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The MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin, at concentrations of 0.25 to 64 ug/ml, to the test panel.

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

• Enterococcus spp. (e.g., Enterococcus faecalis) .
• Staphylococcus spp. ●
• Staphylococcus aureus (including methicillin-resistant strains) .
• Staphylococcus epidermidis (including methicillin-resistant ● strains)

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

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

This 510(k) summary describes a device modification for an existing antimicrobial susceptibility test (AST) system. The modification involves updating the product labeling with new Staphylococcus aureus interpretive criteria for vancomycin.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria from the FDA guidance document are not explicitly stated in the provided text. However, the document states the device demonstrated "acceptable performance" and achieved 97.6% Essential Agreement, implying this met the pre-defined criteria. Essential Agreement (EA) for AST devices typically refers to the agreement between the investigational device and the reference method within ±1 dilution.

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

• Sample Size: Not explicitly stated as a number. The text mentions "Challenge strains were compared to Expected Results determined prior to the evaluation."
• Data Provenance: The S. aureus data came from a "previously cleared vancomycin external evaluation (K060312)." This indicates the data was retrospective relative to this specific 510(k) submission, as it was collected for an earlier clearance. The country of origin is not specified, but given the submission to the US FDA and Siemens Healthcare Diagnostics' presence, it's likely primarily US-based or multi-site clinical trial data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the ground truth was established by comparing the challenge strains to "Expected Results determined prior to the evaluation," and this evaluation used a CLSI frozen Reference panel. This implies the ground truth was based on a highly standardized and accepted reference method in the field of microbiology, which typically has expert consensus underlying its establishment.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. Ground truth was established by comparison to a CLSI frozen Reference panel, rather than human expert consensus requiring adjudication on individual cases.

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

• MRMC Study: No, this is not an MRMC study. This device is an automated in vitro diagnostic (IVD) system for antimicrobial susceptibility testing, which does not involve human readers interpreting images or data directly in a comparative effectiveness study against AI. The comparison is between the automated device and a reference laboratory method.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: Yes. The study directly evaluates the performance of the MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel (the algorithm/device) against a frozen Reference Panel. This is a standalone performance evaluation of the device without human-in-the-loop performance being the primary subject of the comparison.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was a CLSI frozen Reference panel. This is a highly standardized and validated laboratory method for determining antimicrobial susceptibility, widely accepted as a "gold standard" in microbiology. The reference panel essentially provides the "true" MIC values and interpretive categories (S, I, R) for the challenge strains.

8. Sample Size for the Training Set

• Sample Size: This information is not provided in the summary. As an in vitro diagnostic device, the "training set" concept is different from AI/ML models. It would refer to the strains and data used during the development and optimization of the MicroScan® system's AST methodology.

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

• Ground Truth Establishment for Training Set: This information is not provided in the summary. Similar to point 8, the ground truth for any development/training would likely involve standard reference methods, possibly including CLSI guidelines and expert microbiology protocols, but the specifics are not detailed.

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The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Streptomycin Synergy Screen, at a concentration of 1000 ug/ml, for enterococci, to the test panel.

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

Enterococcus species

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

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

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Streptomycin Synergy Screen, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

• Test Set Description: The external validation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
• Sample Size: The exact numerical sample size for the test set is not specified in the provided text.
• Data Provenance: The text does not explicitly state the country of origin. It indicates "external validation," which could imply data collected from various geographical locations or a specific external site. The study seems to be prospective in nature for the "fresh" isolates, and potentially retrospective for the "stock" isolates and challenge strains.

3. 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 used to establish the ground truth for the test set.

4. Adjudication method for the test set:

• The text does not describe any specific adjudication method used for the test set. It mentions "Challenge strains were compared to Expected Results determined prior to the evaluation," implying a pre-defined ground truth for these strains, but not an adjudication process for 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:

• No, an MRMC comparative effectiveness study was not done. This device (antimicrobial susceptibility test panel) is a diagnostic assay, not an AI-assisted reading tool for human interpretation of images or other complex data.

