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The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms.

This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for:

Aerobic facultative Gram-postive microorganisms

Streptoccus agalactiae Streptococcus pyogenes Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and . S. constellatus)

Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.

The provided text is a 510(k) premarket notification letter from the FDA to TREK Diagnostic Systems, Inc. for their Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, specifically for the addition of Tigecycline. This document is a regulatory approval letter and does not contain the detailed study information required to answer most of your questions about acceptance criteria, device performance, study design, or ground truth establishment.

The letter confirms legal marketing authorization but refers to the company's 510(k) submission for the underlying data. Therefore, I can only provide information that is explicitly stated or can be inferred from this specific document.

Here's what can be extracted:

• Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp.
• Indication for Use: The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-positive microorganisms including Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus).

Since the document is a regulatory approval letter and not the study report itself, most of your questions cannot be answered from the provided text. The requested information such as acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies would be detailed in the original 510(k) submission, which is not provided here.

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

This 510(k) is for the addition of Ertapenem in the dilution range of 0.008-16ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Ertapenem is for: Streptococcus pneumoniae ( penicillin susceptible strains only) and Haemophilus influenzae (Beta-lactamase negative strains only). In vitro data. without clinical correlation is provided for: Streptococcus pneumoniae (penicillinintermediate strains only) and Haemophilus influenzae (Beta-lactamase positive strains)

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This document contains information related to the 510(k) premarket notification for the "Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate For Ertapenem 0.008-16ug/ml". The provided text primarily focuses on the regulatory approval and indications for use, but it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance data.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets.
• Data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, etc.).
• How ground truth for the training set was established.

The provided text only states that the device is an "in vitro diagnostic product for clinical susceptibility testing" and for the "addition of Ertapenem." It also mentions "In vitro data without clinical correlation is provided" for certain strains, which implies that some in vitro testing was done but the full details are not present in this excerpt.

To provide a complete answer with all the requested information, you would need to consult the full premarket notification submission (K040846) which would include the detailed study protocols, results, and acceptance criteria.

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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. This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Clindamycin is for: Streptococcus pneumoniae.

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This document is a 510(k) clearance letter for an in vitro diagnostic product, specifically a susceptibility plate for Clindamycin. It does not contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, or performance metrics.

The provided text focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices. It identifies the device, its intended use, and the regulatory classification. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets, or data provenance.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
• The type of ground truth used.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and study details.

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

This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.001 - 16 ug/ml to the Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC Susceptibility plate MIC panel for testing Haemophilus / Streptococcus pneumoniae isolates. The approved primary " Indications for Use" and clinical significance of Gemifloxacin is for: Streptococcus pneumoniae and Haemophilus Influenzae.

Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates

This is a 510(k) premarket notification for adding a new antibiotic (Gemifloxacin) to an existing antimicrobial susceptibility test plate for Haemophilus and Streptococcus pneumoniae. The submission focuses on the performance of Gemifloxacin with these specific bacteria.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical format of sensitivity, specificity, or AUC. Instead, for antimicrobial susceptibility testing, performance is generally evaluated based on agreement rates between the new device and a reference method (often broth microdilution or agar dilution). The key metrics for this type of test are:

• Essential Agreement (EA): The MIC result from the new device is within plus or minus one two-fold dilution of the reference method MIC.
• Categorical Agreement (CA): The interpretive category (Susceptible, Intermediate, Resistant) from the new device matches the reference method.
• Major Discrepancy (MD): The new device reports Susceptible while the reference reports Resistant.
• Minor Discrepancy (mD): The new device reports Intermediate while the reference reports Susceptible or Resistant, or vice versa.
• Very Major Discrepancy (VMD): The new device reports Resistant while the reference reports Susceptible.

Based on standard FDA guidance for AST devices, the acceptance criteria typically involve high EA and CA, with low percentages of MD and VMD.

While the specific numerical acceptance criteria are not stated in the provided text, the approval implies that the sponsor met FDA's expectations for these metrics. The letter focuses on the administrative aspects of approval, not the detailed study results. To provide a table, I would need more detailed information from the actual 510(k) submission, which is not fully included here.

However, based on typical FDA requirements for AST devices, a hypothetical table would look like this (with specific values usually included in the full submission, but not in this high-level letter):

The study described implicitly in the approval process would have demonstrated that the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates, when testing Gemifloxacin, achieved these levels of agreement with a reference method for Haemophilus and Streptococcus pneumoniae isolates.

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

The provided text does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

For AST devices evaluating a new antimicrobial, FDA guidance (e.g., "Guidance for Industry and FDA - Referencing the Clinical and Laboratory Standards Institute Antimicrobial Susceptibility Testing Standards for Device Submissions") typically recommends testing a diverse set of isolates, including those with various resistance mechanisms, and often hundreds of isolates (e.g., >200 for common species, more for less common or resistant phenotypes) across multiple sites. The isolates should be well-characterized.

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

This information is not provided in the text. For AST, the "ground truth" is typically established by performing the reference method (e.g., CLSI-compliant broth microdilution or agar dilution) by trained microbiologists following standard protocols, not by expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set

This is not applicable in the context of AST device evaluation for ground truth. The "ground truth" for AST is determined by the reference method's result, not by expert adjudication of discrepancies, although discrepancies between the test device and reference method are analyzed.

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 question is not applicable to this type of device. The Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plate is an in vitro diagnostic (IVD) device for antimicrobial susceptibility testing, which provides quantitative (MIC) or qualitative (S/I/R) results. It is not an AI-powered diagnostic imaging device that involves human readers interpreting cases with or without AI assistance.

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

This question is not directly applicable in the context of this specific IVD. The device itself is designed to produce results (MIC values) based on the growth or inhibition of bacteria in the presence of various concentrations of antibiotics. The interpretation of these results into S/I/R categories is done based on established breakpoints, which can be done automatically or by a human reviewing the MIC data. The "standalone" performance here refers to the accuracy of the device in determining the MIC values compared to the reference method (as discussed in point 1). There isn't an "algorithm only without human-in-the-loop" performance in the sense of AI image analysis.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC Plates with Gemifloxacin would be the results obtained from a CLSI-compliant (Clinical and Laboratory Standards Institute) reference method, such as broth microdilution or agar dilution. These methods are considered the gold standard for determining MICs of antimicrobials.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning/AI models is not applicable to this type of IVD device. This device is a phenotypic test system (it measures bacterial growth directly), not a software algorithm that learns from data.

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

As the concept of a training set is not applicable, this question is also not applicable.

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