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The MicroScan® Dried Gram Negative Panel is designed for use in the Confirmation of Extended-Spectrum Beta-Lactamase (ESBL) production in Escherichia coli, Klebsiella spp. and Proteus mirabilis.

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 the use of cefotaxime (2, 16 µg/ml), cefotaxime/clavulanic acid (0.5/4, 4/4 µg/ml), ceftazidime (1, 8 µg/ml) and ceftazidime/clavulanic acid (0.25/4, 2/4 µg/ml) for ESBL confirmatory testing on MicroScan® Dried Gram Negative MIC/Combo Panels and the addition of automated read methods.

The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:

Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis

MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp. and P. mirabilis.

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 at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

The provided 510(k) summary focuses on the MicroScan® Dried Gram Negative MIC/Combo Panels for confirming Extended-Spectrum Beta-Lactamase (ESBL) production. The study details are specific to this device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a precise numerical sample size for the "test set" (referred to as "stock challenge strains" within "Design Validation studies"). It mentions "ESBL and non-ESBL-producing strains." Without a specific number, it is impossible to definitively detail the sample size.
• Data Provenance: The data appears to be prospective as it's generated from "Challenge studies" and "Design Validation studies" specifically conducted to confirm the acceptability of the streamlined dilutions. The country of origin of the data is not specified, but given the manufacturer (Dade Behring Inc.) and the FDA submission, it's likely primarily US-based or international data submitted to the FDA for US market clearance.

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

• The ground truth for the test set was established by "molecular characterization." This implies laboratory-based genetic or biochemical testing, not human expert interpretation of images or clinical findings. Therefore, the concept of "number of experts" and their "qualifications" in the traditional sense (e.g., radiologists) is not applicable here. The ground truth relies on the accuracy and established validity of the molecular characterization methods themselves.

4. Adjudication Method for the Test Set:

• Since the ground truth was established by "molecular characterization," the concept of an "adjudication method" involving multiple human readers (like 2+1, 3+1) is not applicable. The molecular characterization itself serves as the definitive reference, and the device's results are compared directly against it.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context typically seen for diagnostic imaging tools involving human readers. This device is an in-vitro diagnostic (IVD) for bacterial susceptibility testing, where the "reader" can be manual or an automated instrument. The study did assess "reproducibility" across "manual, WalkAway® and autoSCAN®-4 instruments," which addresses variation in reading methods but not human diagnostic improvement with AI assistance.
• Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable here because it's not an AI-assisted diagnostic task for visual interpretation by humans.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance study was conducted. The "Overall Agreement of > 93% with ESBL and non-ESBL-producing strains" was determined by comparing the "panel confirmation result" (the device's output) directly against the "molecular characterization result" (the ground truth). This is a standalone assessment of the device's accuracy without human intervention influencing the final classification, other than the initial setup and reading of the panel, which can be automated.

7. Type of Ground Truth Used:

• The ground truth used was molecular characterization (described as "molecular characterization result"). This refers to laboratory techniques (e.g., PCR, sequencing, enzyme assays) that identify the presence or absence of ESBL-producing genes or enzymes, providing a definitive biological determination.

8. Sample Size for the Training Set:

• The document does not explicitly state a sample size for a "training set." This type of device (microdilution panels) is typically developed and validated based on established microbiological principles and chemical formulations rather than machine learning models that require distinct training and test sets. The studies described are validation and challenge studies, which assess the performance of the final device, not the iterative training of an algorithm.

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

• As there's no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The development of such panels relies on a priori chemical and biological knowledge, and subsequent validation against well-characterized reference strains and clinical isolates. The "molecular characterization" served as the gold standard for the validation/test set.

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The MicroScan® Dried Gram Negative Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and screening for suspected ESBL production in E. coli, Klebsiella spp and P. mirabilis.

The MicroScan® ESBL plus Dried ESBL Confirmation Panel is designed for use in the determination of antimicrobial susceptibilities of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in E. coli, Klebsiella spp and P. mirabilis.

After inoculation, panels are incubated for a minimum of 16 hours at 35℃ in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the addition of P. mirabilis to the intended use of the antimicrobics: cefpodoxime (0.015-64 µgml), ceftazidime (0.5-128 µg/ml) and cefotaxime (0.5-128 ug/ml) for ESBL screening, and for the antimicrobics ceftazidime (0.5-128 µg/ml), ceftazidime/clavulanic acid (0.12/4-32/4 µg/ml), cefotaxime (0.5-128 ug/ml) and cefotaxime/clavulanic acid (0.12/4-32/4 µg/ml) for ESBL confirmation.

The Gram Negative organisms which may be used for screening of suspected of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis

The Gram Negative organisms which may be used for confirmation of ESBL production in this panel are:
Escherichia coli
Klebsiella oxvioca
Klebsiella pneumoniae
Proteus mirabilis

MicroScan® Dried Gram Negative MIC/Combo Panels are designed for use in determining quanfitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and screening for suspected ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility for Gram Negative organisms and confirmation of ESBL production in E. coli, Klebsiella spp., and P. mirabilis.