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

• Yes, it was a standalone performance study. The device is designed to provide quantitative and/or qualitative antimicrobial agent susceptibility directly by determining the lowest antimicrobial concentration showing inhibition of growth after incubation. While human intervention is involved in preparing the inoculum and reading (or setting up an instrument to read), the core performance measurement (Categorical Agreement) is against a reference method. The text mentions "the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth," and this reading can be done by the WalkAway® SI system or equivalent, indicating an automated or semi-automated standalone nature for the reading part.

7. The type of ground truth used:

• The ground truth was established by a frozen Reference Panel. For the challenge strains, "Expected Results" were determined prior to the evaluation, which would likely be derived from a validated reference method.

8. The sample size for the training set:

• The text does not mention a training set sample size. This type of device (a diagnostic panel) typically undergoes R&D and validation but not in the same "training set" manner as machine learning algorithms.

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

• As a training set is not explicitly mentioned or applicable in the traditional sense for this type of device, the method for establishing its ground truth is not described. The "frozen Reference Panel" is used for validation/testing, not for training.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Gentamicin Synergy Screen, at a concentration of 500 µg/ml, for enterococci, to the test panel.

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

Enterococcus species

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

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

Acceptance Criteria and Device Performance Study for MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Gentamicin Synergy Screen

This document describes the acceptance criteria and the study that proves the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Gentamicin Synergy Screen device meets its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify a numerical threshold for "acceptable performance" for categorical agreement, reproducibility, or quality control. However, the stated 97.0% categorical agreement is reported as having demonstrated "acceptable performance."

2. Sample Size and Data Provenance

The study utilized two types of strains:

• Efficacy isolates: "fresh and stock" isolates.
• Challenge strains: "stock" strains.

The exact numerical sample size for both efficacy isolates and challenge strains is not explicitly stated in the provided text.

The data provenance is not explicitly mentioned (e.g., country of origin). The study design appears to be retrospective, as it used "stock efficacy isolates and stock challenge strains," and the evaluation was compared against "Expected Results determined prior to the evaluation" for challenge strains, suggesting these were pre-existing collections rather than prospectively collected clinical samples.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set, nor does it provide their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on the performance of the device itself against a reference standard, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "external validation" compared the new device's performance directly with a "frozen Reference Panel" and "Expected Results." This assesses the algorithm/device's performance without human intervention as a primary part of the comparison.

7. Type of Ground Truth Used

The ground truth for the external validation study was established using two methods:

• Frozen Reference Panel: The device's performance was compared against a "frozen Reference Panel," which serves as a gold standard for antimicrobial susceptibility testing.
• Expected Results: For challenge strains, the device's performance was compared to "Expected Results determined prior to the evaluation," implying a pre-established ground truth for these specific strains.

The reference panel is described as a "miniaturization of the broth dilution susceptibility test."

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. The descriptions provided primarily concern the validation/test phase of the device.

9. How Ground Truth for the Training Set Was Established

The document does not describe how the ground truth was established for any potential training set. The provided text focuses on the external validation of the device against established reference methods.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 – 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial tetracycline, at concentrations of 0.25 to 16 µg/ml (7-Dilution MIC Sequence), 0.5 – 8 µg/ml (5-Dilution BP Sequence), and 2 - 8 ug/ml (3-Dilution BP Dilution Sequence), for all Staphylococcus species and Enterococcus species to the test panel.

The Gram-positive organisms which may be used for tetracycline susceptibility testing in this panel are: Staphylococcus aureus, Streptococcus faecalis (Enterococcus faecalis)

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

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

Here's a breakdown of the acceptance criteria and study details for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Tetracycline, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a number, but the study used "fresh and stock Efficacy isolates" and "stock Challenge strains."
   • Data Provenance: Not specified (e.g., country of origin). The study was an "external validation."

