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The MTS (MIC Test Strip) Aztreonam-Avibactam 0.016/4-256/4 μg/mL is a quantitative method intended for in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL should be interpreted at 16-20 hours of incubation.

Testing with MTS Aztreonam-Avibactam at concentrations of 0.016/4-256/4 μg/mL is indicated for Enterobacterales as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL has demonstrated acceptable performance with the following organisms:

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

MTS Aztreonam-Avibactam 0.016/4-256/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient aztreonam across 15 two-fold dilutions like those of a conventional MIC method and avibactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the aztreonam-avibactam code (AZA) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.

Aztreonam-avibactam is the combination of aztreonam (a monobactam) that interferes with bacterial cell wall synthesis and avibactam (a β-lactamase inhibitor) that neutralizes β-lactamase enzymes. It is used in combination with metronidazole to treat complicated intra-abdominal infections (cIAI) caused by susceptible E. coli, K. pneumoniae, K. oxytoca, E. cloacae complex, C. freundii complex and S. marcescens.

MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.

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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 colistin in the dilution range of 0.12-16 ug/mL for testing non-fastidious gram-negative isolates on the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter baumannii complex, 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 Colistin in the dilution range of 0.12-16 ug/mL demonstrated acceptable performance with the following organisms:

• Acinetobacter baumannii complex (Acinetobacter baumannii)
• Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae)
• Pseudomonas aeruginosa

Not Found

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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 aztreonam/avibactam in the dilution range of 0.008/4-64/4 ug/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Enterobacterales, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4-64/4 ug/mL demonstrated acceptable performance with the following organisms:

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)

Not Found

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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

Not Found

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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The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial cefepime at concentrations of 0.12-64 µg/mL to the test panel. Testing is indicated for Enterobacterales, Pseudomonas aeruginosa and Aeromonas spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter koseri, (formerly Citrobacter diversus), Citrobacter freundii complex (Citrobacter freudnii, Citrobacter werkmanii and Citrobacter youngae), Klebsiella oxytoca, Morganella morganii, Proteus vulgaris, Providencia stuartii, Providencia rettgeri, Serratia marcescens)

Pseudomonas aeruginosa

Aeromonas spp.

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

The principle of MicroScan panels with antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The product is single-use and intended for laboratory professional use.

Device Performance Acceptance Criteria and Study Details for MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime

Based on the provided FDA 510(k) Clearance Letter, the device in question is the MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL), which is an Antimicrobial Susceptibility Test (AST) System. The study described focuses on demonstrating the substantial equivalence of this new configuration (with Cefepime) to a predicate device.

Given the nature of the device (an AST System), the "acceptance criteria" are typically related to the accuracy of determining Minimum Inhibitory Concentration (MIC) and the resulting categorical agreement (Susceptible, Intermediate, Resistant) compared to a reference method. The "study that proves the device meets the acceptance criteria" refers to the performance evaluation conducted for the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

For AST systems, the key performance metrics are Essential Agreement (EA) and Categorical Agreement (CA) when compared to a CLSI (Clinical and Laboratory Standards Institute) frozen reference panel. The FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009, likely outlines the specific acceptance criteria thresholds for EA and CA. While the exact numerical acceptance criteria are not explicitly stated in the provided text, the performance "demonstrated acceptable performance" implies meeting these pre-defined thresholds.

Important Note: The document highlights some instances where the performance was "outside of essential agreement" for Enterobacterales with Prompt inoculation and "below 90%" for Aeromonas spp. with turbidity inoculation and WalkAway read method. These discrepancies are "mitigated with a limitation" in the product labeling, suggesting that while initial performance in those specific conditions did not meet implicit criteria, the overall robust performance with other methods/organisms, coupled with labeling limitations, made the device acceptable for clearance.

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

• Sample Size: The document does not explicitly provide a total number for the test set sample size (e.g., number of isolates tested). It refers to "contemporary and stock Efficacy isolates and stock Challenge strains" used for external evaluations.
• Data Provenance: The document does not specify the country of origin of the data. It mentions "external evaluations," which generally implies testing conducted at clinical sites or contract research organizations. The study appears to be retrospective in the sense that it uses "stock Efficacy isolates and stock Challenge strains" which are pre-existing collections of bacterial isolates. It also mentions "contemporary" isolates, suggesting some recent collection. It implies a laboratory-based performance study rather than a clinical trial with patient outcomes.

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

This type of device (AST System) does not typically rely on human expert interpretation for establishing the "ground truth" of the test set. The ground truth for antimicrobial susceptibility testing is established by a reference method, which for this device is stated as a "CLSI frozen Reference Panel."

Therefore:

• Number of Experts: Not applicable in the context of creating the ground truth for AST.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

As the ground truth is established by a reference method (CLSI frozen Reference Panel), there is no human adjudication method like 2+1 or 3+1 typically used for image-based diagnostics. The device's results are directly compared to the quantitatively or qualitatively determined results from the CLSI 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

There is no indication that an MRMC comparative effectiveness study was performed. This type of study is not relevant for this device, which is an automated or manually read laboratory diagnostic for antimicrobial susceptibility, not an AI-assisted diagnostic tool that aids human readers in interpretation. The device itself performs the susceptibility test.

