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The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial oxacillin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence for S. aureus and S. lugdunensis, and 0.03 - 2 ug/ml 7-Dilution MIC Dilution Sequence, and 0.12 -- 2 ug/ml 5-Dilution Breakpoint Sequence, for all Staphylococcus species, to the test panel.

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

. Staphylococcus species

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergics plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The provided document describes the 510(k) submission for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with the addition of oxacillin, intended for antimicrobial susceptibility testing.

Here's an analysis based on your requested information:

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 number. The study mentions "fresh and stock Efficacy isolates and stock Challenge strains." However, the exact count of isolates and strains used for external validation is not provided.
• Data Provenance: The document does not specify the country of origin. It indicates the study was an "external validation."
• Retrospective or Prospective: Retrospective, as "stock Efficacy isolates and stock Challenge strains" are used, implying pre-existing samples.

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

• This information is not provided in the document. The reference panel is described as a "frozen Reference Panel" and "Expected Results," but the process for establishing the ground truth for this reference is not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the document. The comparison is made against a "frozen Reference Panel" and "Expected Results," which implies a single, established ground truth rather than a process requiring adjudication among multiple experts for the test set.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of an automated system (MicroScan® Synergies plus™ panels) compared to a reference method, not on human reader performance with or without AI assistance. The document mentions that the AST portions can be read visually, but the primary validation is for the automated instrument reading.

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

• Yes, a standalone performance evaluation was done. The study explicitly states that the "MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a frozen Reference Panel." The assessment is of the device's ability to determine susceptibility, which is an automated measurement, even though visual reading is also possible.

7. The Type of Ground Truth Used

• The ground truth was established by a "frozen Reference Panel" and "Expected Results." For antimicrobial susceptibility testing (AST) systems, this typically involves a standardized reference broth microdilution method, which is considered the gold standard.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate training set. The study focuses on "external validation" with "fresh and stock Efficacy isolates and stock Challenge strains," which serve as the test set. For AST systems, the "training" aspect is more about the development and optimization of the panel's design and interpretation rules, often involving a large internal collection of characterized strains, rather than a distinct "training set" in the machine learning sense for the final validation study.

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

• As no specific training set is detailed, the method for establishing its ground truth is not provided. If an internal development set was used, its ground truth would have likely been established through similar reference methods as the validation set.

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The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial gentamicin, at concentrations of 0.06 to 32 µg/ml Long Dilution Sequence for staphylococci, to the test panel.

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

Staphylococcus species (coagulase-positive and coagulase-negative) .

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 anacrobic Gram-positive enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The provided 510(k) summary describes the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with gentamicin. The study presented aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003, is cited as defining the criteria for "substantial equivalent performance." While the specific numerical acceptance criteria for Essential Agreement are not explicitly stated in the provided text, a common threshold for AST systems is >90% for Essential Agreement. The reported 94.6% meets this implied threshold. "Acceptable" for reproducibility and quality control indicates that these aspects met their predefined criteria, though the specific quantitative metrics for "acceptable" are not detailed.

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

• Test Set Size: The exact number of isolates ("fresh and stock Efficacy isolates and stock Challenge strains") used for the external validation is not specified in the provided text.
• Data Provenance: The data came from an "external validation," implying that the testing was performed outside of Dade Behring's internal facilities. The country of origin is not specified, but given the FDA submission, it is likely the studies were conducted in the US or in a manner compliant with US regulatory requirements. The study used "fresh and stock Efficacy isolates and stock Challenge strains," which suggests a combination of retrospective (stock strains) and prospective (fresh isolates) data collection, though the ratio or specific timing is not detailed.

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

• The ground truth for the test set was established by a "frozen Reference Panel" and "Expected Results determined prior to the evaluation" for Challenge strains. This suggests a comparison against a recognized standard method rather than expert interpretation of raw data. Therefore, the concept of "experts establishing ground truth" in the traditional sense of clinical opinion is not applicable here. The reference panel itself is the gold standard.

4. Adjudication Method for the Test Set

• The study compared the performance of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel against a frozen Reference Panel. This is a direct comparison method, not an adjudication method in the sense of resolving discrepancies between human readers. For the "Challenge strains," their performance was compared to "Expected Results determined prior to the evaluation," which again indicates a comparison to a predefined standard rather than a multi-reader adjudication 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

• No, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated susceptibility testing system/panel against a reference method, not the impact of AI assistance on human readers.

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

• Yes, a standalone study was performed. The MicroScan® Synergies plus™ system is an automated device designed to determine antimicrobial susceptibility. The study evaluates the performance of this device ("algorithm only" in the sense of the automated panel reading and interpretation) in comparison to the frozen reference panel. The device, after incubation, reads the MIC by "determining the lowest antimicrobial concentration showing inhibition of growth." While human oversight might be involved in initial setup or quality control, the core performance reported (Essential Agreement) is that of the automated system.

