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To determine bacterial antimicrobial agent susceptibility. The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Amoxicillin/Clavulanic Acid, at concentrations of 0.015/0.008 to 16/8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Amoxicillin/Clavulanic Acid susceptibility testing in this panel are: Streptococcus pneumoniae.

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/-1°C in a non-CO2 incubator, and read according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The text states that the external evaluation was conducted with "stock and CDC Challenge strains." It does not specify the exact number of unique isolates or organisms used in the test set.

The provenance of the data is not explicitly stated in terms of country of origin but implies laboratory-based testing from stock and challenge strains. It is a prospective study comparing the device's performance against expected results.

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

The document mentions that the performance was compared with an "expected result generated on a CLSI frozen Reference Panel." While this implies a reference standard, it doesn't specify the number of experts or their qualifications for establishing this "expected result." It refers to a standard reference panel rather than individual expert adjudication for each case.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly a human-expert-based consensus method (e.g., 2+1, 3+1). Instead, the device's instrument read results were compared to an "Expected Result" that was "determined before the evaluation" using a "CLSI frozen Reference Panel." This suggests a pre-established gold standard rather than real-time expert adjudication of each test case.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The study focuses on the performance of the instrument-read method compared to a reference standard.

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 "MicroScan® WalkAway instrument" (which automates the reading) is being evaluated to determine its "instrument read method" performance compared to an "expected result." This is an algorithm/machine-only performance, as it highlights the instrument's ability to read and interpret the results independently.

7. The Type of Ground Truth Used

The ground truth used was based on an expected result generated on a CLSI frozen Reference Panel. This suggests a highly standardized and validated reference method for determining antimicrobial susceptibility, rather than subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It describes the external evaluation (test set) but provides no information about how the instrument's algorithm was developed or trained.

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

The document does not provide information on how the ground truth for the training set (if any) was established. It focuses solely on the performance evaluation of the already developed instrument-read method.

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The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of the antimicrobial Azithromycin at concentrations of 0.12 to 4 mcg/ml to the test panel

The organisms which may be used for Azithromycin susceptibility testing in this panel are:

Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
streptococci (Groups C. F. G)
viridans group streptococci

The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the MicroScan® MICroSTREP plus™ Panel for Azithromycin susceptibility testing:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the acceptance criteria for Essential Agreement as "acceptable performance," and then provides the 99.3% result. For reproducibility and quality control, it simply states "acceptable reproducibility and precision" and "acceptable results," implying these met their internal criteria without providing a specific quantitative benchmark in the summarized text.

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

• Test Set Sample Size: The document indicates the external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains" for streptococcal isolates. However, a specific number for the sample size (number of isolates/strains) is not provided in the summary.
• Data Provenance: The study was an "external evaluation," suggesting it was conducted by an entity separate from the manufacturer. The document doesn't specify the country of origin of the data, but the context is a submission to the FDA in the USA. It's unclear whether the data was retrospective or prospective, though "fresh and stock isolates" suggest a mix, potentially with fresh isolates being prospective and stock isolates being retrospective.

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

The document does not provide any information about the number of experts used or their qualifications to establish the ground truth.

4. Adjudication Method for the Test Set

The document does not provide any information about an adjudication method. The comparison was made against an "NCCLS frozen Reference panel."

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

An MRMC comparative effectiveness study was not performed or reported. The study focuses on the standalone performance of the device against a reference method, not the impact of AI assistance on human readers.

6. Standalone Performance Study

Yes, a standalone study was done. The entire premise of the submission is to demonstrate the performance of the MicroScan® MICroSTREP plus™ Panel (an algorithm/device) in determining antimicrobial susceptibility. Its performance (Essential Agreement) was compared directly to an "NCCLS frozen Reference panel."

7. Type of Ground Truth Used

The ground truth used was an NCCLS frozen Reference Panel. This panel serves as the established gold standard for determining antimicrobial susceptibility in this context. While not explicitly stated as "expert consensus" or "pathology," a reference panel developed by organizations like NCCLS (now CLSI) inherently represents a consensus on accurate susceptibility determination methods.

8. Sample Size for the Training Set

The document does not provide any information about a training set sample size. This type of device relies on established biological and chemical reactions interpreted via a defined protocol, rather than a machine learning model that typically requires a large training set.

