining antimicrobial susceptibility, considered the gold standard for AST systems.

8. Sample Size for the Training Set

The document does not provide information regarding a specific training set or its sample size. This implies that the device's development might have used a different type of underlying data or that the training data details are proprietary and not included in this summary. For biological assays, often historical data and laboratory standards guide algorithm development.

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

Since a specific training set is not mentioned, the method for establishing its ground truth is also not provided.

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VITEK® 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Positive Daptomycin is a quantitative test. Daptomycin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections:

Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramneqative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45 - 0 .50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Positive Daptomycin device, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate "substantially equivalent performance" to the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued March 5, 2007.

The reported performance directly addresses the "Category Agreement" as a key metric for demonstrating substantial equivalence.

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

• Sample Size for Test Set: The exact numerical sample size for "fresh clinical isolates" and "stock challenge strains" is not provided. It is stated as "an external evaluation was conducted with fresh clinical isolates and stock challenge strains."
• Data Provenance: The data is described as an "external evaluation" using "fresh clinical isolates and stock challenge strains." This suggests a prospective collection of isolates, though the specific country of origin is not mentioned. Given bioMérieux's location in Missouri, USA, it's highly probable the isolates were collected in the United States.

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. For Antimicrobial Susceptibility Test (AST) systems, the "ground truth" is typically established by a recognized reference method (like CLSI broth microdilution), rather than human experts adjudicating results. The CLSI method itself has established protocols for accuracy and reliability.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of an AST device where the ground truth is established by a reference method (CLSI broth microdilution), rather than human consensus.

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

This is not applicable to this device. The VITEK® 2 system is an automated AST system that provides quantitative and interpretive results. It is not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant.

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

Yes, this was a standalone performance study. The VITEK® 2 system is automated and its performance was directly compared to the CLSI broth microdilution reference method without human intervention during the test result generation by the VITEK® 2 system. The reported "98.4% overall Category Agreement" reflects the standalone performance of the device.

7. The Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

This information is not provided in the summary. The VITEK® 2 system is a well-established automated diagnostic platform, and its underlying methodology for determining MICs is based on miniaturized doubling dilution techniques rather than machine learning models that require explicit "training sets" in the conventional sense. The "training" for such systems involves extensive development and validation against reference methods to ensure accuracy across a wide range of microorganisms and antimicrobial concentrations.

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

This information is not provided and is likely not applicable in the typical sense of machine learning training. The VITEK 2 system's operational principles are based on established microbiological methods (doubling dilution technique), not on a "training set" that requires external ground truth establishment. The development process for such a system would involve rigorous optimization and internal validation against the CLSI reference method to ensure its algorithms accurately determine MICs.

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VITEK® 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negative microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative is a quantitative test. Doripenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Active in vitro but clinical significance unknown: Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Serratia marcescens

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45 - 0 .50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's an analysis of the provided text, extracting the requested information about the device's acceptance criteria and the supporting study:

VITEK® 2 Gram Negative Doripenem - Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a single number for total isolates. The study refers to "fresh and stock clinical isolates and stock challenge strains." This suggests a diverse collection, but the exact number is missing.
• Data Provenance: The study was an "external evaluation," implying testing conducted outside of bioMérieux's internal labs. There is no explicit mention of the country of origin, but the submission is to the FDA (USA), and the CLSI (Clinical and Laboratory Standards Institute) is a US-based organization, suggesting a US-centric context for the data, or at least data compliant with US standards. The isolates were a mix of "fresh and stock clinical isolates and stock challenge strains," indicating a combination of prospective and retrospective (for stock clinical isolates and challenge strains) data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's implied that the CLSI broth microdilution reference method is the gold standard, and its execution would typically involve trained microbiologists or laboratory personnel experienced in performing and interpreting these reference methods.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The comparison is directly between the VITEK® 2 system and the CLSI broth microdilution reference method. This direct comparison usually implies that the CLSI method's result is taken as the definitive ground truth without a separate expert adjudication process for discordant results, beyond potentially re-testing by the reference method itself if initial results were unclear.

