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The MicroScan® Synergies plus™ Gram-Negative 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-negative bacilli. 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 AST portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Cefazolin, at concentrations of 0.5 to 32 ug/ml, to the test panel.

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

Escherichia coli Klebsiella spp. Proteus mirabilis

The MicroScan® Synergies plus" Gram-Negative Panels with Cefazolin is not intended for use with:

• Klebsiella oxytoca Enterobacter spp. Citrobacter freundii Morganella morganii Proteus vulgaris
  Proteus penneri Providencia spp Serratia spp Yersinia enterolitica

MicroScan® Synergies plus™ Gram-Negative 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-negative bacilli.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton 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 the WalkAway® S7 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.

The MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Cefazolin are designed to determine antimicrobial agent susceptibility. The device's performance was compared to an NCCLS frozen Reference Panel.

Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" but does not specify the exact number of samples used for the external evaluation.
• Data Provenance: The document does not explicitly state the country of origin. The study was a "external evaluation." It utilized both "fresh and stock Efficacy isolates" (implying a mix of recent clinical samples and archived ones) and "stock Challenge strains" (controlled, known strains). This suggests a mixed approach, potentially incorporating both retrospective and prospective elements for the "efficacy isolates" and a controlled retrospective aspect for the "challenge strains."

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

The document does not provide information on the number of experts or their qualifications. The "Expected Results" for the Challenge strains were determined prior to the evaluation, which implies expert consensus or adherence to established standards, but explicit details are not given.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method. It compares the device's performance to an "NCCLS frozen Reference panel" and "Expected Results" for challenge strains. This suggests the reference panel and expected results served as the "ground truth" against which the device was evaluated, rather than an adjudication process between different readers or methods.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of the automated system against a reference method, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was done. The document describes the "external evaluation" where the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel's performance was compared directly with an NCCLS frozen Reference Panel and Expected Results for challenge strains. This is a standalone evaluation of the algorithm/device's performance.

7. Type of Ground Truth Used

The ground truth used was primarily a reference standard: an "NCCLS frozen Reference panel" for efficacy isolates and "Expected Results" for challenge strains. The NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) sets recognized standards for antimicrobial susceptibility testing, making their reference panel a strong gold standard.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description focuses on the evaluation of the device's performance after its development. It's likely that proprietary data was used for developing and training the underlying algorithms, but these details are not provided in the 510(k) summary.

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

The document does not provide information on how the ground truth for any potential training set was established.

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MicroScan® Synergies plus™ Gram-Negative 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-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Ceftriaxone on the Synergies plus™ "Gram-Negative MIC/Combo Panels.

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

Acinetobacter calcoaceticus Escherichia coli Enterobacter spp. (except Enterobacter cloacae) Klebsiella pneumoniae Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia spp. Pseudomonas aeruginosa Serratia marcescens Shigella spp. Salmonella spp.

The MicroScan® Synergies plus™ Gram-Negative with Ceftriaxone is not intended for use with:

Citrobacter son Enterobacter cloacae Proteus vulgaris

MicroScan® rapID/S plus™ Gram-Negative 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-negative bacilli. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SY System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

This document describes the 510(k) premarket notification for the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ceftriaxone. It details the device's intended use and provides a summary of the performance study conducted.

Here is an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a tabulated format with specific pass/fail thresholds. However, it does report performance metrics that imply the criteria met for substantial equivalence.

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

• Sample Size for Test Set: The document mentions "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates/samples used in the test set is not specified.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "external evaluation," and given the FDA approval, it's reasonable to assume the study was conducted to meet US regulatory requirements. The study appears to be retrospective, using "fresh and stock Efficacy isolates and stock Challenge strains."

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

This information is not provided in the document. The ground truth was established by an "NCCLS frozen Reference Panel." The document doesn't detail how this reference panel's results were determined or if expert consensus was involved in its creation.

4. Adjudication method for the test set

This information is not provided in the document.

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 MRMC study was done. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool involving human readers interpreting results. It determines MIC values autonomously.

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

• Yes, a standalone performance study was done. The device (MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels read on the WalkAway® System) was compared against an "NCCLS frozen Reference Panel" without human intervention in the result interpretation from the device itself. The "human-in-the-loop" aspect for this type of device typically involves preparing the inoculum and loading the panels, but the reading and interpretation of MICs are automated.

7. The type of ground truth used

• The ground truth used was an NCCLS frozen Reference Panel. This type of reference standard is typically established through a standardized, highly controlled laboratory method (e.g., broth microdilution or agar dilution) performed by experienced microbiologists, potentially following guidelines set by organizations like the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS).

8. The sample size for the training set

• The document does not specify a training set size. For an antimicrobial susceptibility device, the "training" aspect is more about assay development and optimization rather than machine learning algorithm training with distinct datasets. The performance evaluation focuses on the test set of isolates.

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

• As a training set is not explicitly mentioned in the context of typical machine learning, this question is not directly applicable. If "training" refers to the development of the device's reading algorithms, the ground truth for establishing those algorithms would have been based on established phenotypic antimicrobial susceptibility testing methods. However, the document does not detail this developmental process.

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