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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 amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms:

Acinetobacter spp. (Acinetobacter baumannii)

Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)

Pseudomonas aeruginosa

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The provided FDA 510(k) clearance letter pertains to The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on the system. The indications for use specify its application for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Unfortunately, the provided document does not contain the detailed information required to specifically answer your questions about acceptance criteria, study methodology (sample size, data provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. This clearance letter is a formal notification of substantial equivalence and outlines the intended use and regulatory classifications, but it does not include the full summary of safety and effectiveness data that would typically contain such study specifics.

To get the information you're looking for, you would generally need to refer to the 510(k) Summary document, which is usually part of the full 510(k) submission and is publicly available through the FDA's 510(k) database. This summary typically provides a more detailed overview of the performance studies conducted to support the clearance.

Therefore, I cannot populate the table or answer most of your specific questions based solely on the provided text.

However, I can extract what is implied about acceptable performance:

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

Based only on the statement "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms," we can infer that the device met the manufacturer's internal acceptance criteria for performance for these organisms, as the FDA has cleared it. Without the 510(k) summary, specific numeric thresholds for performance metrics (e.g., Essential Agreement, Category Agreement) for in vitro diagnostic susceptibility tests are not provided in this letter.

The following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (Note: This device is an in vitro diagnostic for antimicrobial susceptibility testing, not typically an AI-assisted diagnostic read by a human expert in the context of imaging or pathology. An MRMC study is highly unlikely for this type of device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (The device itself is the "standalone" test; human interpretation is involved in setting up the test and reading the results, although it's an automated or semi-automated system. Performance is typically measured against a reference method.)
7. The type of ground truth used. (For AST devices, the ground truth is typically a reference method like broth microdilution or agar dilution, performed according to CLSI guidelines.)
8. The sample size for the training set. (While there might be "training" in the sense of model development for an automated reader, a primary training set in the AI/ML sense is not typically discussed for this type of in vitro diagnostic device, which relies on chemical reactions and optical detection.)
9. How the ground truth for the training set was established. (Similar to point 8, this question's premise might not directly apply to this type of device.)

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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.

The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms:

Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis)

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test Disc (ASTD), specifically the "Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50". This type of device is a diagnostic tool used in microbiology laboratories to determine how effective certain antimicrobials are against specific microbial infections.

The information typically requested for AI/ML-based medical devices (such as acceptance criteria, ground truth establishment for training/test sets, sample sizes, MRMC studies, etc.) is not directly applicable to this type of traditional in vitro diagnostic device (IVD).

Here's why and what can be extracted from the document:

• Nature of the Device: The Aztreonam/Avibactam Disc is a physical disc impregnated with antimicrobial agents. Its "performance" refers to its ability to accurately measure the zone of inhibition (a clear area around the disk where bacteria do not grow), which then correlates to the susceptibility or resistance of the microorganism to the antibiotic. It's not an AI/ML algorithm that interprets or processes complex images or data in an automated way.
• Acceptance Criteria for ASTDs: For ASTDs, acceptance criteria typically involve demonstrating a high degree of correlation between the zone diameters produced by the disc and the Minimum Inhibitory Concentration (MIC) values obtained by a reference method (e.g., broth microdilution). This often involves:
  • Essential Agreement (EA): The percentage of isolates for which the disc test and the reference method produce results that categorize the isolate into the same interpretive category (Susceptible, Intermediate, Resistant).
  • Category Agreement (CA): A stricter measure, where both the zone diameter and MIC fall within defined ranges for a specific category.
  • Major Discrepancies (MD): When the disc test indicates Susceptible, but the reference method indicates Resistant.
  • Very Major Discrepancies (VMD): When the disc test indicates Resistant, but the reference method indicates Susceptible.
  • Minor Discrepancies (mD): Discrepancies between Intermediate and Susceptible/Resistant categories.
    The FDA expects these discrepancy rates to be below certain thresholds (e.g., VMD < 1.5% to 3.0%, MD < 3.0%).
• Study Design for ASTDs: Studies for ASTDs involve testing a diverse collection of bacterial isolates (both wild-type and resistant strains) with the new disc and a reference method. The "ground truth" is typically the reference method's result (e.g., standard broth microdilution or agar dilution).

