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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram neqative orqanisms. This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.002 - 16 ug/ml for testing gram positive and 0.002 - 4 ug/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for: Klebsiella pneumonia. Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25ug/mL) or less against most (≥90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and wellcontrolled clinical trials. Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris.

Susceptibility Test Panel for Gemifloxacin 0.002-4μg/ml Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml Gram Positive

This document is a 510(k) clearance letter for an antimicrobial susceptibility test panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a legally marketed predicate device.

However, the provided text DOES NOT contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the comprehensive study details you've requested.

The document states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent...". This implies that the applicant (TREK Diagnostic Systems, Inc.) submitted data and information to support their claims. However, this specific letter does not present that data, nor does it lay out the acceptance criteria used by the FDA for making its determination.

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

To answer your questions, one would need access to the full 510(k) submission (K053243) from TREK Diagnostic Systems, Inc., which would contain the study protocols, raw data, analysis, and stated acceptance criteria.

Based on the provided text, the following aspects are completely unknown:

• Acceptance Criteria Table: Not present.
• Reported Device Performance: Only the claimed MIC ranges are mentioned for Gemifloxacin, but no performance metrics (e.g., accuracy, sensitivity, specificity, or categorical agreement) are given.
• Sample Size (Test Set): Not mentioned.
• Data Provenance (Test Set): Not mentioned.
• Number of Experts (Ground Truth): Not mentioned.
• Qualifications of Experts (Ground Truth): Not mentioned.
• Adjudication method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned as being performed for this particular 510(k). This type of study is more common for imaging AI devices rather than AST panels.
• Effect size of human reader improvement: Not applicable given the type of device and lack of MRMC study description.
• Standalone (algorithm only) performance: This device is a manual or semi-automated system for reading MICs, so the concept of an "algorithm only" performance as typically applied to image-based AI would not directly apply without further context on how "standalone" would be interpreted for an AST panel. However, the study would have involved comparing the device's readings to a reference method (the "ground truth").
• Type of Ground Truth: While it can be inferred that the ground truth for an AST panel would be a reference AST method (e.g., broth microdilution or agar dilution as established by CLSI), the specific method used is not detailed in this document.
• Sample Size (Training Set): Not mentioned.
• Ground Truth for Training Set: Not mentioned.

In summary, this document is a regulatory approval letter, not a scientific study report or a detailed summary of the performance data submitted for approval.

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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 -64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcus faecalis (vancomycin-susceptible strains only), Streptococcus agalactiae and Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.

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The provided text is a 510(k) premarket notification letter for a medical device (Susceptibility Test Panel for Daptomycin), not a report of a study proving a device meets acceptance criteria. Therefore, I cannot extract the specific information requested in your prompt as it is not present in the document.

The document states that the FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This indicates a regulatory approval process based on comparison to existing devices, rather than a detailed study report with specific acceptance criteria and performance metrics as you've requested.

To provide the information you're looking for (acceptance criteria, study details, sample sizes, ground truth establishment, etc.), you would typically need a clinical study report or a premarket submission that includes such data.

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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004-16ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Moxifloxacin is for: Klebsiella pneumoniae. In vitro data, without clinical correlation is provided for: Citrobacter freundi, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirablis.

Susceptibility Test Panel

This looks like a 510(k) clearance letter for an in vitro diagnostic device, specifically a Susceptibility Test Panel for antimicrobial susceptibility testing. The provided text does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary or the full submission.

What is provided is:

• Device Name: Susceptibility Test Panel (Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System)
• Intended Use: In vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. Specifically, this 510(k) is for the addition of Moxifloxacin (0.004-16ug/ml) to the panel for gram-negative isolates, with approved primary indications for Klebsiella pneumoniae.
• Regulatory Information: Class II device, Regulation Number 21 CFR 866.1640.
• Date of Clearance: March 6, 2003

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and study results based only on the provided text. This document is a clearance letter, not the technical submission itself.

To answer your request, I would need access to the 510(k) summary or the full premarket notification for K024353, which would contain the study design, acceptance criteria, and performance data.

If you were to provide that information, I would be looking for the following sections within the submission:

• Performance Data/Clinical Studies: This section would describe the studies conducted.
• Acceptance Criteria: Often explicitly stated for various performance metrics (e.g., essential agreement, categorical agreement).
• Test Methods: Details on how the device's results were compared to a reference method.
• Ground Truth: How the true susceptibility/resistance was determined.
• Sample Description: Details on the isolates used (number, type, source).