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The reference standard was a "frozen Reference Panel" and "Expected Results," which implies a gold standard established by expert consensus or predefined criteria, but the specific individuals are not detailed.

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

   • Adjudication Method: Not specified. The comparison was directly between the MicroScan® panel's results and the "frozen Reference panel" and "Expected Results."

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

   • MRMC Study: No, this was not an MRMC study. This device is an automated antimicrobial susceptibility testing (AST) system, not an AI-assisted diagnostic imaging tool with human interpretation.

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

   • Standalone Performance: Yes, the device's performance was evaluated independently against the reference standard. While the system can be read visually for AST, the primary evaluation detailed here is for the automated system ("read by the MicroScan® Instrumentation"). The "read by determining the lowest antimicrobial concentration showing inhibition of growth" implies an automated or semi-automated reading process for the MIC.

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

   • Ground Truth Type: "Frozen Reference Panel" and "Expected Results." This suggests a highly standardized and validated reference method for antimicrobial susceptibility testing, commonly considered a gold standard in microbiology, likely established by expert consensus guidelines and previous validation studies of the reference method itself.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is a diagnostic test kit based on established biochemical principles and does not involve machine learning or a "training set" in the conventional AI sense.

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

   • Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial clindamycin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence and 0.12 - 2 ug/ml 5-Dilution Breakpoint Sequence, for Staphylococcus spp., to the test panel.

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

• Staphylococcus aureus (penicillinase and non-penicillinase producing strains) ●
• . Staphylococcus epidermidis (penicllinase and non-penicillinase producing strains)

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

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

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

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated regarding the exact number of efficacy isolates and challenge strains. It mentions "fresh and stock Efficacy isolates and stock Challenge strains". The country of origin of the data is not specified. The study appears to be prospective as it's an external validation conducted to confirm acceptability.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "Expected Results" for challenge strains likely imply an expert consensus or established laboratory standards, but the number and qualifications of experts are not provided.

3. Adjudication method for the test set: Not explicitly stated for establishing "Expected Results" for challenge strains or reconciling discrepancies. However, the comparison is against a "frozen Reference Panel" and "Expected Results," suggesting a predefined ground truth or reference standard.

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 study is for an antimicrobial susceptibility testing (AST) system, not an AI-assisted diagnostic imaging device. It focuses on the accuracy and reproducibility of the device itself rather than human reader performance with or without AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in effect. The device (MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel) operates as a standalone system, determining MIC values. While it requires human inoculation, the reading and interpretation of the MIC are performed by the WalkAway® SI instrument (or equivalent), or can be read visually for AST portions. The "Essential Agreement" evaluation directly assesses the device's performance against the reference, without human interpretation variability being the primary focus of the performance metric.

6. The type of ground truth used:

   • Frozen Reference Panel: This serves as a primary ground truth for the "Long Dilution Sequence" comparison, likely representing a gold standard for MIC determination.
   • Expected Results: For the Challenge strains, "Expected Results" were determined prior to evaluation, which usually implies that the MIC values for these strains were previously established through rigorous testing and expert consensus using a reference method.

7. The sample size for the training set: Not applicable and not mentioned. This is a traditional in vitro diagnostic device, not a machine learning or AI-based system that typically utilizes training sets in the same manner. The "frozen Reference Panel" and "Expected Results" are used for validation, not as a training set for an algorithm.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set in the context of an algorithmic or AI model.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial chloramphenicol, at concentrations of 4 to 16 µg/ml, for enterococci and staphylococci, to the test panel.

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

Staphylococcus aureus

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

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

Here's a breakdown of the acceptance criteria and study details based on the provided text for the K063564 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text states: "The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates (sample size) used in the test set is not explicitly provided in the given text.

The data provenance is:

• Country of Origin: Not explicitly stated, but the submission is to the US FDA.
• Retrospective or Prospective: Not explicitly stated, but the phrase "external validation was conducted" suggests a prospective collection or evaluation against an existing reference. The use of "fresh" isolates implies a prospective component.

