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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℃ +/- 1℃ 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 Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Clarithromycin susceptibility testing on 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 ℃ 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 µl 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 an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: MicroScan MICroSTREP plus® Panel with Clarithromycin (0.06 – 2 mcg/ml)
Intended Use: To determine bacterial antimicrobial agent susceptibility, specifically for Clarithromycin against aerobic streptococci, including Streptococcus pneumoniae. This submission focuses on adding instrument-read capability using the MicroScan® WalkAway instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "acceptable performance with an overall Essential Agreement of 98.6%". The "acceptable" for reproducibility, precision, and QC implies these were also acceptance criteria, though no numerical thresholds are given in the provided text.

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

• Sample Size (Test Set): Not explicitly stated. The document mentions "external evaluation was conducted with stock and CDC Challenge strains," but the specific number of strains or isolates tested is not provided.
• Data Provenance: The study was an "external evaluation." While the specific country is not mentioned, the manufacturer (Dade Behring Inc.) is based in the USA, and the FDA submission is to the US regulatory body, suggesting the evaluation would align with US standards and likely involve US-based laboratories or strains. The data appears to be prospective in nature, as it was designed to "confirm the acceptability of the proposed instrument read method" by comparing it to "Expected Results determined before the evaluation."

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

This information is not provided in the given text. The "Expected Result" is mentioned as the comparator, and it was "generated on a CLSI frozen Reference Panel," but the human involvement in establishing these "Expected Results" or "ground truth" is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. While an "Expected Result" was used, the method by which this ground truth was confirmed or adjudicated (e.g., beyond the CLSI reference panel itself) is not described.

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 done. This study is focused on the performance of the instrument-read method for antimicrobial susceptibility testing, comparing it to an "expected result" from a reference method, not on human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate the performance of the MicroScan® WalkAway instrument (an automated system, essentially an algorithm/device only) in reading the MICroSTREP plus® Panel with Clarithromycin. It compares the "instrument read results" to a predefined "Expected Result," implying an algorithm-only evaluation. The primary comparison is the instrument reading versus the CLSI frozen Reference Panel, which serves as the independent standard. The original method was "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," but the study explicitly focuses on the "addition of instrument read capability."

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 indicates a well-established, standardized reference method, likely involving expert consensus and adherence to Clinical and Laboratory Standards Institute (CLSI) guidelines, which are recognized standards for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

The document does not provide information regarding a distinct "training set." The study described is an "external evaluation" conducted to confirm acceptability, implying a validation or test set. For an AST system, the "training" analogous to machine learning often happens during the initial development and optimization of the instrument's reading algorithms, using various characterized strains and concentration ranges. This information is typically proprietary and not part of the 510(k) summary for a post-development validation.

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

As no specific training set is mentioned in the context of this 510(k) summary, the method for establishing its ground truth is not described. If "training" implicitly refers to the initial development of the instrument's reading capabilities, it would have involved a similar process as the ground truth for the test set, likely using CLSI reference methods and expert interpretation to teach the instrument to accurately "read" MIC values.

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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 Cefaclor, at concentrations of 0.5 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefaclor 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 ℃ 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 µl 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.

Acceptance Criteria and Study Details for MicroScan MICroSTREP plus® Panel (Cefaclor)

This submission describes the acceptance criteria and study proving the MicroScan MICroSTREP plus® Panel meets these criteria for determining bacterial susceptibility to Cefaclor using the MicroScan WalkAway instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Essential Agreement (EA) for AST devices typically refers to the percentage of MIC results that are within one doubling dilution of the reference method's MIC result. The FDA guidance document (cited in the submission) specifies the expected thresholds for EA for different AST systems. While the exact threshold isn't explicitly stated in this summary, the 92.5% achieved is reported as "acceptable."

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The study was conducted with "stock and CDC Challenge strains." The exact number of strains/isolates is not explicitly stated in the provided text.
• Data Provenance: The external evaluation was conducted as described, implying prospective testing of these strains. The country of origin for the data is not specifically mentioned, but given the manufacturer (Dade Behring Inc.) and FDA submission, it can be inferred to be a US-based or internationally collected set of strains used in a US regulatory context.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth was established as "Expected Results determined before the evaluation," and also referenced a "CLSI frozen Reference Panel." This suggests that the ground truth was derived from established reference methods, likely interpreted by qualified microbiologists, but the specifics are not detailed.