Therefore, I cannot provide the requested information in the format tailored for AI/ML devices because the provided document is for a traditional diagnostic device.

However, based on general knowledge of IVD submissions, here's what could be inferred and what the document explicitly states:

Inferences for Traditional IVDs (not explicitly stated in the provided text):

• Acceptance Criteria and Reported Performance (Hypothetical for ASTD):

• Sample Size for Test Set: Typically hundreds to thousands of diverse clinical isolates (e.g., 200-500 isolates per species-drug combination, often more for certain categories like resistant isolates).
  • Data Provenance: Usually a mix of retrospective and prospective clinical isolates from various geographic regions (e.g., multiple clinical sites in the US, Europe, etc.) to ensure diversity in resistance mechanisms and strains.
• Number of Experts for Ground Truth: Not applicable in the context of human "experts" establishing truth from images/clinical data. The "ground truth" is established by a reference laboratory method (e.g., CLSI or ISO standard broth microdilution) performed by trained microbiologists.
• Qualifications of Experts: Trained microbiologists and laboratory technicians following standardized protocols for the reference method.
• Adjudication Method: Not applicable. The reference method is the "truth," and results are compared directly to it.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable to this type of device. There are no human "readers" of an AI output to compare.
• Standalone Performance: The "standalone performance" of the disc is its correlation with the reference method.
• Type of Ground Truth Used: Standardized reference antimicrobial susceptibility testing methods (e.g., broth microdilution or agar dilution) and established FDA Susceptibility Test Interpretive Criteria (STIC).
• Sample Size for Training Set: Not applicable for a traditional ASTD; there's no "training" in the ML sense. The formulation of the disc and preliminary testing would involve screening many isolates, but not in an ML training paradigm.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does tell us:

1. Device Identity: Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50.
2. Intended Use: Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection. Specifically, it's intended to determine susceptibility of Enterobacterales to Aztreonam/Avibactam, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).
3. Microorganisms for which performance was demonstrated: Enterobacterales (Citrobacter freundii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, and Proteus mirabilis).
4. Regulatory Classification: Class II, Product Code JTN, Regulation Number 21 CFR 866.1620 (Antimicrobial Susceptibility Test Disc).
5. Performance Statement: "The Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 demonstrated acceptable performance to determine susceptibility to Aztreonam/Avibactam against the following microorganisms:" (followed by the list of microorganisms). This statement implies that the manufacturer successfully met the pre-defined acceptance criteria for performance validation.

In summary, the provided document clears a traditional in-vitro diagnostic device, not an AI/ML powered one, meaning the requested detailed information about AI/ML study methodologies is not present nor relevant for this product.

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The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for micafungin in the dilution range of 0.008-16 ug/mL for testing Candida spp. on The Sensitite YeastOne Susceptibility System. Micafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Candida albicans Candida glabrata Candida guilliermondi Candida krusei Candida parapsilosis Candida tropicalis

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I apologize, but the provided text from the FDA 510(k) clearance letter for "The Sensititre YeastOne Susceptibility System with Micafungin" does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers:

• The trade/device name, regulation number, regulatory class, and product code.
• Confirmation of substantial equivalence.
• Information about general controls, special controls, the predetermined change control plan (PCCP), and other applicable regulations (Quality System, adverse event reporting, UDI Rule).
• Indications for Use of the device.

It specifically lacks the following information that would be necessary to address your request:

1. Acceptance criteria table and reported device performance: The letter does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) or the thresholds for acceptance (e.g., "required to be > X%").
2. Study details (sample size, data provenance, expert counts, adjudication, MRMC, standalone performance, ground truth type, training set details): The letter does not include any information about the design or results of the studies used to validate the device's performance. For an Antimicrobial Susceptibility Test (AST) system, performance is typically assessed by comparing its results (categorization into Susceptible, Intermediate, Resistant) against a reference method.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission summary publically available on the FDA website, or the relevant performance study reports and data that were provided by Thermo Fisher Scientific to the FDA for review. The clearance letter itself is a summary of the FDA's decision, not the underlying data or study methodology.