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

As no training set is mentioned in the context of machine learning, the question of how its ground truth was established is not applicable. The device's operational principles are based on known antimicrobial agent concentrations and visual interpretation of bacterial growth inhibition against an established reference method (NCCLS frozen Reference Panel) for validation.

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To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Ampicillin at concentrations of 0.03 to 16 mcg/ml to the test panel. The organisms which may be used for Ampicillin susceptibility testing in this panel are: Streptococcus spp. other than Streptococcus pneumoniae.

The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus™ Panel with Ampicillin, 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: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation. However, the exact sample size (number of isolates/strains) for the test set is not explicitly stated in the provided text.
• Data Provenance: The data was generated through an "external evaluation," implying independent testing. The text does not specify the country of origin of the data, but the context implies it was likely conducted in the US given the FDA submission. The study involved both "fresh" isolates (suggesting prospective collection at that time) and "stock" isolates/strains (suggesting retrospective use of stored samples).

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

• The document states the proposed device's performance was compared with an "NCCLS frozen Reference Panel." This implies that the ground truth was established by the NCCLS Reference Panel, which is a standardized method for antimicrobial susceptibility testing. The development and validation of such reference panels typically involve multiple experts and rigorous standardization, but the number and specific qualifications of experts involved in establishing the ground truth for this particular study's reference panel are not detailed in the provided text.

4. Adjudication Method for the Test Set:

• The text describes a direct comparison of the MicroScan® MICroSTREP plus™ Panel with the NCCLS frozen Reference Panel. The "Essential Agreement" metric suggests a comparison of MIC values obtained by both methods. There is no mention of an overt adjudication method (like 2+1 or 3+1) involving human expert review for resolving discrepancies between the test device and the reference standard; the NCCLS reference method is treated as the established ground truth.

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 conducted as described in the provided text. The study focuses on comparing the new device's performance to a reference standard, not on the improvement of human readers with or without AI assistance. The device is a diagnostic panel, not an AI assistance tool for human interpretation.

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

• Yes, a standalone performance evaluation was done. The MicroScan® MICroSTREP plus™ Panel itself is the device under test, and its performance is evaluated independently against a reference standard. While human visual reading is part of its intended use ("read visually according to the Package Insert"), the "Essential Agreement" comparison primarily assesses the panel's ability to produce consistent MIC results in comparison to the reference, representing its standalone analytical performance.

7. The Type of Ground Truth Used:

• The type of ground truth used was an expert-established and standardized reference method: the "NCCLS frozen Reference Panel." NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) reference methods are considered the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

• The document does not specify a separate "training set" or its sample size. The information provided is about the performance validation study (test set) of the final device. For a diagnostic panel like this, the "training" (development and optimization) would involve internal R&D processes of the manufacturer, and the details are not typically included in a 510(k) summary focused on validation.

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

• As a training set is not explicitly mentioned or detailed in the provided text, the method for establishing its ground truth is unknown from this document.

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To determine bacterial susceptibility to Levofloxacin. For determining antimicrobic susceptibility of aerobic non-enterococcal streptococci including Streptococcus pneumoniae. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative andor qualitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercococcal streptococci, including or epice oose proam. This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.002 - 16 mcg/ml to the test panel. The organisms which may be used for Levofloxacin susceptibility testing in this panel are; I it organismis without may treptococci including Streptococcus pneumoniae.

MicroScan® MICroSTREP plus™ Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae. 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 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing 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® MICroSTREP plus™ Panel with Levofloxacin:

Acceptance Criteria and Device Performance

Study Details

• Sample Size for Test Set and Data Provenance:

  • Sample Size: Not explicitly stated. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation.
  • Data Provenance: Not explicitly stated, though the use of "fresh" isolates suggests a prospective component, while "stock Efficacy isolates and stock Challenge strains" could be either retrospective or sourced from a library. The study compared the device to an "NCCLS frozen Reference Panel," which implies a standardized, possibly laboratory-derived, set of data.

• Number of Experts and Qualifications:

  • Not applicable. This device determines bacterial susceptibility, which is a quantitative measurement, not a subjective interpretation requiring human experts for ground truth establishment.

• Adjudication Method:

  • Not applicable. The test involves direct comparison to a reference standard with a quantitative outcome (MIC).