4. Adjudication Method for the Test Set

• The text describes the comparison of instrument read results with an "Expected Result generated on a CLSI frozen Reference Panel." This indicates that the CLSI reference panel serves as the gold standard against which the device's performance is measured.
• There is no mention of a traditional expert adjudication (e.g., 2+1, 3+1 consensus) of the device's results. Instead, the device's results are directly compared to the established "Expected Result" from the CLSI reference method.

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

• No, an MRMC comparative effectiveness study was not explicitly done. This study focuses on the mechanical/automated reading of the MicroScan MICroSTREP plus® Panel by the MicroScan WalkAway instrument compared to a defined reference standard ("Expected Result"). The focus is on the instrument's performance, not on direct human reader improvement with or without AI assistance. The original method, to which this instrument-read method is an addition, involves manual reading, but the study described here is not a comparison of human readers with and without the instrument.

6. Standalone Performance Study

• Yes, a standalone study was done. The study's primary objective was to evaluate the "proposed instrument read method" (i.e., the algorithm/instrument's performance without human intervention to interpret the results once the instrument has read them) against a "CLSI frozen Reference Panel" and its "Expected Result." The 92.5% Essential Agreement reflects this standalone performance of the MicroScan WalkAway instrument in reading the panels.

7. Type of Ground Truth Used

• The ground truth used was based on results generated on a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel, which is a widely accepted standard for antimicrobial susceptibility testing. These are referred to as "Expected Results determined before the evaluation." This is a highly robust and standardized form of ground truth for this type of in vitro diagnostic device.

8. Sample Size for the Training Set

• Not explicitly stated. The provided summary describes the validation of the instrument-read method, not the development or training of the underlying algorithm for the instrument reading. While the instrument likely incorporates algorithms, no information on a specific "training set" or its size is given in this document.

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

• Not applicable / Not explicitly stated. As noted above, the document focuses on the performance validation rather than the internal development of the instrument's reading capabilities. Therefore, how any "training set" ground truth might have been established for the instrument's internal algorithms is not detailed. The study's focus is on comparing the instrument's output to an independent ground truth reference method.

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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 Cefepime, at concentrations of 0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefepime susceptibility testing on 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, andiniteroofal agent subceptions, or versite = culation, 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. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation 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.

The information provided is centered around the 510(k) submission for the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Cefepime, specifically for the instrument read method. This submission does not pertain to an AI device or a comparative effectiveness study involving human readers with and without AI assistance. Therefore, some of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only) performance," are not directly applicable or cannot be extracted from the given text.

Based on the provided text, here is a summary of the acceptance criteria and the study details:

Acceptance Criteria and Reported Device Performance

Study Details

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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. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of instrument read capability of the antimicrobial Cefotaxime, at concentrations of 0.015 -8 mcg/ml on the MicroScan MICroSTREP plus® Panel.

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

Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative r no microbial 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 ℃ 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 Muellerecontractle 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 information for the MicroScan MICroSTREP plus® Panel with Cefotaxime, based on the provided text:

Acceptance Criteria and Device Performance

Note: The specific numerical target for "acceptable" essential agreement and other metrics is not explicitly stated but is implicitly met by the reported 93% and "acceptable" statements. The reference to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003, would contain the detailed numerical acceptance criteria.

Study Information

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

• Test Set Sample Size: The text states "The evaluation was conducted with stock and CDC Challenge strains." However, the exact number of strains or isolates used in the test set is not specified in the provided document.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not explicitly stated, but the phrase "The evaluations were designed to confirm the acceptability of the proposed instrument read method... by comparing its performance with Expected Results determined before the evaluation" suggests a prospective comparison against pre-defined expected results.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: The ground truth was referred to as "Expected Results determined before the evaluation" and was based on "a CLSI frozen Reference Panel." This implies the ground truth was established by a recognized standard methodology (CLSI) and likely involved expert consensus in establishing the reference panel.

4. Adjudication method for the test set:

• Adjudication method is not specified. The comparison was against "Expected Results determined before the evaluation" and a "CLSI frozen Reference Panel."

