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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator. Results are read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/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. (including Staphylococcus aureus)
Staphylococcus epidermidis (including methicillin-resistant strains)
Streptococcus agalactiae
Streptococcus bovis

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

This solicitation is for the addition of the antimicrobial vancomycin at concentrations of 0.25 to 128 mcg/ml to MicroScan® Dried Gram-Positive MIC/Combo Panels.

1. Table of Acceptance Criteria & Reported Device Performance:

2. Sample Size & Data Provenance:

• Test Set Sample Size: The document does not specify the exact number of isolates used for the external evaluation. It mentions "fresh and stock Efficacy isolates and stock Challenge strains."
• Data Provenance: Not explicitly stated, but "external evaluation" suggests different sites. The document implies a multicenter evaluation, as it refers to "external evaluation" in plural sense, and thus suggests multicenter data.
• Retrospective/Prospective: Not explicitly stated. The use of "fresh and stock Efficacy isolates" suggests a mix, where "fresh" could imply prospective collection for the study, while "stock" would be retrospective.

3. Number of Experts & Qualifications for Ground Truth (Test Set):

• The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Instead, it refers to a "CLSI (formerly NCCLS) frozen Reference Panel" as the gold standard.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth was established by comparison to a reference standard (CLSI frozen Reference Panel), not through expert adjudication of images/data from the device. "Challenge strains were compared to Expected Results determined prior to the evaluation".

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the standalone performance of the device against a reference method.

6. Standalone Performance Study:

• Yes, a standalone (algorithm only) performance study was conducted. The MicroScan® Dried Gram-Positive MIC/Combo Panel's performance was compared directly to a CLSI frozen Reference Panel.

7. Type of Ground Truth Used:

• Reference Standard: CLSI (Clinical and Laboratory Standards Institute, formerly NCCLS) frozen Reference Panel. This is considered a gold standard for antimicrobial susceptibility testing. For challenge strains, "Expected Results" determined prior to the evaluation were used.

8. Sample Size for the Training Set:

• Not applicable for this type of device and study. Antimicrobial susceptibility test (AST) systems are typically validated against established reference methods (like CLSI) rather than being "trained" in the machine learning sense. The device's underlying principles are based on broth dilution, not a trainable algorithm.

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

• Not applicable (see point 8). The "ground truth" for the development of the AST system itself would be the established scientific principles of antimicrobial activity and bacterial growth inhibition, as defined and standardized by organizations like CLSI.

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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for a revised QC range of ≥ 0.5 mcg/ml for S. aureus ATCC #29213 with Ampicillin.

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

Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing) Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphyloccus saprophyticus (beta-lactamase and non-beta-lactamase producing) Streptococcus faecalis (Enterococcus) Streptococcus pyogenes

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in a non-CO, incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram-Positive MIC/Combo Panel, based on the provided documents:

The 510(k) submission (K020140, later referenced as K020160) is specifically for a revised Quality Control (QC) range for Ampicillin with S. aureus ATCC 29213 on an already marketed device, the MicroScan® Dried Gram-Positive MIC/Combo Panel. Therefore, the information primarily focuses on validating this specific QC range change rather than the entire device's performance.

1. A table of acceptance criteria and the reported device performance

The document states that the proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstrated "substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document 'Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices', dated March 8, 2000."

While specific numerical acceptance criteria for the revised QC range are not explicitly detailed in the provided text, the standard for antimicrobial susceptibility devices typically involves:

• Essential Agreement (EA): Agreement within +/- 1 two-fold dilution between the test device and the reference method.
• Categorical Agreement (CA): Agreement in the interpretive category (Susceptible, Intermediate, Resistant) between the test device and the reference method.
• Discrepancy Rates: Acceptable rates for Very Major Errors (VME), Major Errors (ME), and Minor Errors (mE). VME occurs when a resistant isolate is reported as susceptible. ME occurs when a susceptible isolate is reported as resistant. mE occurs when an intermediate isolate is reported as susceptible or resistant, or vice versa.
• Quality Control (QC) Range Agreement: The QC results must fall within the established acceptable range.