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

The text mentions comparison to "Expected Results determined prior to the evaluation" for Challenge strains, and a "frozen Reference panel." This implies a pre-established ground truth, likely based on well-characterized strains and a reference method.

• Number of Experts: The number of experts involved in establishing the ground truth for the reference panel or "Expected Results" is not explicitly stated.
• Qualifications of Experts: The qualifications of any experts involved in establishing the ground truth are not explicitly stated. However, given the nature of antimicrobial susceptibility testing, it's implied that these would be microbiologists or clinical laboratory experts.

4. Adjudication Method for the Test Set

The text compares the device's performance directly to a "frozen Reference panel" and "Expected Results." This implies a direct comparison rather than an adjudication process among multiple readers or interpretations of the device's output. Therefore, an explicit adjudication method like "2+1" or "3+1" is not applicable or described in this context.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this 510(k) summary. This device is an automated system for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool for human interpretation of images or data.

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

Yes, this study is inherently a standalone performance evaluation of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with chloramphenicol. The device, in conjunction with the WalkAway® SI system, automatically determines the MIC. The performance is compared to a reference standard (frozen reference panel), indicating an assessment of the algorithm's (or system's) output without direct human interpretation being the primary variable.

7. The Type of Ground Truth Used

The ground truth used is a "frozen Reference panel" and "Expected Results" for Challenge strains. This reference panel likely represents the established gold standard method for determining antimicrobial susceptibility, which would typically involve a recognized broth microdilution method read visually by experienced microbiologists or a calibrated instrument.

8. The Sample Size for the Training Set

The text does not provide any information about a specific "training set" or its sample size. This is typical for a traditional microbiology device validation, where the system is designed based on established principles, and then its performance is validated against reference methods, rather than being "trained" in the machine learning sense.

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

Since no training set is mentioned in the context of machine learning, the question of how its ground truth was established is not applicable here. The device's underlying principles are based on established microbiology methods, and its performance is validated against a reference standard.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 -- 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Synercid, at concentrations of 0.12 to 8 µg/ml Long Dilution Sequence and 0.12 – 2 µg/ml 5-Dilution Breakpoint Sequence, for Enterococcus faecium and Staphylococcus spp., to the test panel.

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

• Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains only) .
• Staphylococcus aureus (methicillin-susceptible strains only)

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

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

The provided text describes the 510(k) submission for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Synercid, which is a device used to determine antimicrobial agent susceptibility.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text states that "The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates or strains used for the test set is not explicitly provided.
• Data Provenance: The study involved "external validation," implying that the data was collected from a source external to the device manufacturer's core development environment. The origin of the data (e.g., specific countries or regions) is not mentioned. The isolates included "fresh and stock Efficacy isolates" and "stock Challenge strains," indicating a mix of types that likely included both clinical isolates and characterized strains. The study design sounds retrospective in the sense that existing "stock" strains and isolates were used, but the testing itself was performed prospectively with the device.

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

The text does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. It mentions a comparison with a "frozen Reference panel" and "Expected Results determined prior to the evaluation" for challenge strains. This implies that the ground truth was established by a reference method, likely involving expert consensus or a gold standard test, but the details of this process are not described.

4. Adjudication Method for the Test Set

The text does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The ground truth was established through comparison with a "frozen Reference panel" and "Expected Results," which are likely predetermined values based on established methods, rather than an expert adjudication process for each individual test result in the context of this type of device.

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 type of study is typically associated with medical imaging or diagnostic devices where human readers interpret results, and the AI assists in that interpretation. For Antimicrobial Susceptibility Testing (AST) panels, the device itself provides the result, and performance is measured against a reference method rather than human interpretation alongside the device.