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on validating the instrument-read capability of an antimicrobial susceptibility test panel against a predicate device/reference standard, not on human-AI collaboration or improvement with AI assistance. The "instrument read method" refers to the automated reading by the MicroScan WalkAway instrument.

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

• Yes, a standalone performance study was done. The entire premise of the submission is to validate the "instrument read method" (MicroScan WalkAway instrument) for the MICroSTREP plus® Panel for Cefotaxime. This is a standalone assessment of the automated instrument's performance in reading the Minimum Inhibitory Concentration (MIC) values.

7. The type of ground truth used:

• The ground truth used was Expert Consensus/Reference Standard. It was based on "Expected Results determined before the evaluation" which were generated on a "CLSI frozen Reference Panel." The CLSI (Clinical and Laboratory Standards Institute) provides recognized standards for microbiology testing, and reference panels are established through rigorous testing and expert consensus to provide a reliable "true" value.

8. The sample size for the training set:

• Not applicable/Not specified. This type of device (Antimicrobial Susceptibility Test System based on broth microdilution) typically does not involve a "training set" in the machine learning sense. The "training" of the instrument is inherent in its design and calibration for reading growth inhibition, rather than a data-driven training phase to learn a specific task. The validation focuses on the instrument's performance against established reference methods.

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

• Not applicable/Not specified. As mentioned above, a "training set" in the AI sense is not relevant for this device.

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. 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 Meropenem, at concentrations of 0.03 to 4 mcg/ml on the MicroScan MICroSTREP plus® Panel.

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

Streptoccus 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℃ +/-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.

Acceptance Criteria and Device Performance Study for MicroScan MICroSTREP plus® Panel (Meropenem)

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the MicroScan MICroSTREP plus® Panel with Meropenem, specifically for instrument-read results using the MicroScan® WalkAway instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for Essential Agreement (≥ 90%) is derived from the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (February 5, 2003), which is referenced in the 510(k) summary.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the exact number of isolates or tests performed in the evaluation for Essential Agreement. However, it mentions the evaluation was conducted with "stock and CDC Challenge strains."
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin but is implied to be from Dade Behring Inc. (USA) as the manufacturer. The study is prospective as it involves evaluations designed to confirm acceptability against pre-determined Expected Results.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the use of human experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

No adjudication method is described, as the ground truth was established by a reference method rather than expert consensus.

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

No MRMC comparative effectiveness study was conducted. This study focused on the performance of the instrument-read method compared to a reference standard, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The study evaluated the performance of the algorithm only (MicroScan® WalkAway instrument read method) without human intervention or human-in-the-loop performance, by comparing its results to an established reference method.

7. Type of Ground Truth Used for the Test Set

The ground truth used was an expected result generated on a CLSI frozen Reference Panel. This represents a recognized standard for determining antimicrobial susceptibility, aligning with established laboratory methods.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The evaluation was framed as a comparison against an "Expected Result" from a reference panel, which suggests a validation study rather than a machine learning training process with a distinct training set. If the MicroScan WalkAway instrument uses an algorithm that was previously developed and trained, the details of that training are not provided in this submission.

9. How Ground Truth for the Training Set Was Established

As noted in section 8, a separate training set is not explicitly discussed. For the purpose of the evaluation, the "Expected Results" for comparison were determined before the evaluation, using a CLSI frozen Reference Panel. This implies that the reference panel served as the gold standard for defining correct susceptibility results against which the instrument's performance was measured.

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. 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 Ceftriaxone, at concentrations of 0.015 to 8 mcg/ml on the MicroScan MICroSTREP plus® 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® 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 µl 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.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated, however, the study involved "stock and CDC Challenge strains." The specific number of isolates used for evaluation is not provided.
• Data Provenance: Not explicitly stated, though the use of "CDC Challenge strains" suggests a potentially US-centric origin or at least strains relevant to US public health surveillance. The study appears to be prospective, as it's a comparison to "expected results determined before the evaluation."

3. Number and Qualifications of Experts for Ground Truth

• Not applicable as the ground truth was not established by human experts in the traditional sense of image interpretation or clinical diagnosis. The "expected result" was generated using a CLSI frozen Reference Panel, which is a standardized laboratory method.