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 at 35 °C for a minimum of 16 hours. the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

Here's a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram Negative MIC/Combo Panels, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "both fresh and stock isolates and stock challenge strains" were used, but does not specify the exact sample size for the test set.

• Data Provenance: The document does not explicitly state the country of origin. The study appears to be retrospective as it compares panel results against established reference methods (CLSI frozen Reference result or molecular characterization result).

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It refers to CLSI document M100-S16 and molecular characterization results as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving multiple readers. The comparison is between the device's results and a single reference ground truth (CLSI or molecular characterization).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the device's performance against a reference standard, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, the study describes standalone performance of the device. The "dried Test panel antimicrobial agents demonstrated an overall Agreement of > 90% for both screen and confirmation" when compared against reference methods, indicating the device itself was evaluated. There is no mention of a human-in-the-loop component for the performance evaluation described.

7. Type of Ground Truth Used

The ground truth used was:

• CLSI frozen Reference result
• Molecular characterization result (Challenge)

8. Sample Size for the Training Set

The document does not specify a separate training set sample size. The study describes "Efficacy and Challenge studies" and "Design Validation studies," but these appear to be primarily for performance evaluation against the established ground truth rather than a distinct training phase for an algorithm. This device is a pre-formed panel, not a software algorithm that would typically require a training set in the modern sense.

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

As no distinct training set is described for an algorithm, the method for establishing ground truth for a training set is not applicable in this context. The document focuses on demonstrating the device's performance against established reference standards (CLSI and molecular characterization).

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The MicroScan® Dried 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. Panels are incubated for 16 - 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.

The Gram-Negative organisms which may be used for Amoxicillin/K. Clavulanate susceptibility testing in this panel are:

Enterobacter species
Escherichia coli
Klebsiella species
Proteus mirabilis

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a change to a currently marketed device, specifically the performance evaluation for a reformulated antimicrobial agent (Amoxicillin/K. Clavulanate) on MicroScan® Dried Gram-Negative MIC/Combo Panels.

It describes the FDA's decision to clear the device, but it does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in the manufacturer's submission or a separate study report.

Therefore, I cannot provide the requested information from the text you provided. The document focuses on the regulatory outcome rather than the specifics of the underlying performance study.

To answer your request, I would need access to the actual 510(k) submission document (e.g., the "traditional 510(k)" or "special 510(k)" submission) prepared by Dade MicroScan Inc. This submission would contain the detailed study protocols, results, and analysis.

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For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

This submission requests clearance of the following new Indication for Use:

Panels containing Cefpodoxime, Ceftazidime, Aztreonam Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to screen for Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).

An alternate method is required for confirmation testing.

Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone.

This document describes the acceptance criteria and the study conducted for MicroScan® Dried Gram Negative MIC/Combo Panels with certain antimicrobial agents to detect suspected Extended-Spectrum Beta-Lactamases (ESBLs) in specific bacterial strains.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity/specificity thresholds). However, it implies acceptable performance based on reproducibility and quality control. The efficacy study aimed to confirm acceptability by comparing panel results against molecular characterization data.

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

• Test Set Sample Size: The document states that the efficacy testing was conducted with "ESBL and non-ESBL producing strains and AmpC-type strains." The exact number of strains used in the test set is not specified in the provided text.
• Data Provenance: Not explicitly stated. The document refers to "previously generated molecular characterization data," but the origin (e.g., country, specific labs) is not detailed. The study itself appears to be conducted by Dade MicroScan Inc. (USA). The study is retrospective in the sense that molecular characterization data was "previously generated," and the panel results were compared against this existing data.

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

This information is not provided. The ground truth ("molecular characterization data") was "previously generated," but details on the experts involved in establishing this ground truth are absent.

4. Adjudication Method for the Test Set

This information is not provided. The comparison was against "previously generated molecular characterization data," implying a direct comparison rather than an adjudication process between human readers/interpreters within the scope of the device's performance evaluation.

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

No, an MRMC comparative effectiveness study, as typically understood for human readers, was not performed. This study focuses on the in vitro diagnostic device's ability to detect ESBLs by comparing its results to a ground truth (molecular characterization data), not on how human readers perform with or without AI assistance.

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

Yes, this study represents a standalone performance evaluation of the MicroScan® Dried Gram Negative MIC/Combo Panels. The device itself (the panel and its interpretation via instrument) is being evaluated for its ability to detect ESBLs, independent of human interpretation or assistance beyond the standard operation of the instrument.

7. The Type of Ground Truth Used

The ground truth used was molecular characterization data. The document states, "...comparing the panel susceptibility results against previously generated molecular characterization data." This suggests genetic or biochemical testing to definitively identify ESBL-producing strains.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or detail for algorithm development or machine learning. The study focuses on evaluating the performance of existing panels for a new indication for use. Therefore, no sample size for an algorithm training set is applicable or provided.

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

Since no training set for an algorithm is discussed, this information is not applicable. The "previously generated molecular characterization data" served as the reference standard for the test set evaluation.

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