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

Yes, a standalone performance evaluation was done. The "overall Essential Agreement of 97.4%" was reported for the MicroScan® Synergies plus™ Gram-Positive Panel when compared with the frozen Reference panel. This directly assesses the device's accuracy in determining MIC values without human intervention in the result generation or interpretation process beyond loading the samples and the machine reading the results. The panels are read by "MicroScan® Instrumentation," indicating automated reading.

7. The Type of Ground Truth Used

The ground truth used was primarily a reference method comparison. Specifically:

• For efficacy isolates, the device's performance was compared to a "frozen Reference panel." This "Reference panel" itself would have been established using a recognized gold standard method for antimicrobial susceptibility testing.
• For challenge strains, the device's results were compared to "Expected Results determined prior to the evaluation." These "Expected Results" would also be derived from established reference methods for those specific strains.

The text specifies that the comparison was "as defined in the FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA', dated February 5, 2003," which outlines the standard for such reference methods.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for a training set. This is a 510(k) summary focused on performance validation against a predicate device, not on the underlying development or training of an algorithm (if one were used in a way that required a distinct training set, which is less common for traditional MIC panels compared to more complex AI systems).

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

Since information about a separate "training set" and its sample size is not provided, the method for establishing its ground truth is also not described. For this type of AST device, the "training" may implicitly refer to the development and optimization of the panel formulations and reading algorithms, which would have relied on general microbiological principles and possibly internal datasets, but not necessarily a formally defined "training set" in the context of a public submission like this.

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The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SZ, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial nitrofurantoin, at concentrations of 2 to 256 ug/ml, for enterococci and staphylococci, to the test panel.

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

Enterococcus species Staphylococcus aureus

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

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

1. Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the exact sample size used for the test set. It mentions "external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the specific number of isolates is not quantifiable from the given information.

The data provenance is from an external validation study. The location of this study (e.g., country of origin) is not specified. The study appears to be retrospective in that it uses "stock Efficacy isolates and stock Challenge strains," suggesting they were collected prior to the study.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance of the device was compared against a "frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains. This suggests an objective, standardized reference method was used rather than expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison to a "frozen Reference Panel" and "Expected Results," not through human adjudication.

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

No. The provided text describes a study evaluating the performance of an automated antimicrobial susceptibility testing system against a reference method. It does not involve human readers evaluating cases or comparing human performance with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Yes, this was a standalone performance study. The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels system is an automated device designed to determine antimicrobial susceptibility. The study evaluated the performance of this automated system directly (algorithm only) against a reference method.

7. Type of Ground Truth Used

The ground truth was established by comparison to a "frozen Reference Panel" and "Expected Results" for challenge strains. This implies a standardized, objective, and predefined reference for antimicrobial susceptibility.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The focus is on the validation of the device's performance against a reference.

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

Not applicable, as no training set information is provided.

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The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO, incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin, at concentrations of 0.25 to 64 µg/ml, to the test panel.

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

• Enterococcus spp. (e.g., Enterococcus faecalis)
• Staphylococcus spp.
• Staphylococcus aureus (including methicillin-resistant strains)
• Staphylococcus epidermidis (including methicillin-resistant strains)

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

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

Here's a breakdown of the acceptance criteria and study details for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with vancomycin:

Description of the Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with vancomycin are designed to determine the antimicrobial agent susceptibility of gram-positive staphylococci and enterococci using a microdilution minimum inhibitory concentration (MIC) method. The device's performance was evaluated against a frozen Reference Panel, as per FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems."

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document explicitly states the overall Essential Agreement, reproducibility, and quality control. Specific numerical thresholds for "acceptable" reproducibility and QC are not provided in this summary but are generally defined in the referenced FDA guidance document.

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

• Test Set Sample Size for Efficacy (Rapid Read Method): 507 isolates.
• Provenance: The study used "fresh and stock Efficacy isolates and stock Challenge strains." The specific country of origin is not specified but it's an "external evaluation," implying data collected outside of the manufacturing site, most likely within the US given the FDA submission. The nature of "fresh" and "stock" isolates indicates a mix of prospectively collected and potentially retrospectively stored (stock) samples.