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

• MRMC Study Done: No. This device is an automated antimicrobial susceptibility testing (AST) system, not an imaging or diagnostic device that typically involves human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between an automated system and a reference microbiology method.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done: Yes. The entire study focuses on the "standalone" performance of the VITEK® 2 Gram Negative Doripenem system. The system automatically performs the test, interprets the growth, and generates the MIC value and interpretive category without human intervention during the test run or interpretation beyond initial setup and loading. The reported 97.9% overall Category Agreement is a measure of this standalone performance against the reference method.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus through a reference method. Specifically, the "CLSI broth microdilution reference method," as defined in the FDA Class II Special Controls Guidance Document. This is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document describes the external evaluation for validation (test set), but does not detail the size or nature of the data used to initially train or develop the VITEK 2 AST card and its interpretive algorithms.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not explicitly detailed in the provided summary. However, for AST systems, the ground truth for training (or development/calibration) would similarly be established by comparing the device's readings against established reference methods, like the CLSI broth microdilution method, during the development phase. This process calibrates the system's interpretive algorithms to accurately reflect the true MIC values and interpretive categories.

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The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae:

VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Gram positive Streptococcus pneumoniae and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae is a qualitative test.

This submission is for the addition of an intermediate interpretive criteria.

Ervthromcvin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Streptococcus pneumoniae

VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococus pneumoniae. It is intended for use with the VITEK 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the performance must be "substantially equivalent" to the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003. While specific numerical acceptance criteria (e.g., minimum percentage for category agreement, essential agreement) are often detailed within such guidance documents, they are not explicitly listed in this 510(k) summary. The summary highlights a "98.4% overall Category Agreement" as demonstrating "acceptable performance," implying this met their internal and regulatory expectations.

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

• Sample Size for Test Set: Not explicitly stated as an exact number in the provided text. The text mentions "fresh and stock clinical isolates and stock challenge strains" were used for an "external evaluation." The original 510(k) (K063492) that this submission refers to would contain the detailed sample size.
• Data Provenance: The data was from a retrospective analysis of clinical trial data that was part of the previous 510(k) (K063492). "There was no new clinical data gathered for this 510(k) notification." The country of origin is not specified but implicitly within the US given the submission to the FDA.

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

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The ground truth was established by the "CLSI broth microdilution reference method," which is a standard laboratory procedure, not typically involving human adjudication in the same way as, for example, image interpretation.

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

• MRMC Study Done: No. This device is an automated antimicrobial susceptibility testing system, not an imaging device requiring human reader interpretation or assistance. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study

• Standalone Study Done: Yes. The study focused on the "algorithm only" performance (i.e., the VITEK 2 system) compared to the CLSI reference method. The VITEK 2 System is an automated device designed to provide a result without human intervention for interpretation beyond loading samples and reviewing the final report. The "overall Category Agreement" of 98.4% represents this standalone performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was the CLSI broth microdilution reference method. This is a recognized standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable or specified. This submission is for a software algorithm change to utilize existing FDA breakpoints, re-analyzing previously collected clinical trial data. While the original device (K063492) would have had a development dataset, this specific submission does not involve new training of a machine learning model but rather a modification to how results are interpreted based on established breakpoints. The term "training set" is usually reserved for machine learning models, which is not what is being described here in the conventional sense.

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

• How Ground Truth for Training Set Was Established: Not applicable or specified for this submission. As mentioned above, this involves a re-analysis of existing data with a modified algorithm to apply FDA breakpoints, not the training of a new model. The ground truth for the original data was established using the CLSI broth microdilution reference method.