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The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for meropenem in the dilution range of 0.015 - 32 ug/ml for testing fastidious isolates on the Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.

Meropenem has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Streptococcus spp. Viridians group Haemophilus influenzae

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The provided text is a 510(k) clearance letter from the FDA for an Antimicrobial Susceptibility Test Powder. It does not contain the details of acceptance criteria or a study proving that a device meets such criteria, as it relates to an AI/ML-driven medical device. The document is an administrative letter confirming the substantial equivalence of a new version of an in vitro diagnostic product (Sensititre) used for antimicrobial susceptibility testing, specifically for meropenem against certain bacterial isolates.

Therefore, I cannot extract the information requested about acceptance criteria, device performance, test set details (sample size, provenance, expert adjudication, MRMC study, standalone performance), ground truth, or training set details. This information would typically be found in a detailed study report or premarket submission for an AI/ML device, not in a 510(k) clearance letter for an in vitro diagnostic for antimicrobial susceptibility.

In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving device performance for an AI/ML device.

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The Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System is an in vitro diagnositic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Ceftolozane-tazobactam in the dilution range of 0.03/4 - 64/4 µg/ml for testing H. influenzae on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Ceftolozane-tazobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Haemophilus influenzae

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This FDA 510(k) clearance letter pertains to an in vitro diagnostic (IVD) device, specifically an antimicrobial susceptibility testing system. The questions you've posed (acceptance criteria, study design, ground truth, MRMC, etc.) are highly relevant to the evaluation of AI/ML-driven medical devices, particularly those that interpret images or other complex data to provide a diagnosis or assist in clinical decision-making.

However, the provided text does not contain the detailed study information required to answer your questions. This document is a clearance letter, stating that the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam has been found substantially equivalent to a predicate device.

Here's why the information is not present in this document:

• Type of Device: This is a microbiology susceptibility testing system, not an AI/ML image interpretation device. While it's an IVD, its function is to determine the minimum inhibitory concentration (MIC) or breakpoint susceptibility of an antibiotic against specific bacteria. This is typically done through a standardized laboratory process (e.g., microdilution) where the growth or inhibition of bacteria is observed, not through complex image analysis or AI algorithms in the way you're inferring.
• 510(k) Process: For traditional IVD devices like this, substantial equivalence is often demonstrated by showing the new device performs comparably to a legally marketed predicate device using established laboratory methods. The detailed performance data, including acceptance criteria and study results, would be submitted in the 510(k) application itself, but not typically summarized in the public clearance letter.
• Lack of AI/ML Component: There is no mention of AI or machine learning in the device description. Therefore, concepts like "human readers," "AI assistance," "effect size," "standalone algorithm," "training set," or "adjudication methods" for image interpretation are not applicable to the Sensititre system as described here.

To answer your questions accurately, one would need access to the actual 510(k) submission (K232310) which is often not publicly available in its entirety, or more specifically, the performance data section of that submission.

For illustrative purposes, if this were an AI/ML imaging device, a typical response addressing your questions would look like this (but again, the provided text does not support this):

Hypothetical Example (if this were an AI/ML imaging device and the information was available):

(Disclaimer: The following is entirely hypothetical and fabricated to demonstrate how your questions would be answered if the provided document were about an AI/ML medical device and contained the necessary study details. This information is NOT present in the provided FDA 510(k) clearance letter.)

The device is an AI-powered system designed to assist radiologists in detecting subtle findings on chest X-rays.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 5,000 anonymized chest X-ray images (DICOM format).
• Data Provenance: Retrospective study. Data collected from 10 different hospitals across the United States (70%), Canada (15%), and the UK (15%). Images covered a range of scanner types and patient demographics.

