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The MicroScan Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial daptomycin at concentrations of 0.06-32 µg/mL to the test panel. Testing is indicated for Enterococcus faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

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

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

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

The principle of MicroScan panels with antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

The document mentions "external evaluations" conducted with:

• Fresh and stock Efficacy isolates
• Stock Challenge strains

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for daptomycin in the dilution range of 0.03-64 µg/mL for testing non-fastidious gram-positive isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System.

Daptomycin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Enterococcus faecalis (vancomycin-susceptible isolates only)

Staphylococcus aureus (including methicillin-resistant isolates)

Daptomycin has been shown to be active in vitro only against the following organisms according to the FDA drug label: Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium (including vancomycin-resistant isolates)

Not Found

This document is a 510(k) clearance letter for an in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML specific criteria (such as AI assistance, standalone algorithm performance, number of experts, and training set information) are not applicable.

The document discusses the regulatory clearance of "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL." This system is for antimicrobial susceptibility testing.

Here's an attempt to answer the relevant questions based on the provided text, while noting the inapplicability of AI/ML specific questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of acceptance criteria and reported device performance. It is a clearance letter, assuming these details were part of the 510(k) submission that led to this clearance. The clearance confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards for antimicrobial susceptibility testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the clearance letter. Such details would typically be found in the 510(k) submission itself.

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)

This question is not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" in antimicrobial susceptibility testing would typically involve a reference method (e.g., broth microdilution or agar dilution) against which the device's results are compared.

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

Not applicable as this is not an AI/ML device involving human adjudication of results. The "adjudication" in this context would be the comparison of the device's MIC results against the reference method's MIC results, followed by categorical agreement calculations (e.g., Essential Agreement, Categorical Agreement).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an automated in vitro diagnostic system, not an AI-assisted tool for human readers.

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

This question is framed for AI algorithms. For this device, "standalone performance" would refer to the device's ability to accurately determine MIC values without manual intervention, which is its primary function. The clearance implies that its standalone performance (without human interpretation beyond reading the results) is acceptable.

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

For antimicrobial susceptibility testing devices, the "ground truth" is typically established by reference dilution methods, such as broth microdilution or agar dilution, which are considered the gold standard for determining the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against a microorganism. The results obtained from the Sensititre system would be compared against these reference method results.

8. The sample size for the training set

Not applicable. This is an in vitro diagnostic device, not an AI/ML model that undergoes a "training" process in the dataset sense.

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

Not applicable, as there is no "training set" in the AI/ML context for this type of device.

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VITEK® 2 AST-Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 AST-Gram Positive Daptomycin is a quantitative test. Daptomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active both in vitro and in clinical infections: Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus (including methicillin-resistant isolates)

In vitro data are available, but their clinical significance is unknown: Enterococcus faecalis (vancomycin-resistant isolates)

The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast 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.

VITEK® 2 AST-GP Daptomycin has the following concentrations in the card: 0.5, 1, 2, 4, and 8 ug/mL (equivalent standard method concentration by efficacy in ug/mL).

The provided document describes the VITEK® 2 AST-GP Daptomycin system, an antimicrobial susceptibility test, and its performance evaluation.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility test (AST) systems in the US are generally defined by the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. While specific numerical targets for Essential Agreement (EA) and Category Agreement (CA) are usually outlined in this guidance, the summary states the device demonstrated substantially equivalent performance when compared with the broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document.

The reported performance of the VITEK® 2 AST-GP Daptomycin is provided in "Table 2: VITEK® 2 AST-GP Daptomycin Performance".

Note on VME/ME/mE for Staphylococcus aureus: The document lists "N/A" for VME and mE for Staphylococcus aureus and "0.0%" for ME for Enterococcus faecalis. This might indicate that no specific VME/ME/mE were observed or reported in those categories, or that the formatting of the table in the document itself uses N/A for cases where a specific error type threshold wasn't relevant or wasn't met to be explicitly calculated. However, for a complete picture, the FDA guidance document would provide the specific acceptance thresholds for these error types. The (1/8) 12.5% VME for Enterococcus faecalis and (41/270) 15.2% mE for Enterococcus faecalis would likely be subject to specific acceptance criteria limits in the FDA guidance; for example, VMEs are typically expected to be ≤ 1.5% and MEs ≤ 3.0%, while mEs generally have a higher tolerance but still a limit. The document states a 90.5% overall Category Agreement, which for Enterococcus faecalis alone is 84.4%, falling below the typical 90% threshold for CA. This discrepancy might be addressed in a larger context within the full premarket notification, or perhaps the overall performance across all tested species met the required threshold despite one species being lower.