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No, an MRMC study was not done. The device is for automated or semi-automated susceptibility testing, not for aiding human readers in interpretation.

• Standalone (Algorithm-Only) Performance Study:

  • Yes, this was a standalone performance study. The "device" in this context (the MicroScan® MICroSTREP plus™ Panel) determines the MIC independently, and its results are then compared to a reference standard. The manual reading of the MIC is a step in using the device, but the performance evaluation is of the panel's ability to produce those results.

• Type of Ground Truth Used:

  • Reference Standard: The ground truth was established using an "NCCLS frozen Reference Panel." This is a standardized, well-defined reference method for antimicrobial susceptibility testing.

• Sample Size for Training Set:

  • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a separate training set. The development of the panel itself would involve optimization, but this isn't framed as a "training set" in the machine learning sense.

• How Ground Truth for Training Set Was Established:

  • Not applicable, as there isn't a training set in the context of a machine learning-based device. The reference standard (NCCLS frozen Reference Panel) serves as the benchmark against which the device's performance is measured.

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The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

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

The organisms which may be used for Vancomycin susceptibility testing in this panel are; Aerobic non-enterococcal streptococci, including Streptococcus pneumoniae.

Microdilution Minimum Inhibitory Concentration (MIC) Panels

Here's an analysis of the provided text to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance for MicroScan® MICroSTREP plus™ Panel (Vancomycin)

1. Acceptance Criteria and Reported Device Performance

Note: The specific numerical threshold for "acceptable performance" for Essential Agreement is not explicitly stated in the provided text, but the reported 99% was deemed acceptable.

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

• Sample Size for Test Set: Not explicitly stated in terms of the number of isolates or tests. The study refers to "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation.
• Data Provenance: Not explicitly stated. The study was an "external evaluation," but the country of origin or whether it was retrospective/prospective is not mentioned.

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.
• Ground Truth Method: The ground truth was established by comparison with an NCCLS frozen Reference Panel. This implies a standardized reference method, but not necessarily human expert consensus for each individual case.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable/not described. The study used an NCCLS frozen Reference Panel as the comparator, which serves as the "truth standard" rather than relying on multiple human readers and an adjudication process.

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

• MRMC Study Done: No. This type of study is not relevant for an antimicrobial susceptibility testing device like the MicroScan® MICroSTREP plus™ Panel, which directly measures MIC values and compares them to a reference method, not human interpretation.

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

• Standalone Study Done: Yes. The performance data (99% Essential Agreement, acceptable reproducibility, and QC results) directly represent the standalone performance of the MicroScan® MICroSTREP plus™ Panel in determining Vancomycin susceptibility, as it is a device designed to provide a direct readout.

7. Type of Ground Truth Used

• Ground Truth Type: A reference standard, specifically an NCCLS frozen Reference Panel. This panel provides established, standardized minimum inhibitory concentration (MIC) values for comparison.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document primarily describes the validation (test set) for the new Vancomycin addition, not the original development/training of the panel itself.

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

• Ground Truth for Training Set: Not specified. The document focuses on the validation of the Vancomycin component against a reference panel, not the initial development or training ground truth for the core device technology.

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The intended use of this panel is for determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp.

After incubation in a non-CO2 incubator for 20 - 24 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

The two-fold dilutions of AMPICILLIN in the panel range from 0.015 to 16 mcg/ml for testing Haemophilus spp.

Microdilution Minimum Inhibitory Concentration (MIC) Panels

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade MicroScan Inc. MicroScan® MICroSTREP plus™ Panel - Ampicillin:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated as a single number. The study used "fresh and stock Efficacy isolates and stock Challenge strains of Haemophilus spp." The total number of isolates tested is not provided in this summary.
• Data Provenance: Not explicitly stated, but it was an "external evaluation." The country of origin is not mentioned, and it is a prospective evaluation aimed at confirming performance.

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

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

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method (e.g., 2+1, 3+1).

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

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic panel for susceptibility testing, not an imaging or interpretive device that typically involves human readers. The comparison was between the device and a reference method.

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

• Yes, this was a standalone performance study. The device, a microdilution panel, directly outputs a Minimum Inhibitory Concentration (MIC) value, which is then compared to a reference standard. There isn't an "algorithm only" in the sense of a software-based AI, but rather the performance of the physical test panel itself determining the MIC. Human technicians would "read" the panel, but the performance evaluation is of the panel's result against the reference.