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

• Number of Experts: 3 independent expert radiologists.
• Qualifications: All were board-certified radiologists with subspecialty training in thoracic imaging and a minimum of 10 years of post-fellowship clinical experience reading chest X-rays.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1. Two independent expert radiologists initially reviewed each case. If their initial assessments disagreed, a third, senior expert radiologist reviewed the case to reach a consensus for the final ground truth label.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

• MRMC Study: Yes, an MRMC study was conducted.
• Effect Size:
  • Sensitivity: Human readers demonstrated a statistically significant increase in sensitivity of 7.2 percentage points (e.g., from 78.0% unaided to 85.2% with AI assistance) for detecting actionable findings.
  • Specificity: No statistically significant change in specificity was observed, indicating the AI assistance did not lead to a significant increase in false positives.
  • Reading Time: Average reading time per case decreased by 15% with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Yes, standalone performance was evaluated against the ground truth.
  • Sensitivity: 92.5%
  • Specificity: 83.2%
  • AUC: 0.94 (Receiver Operating Characteristic Area Under the Curve)

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus of 3 board-certified thoracic radiologists, further supported by correlation with available clinical outcomes data (e.g., follow-up imaging, pathology reports, surgical findings) where applicable and available in the retrospective dataset.

8. The Sample Size for the Training Set

• Training Set Sample Size: 50,000 anonymized chest X-ray images.

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

• Ground Truth for Training:
  • Initial labeling was performed by a team of trained clinical annotators.
  • A subset of 10% of the training data was reviewed and verified by a single board-certified radiologist to ensure labeling consistency and accuracy.
  • For particularly challenging or ambiguous cases during annotation, an internal consensus review by two radiologists was performed.
  • A semi-supervised learning approach was employed where initial labels were used for training, and the model's performance on a validation set guided further expert review and refinement of labels for challenging cases.

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The Sensitite YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candido spp. This 510(k) is for Rezafungin in the dilution range of 0.008 - 8 ug/mL for testing Candida spp. on the Sensititer YeastOne Susceptibility System. Rezafungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drup label: Candida albicans Candida glabrata Candida parapsilosis.

Not Found

The provided text is a 510(k) clearance letter for the Sensititre YeastOne Susceptibility System with Rezafungin. It does not contain the detailed study information required to answer your specific questions about acceptance criteria and study design. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include the performance data, sample sizes, ground truth establishment, or expert details that would typically be found in a study report or a more comprehensive FDA review document.

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

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The Sensitite 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for dalbavancin in the dilution range of 0.0005 - 2ug/ml with new FDA breakpoints for testing fastidious Streptococus spp. on the Sensitite 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System.

Dalbavancin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Streptococcus agalactiae Streptococcus pyogenes Streptococcus anginosus group (S. anginosus, S. constellatus and S. intermedius)

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The provided text describes a 510(k) premarket notification for a medical device and includes the Indications for Use, but it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The document is a clearance letter from the FDA, confirming that the device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin) is substantially equivalent to a legally marketed predicate device. While this letter refers to the device and its intended use, it does not provide the technical details of the validation studies.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need to review the actual 510(k) summary document or the underlying clinical/performance study reports that were submitted to the FDA for review.

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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 Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel.

Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Acinetobacter baumannii-calcoaceticus complex

Not Found

This is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices. The document is a regulatory approval for a laboratory diagnostic product, specifically for testing the susceptibility of certain bacteria to a new antibiotic combination (Sulbactam-durlobactam).

The type of "performance" for such a device is related to its accuracy in determining minimum inhibitory concentrations (MICs) or breakpoints, and its ability to correctly classify bacteria as susceptible, intermediate, or resistant to the antibiotic.

Here's how I can address your request based on the provided text, while also noting what is not present:

A. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria or a detailed performance table for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam.

For this type of device (Antimicrobial Susceptibility Test), acceptance criteria typically involve:

• Essential Agreement (EA): The percentage of MIC values that are within ±1 doubling dilution of a reference method.
• Category Agreement (CA): The percentage of isolates that are categorized identically (Susceptible, Intermediate, or Resistant) by the test system and the reference method.
• Major Errors (ME): When the test system reports an isolate as Susceptible when the reference method reports it as Resistant.
• Very Major Errors (VME): When the test system reports an isolate as Resistant when the reference method reports it as Susceptible.

