Search Results

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.

Ask a specific question about this device

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

Not Found

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "MTS Tetracycline 0.016 - 256 ug/mL" which is an antimicrobial susceptibility test powder. This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the given input. The document is primarily a regulatory clearance letter and does not delve into the technical details of the validation study.

Ask a specific question about this device

The Liofilchem® MIC Test Strip (MTS) 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Clindamycin MTS at concentrations of 0.016-256 ug/mL should be interpreted at 16-20 hours of incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Clindamycin according to the FDA label are:

Staphylococcus aureus (methicillin-susceptible strains)

MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent.

I am sorry, but the provided text describes an FDA 510(k) premarket notification for an antimicrobial susceptibility test strip (Liofilchem MIC Test Strip, Clindamycin). This document is a regulatory approval letter and does not contain the detailed study information needed to answer your questions about acceptance criteria and device performance in the context of an AI/machine learning study.

The document discusses:

• The device: Liofilchem MIC Test Strip (MTS), Clindamycin 0.016 - 256μg/mL
• Its purpose: In vitro determination of antimicrobial susceptibility of bacteria.
• Regulation and product codes.
• General controls provisions for marketed devices.
• Indications for Use: Specifically for Staphylococcus aureus (methicillin-susceptible strains) against Clindamycin, with incubation and manual reading procedures.

It does not include any information about:

• A table of acceptance criteria or reported device performance for an AI/ML system.
• Sample sizes for test or training sets related to an AI/ML model.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth for AI/ML.
• Adjudication methods for AI/ML test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm performance.
• Type of ground truth (e.g., pathology, outcomes data) for an AI/ML study.
• How ground truth was established for training sets in an AI/ML context.

Therefore, I cannot provide an answer that meets your requirements based on the given input.

Ask a specific question about this device

The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). 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 (MCC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The Telavancin MTS at concentrations of 0.016 - 256 µg/mL should be interpreted at 16-20 hours of incubation.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against Telavancin according to the FDA label are:

Staphylococcus aureus (including methicillin-resistant isolates) Enterococcus faecalis (vancomycin-susceptible isolates only)

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 (MCC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text describes a 510(k) premarket notification for the Liofilchem MIC Test Strip (MTS) Telavancin. The document grants substantial equivalence, but it does not contain the detailed acceptance criteria or the study results that prove the device meets those criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• Information on MRMC comparative effectiveness studies or effect size.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on the regulatory approval and indications for use, without delving into the specific performance study details that would typically include acceptance criteria and study results.

Ask a specific question about this device

The Liofilchem® MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorthoeae). 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 ug/mL of antimicrobial agents against . teria as tested on agar media using overnight incubation and manual reading procedures.

The indications for use of this 510(k) is specifically for the Meropenen MTS at concentrations of 0.002-32 ug/mL.

The non-fastidious bacteria that have been shown to be active both clinically and in vitro against meropenem according to the FDA label are:

Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

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 ug/mL of antimicrobial agents against . teria as tested on agar media using overnight incubation and manual reading procedures.

The provided text is a 510(k) premarket notification letter from the FDA to Liofilchem s.r.l., regarding their MIC Test Strip (MTS) for Meropenem. This document is a regulatory approval letter for an in-vitro diagnostic test for antimicrobial susceptibility, not for an AI/ML-driven medical device.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria for an AI/ML device: The device is a physical test strip, not an algorithm.
• Study proving device meets acceptance criteria (for an AI/ML device): The "performance" in this context refers to the accuracy of the antimicrobial susceptibility test in determining MIC, not the performance of an AI/ML model.
• Sample size for test set, data provenance: Not relevant for this type of device approval.
• Number of experts, qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size or ground truth establishment: These are all concepts specific to the development and validation of AI/ML algorithms, which are not applicable to the Liofilchem MIC Test Strip.

To summarize, the provided text is about the regulatory approval of a traditional in-vitro diagnostic device and does not offer any details pertinent to the development and validation of an AI/ML-based medical device.

Ask a specific question about this device

The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorhoeae). 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The purpose of this 510(k) is specifically for the ceftolozane/tazobactam MTS at concentrations of 0.016/4 - 256/4 mcg/mL.

Ceftolozane/azobactam has been shown to be active against the following bacteria, both clinically and in vitro according to the FDA label:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Liofilchem MIC Test Strip (MTS) - Ceftolozane/tazobactam." It does not contain the detailed information required to answer your questions about acceptance criteria for an AI/ML device study.

Specifically, the document pertains to an in vitro diagnostic device (MTS) used for antimicrobial susceptibility testing, which involves manual reading procedures and overnight incubation. It's a standard microbiological test, not an AI/ML powered device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML model. It's about substantial equivalence to a predicate device for a manual test strip.
2. Sample sizes used for the test set and the data provenance: Not applicable to an AI/ML study description in this document.
3. Number of experts used to establish the ground truth...: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The device involves manual reading, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, ground truth would be established by standard microbiological methods (e.g., broth microdilution reference method) to determine the true MIC value, but the details of such a comparative study are not in this letter.
8. The sample size for the training set: Not applicable, as this is not an AI/ML training dataset.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the "Indications for Use" for the test strip and lists bacteria against which the antibiotic combination (ceftolozane/tazobactam) has shown activity "both clinically and in vitro according to the FDA label." This refers to the established efficacy of the drug, not the performance metrics of an AI/ML diagnostic alongside a reader.

Ask a specific question about this device