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

• Test Set Sample Size:
  • Staphylococcus aureus: 194 isolates
  • Enterococcus faecalis: 270 isolates
  • Total Clinical Isolates in Performance Study: 194 + 270 = 464 isolates.
  • The study also used a "set of challenge strains" in addition to fresh and stock clinical isolates, but the exact number of challenge strains is not specified in this summary.
• Data Provenance:
  • "An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." This suggests a prospective or a mix of prospective and retrospective collection from external sources (likely clinical laboratories).
  • The document does not specify the country of origin for the data.

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

• The ground truth was established by the CLSI broth microdilution reference method. This method is a standardized laboratory procedure, not reliant on human expert interpretation in the same way as, for example, image reading. Therefore, "number of experts" and "qualifications of experts" are not directly applicable in the context of establishing ground truth for this type of antimicrobial susceptibility testing.

4. Adjudication Method for the Test Set

• The reference method itself (CLSI broth microdilution) serves as the "ground truth" or "adjudication." No separate human adjudication process (e.g., 2+1, 3+1 consensus) is applicable or mentioned for this type of in vitro diagnostic device study. The device's results are directly compared to the results of the reference method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study design is typically used for AI-powered diagnostic imaging devices where human readers interpret images with or without AI assistance. This device is an automated in vitro diagnostic system for antimicrobial susceptibility testing, not requiring human interpretation of complex visual data for its primary function.

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

• Yes, the performance study effectively evaluates the "standalone" performance of the VITEK® 2 AST-GP Daptomycin system. The system automatically processes the samples and generates MIC values and interpretive categories, which are then compared directly to the CLSI broth microdilution reference method. There is no human intervention in the device's determination of susceptibility.

7. The Type of Ground Truth Used

• The ground truth used was the CLSI broth microdilution reference method, which is a highly standardized and accepted laboratory method for determining antimicrobial susceptibility. This is essentially a "gold standard" laboratory method.

8. The Sample Size for the Training Set

• The document does not provide information on the training set size. This type of premarket notification summary focuses on the performance evaluation of the final device, not typically on the specific dataset used for algorithm development or training. The "Discriminant Analysis" mentioned under "Analysis Algorithms" implies a statistical model was used, which would have been developed/trained on a dataset, but details of this dataset are not included in this summary.

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

• As the training set details are not provided, the method for establishing its ground truth is also not described in this summary. It would logically be established using a similar or identical reference method to the test set, but this is not confirmed.

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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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The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin.

This premarket notification is for the addition of the antimicrobial agent daptomycin at concentrations of 0.0313-16 ug/mL to Streptococcus ID/AST or AST only Phoenix panels. Daptomycin 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:

Streptococcus agalactiae Streptococcus dysgalactiae Streptococcus pyogenes

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. For testing Streptococcus species the system includes the following components:

• BD Phoenix instrument and software.
• BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
• BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum.
• BD Phoenix AST-S Broth used for performing AST tests only.
• BD Phoenix AST-S Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. For each isolation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible),

Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the BD Phoenix™ Automated Microbiology System for the antimicrobial agent daptomycin, when compared to the CLSI reference broth microdilution method, are based on Essential Agreement (EA) and Category Agreement (CA).

Note on Table 1: The provided Table 1 is incomplete and practically unreadable due to formatting issues and garbled text. It's impossible to extract the precise reported Essential Agreement and Category Agreement percentages for daptomycin from this table. However, the summary concludes that "The data collected from the substantial equivalence studies demonstrate that testing on the BD Phoenix™ Automated Microbiology System with this antimicrobial agent is substantially equivalent," implying that the acceptance criteria for EA and CA were met.

