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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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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 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 (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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The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically the "MTS Imipenem-relebactam 0.002/4-32/4 ug/mL" for antimicrobial susceptibility testing. This document does not contain the detailed study information required to answer your request.

FDA 510(k) clearance letters generally confirm that a device is substantially equivalent to a predicate device and outline regulatory compliance. They do not typically include the full clinical study reports, acceptance criteria, or performance data in the level of detail you are asking for.

To find the information you've requested, you would typically need to consult:

• The 510(k) summary document: This voluntary document, often available on the FDA's 510(k) database, provides a summary of the clinical and/or performance data and acceptance criteria.
• The full 510(k) submission: This is a much more extensive document submitted to the FDA, which includes all the detailed study protocols, results, and analyses. These are generally not publicly available in their entirety.
• Manufacturer's product insert/labeling: This might contain some performance data.

Therefore, based solely on the provided text, I cannot complete your request. The letter confirms the device (MTS Imipenem-relebactam) is cleared for marketing but does not provide the specific study details.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA clearance letter for a device named "MTS Doxycycline 0.016 - 256 µg/mL" and mainly discusses regulatory matters and compliance.

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The MTS (MIC Test Strip) Gentamicin 0.016-256 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 pre-defined 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 Gentamicin at concentrations of 0.016-256 uq/mL should be interpreted at 16-20 hours of incubation.

MTS Gentamicin can be used to determine the MIC of gentamicin aqainst the following bacteria. Gentamicin 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 freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens

MTS consists of specialized paper impregnated with a pre-defined 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 letter and the Indications for Use statement for the MTS Gentamicin 0.016-256 ug/mL device, which is an antimicrobial susceptibility test. This type of device is for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent against bacteria.

Based on the document, I can provide information on acceptance criteria and device performance from the perspective of an antimicrobial susceptibility test, but not a device that utilizes AI or human-in-the-loop performance, as those concepts are not applicable to this product.

Here's the breakdown of the information that can be extracted or reasonably inferred, and where the document is silent on aspects requested in the prompt:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically found in a clinical study report for an AI/ML device. However, for antimicrobial susceptibility tests like this, the "acceptance criteria" are generally based on the agreement rates with a reference method (e.g., broth microdilution) and the performance against established quality control (QC) ranges for specific organisms. The "reported device performance" would be these agreement rates and successful QC results.

Given the nature of the device, the following would be the high-level performance expectations:

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

The document does not specify the sample size used for the test set (i.e., the number of bacterial isolates tested). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). For such devices, clinical performance data would typically involve testing a large and diverse collection of clinical isolates, often from multiple geographical locations and collected prospectively or retrospectively from clinical laboratories.

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

This information is not applicable and not provided in the document. For antimicrobial susceptibility testing, the concept of "experts" establishing ground truth in the way it's used for AI/ML image interpretation is not relevant. The "ground truth" (or reference method) for MIC determination is typically established by carefully performed and validated laboratory methods, most commonly broth microdilution, followed by interpretation based on established clinical breakpoints set by organizations like CLSI or FDA.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. As stated above, the "ground truth" is determined by a reference laboratory method, not by human adjudication of interpretations.

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

This is not applicable as the device is an antimicrobial susceptibility test strip, not an AI-assisted diagnostic device requiring human interpretation. Therefore, no MRMC study or effect size related to AI assistance would be performed or reported for this device.

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

This is not applicable. The device is a physical test strip that is manually read. There is no algorithm involved in its direct operation or interpretation for a standalone evaluation. The "human-in-the-loop" aspect exists in the manual reading of the inhibition zone and subsequent interpretation based on breakpoints.

7. The type of ground truth used

The type of ground truth used for evaluating this device would be the Minimum Inhibitory Concentration (MIC) values determined by a reference method, most commonly broth microdilution, which is considered the gold standard for antimicrobial susceptibility testing. Clinical breakpoints (Susceptible, Intermediate, Resistant categories) are then applied to these MICs.

8. The sample size for the training set

The concept of a "training set" is not applicable to this device, as it is a physical diagnostic test, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for this type of device.

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The MTS™ (MIC Test Strip) Ciprofloxacin 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures. MTS™ Ciprofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation. MTS™ Ciprofloxacin can be used to determine the MIC of ciprofloxacin against the following bacteria. Ciprofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria Citrobacter freundii Citrobacter koseri Enterobacter cloacae Escherichia coli Morganella morganii Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Serratia marcescens

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

This is a 510(k) clearance letter for the MTS™ Ciprofloxacin 0.002-32 µg/mL, an antimicrobial susceptibility test. The letter indicates substantial equivalence to a predicate device and includes the "Indications for Use" statement. However, it does not contain the detailed information required to fulfill your request regarding acceptance criteria and the study proving device performance.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is primarily an FDA clearance letter outlining the regulatory approval and intended use for the device, rather than a detailed study report. To get the information you requested, you would typically need to refer to the full 510(k) submission summary or a separate clinical/technical study report.

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MTSTM (MIC Test Strip) Levofloxacin 0.002-32 ug/mL is a quantitative method intended for the in viro determination of antimicrobial susceptbility of bacteria. MTS™ consists of specialized paper impremated with a pre-defined concentration eracient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MC) in ug/mL of antimicrobial agents as tested on agar media using overnight incubation and manual reading procedures.

MTS™ Levofloxacin at concentrations of 0.002 - 32 ug/mL should be interpreted at 16-20 hours of incubation.

MTSTM Levofloxacin can be used to determine the MIC of levofloxacin against the following bacteria.

Levofloxacin has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved abel: Gram-negative bacteria

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

Levofloxacin 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 Citrobacter freundii Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii

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

The provided text is a 510(k) clearance letter from the FDA for a device called "MTS™ Levofloxacin 0.002-32 µg/mL." This device is an antimicrobial susceptibility test (AST) and determines the minimum inhibitory concentration (MIC) of levofloxacin against certain bacteria.

This document does NOT contain information about an AI/ML-driven medical device or any study that would typically involve acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC). It describes a traditional in-vitro diagnostic (IVD) device for antimicrobial susceptibility testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert consensus, adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. These concepts are not applicable to the information contained in this 510(k) clearance.

The "study that proves the device meets the acceptance criteria" in the context of this document would refer to the analytical and clinical performance studies conducted by the manufacturer (Liofilchem s.r.l.) to demonstrate that their MTS™ Levofloxacin device is substantially equivalent to a legally marketed predicate device. This typically involves:

• Analytical Performance: Studies to show the accurate and precise determination of MIC values (e.g., reproducibility, precision, linearity).
• Clinical Performance: Studies to demonstrate agreement between the MTS™ Levofloxacin device and a reference method (e.g., broth microdilution) in determining the susceptibility of bacterial isolates to levofloxacin. This generally falls into categories like:
  • Essential Agreement (EA): The percentage of isolates for which the MIC value obtained by the test device is within ±1 doubling dilution of the reference method.
  • Categoryical Agreement (CA): The percentage of isolates for which the susceptibility category (susceptible, intermediate, resistant) determined by the test device matches that of the reference method.
  • Major Discrepancies (MD): When the reference method classifies an isolate as susceptible and the test device classifies it as resistant.
  • Very Major Discrepancies (VMD): When the reference method classifies an isolate as resistant and the test device classifies it as susceptible.

The acceptance criteria for such an IVD device are typically based on established CLSI (Clinical and Laboratory Standards Institute) guidelines or similar regulatory standards for AST devices, focusing on acceptable rates of agreement and low rates of discrepancies.

In summary, the provided text does not describe an AI medical device; therefore, an answer fitting the requested format for such a device cannot be generated from this document.

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