4. Adjudication Method

• Not applicable, as the evaluation was a comparison against a standardized reference panel, not a consensus among human experts.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focused on the standalone performance of the instrument read method against a reference standard. The document describes adding "instrument read capability," not assisting human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was performed. The evaluation specifically compared the "proposed instrument read method" to "Expected Results" generated by a CLSI frozen Reference Panel, indicating an algorithm-only evaluation without human-in-the-loop performance being the primary focus. The purpose was to confirm the acceptability of the instrument's reading of the MICroSTREP plus Panel with Ceftriaxone.

7. Type of Ground Truth Used

• Reference Standard: The ground truth was established by an "expected result generated on a CLSI frozen Reference Panel," as defined in the FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." This represents a standardized, laboratory-based reference method for determining antimicrobial susceptibility.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" as it would for a machine learning model. The evaluation compares the instrument's performance against a reference standard, suggesting that the instrument's "reading" capabilities were either pre-calibrated or designed based on existing knowledge of AST methods, rather than being "trained" on a specific dataset in the modern AI sense. The stock and CDC Challenge strains were used for the evaluation of the instrument's performance.

9. How Ground Truth for the Training Set Was Established

• Not applicable given the nature of the device (an automated reader for a standardized test panel) and the absence of an explicit "training set" in the context of an AI model. The reference for performance was a CLSI frozen Reference Panel, which represents an established and validated method for determining antimicrobial susceptibility.

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. 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 Cefuroxime, at concentrations of 0.12 to 8 mcg/ml on the MicroScan MICroSTREP plus® 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℃ +/-1ºC 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 an analysis of the provided information regarding the MicroScan MICroSTREP plus® Panel's acceptance criteria and the study proving its performance:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions "external evaluations" conducted with "stock and CDC Challenge strains." However, the exact sample size for the test set (number of unique isolates) is not explicitly stated.
   • The data provenance is from in vitro testing using laboratory strains ("stock and CDC Challenge strains"), implying a controlled, laboratory-based study. The country of origin is not specified but given the FDA submission, it's likely primarily US-based or compliant with US standards. The study appears to be prospective for the device's performance evaluation against the established "Expected Result."

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

   • The document implies that the ground truth, referred to as the "Expected Result," was generated on a CLSI frozen Reference Panel. This suggests the ground truth was established by a standardized, validated method (CLSI reference method), rather than by individual human experts per se. It doesn't specify the number or qualifications of experts involved in the initial CLSI reference panel validation or the generation of the "Expected Result" for this specific study.

3. Adjudication method for the test set:

   • The document states that the "external evaluations were designed to confirm the acceptability of the proposed instrument read method... by comparing its performance with Expected Results determined before the evaluation." This indicates a direct comparison to a pre-defined reference standard. There is no mention of an adjudication method as typically understood for human reader discrepancies (e.g., 2+1 or 3+1). The "Expected Result" serves as the single, authoritative ground truth.

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, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of an instrument-read method for antimicrobial susceptibility testing, comparing it to a reference method. It does not involve human readers or AI assistance in the context of an MRMC study.

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

   • Yes, a standalone study was done. The study evaluates the "proposed instrument read method" (MicroScan® WalkAway instrument) for the MICroSTREP plus® Panel. This is a standalone evaluation of the device without human intervention in the reading process, comparing it to an "expected result."

6. The type of ground truth used:

   • The ground truth used was based on an "expected result generated on a CLSI frozen Reference Panel." This is a highly standardized, reference method ground truth (broth dilution method as miniaturized for the panels) which is widely accepted in microbiology for antimicrobial susceptibility testing.

7. The sample size for the training set:

   • The document pertains to the evaluation of an instrument-read method for an existing panel. There is no mention of a separate "training set" for an algorithm in the traditional machine learning sense. The "MicroScan MICroSTREP plus® Panel" itself is a product; the evaluation is about adding "instrument read capability" for a specific antimicrobial (Cefuroxime). If the WalkAway instrument's reading mechanism involved an algorithm that required training, those details are not provided in this 510(k) summary. The study is an evaluation of the instrument's performance, not the development of a new algorithm.