Study Details

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

• Test Set Sample Size: The document mentions "clinical, stock and challenge isolates were tested." No specific numbers are provided for the total test set. However, for reproducibility studies, a "panel of streptococcal isolates" was used.
• Data Provenance: The studies were conducted "across multiple geographically diverse sites across the United States." This indicates prospective data collection.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth was established by comparing to the CLSI reference broth microdilution method, which is a standardized laboratory method, not typically relying on expert interpretation in the same way as, for example, image analysis.

4. Adjudication method for the test set:

• Not applicable/Not specified. The comparison is between the device's quantitative MIC values and categorical interpretations and the CLSI reference method. There is no mention of human adjudication for discrepancies.

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 system for antimicrobial susceptibility testing, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

• Yes, the study describes a standalone performance evaluation of the BD Phoenix™ Automated Microbiology System. The system automatically measures changes to an indicator and bacterial turbidity to determine MIC values and categorical interpretations. These results are then compared directly to the CLSI reference method. While human lab technicians operate the instrument and prepare samples, the interpretation and determination of susceptibility are automated by the device's algorithm.

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

• The ground truth was the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method. This is a recognized gold standard laboratory method for determining antimicrobial susceptibility. For challenge set isolates, "expected results" were used, which would typically be predetermined MICs for control strains.

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a validation study for a specific antimicrobial agent (daptomycin) on an established automated system. The system's underlying algorithms would have been developed and "trained" previously using extensive data, but this specific submission does not detail the training set for the core Phoenix system or for the addition of this new agent.

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

• Not applicable/Not specified, as no training set for this specific submission is detailed. For the development of the broader Phoenix system algorithms, the ground truth would have been established using reference methods like CLSI broth microdilution on a large scale.

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VITEK® Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis and Stapylococcus haemolyticus. VITEK Gram Positive Daptomycin is a qualitative test. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.

Here's a breakdown of the acceptance criteria and study details for the VITEK® Gram Positive Daptomycin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Explicitly stated as "fresh and stock clinical isolates and stock challenge strains." The exact number of isolates is not provided in the summary, but it implies a diverse set of samples.
• Data Provenance: The isolates included "fresh and stock clinical isolates" (implying retrospective clinical samples, potentially from various geographic regions where bioMérieux operates, though not specified) and "stock challenge strains" (likely well-characterized laboratory strains). The study was an "external evaluation," suggesting it was conducted at sites other than just the manufacturer's lab.

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

This information is not provided in the given text. The ground truth method is specified, but not the number or qualifications of experts involved in the reference method.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 section is not applicable to this device. The VITEK® Gram Positive Daptomycin is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. It directly measures Minimum Inhibitory Concentration (MIC) and interpretive categories.

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 VITEK® device. The device itself performs the testing and generates the results automatically without human intervention for interpretation beyond initial setup and reading the final report.

7. The Type of Ground Truth Used

The ground truth used was the CLSI (formerly NCCLS) broth microdilution reference method.

8. The Sample Size for the Training Set

This information is not provided in the given text, as the summary focuses on the external validation study rather than the development or training of the device.

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

This information is not provided in the given text.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacterial isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.

This premarket notification is for the addition of the antimicrobial agent Daptomycin at concentrations of 0.125-32 ug/mL to Gram Positive ID/AST or AST only Phoenix panels. Daptomycin 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:

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

Active In Vitro Against:

Enterococcus faecalis (vancomycin-resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

• BD Phoenix instrument and software. .
• BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . or AST determinations.
• BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
• BD Phoenix AST Broth used for performing AST tests only. .

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• BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells The Phoenix paller is a scaled and sell first and sen interacting must be a purch issues and containing dried reagents. Organisms for susceptime isolate. For each isolate. For each isolation premimarily idontified as a cistandard is prepared in Phoenix ID broth.

The Phoenix AST method is a broth based microdilution test. The Phoenix System uilizes a redox I he Phoenix AST memor is a broaism growth in the presence of an antimicrobial agent.
Indicator for the detection of organism growth in the presence of an the de indicator for the delection of organism growth in als prosectial turbidity are used in the determination Measurements of Changes to the marcator as were as ontains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses the panels where they are continuously incubated at a nominal temperature of I he unstrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).

