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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℃ +/- 1℃ 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 Ertapenem at concentrations of 0.002 to 32 mcg/ml to the test panel.

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

Staphylococcus aureus (methicillin-susceptible strains) 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 an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem:

Acceptance Criteria and Study for MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is assessed against the criteria outlined in the FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." The key metric mentioned is "Essential Agreement."

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact number of isolates used in the external evaluation is not explicitly stated. However, it is mentioned that the evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: The text does not specify the country of origin for the data. The study was an "external evaluation," implying it was conducted independently of the manufacturer, but the location is not provided. The study included both "fresh" and "stock" isolates, indicating a mix of prospective (fresh) and retrospective (stock) data collection.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to an "NCCLS frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains, implying established reference methods and data rather than real-time expert interpretation for each test case. NCCLS (now CLSI) standards are developed by experts, but the direct involvement of individual experts for this specific study's ground truth establishment is not detailed.

4. Adjudication Method

The adjudication method is not explicitly described. The comparison is made against an "NCCLS frozen Reference Panel" and "Expected Results," which serves as the gold standard. This suggests a direct comparison rather than a human-expert adjudication process for discrepancies.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This submission focuses on the performance of the automated system compared to a reference standard, not on how human readers' performance improves with or without the system's assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "external evaluation" directly compares the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem (the algorithm/device) against an NCCLS frozen Reference Panel. The reported Essential Agreement of >96% reflects the standalone performance of the device.

7. Type of Ground Truth Used

The ground truth used was primarily a reference standard. Specifically, the device's performance was compared to:

• An NCCLS frozen Reference Panel. NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) panels are widely accepted reference standards for antimicrobial susceptibility testing.
• Expected Results for stock Challenge strains. These expected results would have been established through validated methods and likely represent a consensus or definitive determination of susceptibility.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This is common for submissions of this nature, as the focus is on the validation of the final product with a distinct test set.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for any potential training set was established. Given the nature of the device (a diagnostic test for antimicrobial susceptibility), if machine learning was involved in its development, the training ground truth would similarly likely rely on established reference methods like NCCLS/CLSI standards or other validated laboratory techniques. However, the text does not elaborate on this aspect.

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The MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility for Gram-Negative organisms and screening for suspected ESBL production in E. coli, K. oxytoca and K. pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the antimicrobials cefpodoxime (0.015-64 ug/ml) and ceftazidime (0.5-64 ug/ml).

The Gram-Negative organisms which may be used for screening for suspected ESBL production in this panel are:

Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with Cefpodoxime (0.015-64 ug/ml) and Ceftazidime (0.5-64 ug/ml)

The provided document is a 510(k) clearance letter for an antimicrobial susceptibility test panel. It announces that the device, MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with specific antimicrobial agents, is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the detailed study information, acceptance criteria, or performance data typically found in a scientific or clinical study report. It is a regulatory clearance letter, not a study publication.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. To answer your questions, I would need access to the actual 510(k) submission data, particularly the sections detailing performance studies for the device.

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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. This particular submission is for the addition of the antimicrobial Clindamycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Clindamycin susceptibility testing in this panel are: Streptococci. The MicroScan ® MICroSTREP plus™ Panel with Clindamycin is not intended for use with: 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 details for the MicroScan® MICroSTREP plus™ Panel with Clindamycin, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the performance was reviewed against the "FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000." This implies that the 96.2% Essential Agreement met the acceptance threshold defined in that guidance document. Specific numeric thresholds for reproducibility and quality control are not explicitly stated but are implied to have been met with "acceptable" results.

Study Details

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

• Test Set Sample Size: Not explicitly stated as a single number. The external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." The text doesn't specify the total number of isolates used in these categories combined for the Clindamycin evaluation.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "external evaluation," suggesting the data was collected from multiple sites beyond the manufacturer's internal labs. It was a prospective study in the sense that the new device's performance was compared to a reference method, but the isolates themselves could be either retrospectively collected "stock" or prospectively collected "fresh."

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

Not applicable. This device determines antimicrobial susceptibility, where the "ground truth" is established by a reference laboratory method (NCCLS frozen Reference Panel), not by human expert interpretation of images or clinical data.

4. Adjudication method for the test set

Not applicable. As the ground truth is established by a reference laboratory method, there is no need for expert adjudication.

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

Not applicable. This is an in vitro diagnostic device for determining microbial susceptibility. It does not involve human readers interpreting cases or AI assistance in that context. The "reading" is manual observation of an MIC for the test organism in the panel.

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

The device is described as being "read visually according to the Package Insert" to observe the "lowest antimicrobial concentration showing inhibition of growth." This indicates a human-in-the-loop process for reading the results. The "device" itself (the panel) is a diagnostic assay, and its performance is assessed based on the accuracy of the manual reading compared to the reference. There is no "algorithm only" performance reported in this context.

