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This submission is for Etest Doripenem for MIC determinations across 0.002-32 µg/mL with Gram negative aerobic bacteria such as Enterchacteriaceae, Accretobacer baumanii, Pseudomonas aeraginesa and Gram negative anaerobic bacteria such as Bacteroides aacae, B. fragilis, B.thetaiotaorracron, B. uniformis and B. ulgatus.

Etest is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterchaceriane, Pseudomnas, Staphylococus and Enteroxous species and fastidious bacteria, such as anaerobes, N. gonombeae, S. preumoniae, Streptoxous and Haemophilus species. The system comprises a predelined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.

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This FDA 510(k) clearance letter pertains to the administrative process of marketing the Etest® Antimicrobial Susceptibility Test for Doripenem, rather than a detailed scientific study report. Therefore, much of the requested information about acceptance criteria and study particulars is not present in this document.

However, based on the context of an antimicrobial susceptibility test and the information provided, we can infer some aspects and acknowledge the limitations:

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

This document does not contain a table of acceptance criteria or specific performance values for the Etest® Doripenem test. Such information would typically be found in the manufacturer's 510(k) submission itself (which this document is a response to), or in scientific publications. However, for a device like this, the acceptance criteria would generally revolve around:

• Essential Agreement (EA) with a reference method: The percentage of MIC values that are within ±1 dilution of the reference method.
• Categorical Agreement (CA) with a reference method: The percentage of isolates where the Etest interpretation (Susceptible, Intermediate, Resistant) matches the reference method's interpretation.
• Minor Errors (mE), Major Errors (ME), and Very Major Errors (VME): These refer to specific types of discordance between the test and reference method, particularly concerning clinical interpretation. The acceptable rates for these errors are usually defined by regulatory bodies (e.g., FDA, CLSI).

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 available in the provided document. A typical premarket submission for an antimicrobial susceptibility test would involve testing a substantial number of bacterial isolates (e.g., hundreds or even thousands) for each drug-bug combination, often collected from diverse geographical locations. The studies would predominantly be prospective.

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 available in the provided document. For antimicrobial susceptibility testing, the "ground truth" (or reference method) is typically established by laboratory-based, standardized methods using trained microbiologists (e.g., broth microdilution or agar dilution). It's not usually based on expert consensus in the same way as, for example, reading medical images.

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

This information is not available in the provided document. Adjudication methods are not typically relevant for establishing the "ground truth" for a microbial susceptibility test; the reference method itself serves as the standard.

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

An MRMC study is not applicable to this type of device. The Etest is a diagnostic test for determining drug susceptibility, not an AI-assisted diagnostic imaging tool.

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

The Etest is a manual, phenotypic test strip. It is not an algorithm, nor does it operate "standalone" in the sense of a software algorithm. Its performance is evaluated based on its interpretability by trained laboratory personnel against a recognized reference method.

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

The "ground truth" for antimicrobial susceptibility testing is typically established using a standardized reference method, such as:

• Broth Microdilution (BMD): Considered the gold standard for MIC determination.
• Agar Dilution: Another standardized method for MIC determination.

These methods involve precise dilutions of the antimicrobial agent and inoculation with a standardized bacterial suspension.

8. The sample size for the training set

This information is not available in the provided document. The Etest method relies on a pre-defined antibiotic gradient within the strip, not a "training set" in the machine learning sense. However, the manufacturer would have conducted extensive internal development and validation studies to determine the appropriate gradient and how to interpret the ellipse.

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

As noted above, there isn't a "training set" in the machine learning context for this device. The development of Etest strips generally involves:

• Careful preparation of the antibiotic gradient: Ensuring precise and stable concentrations along the strip.
• Extensive testing against known bacterial strains: Using reference methods (like BMD) to correlate the ellipse formed by the Etest strip with the actual MIC of the drug for those strains. This helps in establishing the interpretive breakpoints for susceptibility, intermediate, and resistance categories.

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This submission is for the addition of Tigeycline to the Etest® product range for MIC delemination across a concentration range of 0.016-256 ug/mL. In vitro susceptibility testing of Tigecycline is indicated for Gram positive and Gram negative aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and S. pneumoniae and anaerobic bacteria.

Etest® is a quantitative technique for the determination of antimicrobial susceptibility of microorganisms as tested on agar using overnight incubation. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of antimicrobial agents against microorganisms. Etest® can be used to test non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and fastidious bacteria, such as S. pneumoniae, Haemophilus Species, N. gonorrhoeae, and anaerobes.