Given this submission is for a revised QC range, the acceptance criteria would primarily revolve around validating the new range for Ampicillin with S. aureus ATCC 29213. This typically means that a high percentage of QC tests performed with the new range must fall within the specified bounds, demonstrating adequate reproducibility and accuracy for internal quality control.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact sample size for the test set used to validate the revised QC range. It only broadly refers to "data in support of a revised Quality Control range." For AST devices, test sets typically involve a significant number of clinical isolates and challenge organisms. However, for a QC range revision, the sample size would focus on repeated testing of the S. aureus ATCC 29213 strain.
• Data Provenance: Not specified in the provided text. It's likely a controlled laboratory study, but the country of origin or whether it was retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For antimicrobial susceptibility testing, the "ground truth" (or reference method) is typically established by well-defined reference broth microdilution methods, often performed by trained microbiologists following standardized protocols, not individual "experts" in the same sense as image interpretation. The document mentions comparison to "an NCCLS frozen Reference Panel," which implicitly establishes the reference method.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are used for resolving disagreements among human readers in studies, particularly in image interpretation, where subjective decisions are made. For a quantitative test like MIC determination, the NCCLS (now CLSI) reference method provides the objective "ground truth" against which the device is measured.

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

This information is not applicable. The device is a diagnostic an in vitro diagnostic (IVD) device for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant here.

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

The device is an automated or semi-automated system for determining Minimum Inhibitory Concentrations (MICs). While it can be read visually, the "MicroScan instrumentation" implies an automated reading component. The "substantially equivalent performance" claim would inherently reflect the standalone performance of the device (or its automated reading capabilities if used) compared to the reference standard. The study validates the device's ability to accurately determine MICs, which is its standalone function.

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

The ground truth used is an NCCLS frozen Reference Panel. This implies that the reference method is based on the National Committee for Clinical Laboratory Standards (NCCLS, now Clinical and Laboratory Standards Institute - CLSI) standard broth microdilution method, which is the recognized gold standard for antimicrobial susceptibility testing. The frozen reference panels are carefully prepared and verified to ensure accurate MICs.

8. The sample size for the training set

The document does not provide information about a "training set." For this type of IVD device, the development process would involve internal validation and optimization, but the 510(k) summary focuses on the performance of the finalized device (the "test set" in broader terms) against a recognized reference method. It's less about training a machine learning model and more about validating the analytical performance of a chemical/biological assay.

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

As there's no explicit mention of a "training set" in the context of machine learning, this question is not directly applicable. For the overall development of the MicroScan panels, the "ground truth" for calibrating and developing the various antimicrobial concentrations and interpretive criteria would have been established through extensive studies using standard reference methods (like NCCLS/CLSI broth microdilution) over many years, against a wide range of bacterial isolates.

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The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for a revised QC range of ≥ 0.25 mcg/ml for S. aureus ATCC 29213 with Penicillin.

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

Staphylococci (except penicillinase-producing strains)
Streptococci (group A)

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and acceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution usceptibility tost that have been diluted in broth and deliyated. Vanous anninorotat agents are diluted in broth to concentrations bridging the range of chilical interest: Tancis are rears are 16-20 hours, the minimum suspension of the organism. After incubation in a non-CO2 incubation the lowest antimi suspension of the organism. After incuration in a non- Organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

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

Note: The provided document is a 510(k) summary and FDA clearance letter, which means it describes the device and its intended use, but does not contain the full study report with detailed acceptance criteria, sample sizes, and ground truth information. The information below is extracted from what is available in the provided text.

Description of the Acceptance Criteria and the Study

The submission focuses specifically on a revised Quality Control (QC) range for Penicillin (≥0.25 mcg/ml) for S. aureus ATCC 29213 when used with the MicroScan® Dried Gram-Positive MIC/Combo Panels.

The study aimed to demonstrate that the proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with the revised QC range for Penicillin is substantially equivalent in performance to an NCCLS (National Committee for Clinical Laboratory Standards, now CLSI) frozen Reference.