7. The type of ground truth used

The ground truth was an NCCLS frozen Reference Panel. This is a recognized standard laboratory method for determining antimicrobial susceptibility.

8. The sample size for the training set

Not applicable. This is a microbiology susceptibility test panel, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "development" of the panel involves formulating the dilutions and components, not training a model.

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

Not applicable, as there is no "training set" or AI algorithm involved.

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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 Clarithromycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Clarithromycin 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.

The MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Clarithromycin for aerobic streptococci, including Streptococcus pneumoniae. The study compared the performance of the MicroScan® MICroSTREP plus™ Panel with an NCCLS frozen Reference Panel.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated as a numerical value, but the study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation.
• Data Provenance: The document does not specify the country of origin of the data. The study was a comparison against an NCCLS frozen Reference Panel, which typically implies standardized, controlled conditions. It's prospective in the sense that new tests were run using these isolates, but the "stock isolates" could have a retrospective element in their origin.

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

This information is not provided in the document. The ground truth was established by an "NCCLS frozen Reference Panel," which implicitly suggests a recognized standard method, but details about experts or their qualifications for establishing this reference are not given.

4. Adjudication method for the test set

This information is not explicitly stated. The comparison was made against an "NCCLS frozen Reference Panel," suggesting a direct comparison to a gold standard rather than expert adjudication of 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated in vitro diagnostic susceptibility panel, not an AI-assisted human reading system. There is no human-in-the-loop component described in the reading process that would involve different readers or AI assistance. The panels are "read visually according to the Package Insert" after incubation.

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

Yes, essentially a standalone performance study was done for the device. The device's performance (MICroSTREP plus™ Panel) was directly compared against a reference standard (NCCLS frozen Reference panel), without human intervention in interpreting the results from either system, beyond a visual read of the device's output. The "algorithm" in this context refers to the chemical and biological process within the panel that determines susceptibility, and its output is then visually interpreted.

7. The type of ground truth used

The ground truth used was based on an NCCLS frozen Reference Panel. This represents a recognized gold standard method for antimicrobial susceptibility testing.

8. The sample size for the training set

The document does not mention a training set. The descriptions relate to evaluation/test sets for demonstrating performance and equivalence. This is typical for in vitro diagnostic devices based on established biological/chemical principles, rather than machine learning models that require explicit training.

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

As no training set is mentioned, this question is not applicable.

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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 Chloramphenicol at concentrations of 1 to 32 mcg/ml to the test panel. The organisms which may be used for Chloramphenicol susceptibility testing in this panel are: Susceptible streptococci, including 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 (MC) 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, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the acceptance criteria were "as defined in the FDA DRAFT document 'Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices', dated March 8, 2000." However, the specific numerical thresholds for "acceptable reproducibility" and "acceptable results for Quality Control" are not detailed in the provided text. The only specific quantitative criterion mentioned is for "Essential Agreement."

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number. The external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." The specific number of isolates for each category is not provided.
• Data Provenance: Not explicitly stated by country of origin. The study was an "external evaluation" and compared performance against an "NCCLS frozen Reference Panel." NCCLS (National Committee for Clinical Laboratory Standards) is a US-based organization (now CLSI), suggesting the data is likely US-centric or from facilities following US standards. The study appears to be retrospective as it uses existing "stock" isolates and a reference panel.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
• The ground truth reference method was the "NCCLS frozen Reference Panel," which implies that the reference panel itself's values (likely MICs) were established through a standardized, expert-validated process at the time of its creation, but details are not provided here.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method like 2+1 or 3+1. The comparison was described as direct, "comparing its performance with an NCCLS frozen Reference panel."

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

• No, an MRMC comparative effectiveness study was not done. This device is a test panel for determining antibiotic susceptibility, not an imaging device that involves human readers interpreting results in a comparative study with and without AI assistance. The panel results are visually read by a human, but the study focuses on the accuracy of the panel itself against a reference method, rather than the improvement of human interpretation with AI.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence, a standalone performance study was done. The MicroScan® MICroSTREP plus™ Panel's performance was evaluated by directly comparing its results (after manual visual reading) against the "NCCLS frozen Reference panel." While a human reads the final MIC, the "device" in question (the panel and its methodology) is evaluated on its ability to produce accurate MIC values independently of specific human reader variability beyond what is inherent in visual reading. The study aimed to show the panel's inherent performance.

