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The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 μg/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/ml of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Sulbactam- Durlobactam at concentrations of 0.004/4-64/4 μg/ml should be interpreted at 16-20 hours of incubation.

Testing with MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 μg/mL is indicated for Acinetobacter baumannii calcoaceticus complex as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The MTS Sulbactam-Durlobactam 0.004/4-64/4 μg/mL has demonstrated acceptable performance with the following organisms:

Acinetobacter baumannii calcoaceticus complex

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient sulbactam across 15 two-fold dilutions like those of a conventional MIC method and durlobactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the sulbactam-durlobactam code (SUD) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.

Sulbactam-durlobactam is an intravenous beta-lactam combination antibiotic used to treat hospital-acquired pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.

Here is a description of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the MTS Sulbactam-Durlobactam device:

Device: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
Intended Use: Quantitative method for in vitro determination of antimicrobial susceptibility of Acinetobacter baumannii calcoaceticus complex using MIC Test Strips with manual reading after overnight incubation.

1. Acceptance Criteria and Reported Device Performance

The study evaluated the performance of the MTS Sulbactam-Durlobactam device against a reference broth microdilution MIC method. The primary metrics for performance were Essential Agreement (EA) and Category Agreement (CA), along with an analysis of errors (very major, major, minor). While explicit "acceptance criteria" percentages are not directly stated in the summary, typical FDA criteria for AST systems are implied by the reported results. The guidance document referenced "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, August 28, 2009" would contain the specific acceptance thresholds. Based on the provided summary, the device performance is reported as follows:

Table of Device Performance

Implied Acceptance Criteria (based on typical FDA AST requirements, generally >90% for EA and CA, and strict limits on major/very major errors):
The reported performance values of 97.3% EA and 92.7% CA, along with very low major errors and zero very major errors, indicate that the device met the acceptance criteria as determined by the FDA. Specifically, the zero very major errors are critical for patient safety, as they avoid situations where a resistant infection might be incorrectly identified as susceptible, leading to inappropriate treatment.

2. Sample Size and Data Provenance

• Test Set Sample Size: 588 isolates for the combined clinical and challenge organism groups.
• Data Provenance:
  • Clinical Testing: Performed at three (3) sites. The precise country of origin is not explicitly stated for the clinical sites, but the submitter (Liofilchem s.r.l.) is based in Italy, and their contact person for the 510(k) is in Westlake, Ohio, USA. The FDA clearance suggests testing was appropriate for the US market.
  • Challenge Isolate Testing: Performed at one site (Laboratory Specialists, Inc., which is the 510(k) preparer's company in Westlake, Ohio).
  • Nature of Data: The data combines retrospective (challenge isolates specifically selected to ensure MIC range coverage, including resistant isolates) and prospective (fresh clinical isolates tested at multiple sites) elements.

3. Experts Used for Ground Truth and Qualifications

This section does not directly apply as the device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not an imaging AI device requiring expert interpretation of images. The "ground truth" for antimicrobial susceptibility is established by a standardized laboratory method (broth microdilution) rather than human expert consensus on subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, etc.) are typically used in studies involving human interpretation or subjective assessments. For this AST device, the ground truth is established by a quantitative, objective laboratory method (CLSI broth microdilution guidelines). Therefore, no human adjudication method was employed for establishing the ground truth of the MIC values. Minor discrepancies or errors between the device and the reference method are simply categorized as such (major, minor, very major errors).

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

An MRMC study is not applicable to this type of device. The MTS Sulbactam-Durlobactam is a manual antimicrobial susceptibility test system that determines the MIC directly. It is not an AI-assisted diagnostic imaging system where human readers interpret data with or without AI assistance. The performance is assessed by comparing the device's MIC readings to a gold standard laboratory method, not by comparing human reader performance.

6. Standalone (Algorithm Only) Performance

This concept is applicable, and the study provided details on the standalone performance of the MTS Sulbactam-Durlobactam device. The "performance data" table (Essential Agreement, Category Agreement, and Error Rates) directly refers to the device's ability to accurately determine MIC values and susceptibility categories when compared to the reference method, essentially its "algorithm-only" performance in the context of an IVD. There is no "human-in-the-loop" component for interpretation; the user manually reads the MIC from the strip.