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Here's an analysis of the provided text to extract information about the Etest® Antimicrobial Susceptibility Test – Tigecycline, focusing on acceptance criteria and study details:

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

The provided text does not explicitly state specific quantitative acceptance criteria or the reported device performance in a clear, tabulated format. It is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device rather than presenting detailed study results and acceptance criteria directly.

Typically, such studies would compare the Etest® results to a reference method (e.g., broth microdilution) and report metrics like Categorical Agreement (CA), Essential Agreement (EA), statistical correlation (e.g., R-squared), or percentages of minor, major, and very major errors. These quantitative measures would be compared against predefined acceptance criteria (e.g., CA ≥ 90%, Major Error < 3%).

However, based on the nature of antimicrobial susceptibility testing device clearances, the general expectation is that the device demonstrates performance comparable to the reference method.

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

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application, which is not included here.

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth. For antimicrobial susceptibility testing, the "ground truth" is typically established by a recognized reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel, rather than expert clinicians/radiologists.

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

The document does not detail any adjudication method used for the test set. Adjudication is less common in direct comparison studies for quantitative results like MICs, where a reference method provides a definitive value.

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

No MRMC comparative effectiveness study was done. This device is an antimicrobial susceptibility test, which quantifies the Minimum Inhibitory Concentration (MIC) of an antibiotic for a microorganism. It is not an AI-powered diagnostic imaging device that requires human interpretation and thus, MRMC studies and "human readers improving with AI" are not relevant to this type of device.

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

This device, the Etest®, is a physical strip with a predefined antibiotic gradient. While its reading involves visual interpretation of the ellipse of inhibition, it is not an "algorithm only without human-in-the-loop performance" in the context of modern AI. The reading of the MIC from the Etest strip is typically performed visually by a trained human. The "performance" being assessed is the accuracy of the Etest method itself when read by a human, compared to a reference method.

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

For antimicrobial susceptibility testing, the "ground truth" is established by a reference culture-based method, typically broth microdilution or agar dilution. These methods are standardized by organizations like the Clinical and Laboratory Standards Institute (CLSI) and are considered the gold standard for determining MIC values. The Etest's performance is compared against these reference methods.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. For Etest®, "training set" doesn't apply in the same way as for machine learning models. Instead, the device's design and initial validation would have been based on extensive historical data and development work, but specific "training set" sizes are not relevant in this context.

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

As with the "training set" concept being largely irrelevant for this type of device, the "ground truth for the training set" is also not discussed. The development and validation of the Etest® method itself relied on established microbiological principles and comparisons to standard reference methods over time.

Summary of Missing Information:

It's crucial to understand that a 510(k) clearance letter like this is an outcome document confirming substantial equivalence. It does not typically contain the detailed technical data, study protocols, or results that were submitted in the full 510(k) application. To get the specific quantitative data for acceptance criteria, sample sizes, and detailed methodology, one would need to review the full 510(k) submission, which is often not publicly available in its entirety.

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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A)

This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp.

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation.

This document is a 510(k) clearance letter from the FDA for a new Etest® Daptomycin antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've requested for typical AI/diagnostic device applications.

The provided text is a regulatory clearance document, not a detailed study report. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information you're asking for (e.g., sample sizes, expert qualifications, study methodologies, performance metrics like sensitivity/specificity) is usually found in a separate clinical study report, which is typically summarized in the 510(k) submission but not fully detailed in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based only on the text provided because it does not contain that level of detail.

However, I can tell you what is typically expected for such a device in terms of performance and how its substantial equivalence would have been established, based on the nature of antimicrobial susceptibility testing (AST) devices.

For AST devices like the Etest®, "acceptance criteria" usually refer to agreement rates with a reference method (e.g., broth microdilution or agar dilution). The "study" would be a clinical study comparing the Etest® results to these reference methods.

Here's how I would hypothetically complete your request for an AST device, based on common FDA requirements for such submissions, and indicate what is not present in the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Device: Etest® Daptomycin 0.016-256 µg/mL

Intended Use: For in vitro diagnostic use to determine the minimum inhibitory concentration (MIC) of Daptomycin for specific bacterial species (E. faecalis, E. faecium, Staphylococcus spp., Streptococcus spp.).

This 510(k) clearance letter from the FDA indicates that the Etest® Daptomycin has been found substantially equivalent to a legally marketed predicate device. While the provided document does not contain the detailed study results or explicit acceptance criteria, for antimicrobial susceptibility testing (AST) devices, the performance is typically evaluated by comparing results to a recognized reference method.