Here's a summary of the acceptance criteria and study details based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Test Set Size:
  • Essential Agreement (EA): 1568 isolates
  • Categorical Agreement (CA): 1268 isolates (This discrepancy might indicate that not all isolates yielding EA also had a defined categorical interpretation that could be compared, or simply a reporting choice).
• Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites. This suggests a mix of "real-world" clinical samples and controlled laboratory strains, with a prospective element (testing performed for the study). The country of origin is not explicitly stated but implied to be the US given the FDA submission.

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

The ground truth was established by the CLSI reference broth microdilution method. No human experts are explicitly mentioned as establishing the ground truth for the test set in the way a diagnostic imaging study would use radiologists. The CLSI method itself is the "expert" ground truth.

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

Not applicable. The ground truth was established by the CLSI reference broth microdilution method, which is a standardized laboratory procedure, not a human consensus process.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This device is an automated microbiology system for antimicrobial susceptibility testing, not an AI-assisted diagnostic imaging or human-read interpretation system. The comparison is between the automated system and a reference laboratory method.

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

Yes, the study was a standalone evaluation of the BD Phoenix™ System. Its performance (MIC values and categorical interpretations) was directly compared to the CLSI reference method. The device is described as "fully automated" and the study evaluates its performance as such.

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

The ground truth used was the CLSI reference broth microdilution method. This is a well-established, standardized laboratory method recognized as the gold standard for antimicrobial susceptibility testing.

8. The sample size for the training set:

The document does not explicitly state a separate "training set" size. The development and validation of an automated microbiology system like the Phoenix System typically involve extensive internal testing and refinement before formal clinical studies for regulatory submission. The provided study focuses on the performance validation for regulatory submission, where the system is evaluated against a reference method using the described test set.

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

Not applicable, as a distinct training set with explicitly defined ground truth establishment methods is not detailed in this regulatory submission for the addition of a new antimicrobial agent to an existing device. For an algorithm-based device, the ground truth for training would typically be established using the same CLSI reference method or similar gold standard laboratory techniques on a large, diverse collection of bacterial isolates.

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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, and S. pneumoniae. VITEK 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. VITEK 2 Gram Positive Daptomycin is a quantitative test. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 automatically fills, seals and places the card into the incubator/reader. 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 based on the provided text for the VITEK® 2 Gram Positive Daptomycin device:

Acceptance Criteria and Device Performance

Note: The specific numerical acceptance thresholds are not explicitly stated in the provided text, but the reported performance values are presented as demonstrating "acceptable performance" and "substantially equivalent performance" when compared to the 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.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated as a numerical value. The study mentions "fresh and stock clinical isolates and stock challenge strains."
   • Data Provenance: Not explicitly stated (e.g., country of origin). The nature ("fresh and stock clinical isolates") suggests real-world patient samples, but the geographic origin is not specified. It was a prospective evaluation in the sense that the VITEK 2 was compared against a reference method in a controlled study design.

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

   • Not applicable/Not mentioned. The ground truth was established by a recognized reference method, not by expert consensus.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication by experts is not relevant when comparing a device to a defined reference standard method.

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:

   • Not applicable. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic intended for human reader interpretation improvement. The comparison is between the automated system and a laboratory reference method.

5. 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 an automated device designed to "automatically fills, seals and places the card into the incubator/reader" and "monitors the growth of each well... At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result." The study confirms its performance against a reference method without human intervention in the interpretation process of the device results.

6. The type of ground truth used:

   • Expert Consensus/Pathology/Outcomes Data, etc.: The ground truth was established by the NCCLS reference broth microdilution method. This is a laboratory-based, standardized reference method for determining antimicrobial susceptibility.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is described as an "essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology." It is a hardware/chemistry-based system with an automated readout, not a machine learning or AI algorithm that requires a separate training set in the conventional sense. Its "training" or calibration would likely involve precise manufacturing and chemical formulation, not a data-driven training set.

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

   • Not applicable. As noted above, this device does not appear to rely on a data-driven training set with an established ground truth in the way AI algorithms do.

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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Daptomycin at concentrations of 0.03 to 16 mcg/ml to the test panel.

