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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 non fastidious isolates.

This 510(k) is for the newly approved Tedizolid in the dilution range of 0.03-4 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel.

The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates:

Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis

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The provided text is a 510(k) premarket notification approval letter for an antimicrobial susceptibility test system. It describes the device and its intended use, but it does not contain information about acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details of the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document focuses on the regulatory approval of the "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Tedizolid" for clinical susceptibility testing of non-fastidious isolates, specifically Staphylococcus aureus and Enterococcus faecalis. It outlines the device's name, regulation number, product code, and the regulatory class (Class II). It also reiterates that the device is substantially equivalent to legally marketed predicate devices.

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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 negative organisms. This 510(k) is for addition of Minocycline in the dilution range of 0.03 - 32μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia coll Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Staphylococcus aureus* *Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.

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The provided text is an FDA 510(k) clearance letter and an "Indications for Use" statement for a medical device. It does not include information about acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

The document states that the Sensititre 18-24 hour Susceptibility Plates with Minocycline are "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective for its stated indications for use based on comparison to existing devices, not necessarily a new clinical study.

To provide the requested details, I would need a different document, such as a summary of safety and effectiveness data, a clinical study report, or a regulatory submission detailing the validation of the device.

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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 Gatifloxacin in the dilution range of 0.008 - 16 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Gatifloxacin is for: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. In vitro data, without clinical correlation is provided for: Acinetobacter lwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris

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The provided text is a 510(k) premarket notification letter from the FDA for a diagnostic device, specifically a "Susceptibility Test Panel." It approves the addition of Gatifloxacin to an existing panel for testing gram-negative isolates. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The letter is a regulatory approval document and focuses on the "substantial equivalence" of the device to legally marketed predicate devices, not on the detailed performance study data itself.

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

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The Sensititre 18 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 Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Test Panel

This document is a 510(k) clearance letter for a medical device and thus does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.

However, I can extract information related to the device, its intended use, and the type of information that was likely considered for its clearance.

Device Name: Sensititre 18-24 Hour Susceptibility Plates (specifically, the addition of Cefdinir to the Sensititre 18-24 hour MIC panel).
Regulatory Class: II
Product Code: JWY

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be fully provided as typical performance metrics (e.g., sensitivity, specificity, accuracy) are not included in this document.
• The acceptance criteria for substantial equivalence are generally that the device is as safe and effective as a legally marketed predicate device.
• The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the core finding, implying the performance met the FDA's criteria for equivalence based on the submitted data.
• The "reported device performance" is summarized as the ability of the Sensititre 18-24 hour MIC panel to test for Cefdinir susceptibility in specific non-fastidious gram-negative isolates (Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis) in a dilution range of 0.06 - 64 ug/ml.

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

• Not explicitly stated in the provided text. The letter mentions "In vitro data" was provided. Details about the sample size (number of isolates tested), country of origin, or study design (retrospective/prospective) are not present.

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)

• Not explicitly stated in the provided text. For susceptibility testing, ground truth is typically established by a reference method (e.g., agar dilution or broth microdilution following CLSI guidelines), not by human expert consensus in the way it might be for image interpretation.

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

• Not applicable and not stated. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where consensus among experts is needed. For an in vitro diagnostic device measuring antimicrobial susceptibility, the ground truth is usually an objective measurement from a reference method.

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. This device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, which is a laboratory assay. It does not involve "human readers" interpreting images or other complex data that would necessitate an MRMC study or AI assistance in the way described.

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

• Not applicable in the AI sense. The Sensititre system is a standalone automated/semi-automated system for determining Minimum Inhibitory Concentration (MIC). Its performance is evaluated independently of human interpretation of complex patterns, but a laboratory technologist would still perform the test and interpret the numerical MIC results against breakpoints. So, while it's an "algorithm only" in the sense it provides a direct result, it's not "AI" in the modern sense of machine learning for complex pattern recognition. The "standalone performance" would refer to its accuracy compared to a reference method, which is implied by the substantial equivalence determination.

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

• For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as the Clinical and Laboratory Standards Institute (CLSI) recommended broth microdilution or agar dilution methods. The device's results (MIC values) would have been compared to these reference method results for accuracy.

8. The sample size for the training set

• Not explicitly stated in the provided text. This is not typically disclosed in a 510(k) clearance letter. For an IVD like this, there isn't a "training set" in the machine learning sense. Instead, there are validation studies performed with a sufficient number of bacterial isolates to demonstrate the device's accuracy and reproducibility.

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

• Not applicable for a "training set" in the AI sense. As mentioned above, ground truth for such IVDs is established by comparing results to a recognized reference method for antimicrobial susceptibility testing (e.g., CLSI guidelines).

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The Sensititre 18 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 Grepafloxacin in the difution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "indications for use" and the clinical significance of Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

Susceptibility Test Panel

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

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The Sensititre 18 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 Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria. The letter primarily addresses the substantial equivalence determination for the "Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin" and its regulatory classification.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document.

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The Sensititre 18 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 Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.

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I apologize, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, and ground truth establishment for a medical device.

The document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 Hour Susceptibility Plates with Trovafloxacin." This letter indicates that the device has been deemed substantially equivalent to a legally marketed predicate device. While it mentions the "indications for use" and the product code, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the type of study conducted to demonstrate performance (e.g., test set, training set, retrospective/prospective).
• Information about experts used for ground truth, adjudication methods, or the type of ground truth.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The letter is a regulatory document confirming clearance, not a scientific study report with performance metrics.

To answer your questions, I would need access to the actual 510(k) submission document or a scientific paper detailing the validation study for this device.

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