7. The Type of Ground Truth Used:

• The ground truth used was an NCCLS frozen Reference, which serves as the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

• The document does not mention a "training set" as this is not an AI/machine learning device that requires training data in that sense. The device's performance is evaluated against a reference standard in a verification study.

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

• Not applicable as there is no "training set" in the context of this device's development or evaluation as described. The "ground truth" for the evaluation set was the NCCLS frozen Reference.

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To determine bacterial antimicrobial agent susceptibility. For use with aerobic non-enterococcal streptococci including S. pneumoniae. The MicroScan® MICroSTREP plus™ Panel is used to determine antimicrobial susceptibility of aerobic non-enterococcal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial AMOXICILLIN at concentrations of 0.008 - 16 mcg/ML to the test panel. The organisms which may be used for AMOXICILLIN susceptibility testing in this panel are; Streptococcus pneumoniae.

Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® MICroSTREP plus™ Panel - Amoxicillin.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Dade Behring MicroScan® MICroSTREP plus™ Panel - Amoxicillin:

The provided document describes the submission and FDA clearance for the Dade Behring MicroScan® MICroSTREP plus™ Panel, specifically for the addition of Amoxicillin. The core of the study is a comparison between the new device and a predicate device (NCCLS Frozen Reference Panels) to demonstrate "substantial equivalence."

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for the device's performance is "acceptable Essential Agreement performance" when compared to the frozen Reference panel. While specific numerical targets for Essential Agreement are not explicitly stated within the provided text, the FDA's "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991) is referenced as the guiding document for defining acceptable performance. For reproducibility testing, the criterion was "acceptable reproducibility and precision." Similarly, for Quality Control, the criterion was "acceptable results."

Study Details

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

   • Sample Size: Not explicitly stated with a numerical value. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation.
   • Data Provenance: Not explicitly stated, though the manufacturer is based in West Sacramento, CA, suggesting the study was likely conducted in the US. The isolates themselves could have varied origins.
   • Retrospective or Prospective: Not explicitly stated. Given the use of "fresh and stock Efficacy isolates and stock Challenge strains," it likely involved elements of both, with "fresh" isolates suggesting prospective collection and "stock" isolates being retrospective.

2. 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 comparison to NCCLS Frozen Reference Panels, which themselves represent a gold standard for susceptibility testing, implying expert-derived methodologies.

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

   • Adjudication Method: Not explicitly stated. The comparison is against a "Reference panel," which generally serves as the definitive result rather than requiring further human adjudication for discrepancies between methods.

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:

   • MRMC Study: No, an MRMC study was not performed. This device is an in-vitro diagnostic (IVD) antimicrobial susceptibility test, not an AI-assisted diagnostic imaging device that typically involves human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

   • Standalone Performance: Yes, in essence, the "external evaluation" against the NCCLS Frozen Reference Panel is a standalone performance assessment of the new MicroScan panel. It assesses the panel's ability to accurately determine MIC values and susceptibility categories independently, without human interpretation influencing the primary measurement of MIC. However, it's important to note that the instruction states "read visually according to the Package Insert," implying a human reading step for the MicroScan panel. The "standalone" here refers to the algorithm's performance in the context of generating the MIC, not necessarily a fully automated system from specimen to result without any human interaction.

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

   • Type of Ground Truth: The ground truth was established by NCCLS Frozen Reference Panels. These panels are considered the gold standard for antimicrobial susceptibility testing, representing a highly standardized and validated method, effectively serving as an expert-derived and experimentally confirmed ground truth.

7. The sample size for the training set:

   • Sample Size for Training Set: The document does not explicitly mention a "training set" or its size in the context of machine learning. This device predates widespread AI/ML applications in IVD. The data cited ("fresh and stock Efficacy isolates and stock Challenge strains") appears to be for the evaluation/test of the device's performance, not for training a model.

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

   • How Ground Truth for Training Set was Established: Not applicable, as a distinct training set (in the ML sense) is not described or implied for this device. The development of the MicroScan panel itself would have relied on established microbiological principles and validation methods to ensure its accuracy against known microbial responses, which informally serve as "ground truth" for its design.

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