7. Type of Ground Truth Used

• The ground truth used was established by an NCCLS frozen Reference Panel. This type of ground truth represents a reference standard method that is widely accepted in microbiology for determining minimum inhibitory concentrations (MICs). It is typically established through rigorous, standardized procedures, often reflecting expert consensus on the methodologies.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" or its sample size. The information provided focuses on the evaluation of the device against a reference. For a device like this (which appears to be a chemical assay system rather than an AI/ML algorithm that requires explicit machine learning training), the concept of a "training set" in the context of AI is not directly applicable. The development of the panel itself would have involved extensive R&D and optimization, but not in the sense of a machine learning training set described here.

9. How Ground Truth for the Training Set Was Established

• As there's no explicitly mentioned "training set" in the AI/ML context, there's no information on how its ground truth was established. The development process for a chemical assay panel would rely on established microbiological principles and validated experimental results to optimize the concentrations and reagents, not on a machine learning training process.

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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 Erythromycin at concentrations of 0.015 to 2 mcg/ml to the test panel. The organisms which may be used for Erythromycin susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes, 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% brsed 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-COincubator 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 summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: MicroScan® MICroSTREP plus™ Panel with Erythromycin

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states "Efficacy isolates" and "Challenge strains" were used, but does not provide specific numbers for the test set.
• Data Provenance: The external evaluation was conducted using "fresh and stock Efficacy isolates and stock Challenge strains." The country of origin is not specified, but the evaluation was external. The study was conducted on already isolated and characterized strains, indicating a retrospective nature for the "stock" strains, and potentially prospective collection for "fresh" isolates.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. It refers to an "NCCLS frozen Reference Panel" as the comparator, implying that the reference method itself serves as the ground truth, rather than expert consensus on individual test cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers. The comparison was made against an "NCCLS frozen Reference Panel," which implies a direct comparison of results from the device to the reference standard, not a human reader adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on the standalone performance of the device against a reference method, not on the improvement of human readers with AI assistance.

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

Yes, a standalone study was performed. The device, the MicroScan® MICroSTREP plus™ Panel, is intended to be read visually by a human, but the performance comparison outlined (Essential Agreement against an NCCLS frozen Reference panel) is evaluating the inherent accuracy of the device's determination of MIC, not the human interpretation of the device's output or any AI assistance for visual reading. The context refers to the device and its output, which is then read by a person according to a package insert. The "algorithm" in this case is the chemical and biological reaction within the panel that produces the visible growth inhibition, and its performance is evaluated in a standalone manner against the reference.

7. Type of Ground Truth Used

The ground truth used was the results obtained from an NCCLS frozen Reference Panel. This is a recognized standard method for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description focuses on an "external evaluation" against a reference panel. Given that this is a chemical/biological test panel rather than an AI/machine learning algorithm that requires explicit training, the concept of a "training set" in the common sense (e.g., for model development) is not applicable here. The assay development itself would have involved extensive optimization, but this wouldn't be referred to as a "training set" in this context.

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

As noted in point 8, a "training set" in the conventional sense is not applicable. The device's performance is inherently tied to its design and manufacturing. The "ground truth" for the performance evaluation was established by a recognized standard: the NCCLS frozen Reference Panel.

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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 Cefotaxime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefotaxime susceptibility testing in this panel are: Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B streptococci), Streptococcus pneumoniae (formerly Diplococcus 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, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document indicates that "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact sample size for the test set is not explicitly stated. The data provenance is not specified regarding country of origin, but it is clear that the data relates to a pre-market submission, implying prospective testing for the device's validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The ground truth was established by comparing performance to an "NCCLS frozen Reference panel," which implies a standardized method rather than expert consensus on individual cases.

3. Adjudication method for the test set: Not applicable, as the comparison was against a standardized reference panel (NCCLS frozen Reference panel) rather than individual case adjudication.

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 study evaluates the performance of an in vitro diagnostic device against a reference method, not an AI system assisting human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device operates as a standalone system (microdilution panels read visually). The performance described is its standalone performance against a reference standard. There is no "algorithm only" component in the sense of a software-based AI algorithm. The device, after incubation, is "read visually" as per the package insert.

6. The type of ground truth used: The ground truth was established by an "NCCLS frozen Reference panel." This is a standardized, recognized reference method for antimicrobial susceptibility testing, which serves as the gold standard for comparison in this context.

7. The sample size for the training set: This information is not provided. The document focuses on the validation study (test set) of the device against a reference standard. The concept of a "training set" in the context of machine learning or AI is not directly applicable here, as it's a traditional in vitro diagnostic device.

8. How the ground truth for the training set was established: Not applicable, as no training set (in the machine learning sense) is mentioned or implied for this traditional in vitro diagnostic device. The device's mechanism involves chemical reactions and visual interpretation, not an algorithm that learns from a training set.

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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 Cefepime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefepime susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Lancefield's Group A streptococci), Streptococcus agalactiae (Lancefield's Group B streptococci), 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 (MC) 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 Cefepime, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Size: Not explicitly stated as a number, but the evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
   • Data Provenance: The external evaluation was conducted to compare performance with an "NCCLS frozen Reference Panel." The origin of the actual bacterial isolates (countries, etc.) is not specified, nor is whether the data was retrospective or prospective. It is implied to be prospective for the purpose of the study.

