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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Cephalothin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 8 µg/ml, Intermediate 16 µg/ml and Resistant ≥ 32 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

I am sorry, but the provided text from K984581 does not contain the specific details required to answer your request about acceptance criteria and a study proving the device meets them.

The document is an FDA 510(k) clearance letter for a device called "System U3™ for Cephalothin". It outlines the regulatory clearance process and includes the intended use for the device. However, it does not include:

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

The document states "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates the FDA reviewed data provided by the manufacturer (AB BIODISK) that demonstrated equivalence to a previously cleared device, but the specifics of that data and the acceptance criteria used are not detailed in this clearance letter.

To provide the information you requested, I would need access to the actual 510(k) submission from AB BIODISK, which would contain the study results and the acceptance criteria used to demonstrate substantial equivalence. This public document only acts as an approval letter.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Cefuroxime susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8-16 µg/ml and Resistant ≥ 32 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. The system comprises an antibiotic gradient with MIC break-point concentrations.

This document is an FDA 510(k) clearance letter for the "System U3™ for Cefuroxime." It doesn't contain the specific details of acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed section of the 510(k) submission itself.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs as well as, or is as safe and effective as, existing devices on the market for the same intended use. The provided text is the result of the FDA's review, not the detailed review itself.

Therefore, I cannot directly answer your questions with the provided text because the detailed information about acceptance criteria and the study that proves the device meets those criteria is not present in this regulatory clearance letter.

To provide the information you requested, I would need access to the full 510(k) submission, which would include the performance data, acceptance criteria, study design, and statistical analysis.

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For in vitro diagnostic use: System U3 is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Piperacillin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 64 µg/ml and Resistant ≥ 128 µg/ml for use with P. aeruginosa, and Susceptible ≤ 16 µg/ml, Intermediate 32-64 µg/ml and Resistant ≥ 128 µg/ml for use with non-fastidious Gram negative aerobic bacteria.

The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

The provided text describes a 510(k) premarket notification for the "System U3 for Piperacillin," an in vitro diagnostic device for antimicrobial susceptibility testing. The document focuses on regulatory approval rather than a detailed study report with specific acceptance criteria and performance data. Therefore, many of the requested details are not available in the provided text.

Based on the information available, here's what can be extracted and what cannot:

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

The document mentions MIC breakpoints for Piperacillin, which serve as acceptance criteria for susceptibility categories. However, it does not provide a table of the device's reported performance against these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the text. The ground truth for antimicrobial susceptibility testing would typically be established by reference methods or expert consensus on those methods, but the specifics are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the text.

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 an in vitro diagnostic device for antimicrobial susceptibility testing, which typically does not involve human "readers" in the same way as an imaging device would. Therefore, an MRMC study with human readers improving with AI assistance is not applicable to this type of device and is not mentioned.

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

The "System U3" is a qualitative technique, not an algorithm in the AI sense. It's used to determine susceptibility categories based on an antibiotic gradient and MIC breakpoints. The performance described would inherently be "standalone" in the sense that the device itself performs the test, and the interpretation relies on direct measurement against predefined breakpoints. However, the exact experimental design for evaluating this standalone performance is not described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for antimicrobial susceptibility testing is typically established using reference methods (e.g., broth microdilution, agar dilution) that are well-defined and accepted in microbiology. The document mentions "MIC break-point concentrations," implying comparison against these established standards. However, the specific ground truth method used in the study is not explicitly stated.

8. The sample size for the training set

This information is not provided in the text. For an in vitro diagnostic device of this nature, there isn't typically a "training set" in the machine learning sense. Instead, the device is developed and validated against a representative collection of bacterial isolates with known susceptibility profiles.