7. Type of Ground Truth Used

The ground truth used for this study was reference broth microdilution MIC method, conducted according to CLSI M7-A11 guidelines. This is a well-established and standardized laboratory method for determining antimicrobial minimum inhibitory concentrations, considered the gold standard for AST.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the development of the MTS Sulbactam-Durlobactam device. For IVDs like AST systems, the "training" typically refers to the initial development and optimization of the test strip's design, antimicrobial gradient, and manufacturing process to reliably produce specific drug concentrations and diffusion patterns. This is primarily a chemical and engineering development process, not a machine learning training process with a distinct data set. The 588 isolates discussed are for the performance validation (test set) rather than initial model training.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" and associated "ground truth establishment" in the machine learning sense are not described for this type of medical device. The "ground truth" for the performance validation was established by the CLSI broth microdilution reference method. For the initial development and optimization phase of such a device, the "ground truth" would implicitly be the accurate and precise measurement of drug concentration gradients and their biological effect on various bacterial strains, guided by established AST principles and drug properties.

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Sulopenem SPM 2 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation.

The Sulopenem SPM 2 μg is intended to determine susceptibility of Enterobacterales to sulopenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.

The Sulopenem SPM 2 μg demonstrated acceptable performance with the following organisms:

Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii).

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This FDA 510(k) clearance letter details the clearance of an Antimicrobial Susceptibility Test Disc, not an AI/ML medical device. Therefore, the information typically requested in an AI/ML device acceptance criteria and study section (such as human-in-the-loop performance, expert consensus on ground truth, training set details, or MRMC studies) is not applicable and is not present in the provided text.

The information from the letter describes a Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc, a device used in vitro to determine the susceptibility of Enterobacterales to sulopenem. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and validation studies required for such an in vitro diagnostic (IVD) device.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "The Sulopenem SPM 2 µg demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii)."

However, the specific quantitative acceptance criteria (e.g., minimum essential agreement, categorical agreement percentages) and the reported performance values (e.g., actual percentages of agreement achieved) are not detailed in this clearance letter. These would typically be found in the more comprehensive 510(k) submission summary or review memorandum, which is not provided here.

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

The letter does not specify the sample size (number of isolates tested) used for the performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective nature of the isolate collection).

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" for an antimicrobial susceptibility test is typically established by a reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel following standardized protocols, not by expert consensus in the way it is for imaging AI.

4. Adjudication method for the test set

Not applicable in the context of an AST device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are relevant for imaging AI devices that assist human readers. This is an in vitro diagnostic disc.

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

Not applicable. This device is a physical disc; its "standalone performance" refers to its accuracy against a reference method. The letter confirms "acceptable performance" but does not detail the specific study methodology.

7. The type of ground truth used

The ground truth for antimicrobial susceptibility testing is typically established by comparing the device's results (zone of inhibition for a disc) to a gold standard reference method, such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC). The letter references the "FDA Susceptibility Test Interpretive Criteria (STIC)," implying these are the standards used for interpretation against a reference method. The letter also specifies "clinical isolates," indicating the testing was performed on real-world samples.

8. The sample size for the training set

This concept (training set) is typically associated with AI/Machine Learning models, not with a physical antimicrobial susceptibility test disc. Therefore, no "training set" or its size is mentioned.

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

Not applicable for the same reason as point 8.

In summary, based only on the provided FDA 510(k) clearance letter:

The letter confirms the Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc has demonstrated "acceptable performance" for determining susceptibility of specific Enterobacterales (listed in the document) to sulopenem, according to FDA Susceptibility Test Interpretive Criteria (STIC) when interpreted at 16-18 hours of incubation. However, the specific quantitative results of the performance study and the details of the study methodology (like exact sample sizes, and the precise nature of the "acceptable performance" criteria in terms of agreement percentages) are not disclosed in this high-level clearance summary. These details would be contained within the full 510(k) submission.

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Liofilchem Antibiotic Discs are a semi-quantitative agar diffusion method for in vitro determination of antimicrobial susceptibility of clinical isolates tested on agar media after overnight incubation.

The Ceftobiprole BPR 5 µg Disc is intended to determine susceptibility of Enterobacterales and Staphylococcus aureus to ceftobiprole, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Ceftobiprole at concentrations of 5 μg should be interpreted at 16-18 hours of incubation.

The Ceftobiprole BPR 5 µg Disc demonstrated acceptable performance with the following organisms:

• Enterobacterales (Escherichia coli and Klebsiella pneumoniae)
• Staphylococcus aureus (includes methicillin resistant isolates)

Not Found

Based on the provided FDA 510(k) Clearance Letter, the device in question is a "Ceftobiprole BPR 5 µg Disc." This is an Antimicrobial Susceptibility Test (AST) disc, not a medical imaging or AI-driven diagnostic device. Therefore, the acceptance criteria and study design elements typically associated with AI/ML-based devices (such as MRMC studies, multi-reader consensus, training/test sets for AI, pixel-level ground truth, etc.) are not applicable in this context.