The general principle of the device is to determine antimicrobial agent susceptibility by miniaturized broth dilution. Antimicrobial agents are diluted in broth, and a suspension of the organism is added. After incubation, the lowest antimicrobial concentration showing inhibition of growth (Minimum Inhibitory Concentration - MIC) is determined.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the specific acceptance criteria for the S. aureus ATCC 29213 with Penicillin QC range are mentioned as:

Specific quantitative acceptance metrics (e.g., essential agreement, category agreement percentages) are not provided in the summary. The statement "demonstrates equivalent performance" is a general claim based on the FDA's guidance document for such devices.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study refers to "assessments data in support of a revised Quality Control (QC) range," implying data collected for this purpose.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (This type of study typically involves laboratory personnel, but their qualifications are not detailed here).

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. For QC range verification, it's typically a direct comparison, rather than an adjudication process between multiple human readers evaluating a result.

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

• Was an MRMC study done? No.
• Effect size of human reader improvement: Not applicable, as this is a device for automated/semi-automated susceptibility testing, not a diagnostic imaging aid for human readers.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, inherently. The "demonstrates equivalent performance" claim is for the device (algorithm/system) itself in comparison to a reference standard, without direct human intervention in the MIC determination process after inoculation. The panels can be read visually or with MicroScan instrumentation, but the comparison is directly between the MicroScan panel's result and the reference method.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established using an NCCLS frozen Reference method. The document refers to the "FDA DRAFT document 'Guidance on Review Criteria for Assessments data...'" for Antimicrobial Susceptibility Devices, indicating that this reference method is a recognized standard for establishing ground truth in this context.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. The document focuses on demonstrating the performance of the pre-developed device with a specific QC range, rather than describing the development/training of the device itself.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established (Training Set): Not applicable/not specified. The document describes a performance evaluation of an existing product with a revised QC range, not the initial development or training phase where a "training set ground truth" would typically be detailed. The device itself (broth dilution method) is a well-established technology; the submission is for a specific product and a revised QC parameter within it.

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To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid.

Organisms with indications for testing include:

FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99)

Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A)

FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99).

Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Microdilution Minimum Inhibitory Concentration (MIC) Panel

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

Acceptance Criteria and Device Performance

Note: The specific numerical thresholds for "acceptable" reproducibility and Quality Control performance are not provided in the document.

Study Details

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

   • The study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluations.
   • The exact sample size (number of isolates/strains) is not specified.
   • The provenance is not explicitly stated (e.g., country of origin) but the study was an "external evaluation," implying independent data collection. The data is retrospective, as "stock isolates" and "stock challenge strains" were used.

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

   • Not applicable/Not mentioned. The ground truth was established by comparison to a "NCCLS frozen Synercid Reference panel," which is a standardized method, not human expert consensus.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The comparison was against a reference panel, not requiring human adjudication of discrepancies.

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) panel, which is a laboratory device, not an AI-based diagnostic tool for human readers.

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

   • Yes, this was a standalone performance study of the device (MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid). Its performance was compared directly to a "NCCLS frozen Synercid Reference panel." The "human-in-the-loop" aspect would involve the lab technician performing the test, but the evaluation is of the device's output accuracy against a reference.

6. The type of ground truth used:

   • Reference Standard: The ground truth was established by an "NCCLS frozen Synercid Reference panel." This is a recognized and standardized reference method for antimicrobial susceptibility testing.

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic testing panel, not an AI model that requires a training set in the conventional sense. The "training" of such a device is in its manufacturing and calibration process, not through a data-driven model training phase.

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

   • Not applicable, as there is no training set in the context of an AI model. The device's design and manufacturing rely on established microbiological and chemical principles, with performance validated against reference standards.

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To determine antimicrobial agent susceptibility
To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Positive Bacteria Viridans group streptococci
Although viridans streptococci are indicated for testing* with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScun Dried Gram-Positive MIC/Combo Panels.

• As taken from the Indications and Usage section of each manufacturers' package insert (Zeneca).

Microdilution Minimum Inhibitory Concentration (MIC) Panels
MicroScan® Dried Gram-Positive MIC/Combo Panels

The provided text describes the 510(k) submission for the Dade MicroScan Inc. MicroScan Dried Gram-Positive MIC/Combo Panels with Meropenem. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document references "FDA DRAFT document 'Review Criteria for Assessment of Antimicrobial Susceptibility Devices' (dated May 31, 1991)" as defining the acceptability. Specific numerical thresholds for "acceptable reproducibility" and "acceptable quality control performance" are not explicitly stated in this summary.