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VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicrobial susceptibility testing of Staphylococcus species. A positive ICR test is indicative of inducible MLS, resistance, which confers resistance to macrolides, lincosamides, and type B inducible MLS, resistance, which confers resistance to macrolides, and VITEK® 2 Co laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System belomatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is over a delined pend of the (up to To Tronice). It the interpretive category result for each antibiotic contained on the card.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "Acceptable performance when compared with the CLSI Disk Approximation Test reference method.",
    "Reported Device Performance": "99.3% overall Category Agreement."
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Sample Size": "Not specified, but states 'fresh and stock clinical isolates and stock challenge strains'.",
    "Data provenance": "External evaluation (implying clinical samples), prospective for fresh isolates and retrospective for stock isolates."
  },
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable, as ground truth was established by the CLSI Disk Approximation Test reference method, not human experts.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable, as ground truth was established by the CLSI Disk Approximation Test reference method, not human 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": "No MRMC comparative effectiveness study was done. This is a standalone diagnostic device comparison to a reference method, not an AI assistance tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone comparison of the VITEK 2 System to the CLSI Disk Approximation Test reference method was performed.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "CLSI Disk Approximation Test reference method.",
  "8. The sample size for the training set": "Not specified, as this device likely uses a rule-based or predefined algorithm rather than a machine learning model that requires a training set in the conventional sense. The 'training' would be the development and validation against CLSI standards.",
  "9. How the ground truth for the training set was established": "Not applicable for a training set in the context of typical machine learning. The device's performance was validated against the CLSI Disk Approximation Test reference method."
}

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VITEK® 2 Gram Negative Piperacillin/tazobactam is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin/tazobactam is a quantitative test. Piperacillin/ tazobactam has been shown to be active against most strains of the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections Klebsiella pneumoniae Acinetobacter baumanii Escherichia coli Pseudomonas aeruginosa

Active in vitro but their clinical significance is uknown:

Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Citrobacter koseri Morqanella morganii Proteus mirabilis

Salmonella enterica Serratia marcescens

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

VITEK® 2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Citrobacter koseri, Morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Salmonella enterica and Serratia marcescens. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mod/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device Name: VITEK® 2 Gram Negative Piperacillin/Tazobactam (≤ 4 - ≥ 128 µg/ml)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a numerical value for the test set. The document mentions "fresh and stock clinical isolates" were used.
• Data Provenance: The study was an "external evaluation" designed to confirm performance by comparing it with the CLSI broth microdilution reference method. The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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

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

4. Adjudication Method for the Test Set:

• Not explicitly stated. The ground truth method (CLSI broth microdilution) is a standardized laboratory method, so expert adjudication in the traditional sense (e.g., radiologists reviewing images) is not applicable here.

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 device is an automated antimicrobial susceptibility test system, not an imaging device requiring human reader interpretation in the context of AI assistance. The performance is assessed against a reference laboratory method.

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

• Yes, the core of the study is a standalone performance evaluation. The VITEK® 2 system is an automated device designed to determine antimicrobial susceptibility. Its performance (Essential Agreement, Category Agreement) is directly compared to a reference method (CLSI broth microdilution), which represents its "standalone" diagnostic accuracy without human intervention in the susceptibility determination process itself.

7. The Type of Ground Truth Used:

• The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a separate training set. The VITEK 2 system's underlying algorithm for determining MICs and interpretive categories would have been developed and validated previously, and this submission focuses on the performance of a specific antimicrobial-device combination (Piperacillin/Tazobactam on the VITEK 2 AST-GN card) against a reference method. It's possible the "training" (development) of the MIC interpretation algorithms for the VITEK 2 system happened prior to this specific submission, and this study is a validation for a new antimicrobial.

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

• Since no specific training set for this particular antimicrobial validation is mentioned, the method for establishing its ground truth is also not specified. However, for the underlying VITEK 2 system's development, it would have involved extensive testing against reference methods like CLSI broth microdilution.

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VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of gram-negative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Trimethoprim/sulfamethoxazole is a quantitative test. Trimethoprim/sulfamethoxazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections

Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea)

Klebsiella species Enterobacter species Morganella morganii Proteus vulgaris

Proteus mirabilis Shigella flexneri Shigella sonnei

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's an analysis of the provided text regarding the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003. The specific metric mentioned for performance is overall Category Agreement.