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

• This information is not provided in the summary. For AST panels, the "ground truth" is typically established by comparative testing against a recognized reference method (e.g., broth microdilution or agar dilution as per CLSI guidelines), often performed by trained microbiologists. The "Expected Results" for challenge strains would have been determined using such reference methods.

4. Adjudication Method for the Test Set

• This information is not provided. In AST studies, direct adjudication of results in the traditional sense (like in image reading) is less common. Instead, the comparison is directly between the device's MIC determination and the reference method's MIC, and agreements/disagreements are categorized based on defined criteria (Essential Agreement, Categorical Agreement).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• No. This type of study (MRMC, AI assistance) is not applicable to this device. This device is an automated antimicrobial susceptibility test system, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

• Yes, indirectly. The "Rapid read method" describes the automated instrumental reading of the panels. The performance claims are based on this automated rapid read. While human involvement is required for initial inoculum preparation and loading, the reading and interpretation for performance claims are automated. The summary also notes that "Overnight Instrument and Manual read method(s) Essential Agreement & Categorical Agreement percentages were of equal, or greater, values than the Rapid read method," indicating other reading methods were also assessed, but the primary claims are based on the automated rapid read.

7. The Type of Ground Truth Used

• Reference Panel: The ground truth was established using a frozen Reference Panel. This reference panel serves as the gold standard for comparison, with results typically derived from established reference methods for antimicrobial susceptibility testing (e.g., broth microdilution methods conforming to CLSI standards). For "Challenge strains," the ground truth was "Expected Results determined prior to the evaluation," which would have been established by similar reference methods.

8. The Sample Size for the Training Set

• This information is not provided in the summary. For AST devices, there isn't typically a "training set" in the machine learning sense, as the device operates based on predefined biochemical reactions and algorithms rather than learning from data in a training phase. The "efficacy isolates" and "challenge strains" are primarily for validation/testing.

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

• As a "training set" in the machine learning context is not applicable, the method for establishing ground truth for a training set is not relevant here. The ground truth for the evaluation was established using a frozen Reference Panel and pre-determined expected results for challenge strains, which are standard reference methods for AST.

Ask a specific question about this device

The MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin, at concentrations of 0.12 to 16 ug/ml, 0.5-4 ug/ml and 0.5-1, 4 ug/ml for Staphylococci, to the test panel.

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

Staphylococcus aureus

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The text states that the external validation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." However, the specific sample size (number of isolates/strains) used for the test set is not provided. The data provenance is not explicitly stated as country of origin, but it is clear that it was a prospective study as it describes an "external validation" designed to "confirm the acceptability of the proposed" panel.

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

This information is not provided in the document. The ground truth for the test set was established by a "frozen Reference Panel" and "Expected Results" for challenge strains, but details about the experts involved in creating these references are missing.

4. Adjudication Method for the Test Set:

This information is not provided. The comparison was made to a "frozen Reference Panel" and "Expected Results," but the method of adjudication (e.g., how discrepancies between the test device and the reference were resolved or if there was any expert review of results) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:

This was not an MRMC comparative effectiveness study. The device described is an automated antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that helps human readers. Therefore, there is no information about human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The device is an automated system that determines antimicrobial susceptibility. The study describes the performance of the "MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel" itself, comparing its readings to a reference panel, indicating an algorithm-only performance. The "MicroScan® Instrumentation" is mentioned as reading the panels, further supporting this.

7. The Type of Ground Truth Used:

The ground truth used was based on a "frozen Reference Panel" for efficacy isolates and "Expected Results" for stock challenge strains. These reference methods represent a form of expert consensus or established laboratory standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

The sample size for the training set is not provided. The document focuses on the validation study.

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

This information is not provided. The document describes the validation of the device against reference methods but does not detail how any potential training data or the associated ground truth for such data (if applicable to the development process) was established.

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