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

   • Since there's no explicit training set mentioned in the context of algorithm development, the method for establishing its ground truth is not applicable or detailed here. The "Expected Results" for the test set were established using the CLSI 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. 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 Erythromycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Erythromycin susceptibility testing on 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 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 15 µl 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.

This 510(k) summary describes the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Erythromycin using a MicroScan® WalkAway instrument an in vitro diagnostic device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number. The document mentions "stock and CDC Challenge strains" for external evaluation. It indicates the study was designed to confirm acceptability by comparing performance with "Expected Results determined before the evaluation," implying a retrospective comparison against a pre-established reference standard.
• Data Provenance: The document refers to "external evaluation" but does not specify the country of origin of the data. The use of "CDC Challenge strains" suggests a U.S. context for some of the strains, but this doesn't definitively determine the origin of all test data.

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

• This information is not provided in the given text. The ground truth (referred to as "Expected Result" or "CLSI frozen Reference Panel") was established prior to the evaluation, but the specifics of who established it or their qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. The document states that the test set's performance was compared with an "Expected Result generated on a CLSI frozen Reference Panel." This implies a reference standard rather than multi-expert adjudication for individual test cases.

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 an automated instrument for reading antimicrobial susceptibility panels, not an AI intended to assist human readers in interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, a standalone performance evaluation was conducted. The study assesses the performance of the MicroScan® WalkAway instrument in reading the MICroSTREP plus® Panel with Erythromycin. The performance is compared against an "Expected Result," implying the instrument's automated reading capability without human intervention for interpretation.

7. The Type of Ground Truth Used

• The ground truth used was based on an Expected Result generated on a CLSI frozen Reference Panel and determined before the evaluation. This serves as a reference standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

• This information is not provided. The document describes an evaluation of an existing measurement instrument with an added capability, not the development or training of a new algorithm. It does not mention a training set in the context of an AI/ML model where a training set would be explicitly defined.

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

• This information is not applicable/provided as no training set for an AI/ML model is described or referenced in the document.

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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. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of instrument read capability of the antimicrobial Penicillin, at concentrations of 0.015 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.

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. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. The antimicrobial agents are diluted in water, buffer or minute concentrations of broth to various concentrations. Panels are rehydrated with 115 ul Mueller Hinton Broth 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 organism is read by observing the lowest antimicrobial concentration that inhibits visible growth.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The FDA guidance document mentioned for Essential Agreement (February 5, 2003) would contain the specific numerical thresholds for "acceptable performance." Without access to that document, the exact numerical threshold can't be filled in, but the device explicitly states it met this criteria.

Study Details

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

• Sample Size for Test Set: The document mentions "stock and CDC Challenge strains" were used for the external evaluation. However, the exact number of strains or individual isolates tested is not specified in the provided text.
• Data Provenance: The study was an "external evaluation" conducted with "stock and CDC Challenge strains." This suggests a controlled laboratory setting, likely with well-characterized strains from established repositories like the CDC. It is a prospective evaluation designed to assess the new instrument's performance against established methods. The country of origin for the data is not explicitly stated, but given the FDA submission and CDC strains, it's highly likely to be the United States.

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.
  The "Expected Results" were determined by the company's MicroScan MICroSTREP plus® Panel. This implies that the standard, predicate method (read visually or by a human) was used to establish the ground truth. While experts would be involved in interpreting those results, the specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: The ground truth was established by "Expected Results determined [from] the MicroScan MICroSTREP plus® Panel" (likely the predicate device's standard method). This suggests a comparative method rather than typical expert adjudication. The text does not describe a specific adjudication method like 2+1 or 3+1. It's an "external evaluation" where the instrument's performance is compared against these predetermined "Expected Results."