Hypothetical Acceptance Criteria and Reported Device Performance (Based on typical AST device standards):

Detailed Study Information (Based on common AST device studies – not available in the provided document):

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

   • Sample Size: This information is not present in the document. Typically, hundreds to thousands of isolates covering the relevant species and resistance mechanisms would be tested.
   • Data Provenance: This information is not present in the document. Clinical isolates would be collected from diverse geographical regions (e.g., USA, Europe) and could be a mix of retrospective and prospectively collected strains, often including challenge strains with known resistance phenotypes.

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

   • Number of Experts/Ground Truth Method: This information is not present in the document. For AST devices, the "ground truth" is typically established by a reference method (e.g., CLSI-recommended broth microdilution or agar dilution) performed by trained microbiologists, rather than a consensus of experts interpreting images or complex data. The interpretation of the reference method's MIC value into categorical results (S/I/R) is based on established clinical breakpoints (e.g., CLSI guidelines).

3. Adjudication method for the test set:

   • Adjudication Method: This information is not present in the document. Discrepancies between the candidate device and the reference method would typically be adjudicated by repeat testing on both the candidate device and the reference method, or by using an alternative reference method, performed by experienced microbiologists.

4. 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:

   • MRMC Study: No. This type of study (MRMC for AI assistance) is not relevant for this device. Etest® is a manual, interpretive test where a trained microbiologist reads the MIC value directly; it is not an AI-powered image analysis or diagnostic support tool. The comparison is between the device's output and a reference method's output, not human performance with/without AI.

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

   • Standalone Performance: Not applicable in the context of AI. Etest® is a manual test and requires a human to interpret the ellipse and read the MIC value. Its performance is directly tied to this human interpretation, albeit a standardized one.

6. The type of ground truth used:

   • Ground Truth Type: This information is not explicitly stated but for AST devices, the ground truth is established by a reference method, such as broth microdilution or agar dilution, performed according to recognized standards (e.g., CLSI M07 guidelines).

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. Etest® is a phenotypic test method based on diffusion gradients, not a machine learning model that requires a "training set." The methodology is predetermined.

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

   • Training Set Ground Truth: Not applicable (as above).

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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that is used to determine the minimum inhibitory concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.

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This document is a 510(k) premarket notification decision letter from the FDA for the Etest® Gemifloxacin 0.002-32 µg/mL. This document is a regulatory approval, and as such, it does not contain the detailed study information required to answer the prompt.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its substantial equivalence to a predicate device, not necessarily on a new, comprehensive study detailed within this document. The "Indications for Use" section further clarifies that the submission is "for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae."

To obtain the requested information, one would need to refer to the full 510(k) submission document (K042390) itself, which would contain the study results and details that supported the substantial equivalence claim.

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Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions. This 510k submission is for an application for in wire diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Candida species.

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The provided document is an FDA 510(k) clearance letter for an antimicrobial susceptibility test. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot extract the information required in the prompt (acceptance criteria, reported device performance, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from this letter.

The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use. It doesn't present the underlying data or the specific criteria against which that data was evaluated.

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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Cefditoren in the range of 0.002 - 32 µg/ml with S. pneumoniae (penicillin susceptible strains only) and H. influenzae.

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This document is a 510(k) clearance letter from the FDA for a device called "Etest® Cefditoren." It does not contain information about acceptance criteria, device performance, or details of a study as requested. The content only confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Therefore, I cannot provide the requested information based solely on the provided text. The document is essentially a regulatory approval notice, not a study report.

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For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both aerobic bacteria, such as Enterobacteriaceae, non-fastidious Gram negative and Enterococcus species and fastidious bacteria, such as Pseudomonas, Staphylococcus and Enterococcus and Haemophilus species. The system comprises a preformed antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 0.002-32 μg/mL against Enterobacteriaceae, E. coli, K. pneumoniae, S. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), S. agalactiae, S. pyogenes, H. influenzae (β-lactamase negative strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp.

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The provided document is a 510(k) clearance letter from the FDA for the Etest® Ertapenem device, an antimicrobial susceptibility test. While it indicates that the device has been found substantially equivalent to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a comprehensive submission.

Therefore, I cannot extract the requested information. The letter only broadly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

To answer your request, I would need access to the full 510(k) submission document, which would include the study design, acceptance criteria, test results, and other details about the device's performance.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device