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of isolates or tests. The document mentions "gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number is not provided.
• Data Provenance: The evaluations were "external", but the country of origin is not specified. The data is retrospective as it involves testing with "fresh and stock Efficacy isolates and stock Challenge strains" that were pre-existing.

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.

4. Adjudication Method for the Test Set:

• The ground truth was established by comparison with an "NCCLS frozen Meropenem Reference panel." This implies a reference standard rather than human adjudication of results from the device itself. No explicit human adjudication method (e.g., 2+1, 3+1) is mentioned.

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the device against a reference method, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Yes, the described study is effectively a standalone performance evaluation. The device (MicroScan Dried Gram-Positive MIC/Combo Panel with Meropenem) is evaluated for its ability to determine antimicrobial susceptibility independently, without human-in-the-loop interaction for the primary measurement. The overall Essential Agreement of 97.2% is a measure of its standalone performance against a reference.

7. Type of Ground Truth Used:

• The ground truth used was a reference standard: the "NCCLS frozen Meropenem Reference Panel." This is a laboratory-based, established method for determining antimicrobial susceptibility.

8. Sample Size for the Training Set:

• The document does not provide information about a separate "training set" or its sample size. The description refers to evaluation against a reference panel, indicating a validation or verification study rather than a development and training process for an AI/algorithm in the contemporary sense. This product precedes modern AI development frameworks.

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

• As no training set is described, this information is not applicable based on the provided document. The device's performance was compared to an NCCLS reference method for validation.

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To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus

Microdilution Minimum Inhibitory Concentration (MIC) Panels

This document describes the acceptance criteria and the study that proves the MicroScan® Dried Gram-Positive MIC/Combo Panels with Sparfloxacin meet those criteria.

1. Table of acceptance criteria and the reported device performance:

   Performance Metric	Acceptance Criteria (implied from predicate)	Reported Device Performance
   Essential Agreement	Substantially equivalent performance compared to NCCLS frozen Sparfloxacin Reference Panels (implied overall >90%)	98.4% overall Essential Agreement
   Reproducibility	Acceptable reproducibility and precision	Acceptable reproducibility and precision across inoculum methods (Turbidity, Prompt) and instruments (autoScan-4, WalkAway Systems)
   Quality Control	Acceptable Quality Control performance	Acceptable Quality Control performance

   Note: The specific numerical acceptance criteria for Essential Agreement were not explicitly stated in the provided text but are implied by the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991), which typically requires high agreement for such devices.

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

   • Sample Size: Not explicitly stated. The study used "fresh and stock Efficacy isolates and stock Challenge strains" for gram-positive external evaluations.
   • Data Provenance: Not explicitly stated, but given this is a US regulatory submission, it is highly likely the data was generated in the US or in compliance with US regulatory standards. The study appears to be prospective in the sense of evaluating the new Sparfloxacin panel against a reference standard in a controlled manner, though the originating isolates (efficacy and challenge strains) could have been collected retrospectively.

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

   • This is not applicable as the "ground truth" was established by a reference method (NCCLS frozen Sparfloxacin Reference Panels), not by individual expert consensus readings of data.

4. Adjudication method for the test set:

   • Not applicable, as the evaluation was a direct comparison to a reference standard, not an expert consensus process.

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

   • Not applicable. This is a study for an antimicrobial susceptibility device, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, this was a standalone performance study of the MicroScan® Dried Gram-Positive MIC/Combo Panels compared to a reference method. Human interpretation of the panel results is inherent to its use, but the study itself is evaluating the device's accuracy against a gold standard, not human performance with or without the device.

7. The type of ground truth used:

   • Reference Method: The "ground truth" was established by the NCCLS frozen Sparfloxacin Reference Panels. This is a recognized standard method for determining antimicrobial susceptibility.

8. The sample size for the training set:

   • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a training set in that context. The "development" of the panel would involve internal optimization, but there isn't a "training set" in the sense of AI/ML.

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

   • Not applicable (see point 8).

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