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

   • This information is not provided in the document. The ground truth was established by comparing the device performance to an "NCCLS frozen Reference Panel," which acts as the gold standard, but details on how that reference panel's "ground truth" was initially established (e.g., how many experts, their qualifications, etc.) are absent.

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

   • This information is not provided in the document. The comparison was made directly against the NCCLS frozen Reference Panel, suggesting no explicit human adjudication process for the test results themselves beyond the visual reading specified for the device.

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

   • No. This is not an AI device. It's an in vitro diagnostic device (microdilution panel) for antimicrobial susceptibility testing. The readings are described as "manually read by observing." Therefore, an MRMC study related to AI assistance is not applicable.

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

   • No. The device requires human interaction ("manually read by observing the lowest antimicrobial concentration showing inhibition of growth"). It is not a standalone algorithm.

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

   • The ground truth was established by an NCCLS frozen Reference Panel. This reference panel serves as the accepted standard for determining minimum inhibitory concentrations (MICs). This is a form of reference standard comparative data, where the new device's results are compared to a well-established and validated method.

7. The sample size for the training set:

   • The document primarily describes an external evaluation or test set that compared the device to a reference panel. It does not explicitly mention a separate training set or its size. Microdilution panels like this are generally developed based on established microbiological principles rather than machine learning training sets.

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

   • Since a distinct "training set" in the context of machine learning is not described for this device, information on how its ground truth was established is not applicable/provided. The development of these types of panels typically relies on extensive historical microbiological data and standardized methodologies to determine appropriate antimicrobial concentrations and efficacy.

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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 Ceftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel

The organisms which may be used for Ceftriaxone susceptibility testing in this panel are:
Streptococcus pneumoniae
Streptococcus pyogenes
viridans group streptococci

The MicroScan® MICroSTREP plus™ 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% bysed 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.

The MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Ceftriaxone. The study aimed to demonstrate substantial equivalence to an NCCLS frozen Reference Panel.

1. Acceptance Criteria and Reported Device Performance

Essential Agreement (EA): This typically means that the MIC result of the device is within one doubling dilution of the reference method's MIC result. The FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000, defines the specific criteria for acceptable performance. The 97.5% Essential Agreement indicates that the device's results are very close to the reference standard for Ceftriaxone.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document mentions "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains". However, the exact number of isolates/strains used in the test set is not explicitly stated.
• Data Provenance: The study was an "external evaluation," meaning it was likely conducted independently from the device manufacturer to ensure impartiality. The data provenance is not specified by country, but it adheres to FDA guidelines, implying a US regulatory context for the study design and evaluation. The data included both fresh isolates (prospective collection) and stock isolates/strains (likely retrospective or historical collections).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their detailed qualifications for establishing the ground truth. However, the ground truth was established by comparing the device's performance against an "NCCLS frozen Reference Panel." The NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) sets recognized standards for antimicrobial susceptibility testing. The processes for maintaining and evaluating these reference panels would involve highly qualified microbiologists and laboratory professionals.

4. Adjudication Method

The document does not explicitly mention an adjudication method for the test set. Given that the comparison is against an NCCLS frozen Reference Panel, the reference panel itself serves as the agreed-upon gold standard, and individual results are compared directly to this standard. Discrepancies would typically be analyzed against established NCCLS criteria rather than through a separate adjudication panel for each case.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device is a semi-automated system for determining Minimum Inhibitory Concentration (MIC) and involves visual reading, but the study focuses on the accuracy of the panel itself against a reference method rather than reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The study primarily focuses on the standalone performance of the MicroScan® MICroSTREP plus™ Panel itself. It compares the device's MIC results to those of the NCCLS frozen Reference Panel. While the visual reading component involves human interpretation, the "acceptable performance with an overall Essential Agreement of 97.5% for Ceftriaxone" refers to the system's ability to produce accurate MIC values when interpreted according to its instructions. No human-in-the-loop enhanced performance is discussed as a separate variable.

7. Type of Ground Truth Used

The ground truth used was expert consensus (reference method), specifically the results obtained from an NCCLS frozen Reference Panel. This type of ground truth is a well-established and accepted standard in clinical microbiology for evaluating antimicrobial susceptibility testing devices.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The study describes an "external evaluation" conducted to confirm acceptability by comparing performance with the NCCLS frozen Reference Panel, which typically refers to a validation or test set rather than a training set for model development.

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

As no specific training set is mentioned as part of this device submission, the method for establishing its ground truth is not described. The focus of the provided information is on the reference standard used for validating the device's performance.

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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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