Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Meropenem at concentrations of 0.03 to 4 mcg/ml to the test panel

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

Streptococcus pneumoniae (excluding penicillin-resistant strains) 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-CO 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 an analysis of the acceptance criteria and study detailed in the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Note: The specific numerical threshold for "acceptable" reproducibility and quality control is not explicitly stated in the summary, only that the results were deemed acceptable.

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

The summary does not explicitly state the exact sample size for the test set. It mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation. The provenance of the data (country of origin, retrospective/prospective) is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment

The summary does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. The ground truth was established by an "NCCLS frozen Reference Panel," implying a standardized, presumably expert-validated, method.

4. Adjudication Method for the Test Set

The summary does not describe an adjudication method for the test set. The external evaluation compared the MicroScan® MICroSTREP plus™ Panel directly against an NCCLS frozen Reference panel.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not a medical imaging or diagnostic device that would typically involve human readers interpreting results in a comparative study.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was conducted. The MicroScan® MICroSTREP plus™ Panel's performance was evaluated by comparing its results directly with an NCCLS frozen Reference Panel. There isn't a "human-in-the-loop" component described for interpreting the panel's results in this evaluation, as the panels are read visually according to the package insert. The comparison is between two automated/semi-automated methods of determining MIC.

7. Type of Ground Truth Used

The ground truth used was an NCCLS frozen Reference Panel. This is a standardized, recognized reference method for antimicrobial susceptibility testing, providing a benchmark for accuracy.

8. Sample Size for the Training Set

The summary does not explicitly mention a "training set" or its sample size. For an IVD device like this, the development process likely involves internal testing and calibration with various strains, but this information is not detailed in the provided 510(k) summary, which focuses on the validation of the final product.

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

As no specific "training set" is described for this type of device in the summary, information on how its ground truth was established is not provided. The development of such panels would typically involve extensive testing against established reference methods, much like the external evaluation described for the final product.

Ask a specific question about this device

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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefuroxime at concentrations of 0.12 to 8 mcg/ml to the test panel. The organisms which may be used for Cefuroxime 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 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 acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance Study

The MicroScan® MICroSTREP plus™ Panel with Cefuroxime is designed to determine the minimum inhibitory concentration (MIC) of Cefuroxime for Streptococcus pneumoniae. The primary study to demonstrate substantial equivalence compared the device's performance to an NCCLS frozen Reference Panel.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria for essential agreement, reproducibility, and quality control are not detailed in the provided text. The document states "acceptable performance" and "acceptable reproducibility/results" without numerical thresholds other than the Essential Agreement percentage.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • The document refers to "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the specific number of isolates/strains used is not provided in the summary.
• Data Provenance: The document does not explicitly state the country of origin. The test isolates included "fresh and stock Efficacy isolates and stock Challenge strains." It is implied that these were clinical isolates and standardized challenge strains, respectively. The study design was a prospective comparison against a reference standard.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth (reference MIC values) was established using an NCCLS frozen Reference Panel. This implies that the reference panel itself underwent rigorous characterization, likely involving expert consensus and standardized protocols, but the details are not described in this submission. The device is read "visually" by a human, but this is the device's output, not the ground truth establishment.

4. Adjudication Method

• The document does not describe an adjudication method (e.g., 2+1, 3+1). The performance was compared directly to an NCCLS frozen Reference Panel, which serves as the established ground truth. Discrepancies between the device and the reference panel would traditionally be analyzed, but no specific adjudication process for these discrepancies is mentioned.

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

• No MRMC comparative effectiveness study was done comparing human reader performance with and without AI assistance (or device assistance in this context). This device is a diagnostic panel that is read visually by a human. The study focuses on the accuracy of the panel itself in providing the MIC value compared to a reference method, not on the improvement of a human reader's diagnostic accuracy with the panel's assistance.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The "MicroScan® MICroSTREP plus™ Panel" itself, when read visually according to instructions, constitutes the "device" whose performance was evaluated in comparison to the NCCLS frozen Reference Panel. While a human performs the visual reading, the performance evaluation is centered on the panel's ability to accurately present the MIC, not on the human's interpretation skills in isolation or with assistance. The comparison of the panel's results to a reference standard is a standalone assessment of the device's diagnostic output.

7. Type of Ground Truth Used

• The ground truth used was comparison to an NCCLS frozen Reference Panel. This type of ground truth represents a highly standardized and recognized reference method for antimicrobial susceptibility testing, considered the "gold standard" in the field at the time.

8. Sample Size for the Training Set

• The document does not explicitly describe a separate "training set" for the MicroScan® MICroSTREP plus™ Panel. As a diagnostic device for antimicrobial susceptibility, it is typically developed through extensive R&D and internal testing with various isolates. The provided submission describes the validation/testing of the market-ready device. Therefore, a specific "training set" sample size for an AI/algorithm context is not applicable or provided.

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

• Since a separate "training set" is not explicitly mentioned in the context of an AI/algorithm development and validation, the method for establishing its ground truth is not applicable or detailed. The device's underlying principles are based on established broth dilution susceptibility testing. Any internal development or calibration would have used similar laboratory reference methods to establish the 'true' MIC values for those internal isolates.

Ask a specific question about this device

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℃ +/- 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/Clavulanic Acid at concentrations of 0.015/0.008 to 16/8 mcg/ml to the test 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 inculation, 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.

The MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Amoxicillin/Clavulanic Acid, specifically for Streptococcus pneumoniae. The device is a microdilution minimum inhibitory concentration (MIC) panel that provides quantitative and/or qualitative antimicrobial agent susceptibility readings.

1. Acceptance Criteria and Reported Device Performance

Essential Agreement is defined as the agreement between the MIC obtained by the test device and the MIC obtained by the reference method (NCCLS frozen Reference Panel) within ±1 doubling dilution.

2. Sample Size and Data Provenance

The study used "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. No specific numerical sample size is provided for the test set.

The provenance of data is not explicitly stated in terms of country of origin. The study was a retrospective evaluation comparing the device's performance to an established reference method.

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 for the test set. The ground truth was established by an "NCCLS frozen Reference Panel," which implicitly suggests standardized and expert-derived values based on established guidelines.

4. Adjudication Method

The adjudication method is not explicitly mentioned. However, the comparison was made against a "NCCLS frozen Reference Panel," implying a predefined and standardized ground truth rather than a real-time adjudication process by experts on a case-by-case basis.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. The evaluation focuses on the device's performance against a reference panel, not on the improvement of human readers with AI assistance. The reading of the panels is described as "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," implying a human-in-the-loop, but without comparison to AI assistance.

6. Standalone Performance Study

A standalone performance study was conducted. The "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains" to confirm the acceptability of the proposed MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. This directly measures the algorithm's performance (the MicroScan panel's ability to produce accurate MICs) in isolation.

7. Type of Ground Truth Used

The ground truth used was based on an NCCLS frozen Reference Panel. This represents a standardized, expert-developed reference method for antimicrobial susceptibility testing, which serves as the gold standard for comparison in such studies.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The focus is on the performance of the device against the reference standard. Given the nature of a microdilution panel (a physical product with pre-determined reagent concentrations), it's unlikely to have a "training set" in the context of machine learning algorithms. The development of such panels relies on extensive microbiological research and standardization.

9. How Ground Truth for the Training Set was Established

As there is no explicit mention of a training set in the context of the device's development as an AI/ML product, this information is not applicable. The device relies on a chemical and biological methodology for determining susceptibility, not a machine learning model that requires a training phase with labeled data. The "ground truth" for the overall methodology would stem from established microbiological principles and NCCLS (now CLSI) guidelines.

Ask a specific question about this device