The 510(k) letter discusses the substantial equivalence of this AST disc to legally marketed predicate devices. The "study" proving the device meets acceptance criteria for an AST disc involves demonstrating its performance in determining antimicrobial susceptibility for specific organisms, as recognized by FDA Susceptibility Test Interpretive Criteria (STIC).

Here's how to interpret the provided information in the context of an AST disc:

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

For an AST disc, "acceptance criteria" typically refer to the agreement of the new device's zone diameters or interpretations (Susceptible, Intermediate, Resistant) with a reference method (e.g., broth microdilution or another FDA-cleared AST method) and demonstrating acceptable categorical agreement (CA) and essential agreement (EA) rates, as well as addressing very major errors (VME), major errors (ME), and minor errors (mE). The specific numerical targets for these metrics are not provided in this 510(k) letter but are standard for AST device clearance.

The letter states:

• Enterobacterales (Escherichia coli and Klebsiella pneumoniae)
• Staphylococcus aureus (includes methicillin resistant isolates)"

While specific percentages for CA, EA, VME, ME, mE are not in this letter, "acceptable performance" implies these standard metrics were met as per FDA guidance for AST devices. |

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

• Sample Size for Test Set: The 510(k) letter does not specify the number of isolates (sample size) used for the performance testing. For AST devices, this would typically be a pre-defined number of clinical isolates, often including a challenge set (e.g., resistant strains).
• Data Provenance: The letter doesn't directly state the country of origin or if the study was retrospective or prospective. For AST studies, the isolates are usually collected from various clinical sources to ensure representativeness. They are often cultivated and tested prospectively in a lab setting.

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

• For an AST disc, the "ground truth" is not established by human experts in the same way it is for image interpretation. Instead, the ground truth is established by a reference method, typically a CLSI-standardized broth microdilution method or another FDA-cleared AST system, using precisely controlled laboratory conditions.
• The "experts" involved would be trained microbiologists and laboratory technicians who perform these standardized susceptibility tests accurately. Their qualification lies in their adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines and good laboratory practices. The number of such individuals is not specified and is less relevant than the accuracy and standardization of the reference method itself.

4. Adjudication method for the test set:

• Adjudication methods (e.g., 2+1, 3+1) are for subjective interpretations, primarily in medical imaging. For AST, the interpretations are quantitative (zone diameters) and then categorically assigned based on established breakpoints. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies. The results from the test disc are compared directly to the results from the reference method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. MRMC studies are for evaluating human reader performance, often with and without AI assistance, especially in radiology. This is not applicable to an antimicrobial susceptibility test disc, which is a laboratory diagnostic tool that provides a direct measurement for interpretation.

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

• This concept is also not applicable. The "device" is a physical disc that produces a zone of inhibition. A human (trained lab personnel) measures this zone and interprets it based on established criteria. There is no "algorithm" in the AI sense that performs a standalone diagnosis without human involvement. The interpretation is human-in-the-loop, though it's rule-based rather than expert opinion-based as in image reading.

7. The type of ground truth used:

• The ground truth for an AST disc is typically established by comparison to a CLSI-standardized reference method, such as broth microdilution or agar dilution, or an existing FDA-cleared AST system with well-defined performance characteristics. The relevant outcome data is the in vitro susceptibility phenotype of the bacterial isolate. It is not expert consensus, pathology, or direct patient outcomes in this context, but rather highly controlled laboratory measurements.

8. The sample size for the training set:

• For an AST disk like this, there isn't a "training set" in the AI/ML sense. The "training" of the device is through its precise manufacturing to consistently release the specified antimicrobial concentration and create reproducible inhibition zones. The "training data" for setting interpretive criteria (breakpoints) involves extensive in vitro testing of many strains, correlation with clinical outcomes, and pharmacokinetic/pharmacodynamic (PK/PD) studies, which often span decades of research. The 510(k) letter doesn't provide details on this broader historical "training" data.

