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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae.

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 Telithromycin in the dilution range of 0.002-16µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcusion pneumoniae and the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus_pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).

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Here's a breakdown of the acceptance criteria and study information for the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC/Susceptibility Plate and Test Panel for Telithromycin 0.002-16μg/ml, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) clearance letter, which indicates the device is substantially equivalent to a legally marketed predicate device. For such submissions, the acceptance criteria are generally based on agreement rates between the new device and a reference method (often a standard broth microdilution method). The specific acceptance criteria (e.g., Categorical Agreement and Essential Agreement percentages) and the reported performance are not explicitly detailed in this clearance letter. However, the letter implies that the device successfully met these benchmarks.

As a typical example for antimicrobial susceptibility tests (ASTs) in 510(k) submissions, the acceptance criteria and performance would look something like this (actual values are usually found in the full 510(k) summary, not just the clearance letter):

Note: The document only states that the device was deemed "substantially equivalent." This means that the performance was considered comparable to the predicate device, which inherently means it met the necessary agreement criteria with a reference method. The specific numerical values for acceptance criteria and performance are not present in this clearance letter.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document.
• Data Provenance: Not explicitly stated. For clinical trials supporting 510(k) submissions for ASTs, data typically comes from clinical laboratories, often across multiple sites, within the US. The document does not specify if it was retrospective or prospective, but clinical test validation data for ASTs is often prospective collection and testing of isolates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable in the context of an antimicrobial susceptibility test (AST) device.
• For ASTs, the "ground truth" is established by a reference method (e.g., broth microdilution or agar dilution) performed by trained microbiologists following standardized protocols, not by expert interpretation of images or other subjective data. These methods are quantitative and provide the minimum inhibitory concentration (MIC) values directly.

4. Adjudication Method for the Test Set

• This is not applicable for an AST device. The ground truth for ASTs is determined by a quantitative reference method, not by expert consensus or adjudication. Discrepancies are often resolved by re-testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret data (e.g., radiology images) and the AI's role is to assist or replace that interpretation.
• The Sensititre device is an in vitro diagnostic product designed to directly measure antimicrobial susceptibility. Its performance is evaluated against a reference method, not by comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence, standalone performance is what is primarily evaluated for this device. The Sensititre plate is designed to provide MIC values automatically or semi-automatically. The "algorithm" here is the system's ability to accurately measure growth inhibition relative to a reference method, without significant human interpretation beyond setting up the test and reading the final result (which is often automated). The performance data cited for substantial equivalence would be the standalone performance of the device against the reference method.

7. The Type of Ground Truth Used

• Expert Consensus: Not used.
• Pathology: Not used.
• Outcomes Data: Not used.
• The ground truth for AST devices is typically established by a recognized reference method, such as CLSI (Clinical and Laboratory Standards Institute) or ISO (International Organization for Standardization) standard broth microdilution or agar dilution methods. These methods provide quantitative Minimum Inhibitory Concentration (MIC) values.

8. The Sample Size for the Training Set

• This information is not explicitly provided in the clearance letter.
• For an AST plate, the concept of a "training set" in the machine learning sense (for training an algorithm) is less direct. Instead, a large bank of characterized bacterial isolates (many of which are historical and well-studied) is used during the development and optimization phase to ensure the test system can accurately detect susceptibility and resistance across a wide range of relevant organisms and resistance mechanisms. The letter doesn't specify the size of this internal development/optimization data.

9. How the Ground Truth for the Training Set Was Established

• Similar to the test set, the "ground truth" for any internal development or optimization of an AST device (analogous to a training set) would be established using standardized reference methods (e.g., CLSI broth microdilution) for each isolate. This involves growing the bacteria in the presence of varying concentrations of the antimicrobial and observing the lowest concentration that inhibits visible growth.

In summary, the provided document is a 510(k) clearance, which confirms substantial equivalence based on prior studies. However, it does not contain the granular details of the specific acceptance criteria, study design parameters (like sample sizes or ground truth establishment methods) that would typically be found in the full 510(k) summary or clinical study reports. The nature of the device (an in vitro diagnostic AST) means many questions related to expert interpretation or AI assistance are not directly applicable.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Meropenem in the dilution range of 0.016 - 2 ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzac isolates. The "Indications for Use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (excluding penicillin-resistant strains)

Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Meropenem

The provided text describes the 510(k) premarket notification for the "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Meropenem." This submission is for the addition of Meropenem to an existing in vitro diagnostic product for clinical susceptibility testing.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document is a 510(k) clearance letter. In 510(k) submissions for antimicrobial susceptibility testing (AST) devices, the acceptance criteria typically involve demonstrating substantial equivalence to a predicate device, which usually means meeting specific performance targets (e.g., essential agreement and categorical agreement within defined percentages) when comparing the new device's results to a reference method (like broth microdilution or agar dilution). However, these specific numerical criteria and the actual performance results are not detailed in this summary letter. The letter simply confirms the FDA's determination of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number or qualifications of experts used to establish ground truth. For AST devices, the "ground truth" (or reference method) is typically established by well-defined laboratory methodologies, not individual expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. For AST, the reference method results are generally considered definitive, not subject to adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done, as this is not applicable for an in vitro diagnostic device like an antimicrobial susceptibility test. MRMC studies are typically used to evaluate the performance of diagnostic imaging devices or other tests that rely on human interpretation.

6. Standalone Performance Study

Yes, a standalone performance study would have been performed as part of the 510(k) submission to demonstrate the performance of the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates with Meropenem. This study would involve testing a set of bacterial isolates with known susceptibility to Meropenem using the device and comparing the results to a reference method (e.g., broth microdilution). While the results of this study are not in this letter, such a study is fundamental to gaining 510(k) clearance for an AST device.

7. Type of Ground Truth Used

The ground truth for antimicrobial susceptibility testing is typically established by a reference method, most commonly:

• Broth Microdilution (BMD): This is the gold standard for determining minimum inhibitory concentrations (MICs).
• Agar Dilution: Another established reference method.

The FDA's review for AST devices requires comparison to these standard methods.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. For in vitro diagnostic products, particularly those using established methodologies, a distinct "training set" in the machine learning sense is often not applicable in the same way as for AI/ML-driven devices. The development of an AST panel relies on extensive historical data and established breakpoints.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the typical sense of AI/ML training data. The "ground truth" (reference method) for establishing the validity and accuracy of the susceptibility plate would have been based on standardized laboratory protocols (e.g., CLSI guidelines) for determining resistance and susceptibility profiles of various bacterial isolates to Meropenem. These protocols define how to obtain accurate MIC values using reference methods.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro quantitative and qualitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Clarithromycin is for: Streptococcus pneumoniae

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Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) clearance letter for a modified antimicrobial susceptibility testing plate, specifically for the addition of Clarithromycin. It does not contain a table of acceptance criteria or detailed performance data. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

To provide an example relevant to this type of device, typical acceptance criteria for an antimicrobial susceptibility test (AST) in a 510(k) submission would involve demonstrating acceptable agreement with a reference method (e.g., broth microdilution or agar dilution). The performance metrics would generally be:

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