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

As with point 8, the concept of a "training set" as in AI/machine learning isn't directly applicable here. If referring to the development and validation data, the ground truth would have been established by reference methods for antimicrobial susceptibility testing. The specific methods are not detailed in the provided text.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Amoxicillin/clavulanic acid susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4/2 µg/ml and Resistant ≥ 8/4 µg/ml for use with Staphylococcus, and Susceptible ≤ 8/4 µg/ml, Intermediate 16/8 µg/ml and Resistant ≥ 32/16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This document is an FDA 510(k) clearance letter for a medical device called "System U3™ for Amoxicillin/clavulanic acid," which is used for antimicrobial susceptibility testing. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include details about specific acceptance criteria or the study used to prove the device meets those criteria. This type of information is typically found within the full 510(k) submission, not in the clearance letter itself.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

Based on the nature of the document, the following points can be inferred:

• Device Type: In vitro diagnostic device for antimicrobial susceptibility testing.
• Regulatory Classification: Class II.
• Purpose: To determine the susceptibility categories (Susceptible, Intermediate, Resistant) of microorganisms to Amoxicillin/clavulanic acid.
• Ground Truth (implied for test set): Likely based on established antimicrobial susceptibility testing methods and MIC breakpoints, which are specified in the "Indications for Use" (e.g., Susceptible ≤ 4/2 µg/ml for Staphylococcus).
• Study Type (implied): For devices like this, the FDA typically requires studies demonstrating agreement with a predicate device or established reference method across a range of bacterial isolates with known susceptibility profiles. However, the specifics of such a study (sample size, expert involvement, adjudication, etc.) are not in this document.

To answer your questions, I would need access to the full 510(k) submission or a summary of its data.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Ampicillin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 8 µg/ml, Intermediate 16 µg/ml and Resistant ≥ 32 µg/ml for use with non-fastidious Gram negative aerobic bacteria, Susceptible ≤ 0.25 µg/ml and Resistant ≥ 0.5 µg/ml for use with Staphylococcus, Susceptible ≤ 8 µg/ml and Resistant ≥ 16 µg/ml for use with Enterococcus.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

The provided document is a 510(k) clearance letter from the FDA for the System U3™ for Ampicillin. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the given input document.

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For in vitro diagnostic use: System U3 is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Nitrofurantoin susceptibility testing based on the MIC breakpoints of Susceptible 5 32 yylml, Intermediate 64 ug/ml and Resistant ≥ 120 ug/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria from urines only.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "System U3TM for Nitrofurantoin." It describes its intended use for antimicrobial susceptibility testing. The provided text does not contain the detailed information needed to answer the specific questions about acceptance criteria and study design elements you've requested.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the FDA found the device to be similar enough to an existing approved device that it doesn't need to undergo the more rigorous premarket approval process.

To gain insights into the acceptance criteria and the study that proves the device meets them, you would typically need to refer to the original 510(k) submission itself (K983562), which would contain a comprehensive description of the device, its performance data, and the comparison to the predicate device.

Therefore,Based on the provided text, I cannot extract the information required to populate the fields you requested. The document is a 510(k) marketing clearance letter, not a performance study report.

Here's why and what's missing:

• Acceptance Criteria and Reported Device Performance: This letter only states "substantially equivalent" to predicate devices. It doesn't detail performance metrics or specific acceptance criteria met by the System U3.
• Sample Size, Data Provenance, Expert Information, Adjudication: These are all details of the study that would have been submitted in the 510(k) to demonstrate substantial equivalence, but are not present in this clearance letter.
• MRMC study, Standalone performance: These types of studies would be described in the 510(k) submission, not summarized in the clearance letter.
• Ground Truth Type, Training Set Size, Training Set Ground Truth: Similar to above, these are elements of a detailed study report that are not included in this document.

To get answers to your questions, you would need to access the full 510(k) submission for K983562, which would contain the performance data and study details that the FDA reviewed to make its substantial equivalence determination.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Tetracycline susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "System U3™ for Tetracycline," which confirms its substantial equivalence to a legally marketed predicate device.

It includes:

• The device name and its intended use (in vitro diagnostic for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria).
• The MIC breakpoints for Tetracycline (Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml, and Resistant ≥ 16 µg/ml).

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts used for ground truth or adjudication methods.
4. Information about MRMC comparative effectiveness studies.
5. Details about standalone algorithm performance.
6. The type of ground truth used in a study.
7. Sample size or ground truth establishment for a training set.