7. The Type of Ground Truth Used

• The ground truth used was a "frozen Reference Panel" for efficacy isolates and "Expected Results" for challenge strains. This constitutes a recognized, standardized reference method (broth microdilution in this context) that is considered the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate training set or its sample size. This type of submission focuses on the validation of the device against a predicate, typically using a test set against a defined ground truth, rather than detailing the development and training phases of an algorithm.

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

• As no information about a training set is provided, how its ground truth was established is unknown/not applicable from this document.

Ask a specific question about this device

The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial linezolid, at concentrations of 0.5 to 16 ug/ml Long Dilution Sequence and 0.5 - 4 ug/ml 4-Dilution Breakpoint Sequence, for enterococci and staphylococci, to the test panel.

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

Enterococcus faecium (vancomycin-resistant) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant)

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus™ Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with linezolid:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to the FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA" dated February 5, 2003. This document would contain the explicit, quantitative acceptance criteria for Essential Agreement, Category Agreement, and reproducibility that the device must meet. The provided summary only states that the device "demonstrated acceptable performance" and met the criteria.

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

• Sample Size: The document does not explicitly state the total number of isolates (fresh, stock efficacy, and stock challenge strains combined) used for the external validation.
  • It mentions that "external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains."
  • For the reported performance of linezolid, it states "Essential Agreement (EA) and 4-Dilution Agreement of 76.0%," which implies a certain number of comparisons were made, but the exact count is not given.
• Data Provenance: The text does not specify the country of origin. The study was an "external validation." It involved both retrospective (stock isolates) and potentially prospective (fresh isolates) data, though the exact proportion is not mentioned.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set. The ground truth appears to be established by comparison to a "frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains, rather than expert consensus on individual cases.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test system, not a diagnostic imaging device that typically involves human readers interpreting results.

6. Standalone Performance Study

Yes, a standalone study was done. The study specifically compared the performance of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with linezolid against a "frozen Reference Panel" and "Expected Results" for challenge strains. This evaluates the algorithm's (or system's) performance purely in terms of its output (MIC values and agreement) without direct human intervention in the interpretation phase beyond setting up the test and reading the final MIC.

7. Type of Ground Truth Used

The ground truth was established by:

• Comparison to a frozen Reference Panel for efficacy isolates. This suggests a pre-established, highly reliable method for determining antimicrobial susceptibility.
• "Expected Results determined prior to the evaluation" for stock Challenge strains. These are typically well-characterized strains with known susceptibility profiles.

8. Sample Size for the Training Set

The document does not provide any information about a discreet training set used for developing the device. This is typical for a microbiology susceptibility panel, where the "training" (if it can be called that) often comes from years of established methodology and the development of the panel's design, rather than a machine learning training phase on a specific dataset.

9. How Ground Truth for the Training Set Was Established

Since no explicit training set is mentioned, the method for establishing its ground truth is not applicable/not provided. The device's design and expected performance would be based on well-established microbiological principles and previous generations of AST systems, rather than a separate "training phase" and associated ground truth process as seen in AI algorithms.

Ask a specific question about this device

Ask a specific question about this device

The MicroScan® Synergies plus™ 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 staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial agent Trimethoprim/Sulfamethoxazole, at concentrations of 0.5/9.5 to 8/152 ug/ml, to the test panel.

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

Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus species - Coagulase Negative
Staphylococcus saprophyticus

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptbility Testing (AST) technologies, are designed for use in determining quantitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Trimethoprim/Sulfamethoxazole:

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. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation. It does not provide the total number of isolates or challenge strains.
• Data Provenance: Retrospective, as indicated by the use of "stock Efficacy isolates and stock Challenge strains." The country of origin is not specified but implicitly within the US given the FDA submission.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not specified. The ground truth (Expected Results) for Challenge strains was "determined prior to the evaluation," implying expert consensus or established references.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The comparison is made against a "CLSI frozen Reference Panel" for the main evaluation and "Expected Results" for challenge strains. This suggests a direct comparison against established standards rather than an adjudication process between multiple readers of the device's results.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or subjective interpretation devices. For a highly automated system like an AST panel, the comparison is typically against a reference method rather than human readers.

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

• Standalone Performance: Yes, the study evaluates the performance of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel itself without human interpretation as the primary outcome. The device automatically determines the Minimum Inhibitory Concentration (MIC) for the test organism, and this is then compared to a reference method. While human interaction is involved in setting up the test and reading results, the "performance" described (Essential Agreement, Reproducibility, QC) refers to the device's output.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • External Evaluation: "CLSI frozen Reference Panel" for performance comparison, which represents a recognized gold standard for antimicrobial susceptibility testing.
  • Challenge Strains: "Expected Results" which were "determined prior to the evaluation," likely based on expert consensus, established reference methods, or known characteristics of the challenge strains.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not provided. This device is not described as using a machine learning algorithm that requires a "training set" in the traditional sense. It's a chemical and instrumentation-based system that follows established protocols.

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

• Ground Truth Establishment: Not applicable as there is no "training set" for this type of device. The system relies on precise dilutions, reagent reactions, and growth inhibition principles, rather than learning from data.

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