Regulatory guidance for AST devices usually sets specific thresholds for these metrics (e.g., >90% EA, >90% CA, <3% ME, <1.5% VME). However, these specifics are not in the provided document. The document is the FDA's clearance letter, not the detailed submission itself.

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

The provided text does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For an AST device, this would typically involve a collection of clinical bacterial isolates and challenge isolates tested against a reference method.

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

The provided text does not mention experts or their qualifications for establishing ground truth. For AST devices, the "ground truth" is typically established by:

• A reference AST method, such as broth microdilution, performed by trained microbiologists.
• Concordance with CDC or CLSI guidelines for interpreting MIC values.

D. Adjudication Method

The provided text does not mention an adjudication method. This is common for AST devices, as the reference method typically provides the definitive result without requiring expert adjudication in the same way as an imaging AI product.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are typically used for imaging AI products to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting images). This device is a diagnostic test kit for antimicrobial susceptibility, not an AI imaging tool. Therefore, there is no discussion of human readers improving with or without AI assistance.

F. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The concept of a "standalone algorithm" is not directly applicable in the same way it would be for an AI/ML device. For an AST system, the "standalone performance" refers to the accuracy of the test panel itself in determining MICs or breakpoints when compared to a gold standard reference method.

The FDA clearance implies that such performance data was submitted and found acceptable, demonstrating the system's ability to accurately determine susceptibility to Sulbactam-durlobactam for the specified organisms. However, the details of this study (e.g., specific metrics like EA, CA, ME, VME) are not included in this clearance letter.

G. Type of Ground Truth Used

The ground truth for this type of device (Antimicrobial Susceptibility Test) would typically be established by a broth microdilution reference method or another CLSI-standardized AST method, along with established clinical breakpoints or interpretive criteria. The FDA drug label for Sulbactam-durlobactam would also provide essential information on activity against specific organisms. The document states: "Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Acinetobacter baumannii-calcoaceticus complex." This implicitly references established in-vitro and clinical data as part of the ground truth.

H. Sample Size for the Training Set

The provided text does not contain information about a "training set" sample size. This term is primarily relevant for AI/ML devices that learn from data. An AST system is a chemical and biological assay, not a machine learning model, so there isn't a "training set" in the AI sense.

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

As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable and therefore, no information is provided on how its ground truth was established.

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The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae MC or Breakpoint System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for Imipenem-relebactam in the dilution range of 0.03/4-128/4 ug/ml for testing fastidious Haemophilus influenzae on the Sensitite 20 - 24 hour Haemophilus influenzae/Streptoccus pneumoniae MIC or Breakpoint Susceptibility System.

Imipenem-relebactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Haemophilus influenzae

Not Found

The provided text describes a 510(k) premarket notification for a medical device called the "Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam". This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically focusing on Imipenem-relebactam for Haemophilus influenzae.

However, the provided document is a regulatory approval letter and indications for use statement. It does not contain any information regarding the acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your specific questions about the device's performance and the study that proves it meets acceptance criteria.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed test report.

Therefore, I cannot provide the requested table or information regarding the study.

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The Sensititre 20 - 24-hour Haemophilus influenzae Streptococcus pneumoniae MIC or Break is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for Delafloxacin in the dilution range of 0.00025-8 ug/ml for testing fastidious Streptococcus spp., (including S. pneumoniae) and delafloxacin in the dilution range of 0.000125 - 8 ug/mL for testing H. influenzae on the Sensititre 20 - 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System. Delafloxacin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: For Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus grp. For Community Acquired Bacterial Pneumonia (CABP) Streptococcus pneumoniae Haemophilus influenzae

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The provide FDA 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.

The document is a clearance letter for a medical device (Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin), indicating it has been deemed substantially equivalent to a predicate device. While it mentions the device's intended use and the specific drug for susceptibility testing, it does not include the specifics of the performance study.

Typically, such information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details) would be explicitly laid out in the 510(k) summary submitted by the manufacturer to the FDA. The provided text is the FDA's response to that submission and does not detail the underlying studies.

Therefore, I cannot provide the answer in the requested format based on the given input.

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