To answer your request, I would need a different document that details the device's validation studies, performance data, and the specific acceptance criteria used for its clearance.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Norfloxacin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This document is a FDA 510(k) clearance letter for the "System U3 for Norfloxacin". It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not contain the acceptance criteria or a study describing the device's performance against such criteria.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance data. Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device

For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Trimethoprim/sulfamethoxazole susceptibility testing based on the MIC breakpoints of Susceptible ≤ 2 µg/ml and Resistant ≥ 4 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This document is a 510(k) premarket notification decision letter from the FDA for the "System U3™ for Trimethoprim/sulfamethoxazole." It primarily focuses on the regulatory approval and substantial equivalence to a predicate device, rather than detailed performance and study information of the device itself.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. This letter confirms approval and outlines regulatory responsibilities but does not contain the technical study data.

However, I can extract the following:

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

Based on the "Indications For Use" section, the acceptance criteria relates to the determination of susceptibility categories using specific MIC breakpoints for Trimethoprim/sulfamethoxazole. No specific performance metrics (like sensitivity, specificity, accuracy) or a table comparing them to acceptance criteria are provided in this regulatory letter.

The document states: "This 510(k) application is for System U3/Trimethoprim/sulfamethoxazole susceptibility testing based on the MIC breakpoints of Susceptible ≤ 2 µg/ml and Resistant ≥ 4 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria." This defines the criteria the device aims to meet.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size for the test set: Not available in this document.
• Data provenance: Not available in this document.

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

• Not available in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not available in this document.

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

• Not applicable/Not available. This device is an in vitro diagnostic for antimicrobial susceptibility testing, not an AI-assisted imaging device that would typically involve human readers interpreting images.

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

• This device, System U3™, is described as a "qualitative technique for antimicrobial susceptibility testing" and an "antibiotic gradient with MIC break-point concentrations." It functions as an in vitro diagnostic test. It's likely designed for standalone performance in a laboratory setting to determine susceptibility, meaning the result is read directly from the test. However, the exact "standalone performance" metrics (like accuracy vs. a gold standard) are not provided in this regulatory letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For antimicrobial susceptibility testing, the "ground truth" (or reference method) typically involves a standardized reference method for MIC determination, such as broth microdilution or agar dilution, against which the device's results are compared. The document does not specify the exact ground truth method used in the studies supporting this 510(k) submission.

8. The sample size for the training set:

• Not available in this document. This document pertains to a 510(k) submission, not typically a machine learning device that requires "training sets" in the same way. Performance data would usually come from validation studies.

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

• Not applicable/Not available, as this is not an AI/machine learning device that would have a "training set" in the conventional sense. The ground truth for validation (if discussed) would likely be established using a reference method for antimicrobial susceptibility testing.

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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Gentamicin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 g/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "System U3™ for Gentamicin." It doesn't contain information about acceptance criteria or a dedicated study proving the device meets said criteria in the way a clinical trial report would.

However, based on the provided text, we can infer some aspects relevant to its regulatory acceptance and what would be expected for such a device. Since this is a 510(k) submission, the primary criterion for acceptance is substantial equivalence to a legally marketed predicate device.

Here's an analysis of what can be gleaned, and where information is missing for a complete answer:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) clearance letter confirms that the device has met the criteria for substantial equivalence, allowing it to be marketed. However, it does not detail the specific study results that led to this conclusion. Those details would be in the original 510(k) submission file, which is not provided here.

Based on the provided text, the following information is either not present or cannot be definitively extracted:

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method for the test set: Not mentioned.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable/mentioned for this type of in vitro diagnostic device (antibiotic susceptibility testing). MRMC studies are usually for imaging diagnostics where human interpretation is a significant factor.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "System U3" is a qualitative technique, not an "algorithm" in the modern AI sense. It determines susceptibility categories, likely through a standardized method that is inherently standalone in its result generation, even if a human reads the final result. However, the exact performance metrics of such a standalone component are not detailed here.
• 7. The type of ground truth used: Not explicitly stated, but for antimicrobial susceptibility testing devices, the "ground truth" is typically established by reference methods (e.g., broth microdilution or agar dilution as described by CLSI guidelines), which are considered the gold standard for determining MIC values.
• 8. The sample size for the training set: Not applicable and not mentioned. This device is not described as an AI/ML algorithm that requires a training set in the contemporary sense. It's an established qualitative technique.
• 9. How the ground truth for the training set was established: Not applicable and not mentioned.

In summary, the provided document is a regulatory clearance letter, not a detailed study report. It confirms the device's market approval based on the FDA's assessment of the 510(k) submission, which would have contained the underlying performance data and justification for substantial equivalence.

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