Without that technical information, I cannot generate the requested table or answer the specific questions about the study design.

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The Sensititie 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the elimination of limitations in the sensititre technical insert. The limitation to be removed are as follows: - 1) The AutoReader system should not be used to read coagulase-negative Staphylococcus Species as they will not generate adequate signal to give a susceptibility result. Such strains should be read manually. Maintain limitation 8 with a modification: Staphylococcus Species - tested against Penicillin G. Should also be tested for Beta lactamase production, especially in strains with borderline MIC's (0.06 -- 0.25 µg/ml). If these strains test Beta Lactamase positive a repeat test should be done to ensure resistance is reported. The addition of the following limitation in the Sensititre Technical Insert: The Autoreader system should not be used to read SXT with CNS. SXT should be read manually.

Susceptibility Test Panel

This is a 510(k) premarket notification for a Susceptibility Test Panel, which is an in vitro diagnostic product. The document does not contain the detailed study information required to fill out the table regarding acceptance criteria and performance, as it is a regulatory letter rather than a clinical study report. It primarily discusses the regulatory review and approval of the device, along with proposed changes to its labeling and limitations for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details from the provided text. This information is typically found in a clinical or validation study report, which is not present here.

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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the elimination of limitations in the sensititre technical insert. The limitation to be removed are as follows: 2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillin/clavulanic acid with Enterococcus sp., and gentamicin (500 ug/mL) with Enterococcus faccium is unknown because too few resistant strains were available at the time of comparative testing. The addition of the following limitation in the Sensititre technical insert: The autoreader system should not be used Nitrofurantoin with Enterococcus species. Nitrofurantoin should be read manually. The ability to detect resistance with nitrofuantoin is unknown because too few resistant strains were available at the time of comparative testing.

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This document is a 510(k) premarket notification acceptance letter from the FDA for a Susceptibility Test Panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. However, it does not include detailed study information, acceptance criteria tables, or performance data typically found in a clinical study report or a summary of safety and effectiveness.

Therefore,Based on the provided document, I cannot fulfill all components of your request, as the document is an FDA acceptance letter and not a detailed study report. It states what limitations are being removed and added to the device's technical insert, implying that certain studies were done to support these changes, but it does not provide the study details requested.

Here's what I can extract or infer from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document is an FDA clearance letter, not a scientific study report. It mentions the "elimination of limitations" and "addition of a limitation" for the Sensititre system, implying that testing was conducted to support these changes, but the specific acceptance criteria and performance results are not detailed.

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 document. The text mentions "lack of performance data on emerging resistant Enterococcus sp." and "too few resistant strains were available at the time of comparative testing" for specific drug-organism combinations, suggesting that the initial testing datasets had limitations, but it does not detail the sample sizes or provenance of the data used for the re-evaluation.

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 document. For antimicrobial susceptibility testing, the "ground truth" is typically established by reference methods and expert interpretation of results, but the specifics are not included here.

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

This information is not provided in the 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:

This is not applicable to this device. The device is an "Antimicrobial Susceptibility Test" system (Susceptibility Test Panel), not an AI-assisted diagnostic imaging device that involves human readers interpreting images. The mention of "AutoReader system" refers to an automated instrument for reading the susceptibility tests, not an AI for human augmentation.

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

The device described is the "Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System." The document mentions the "AutoReader system" and limitations regarding its use for certain organisms (e.g., Enterococcus sp.) and drugs (Nitrofurantoin), suggesting there is an automated component. The statement "The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually" implies that a standalone (automated) assessment for Enterococcus sp. was initially not sufficient. The subsequent removal of this limitation suggests improved standalone performance was demonstrated. However, specific standalone performance metrics are not given.

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

For antimicrobial susceptibility testing, the ground truth is typically established by reference methods, such as broth microdilution or agar dilution as defined by CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state the ground truth method but implies the use of comparative testing against established methods.

8. The sample size for the training set:

This information is not provided in the document.

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

This information is not provided in the document. As mentioned for the test set, it would likely be established using reference antimicrobial susceptibility testing methods.

In summary, this FDA letter confirms the clearance of a device based on its substantial equivalence and the resolution of previous limitations. It does not contain the detailed study results, methodologies, or specific performance metrics that would answer most of your questions. Such information would typically be found in the 510(k) submission itself or a summary of safety and effectiveness, neither of which is part of these provided pages.

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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

Ask a specific question about this device