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

• Sample Size for Test Set: The document mentions "fresh and stock clinical isolates and stock challenge strains" for the external evaluation, but it does not specify the exact number (sample size) of isolates used in this test set.
• Data Provenance: The external evaluation was conducted. The country of origin is not explicitly stated, but it's likely primarily US-based given the FDA regulatory context. The isolates included "fresh and stock clinical isolates and stock challenge strains," indicating a mix of retrospective (stock isolates) and prospective (fresh clinical isolates) data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. However, for antimicrobial susceptibility testing, the "gold standard" or reference method (CLSI broth microdilution) inherently involves expert-defined protocols and interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the traditional sense of multiple readers reviewing results. The comparison is made directly against the CLSI broth microdilution reference method.

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

• Was it done? No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating human reader performance with and without AI assistance in diagnostic imaging, which is not applicable to an automated antimicrobial susceptibility test system.
• Effect size: Not applicable, as no such study was performed.

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

• Was it done? Yes, the performance described for the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is a standalone (algorithm only) performance. The device determines the MIC value and interpretive category automatically after incubation. The comparison is against the reference method, showing the device's inherent accuracy.

7. Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is considered the gold standard for antimicrobial susceptibility testing, providing quantitative Minimum Inhibitory Concentration (MIC) values.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" sample size or details about the development process that would typically involve a training phase for a machine learning model. For AST devices like VITEK, the "training" analogous to model development often involves extensive internal testing and refinement against reference methods during product development, prior to the external validation described. The current submission focuses on the validation of the finalized device.

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

Since a distinct "training set" with established ground truth is not explicitly described, the method for establishing its ground truth is not provided. However, based on the nature of these devices, the development process would involve comparing device results against the CLSI broth microdilution reference method for a vast number of isolates during the initial design and optimization phases.

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VITEK® 2 Gram Negative Piperacillin is designed for antimicrobial susceptibility testing of gramnegative organisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Piperacillin is a quantitative test. Piperacillin has been shown to be active against most strains of the organisms listed below according to the FDA label for the antirocrobial.

Active in vitro and in clinical infections

Acinetobacter species Enterobacter species Escherichia coli Klebsiella species

Morganella morganii Providencia rettgeri Proteus mirabilis Proteus vulgaris

Pseudomonas aeruginosa Serratia species

Active in vitro but their clinical significance is uknown: Burkholderia cepacia Citrobacter koseri (formerly C. diversus)

Citrobacter freundii Pseudomonas fluorescens

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilii, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Negative Piperacillin device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated as a number of isolates. The document mentions "fresh and stock clinical isolates and stock challenge strains."
   • Data Provenance: Not explicitly stated, but it was an "external evaluation," implying data was collected outside of bioMérieux's internal development environment. The country of origin is not specified. It included both "fresh and stock clinical isolates," indicating a mix of prospective and retrospective (archived) clinical data.

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

   • Not specified. The ground truth method (CLSI broth microdilution) is a standardized laboratory method rather than expert consensus on individual cases.

3. Adjudication Method for the Test Set:

   • Not applicable. The ground truth was established by the CLSI broth microdilution reference method, which is an objective measurement, not requiring human adjudication of differing interpretations.

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

   • No, an MRMC study was not done. This device is an automated in vitro diagnostic (IVD) system for antimicrobial susceptibility testing, not a device intended for direct human interpretation or improvement of human reader performance. The study compared the device's performance to a reference laboratory method.

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

   • Yes, this was a standalone performance study. The VITEK® 2 system is an automated device, and its performance was evaluated against the CLSI reference method to determine its accuracy without human intervention other than sample preparation and loading.

6. The Type of Ground Truth Used:

   • Expert Consensus: No
   • Pathology: No
   • Outcomes Data: No
   • Other: CLSI broth microdilution reference method. This is a universally accepted standardized laboratory procedure for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.

7. The Sample Size for the Training Set:

   • Not applicable/Not mentioned. The document describes a validation study for a device. For a traditional in vitro diagnostic, the "training set" concept (as in machine learning) is generally not applied in the same way. The device's underlying methodology is based on established microbiological principles, and its performance is validated using a test set against a gold standard.

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

   • Not applicable/Not mentioned (see point 7).

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