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

• As above, for an AST disc, the concept of a "training set" and "ground truth" establishment for it, as understood in AI/ML, doesn't directly apply. The establishment of ground truth for setting the specific concentration of the disc (5 µg) and the interpretive breakpoints (STIC) is a highly complex process within clinical microbiology. It involves:
  • Extensive in vitro susceptibility testing: Using reference methods like broth microdilution against thousands of bacterial isolates to determine the minimal inhibitory concentrations (MICs).
  • Pharmacokinetic/Pharmacodynamic (PK/PD) studies: To understand drug concentrations in the body and how they relate to the MICs needed to inhibit bacterial growth.
  • Clinical Efficacy Data: Correlation between in vitro susceptibility results and patient outcomes in clinical trials (though these trials are usually for the drug itself, not the disc).
  • Expert Consensus and Regulatory Body Review: Committees (like CLSI and FDA) review all the available data to establish and officially recognize Susceptibility Test Interpretive Criteria (STIC) or breakpoints.

In summary, the information in the 510(k) letter pertains to an Antimicrobial Susceptibility Test Disc, which follows a different regulatory and validation pathway than AI/ML-driven diagnostic devices. The details requested primarily apply to AI-based systems.

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The MTS (MIC Test Strip) Ceftobiprole (BPR) 0.002-32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Ceftobiprole at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation.

MTS BPR can be used to determine the MC of ceftobioprole against the following microorganisms for which ceftobiprole has been shown to be active both clinically and/or in vitro according to the FDA drug approved label:

Escherichia coli Klebsiella pneumoniae Staphylococcus aureus (includes methicillin resistant isolates)

MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MTS Ceftobiprole 0.002-32 µg/mL antimicrobial susceptibility test). This document is an administrative letter regarding the clearance of the device and does not contain the detailed information about the acceptance criteria or the specific study that proves the device meets those criteria, as typically found in a clinical study report or a premarket notification summary.

Therefore, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and study details.

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The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtier panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in ug/mL using over overnight incubation and manual reading procedures. ComASP® Cefiderocol at concentrations of 0.008-128 ug/mL should be interpreted at 16-20 hours of incubation.

ComASP® Cefiderocol can be used to determine the MC of cefiderocol against the following microorganisms for which cefiderocol has been shown to be active clinically and in vitro according to the FDA drug approved label:

Acinetobacter baumannii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens

The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtier panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in ug/mL using over overnight incubation and manual reading procedures.

This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically the ComASP Cefiderocol 0.008-128, which is an antimicrobial susceptibility test. The information provided in the prompt is not about an AI/ML medical device, and therefore the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," "human improvement with AI assistance," or "standalone algorithm performance" are not applicable to this type of device submission.

Antimicrobial susceptibility tests (ASTs) are evaluated based on their ability to accurately determine the Minimum Inhibitory Concentration (MIC) of an antibiotic against a microorganism, and to correctly categorize the susceptibility (e.g., Susceptible, Intermediate, Resistant) compared to a reference method.

Therefore, I cannot fulfill the request as it is phrased for an AI/ML device. However, I can describe the acceptance criteria and the study that would typically be done for an antimicrobial susceptibility test device based on the information that would be relevant to such a device, and extrapolate what "acceptance criteria" and "performance" would mean in this context.

Revised Response based on Antimicrobial Susceptibility Test Device Evaluation:

The ComASP Cefiderocol 0.008-128 is an antimicrobial susceptibility test (AST) device. The acceptance criteria and the study proving it meets these criteria for AST devices typically involve comparing the device's results (MICs and categorical interpretations) to a recognized reference method.

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

For an AST device, acceptance criteria are generally defined as the acceptable rates of agreement between the new device and the reference method for MIC results and categorical interpretations. The reported device performance would be the actual agreement rates achieved in the study.

• Essential Agreement (EA): The MIC result from the device is within one doubling dilution of the reference method's MIC result.
• Categorical Agreement (CA): The categorical interpretation (e.g., Susceptible, Intermediate, Resistant) from the device matches the reference method's interpretation.
• Major Discrepancies (MD): The device reports "Susceptible" when the reference method reports "Intermediate" or "Resistant." This is a significant error as it could lead to ineffective treatment.
• Very Major Discrepancies (VMD): The device reports "Resistant" when the reference method reports "Susceptible." This is a significant error as it could lead to unnecessary use of alternative, potentially more toxic, or broader-spectrum antibiotics.

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

For an AST, the "test set" would be a collection of bacterial isolates.