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

Enterococcus faecalis (vancomycin-susceptible and resistant strains)
Enterococcus faecium (including vancomycin-resistant strains)
Staphylococcus aureus (including methicillin-resistant strains)
Staphylococcus epidermidis (including methicillin-resistant strains)
Staphylococus haemolyticus
Streptococcus agalactiae

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

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's a summary of the acceptance criteria and study details for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Daptomycin, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Sizes and Data Provenance:

   • Test Set:
     • Clinical Isolates: "fresh and stock Efficacy isolates"
     • Challenge Strains: "stock Challenge strains"
     • The specific number of isolates/strains is not provided, only the categories.
     • Data Provenance: Not explicitly stated, but clinical isolates often come from various clinical sites (implicitly retrospective as 'stock' or 'fresh' isolates) for such studies. Challenge strains are typically laboratory-derived.

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

   • External Evaluation: The study was an "external evaluation," implying independent assessment.
   • Ground Truth Determination: Comparison was made against an "NCCLS frozen Reference panel" and "Expected Results determined prior to the evaluation" for challenge strains. No specific number or qualifications of experts involved in establishing the NCCLS reference or "expected results" are detailed in this summary, but these are standard reference methods in microbiology.

3. Adjudication Method (Test Set):

   • Not explicitly stated. The comparison was primarily against a reference panel and predetermined expected results.

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

   • No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned. This device is an automated antimicrobial susceptibility testing system, not an image-based diagnostic intended for human interpretation with or without AI augmentation.

5. Standalone Performance (Algorithm Only):

   • Yes, this was a standalone performance study. The "MicroScan® Dried Gram-Positive MIC/Combo Panel" itself is the device being evaluated for its ability to determine MICs compared to a reference standard. The results are read either "visually or with MicroScan instrumentation." The reported performance of ">97% essential agreement" refers to the device's accuracy in producing results.

6. Type of Ground Truth Used:

   • Reference Standard: NCCLS frozen Reference Panel. NCCLS (now CLSI) reference panels are accepted gold standards for antimicrobial susceptibility testing, representing expert consensus on methodology and expected results for known strains.
   • Predetermined Expected Results: For Challenge strains, results were compared to "Expected Results determined prior to the evaluation," which would have been established using a defined reference method.

7. Sample Size for Training Set:

   • Not applicable as this is not a machine learning model requiring a training set in the typical sense. The device's performance is based on its inherent biochemical and mechanical design, not on a learned algorithm from a dataset in the way AI/ML products are.

8. How Ground Truth for Training Set was Established:

   • Not applicable for the reason stated above. The system's "training" would be its initial chemical and biological design and manufacturing processes, validated through studies like this.

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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A)

This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp.

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation.

This document is a 510(k) clearance letter from the FDA for a new Etest® Daptomycin antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've requested for typical AI/diagnostic device applications.

The provided text is a regulatory clearance document, not a detailed study report. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information you're asking for (e.g., sample sizes, expert qualifications, study methodologies, performance metrics like sensitivity/specificity) is usually found in a separate clinical study report, which is typically summarized in the 510(k) submission but not fully detailed in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based only on the text provided because it does not contain that level of detail.

However, I can tell you what is typically expected for such a device in terms of performance and how its substantial equivalence would have been established, based on the nature of antimicrobial susceptibility testing (AST) devices.

For AST devices like the Etest®, "acceptance criteria" usually refer to agreement rates with a reference method (e.g., broth microdilution or agar dilution). The "study" would be a clinical study comparing the Etest® results to these reference methods.

Here's how I would hypothetically complete your request for an AST device, based on common FDA requirements for such submissions, and indicate what is not present in the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Device: Etest® Daptomycin 0.016-256 µg/mL

Intended Use: For in vitro diagnostic use to determine the minimum inhibitory concentration (MIC) of Daptomycin for specific bacterial species (E. faecalis, E. faecium, Staphylococcus spp., Streptococcus spp.).

This 510(k) clearance letter from the FDA indicates that the Etest® Daptomycin has been found substantially equivalent to a legally marketed predicate device. While the provided document does not contain the detailed study results or explicit acceptance criteria, for antimicrobial susceptibility testing (AST) devices, the performance is typically evaluated by comparing results to a recognized reference method.

Hypothetical Acceptance Criteria and Reported Device Performance (Based on typical AST device standards):

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