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly described in the provided text. The study focused on the performance of the instrument-read method compared to "Expected Results" from the predicate device, not on comparing human readers with and without AI assistance.
• Effect Size of Human Improvement: Therefore, no effect size for human readers with and without AI assistance is provided.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, a standalone performance evaluation was conducted. The entire study describes the performance of the "proposed instrument read method" (the MicroScan® WalkAway instrument reading the panels) for Penicillin, without explicit human intervention in the reading process that is being evaluated. The device itself is the "algorithm only" component being assessed for reading the MIC panels.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established by the "Expected Results determined [from] the MicroScan MICroSTREP plus® Panel." This refers to the results obtained from the predicate method (which can be read visually or by a WalkAway instrument, but for the purpose of establishing ground truth for the new instrument-read claim, it would be the established/validated method). This is a form of expert consensus/established method comparison, where the predicate device's validated results serve as the reference standard.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide any information about a training set or its sample size. This type of device (an automated reader for MIC panels) is typically validated through comparison to known reference methods with a test set, rather than "training" in the machine learning sense.

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

• Ground Truth for Training Set: Since no training set is mentioned, information on how its ground truth was established 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 degrees C +/- 1 degree 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 Tetracycline, at concentrations of 0.06 to 16 mcg/ml on the MicroScan MICroSTREP plus Panel. The organisms which may be used for Tetracycline susceptibility testing on this panel are: Streptococcus spp., 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 degrees C +/- 1 degree C in a non-CO2 incubator, and read according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. The antimicrobial agents are diluted in water, buffer or minute concentrations of broth to varying concentrations in the wells of the panels. Panels are rehydrated with 115 ul Mueller-Hinton broth 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 usually read by observing the lowest antimicrobial concentration that inhibits visible growth of the test organism. Panels may be incubated in and read by a MicroScan WalkAway instrument.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan MICroSTREP plus® Panel with Tetracycline:

Acceptance Criteria and Device Performance

Note: The FDA guidance document likely specifies numerical thresholds for "Essential Agreement" and criteria for "acceptable reproducibility" and "acceptable Quality Control results." These specific numerical acceptance thresholds are not provided in the summary. The summary only states that the device met these acceptable criteria.

Study Information

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

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

   • Test Set Sample Size: Not explicitly stated as a single number. The study utilized "stock and CDC Challenge strains." The text notes that the "proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantial equivalence with streptococcal isolates when compared with an expected Substantially Equivalent result generated on a CLSI frozen Reference Panel." While the types of strains are mentioned, the exact number of isolates used in the external evaluation for performance assessment is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The use of "CDC Challenge strains" suggests some US-based origin, but this isn't definitive for the entire "stock" collection. The study was an "external evaluation." It is implicitly prospective in the sense that new data was generated for this specific submission, comparing instrument reads to expected results.

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

   • The text does not specify the number of experts or their qualifications for establishing the "Expected Result" (ground truth). It refers to the "CLSI frozen Reference Panel" as the basis for the "Expected Result," implying that CLSI (Clinical and Laboratory Standards Institute) standards and potentially expert consensus or established methodologies were used to define these reference results.

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

   • Not specified. The "Expected Result" is associated with the "CLSI frozen Reference Panel," implying a standardized, reference-based determination rather than a multi-reader visual adjudication process.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focuses on validating an instrument read method compared to an "Expected Result" based on a reference standard, not on human reader performance or improvement with AI assistance. The "instrument read method" is an automated reading by the MicroScan® WalkAway instrument, replacing or supplementing visual reading, rather than an AI-assisted human reading. The summary states panels "may be incubated in and read by a MicroScan® WalkAway instrument" in addition to visual reading, indicating it's an alternative or supplemental method, but not explicitly an AI-assisted human reading.

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

   • Yes, this was a standalone performance evaluation of the "instrument read method" (referred to as the "proposed instrument read method" and instrument read results). The MicroScan® WalkAway instrument's reading is essentially an algorithm-only or automated standalone performance, independent of a human directly interpreting results for the performance metric of "Essential Agreement."

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

   • The ground truth was established by "Expected Results determined [from] the CLSI frozen Reference Panel." This suggests a reference standard method (broth dilution susceptibility test, as described in the summary) and likely expert-developed CLSI guidelines. It's akin to a "gold standard" derived from established laboratory protocols and reference materials.

7. The sample size for the training set:

   • Not applicable/Not provided. The text describes an evaluation or validation study for a device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not relevant here. The device determines MIC values based on a pre-programmed methodology, not learned from a dataset.

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

   • Not applicable (as it's not an AI/ML model with a training set).

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