• Sample Size: Typically, hundreds of isolates are tested for each organism-drug combination to ensure robust statistical analysis. A common number is 100-300 isolates per species-drug combination, with a sufficient number of resistant strains (often 50% or more) included to adequately assess VMDs.
• Data Provenance:
  • Country of Origin: Studies are often conducted at multiple clinical sites across different geographical regions (e.g., US, Europe) to ensure generalizability and capture diverse resistance mechanisms.
  • Prospective/Retrospective: Isolates are usually a mix of fresh, prospectively collected clinical isolates and well-characterized challenge strains (retrospectively collected or laboratory strains) with known resistance profiles. This ensures both clinical relevance and the ability to test the device against specific, difficult-to-detect resistance mechanisms.

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

For AST devices, "ground truth" is not established by human experts in the same way as image interpretation. Instead, it is established by a reference method.

• Ground Truth Method: The gold standard reference method for MIC determination is typically broth microdilution (BMD) as described by clinical and laboratory standards organizations (e.g., CLSI, EUCAST). This reference BMD is performed meticulously in a laboratory setting.
• "Experts": The "experts" involved are highly trained microbiologists and medical technologists who meticulously perform the reference BMD and interpret results according to established guidelines. Their qualifications would include extensive experience in clinical microbiology and proficiency in AST methodologies. The reference method performance itself is standardized and validated, limiting subjectivity.

4. Adjudication method for the test set:

Adjudication as typically understood for AI models (e.g., 2+1, 3+1) is not directly applicable. Discrepancies between the new device and the reference method are thoroughly investigated.

• Discrepancy Resolution: If there's a discrepancy, the typical "adjudication" involves:
  • Re-testing both the new device and the reference method.
  • Confirming isolate identity and purity.
  • Potentially testing with an alternative reference method or molecular methods (e.g., sequencing for resistance genes) to understand the discrepancy.
    The goal is not to "vote" on the ground truth, but to understand the reason for the disagreement and ensure the original reference result was accurate.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, an MRMC study is not conducted for an AST device. The device provides a quantitative (MIC) and categorical result, not an image for human interpretation. Therefore, there's no "human reader" component whose performance would be improved by AI assistance.

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

The AST device is a standalone diagnostic test in terms of its direct output. The "algorithm" is the biochemical reaction and the method for reading the turbidity/growth. The performance evaluation is the standalone performance of the device against the reference method. While humans perform the manual reading for ComASP Cefiderocol (as stated in the Indications for Use: "manual reading procedures"), the evaluation specifically assesses the accuracy of the MIC determination by the device itself once inoculated, incubated, and read.

7. The type of ground truth used:

As explained above, the primary ground truth for AST devices is the reference broth microdilution (BMD) method as defined by recognized standards bodies (e.g., CLSI, EUCAST). In some cases, for specific resistance mechanisms, molecular methods (e.g., gene sequencing) might be used as confirmatory ground truth, or clinical outcomes data might support the relevance of the breakpoints.

8. The sample size for the training set:

For an AST device of this nature (lyophilized concentrations in microtiter panels), there isn't a "training set" in the AI/ML sense. The device's design and performance characteristics are based on established microbiological principles and in vitro studies carried out during its development. The "training" in this context would be the empirical optimization of the media formulation, drug concentrations, and well design during product development, which occurs prior to pivotal performance studies. This is not typically quantified in terms of a "sample size" like a machine learning training set.

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

Again, for this type of device, the "training set" and "ground truth" establishment are not applicable in the AI/ML sense. The reference method (BMD) is used throughout the development process to ensure the accuracy and reliability of the new device relative to the established gold standard. The development process involves iterative testing and refinement of the device's components and procedures against known bacterial isolates and their reference MICs.

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The provided FDA letter (K211672) is for an Antimicrobial Susceptibility Test Powder (MTS Piperacillin-tazobactam). This type of device is used to determine the susceptibility of microorganisms to antimicrobial agents, which is crucial for guiding antibiotic treatment. The information provided in the FDA letter and its attachments does not typically contain the detailed performance study information common for AI/ML-based medical devices or imaging analysis software.

Therefore, many of the specific details requested in your prompt (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size, AI assistance) are not applicable (N/A) to this specific device/submission type, as it is a microbiology culture-based test, not an AI/ML device.

However, I can extract the relevant information regarding the acceptance criteria and performance as typically presented for such devices.

Here's the summary based on the provided documents:

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

For Antimicrobial Susceptibility Testing (AST) devices like this, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device and achieving acceptable Essential Agreement (EA) and Category Agreement (CA) with a reference method (e.g., CLSI broth microdilution). The acceptance criteria often align with FDA guidance for AST devices.

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The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.

Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:

Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates)

Gram-Negative bacteria Haemophilus influenzae

MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) clearance letter from the FDA for a device named "MTS Lefamulin 0.016- 256 μg/mL." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use of the device, which is a quantitative method for the in vitro determination of antimicrobial susceptibility of bacteria using Lefamulin.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, ground truth details, MRMC study, etc.) from the given text.

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The MTS (MIC Test Strip) Omadacycline 0.002 - 32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTSTM consists of specialized paper impregated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum infortory concentration (MC) in ugimL of antimicrobial agents agamst bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 ugimL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.

Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-Positive bacteria Staphylococcus aureus Staphylococcus lugdunensis Enterococcus faecalis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus anginosus group (includes S. anginosus and S. constellatus) Gram-Negative bacteria Enterobacter cloacae Klebsiella pneumoniae Haemophilus influenzae Haemophilus parainfluenzae

Omalacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:

Gram-Positive bacteria Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Gram-Negative bacteria Escherichia coli Citrobacter freundii

Citrohacter koseri lebstella aerogenes

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The provided text is a 510(k) clearance letter from the FDA for an antimicrobial susceptibility test system (MTS Omadacycline 0.002 - 32 µg/mL). It does not contain the acceptance criteria or details of a study proving the device meets acceptance criteria as typically found in a clinical trial report or a more detailed submission summary.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device meets the regulatory requirements for clearance without requiring an approval of a premarket approval application (PMA). However, the specific performance data against acceptance criteria that led to this determination is not present in this letter.

Therefore, I cannot provide the requested information based only on the input text. The input document is a regulatory clearance letter, not a detailed study report.

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MTS (MC Test Strip) Ampicilin-sulbactarn 0.016/0.08 - 256/128 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ugimL of animicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS Ampicillin-sulbactam at concentrations of 0.016/0.008 - 256/128 ug/mL should be interpreted at 16-20 hours of incubation.

Ampicillin-sulbactam has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label:

Gram-negative bacteria Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Acinetobacter baumannii/Acinetobacter calcoaceticus complex

Ampicillin'sulbactam has been shown to be active in viro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii

MTS (MC Test Strip) Ampicilin-sulbactarn 0.016/0.08 - 256/128 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ugimL of animicrobial agents as tested on agar media using overnight incubation and manual reading procedures.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ug/mL." This device is an antimicrobial susceptibility test (AST) system. It is important to note that this is NOT an AI-powered device, nor is it an imaging device. Therefore, many of the requested details about acceptance criteria for an AI-powered imaging device (such as multi-reader multi-case studies, expert adjudication, and ground truth for training sets) are not applicable to the information provided in this document.

However, I can extract the relevant information regarding acceptance criteria and performance as it relates to this specific type of device.

Device Description:
The MTS (MC Test Strip) Ampicillin-sulbactam is a quantitative method for in vitro determination of antimicrobial susceptibility of bacteria. It consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent to determine the minimum inhibitory concentration (MIC) in µg/mL.

Acceptance Criteria and Reported Device Performance (based on typical AST device clearance)

While the document does not explicitly state a table of "acceptance criteria" in the format typically used for AI/imaging devices, we can infer the performance validation based on the purpose of the device and information commonly required for AST device clearance. For AST devices, the primary acceptance criteria revolve around the accuracy of MIC determination when compared to a reference method.

Note: The provided document is the 510(k) clearance letter, which summarizes the FDA's decision but does not contain the full study report with detailed performance tables. To provide a complete performance table, one would typically need access to the full 510(k) submission or a summary of safety and effectiveness. However, I can infer the general categories of performance metrics considered for such devices.

Inferred Acceptance Criteria Categories for Antimicrobial Susceptibility Tests:

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MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Imipenem at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation.

Imipenem has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:

Gram-negative bacteria

Citrobacter koseri Citrobacter freundii Enterobacter asburiae Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus vulgaris Providencia rettgeri Serratia marcescens Acinetobacter baumannii Pseudomonas aeruginosa

Imipenem has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:

Gram-negative bacteria

Providencia stuartii

MTS (MIC Test Strip) Imipenem 0.016 - 256 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL against bacteria as tested on agar media using overnight incubation and manual reading procedures.

I am sorry, but the provided text does not contain the detailed study information I need to fulfill your request. The document is an FDA 510(k) clearance letter for the MTS Imipenem device, which indicates its intended use and lists bacterial species it's effective against. However, it does not include:

• A table of actual acceptance criteria or reported device performance against those criteria.
• Details about sample sizes for test sets, data provenance, or training sets.
• Information on expert qualifications, ground truth establishment, or adjudication methods for studies.
• Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device