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

Yes, the performance data presented is effectively standalone performance of the device (MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime). The device "read either visually or with MicroScan instrumentation" and its performance (Essential Agreement, Categorical Agreement) is directly compared to the reference standard. The "human-in-the-loop" would be the laboratory professional reading the results, and the study evaluates the accuracy of the device itself in producing those results. Where visual reads are mentioned, it's about the device's ability to produce clear inhibition patterns for visual interpretation, not a human independently interpreting raw data without the device.

7. The Type of Ground Truth Used

The ground truth used was established by a CLSI frozen Reference Panel. This is a recognized and standardized method for determining antimicrobial susceptibility, often involving broth microdilution or agar dilution methods where organisms are tested against known concentrations of antimicrobials. It is a highly controlled and quantitative method to determine the true MIC value against which the device's performance is compared.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about its sample size. This is consistent with the nature of the device. AST systems are generally rule-based or empirically derived systems based on established microbiological principles, rather than machine learning models that require distinct training sets. The development of such panels involves extensive empirical testing during the R&D phase to ensure the correct concentrations and formulations, but this isn't typically referred to as a "training set" in the context of an AI/ML model.

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

As no training set (in the AI/ML sense) is indicated, this point is not applicable.

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The MTS (MIC Test Strip) Sulbactam-Durlobactam 0.004/4-64/4 μg/ml is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/ml of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. MTS Sulbactam- Durlobactam at concentrations of 0.004/4-64/4 μg/ml should be interpreted at 16-20 hours of incubation.

Testing with MTS Sulbactam-Durlobactam at concentrations of 0.004/4-64/4 μg/mL is indicated for Acinetobacter baumannii calcoaceticus complex as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The MTS Sulbactam-Durlobactam 0.004/4-64/4 μg/mL has demonstrated acceptable performance with the following organisms:

Acinetobacter baumannii calcoaceticus complex

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 μg/mL is made of special high-quality paper impregnated with a predefined concentration of gradient sulbactam across 15 two-fold dilutions like those of a conventional MIC method and durlobactam at a fixed concentration of 4 μg/mL. One side of the strip is labeled with the sulbactam-durlobactam code (SUD) and the MIC reading scale in μg/mL. When the MTS is applied onto an inoculated agar surface, the performed exponential gradient of antimicrobial agent diffuses into the agar for over an hour. After 16-20 hours incubation, a symmetrical inhibition ellipse centered along the strip is formed. The MIC is read directly from the scale in terms of μg/mL at the point where the edge of the inhibition ellipse intersects the MIC Test Strip. The MIC Test Strip (MTS) is single use only.

Sulbactam-durlobactam is an intravenous beta-lactam combination antibiotic used to treat hospital-acquired pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
MTS is supplied in 3 different packaging options (no additional reagents are included). There is a 10- test box, a 30- test box and a 100-test box.

Here is a description of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the MTS Sulbactam-Durlobactam device:

Device: MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
Intended Use: Quantitative method for in vitro determination of antimicrobial susceptibility of Acinetobacter baumannii calcoaceticus complex using MIC Test Strips with manual reading after overnight incubation.

1. Acceptance Criteria and Reported Device Performance

The study evaluated the performance of the MTS Sulbactam-Durlobactam device against a reference broth microdilution MIC method. The primary metrics for performance were Essential Agreement (EA) and Category Agreement (CA), along with an analysis of errors (very major, major, minor). While explicit "acceptance criteria" percentages are not directly stated in the summary, typical FDA criteria for AST systems are implied by the reported results. The guidance document referenced "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, August 28, 2009" would contain the specific acceptance thresholds. Based on the provided summary, the device performance is reported as follows:

Table of Device Performance

Implied Acceptance Criteria (based on typical FDA AST requirements, generally >90% for EA and CA, and strict limits on major/very major errors):
The reported performance values of 97.3% EA and 92.7% CA, along with very low major errors and zero very major errors, indicate that the device met the acceptance criteria as determined by the FDA. Specifically, the zero very major errors are critical for patient safety, as they avoid situations where a resistant infection might be incorrectly identified as susceptible, leading to inappropriate treatment.

2. Sample Size and Data Provenance

• Test Set Sample Size: 588 isolates for the combined clinical and challenge organism groups.
• Data Provenance:
  • Clinical Testing: Performed at three (3) sites. The precise country of origin is not explicitly stated for the clinical sites, but the submitter (Liofilchem s.r.l.) is based in Italy, and their contact person for the 510(k) is in Westlake, Ohio, USA. The FDA clearance suggests testing was appropriate for the US market.
  • Challenge Isolate Testing: Performed at one site (Laboratory Specialists, Inc., which is the 510(k) preparer's company in Westlake, Ohio).
  • Nature of Data: The data combines retrospective (challenge isolates specifically selected to ensure MIC range coverage, including resistant isolates) and prospective (fresh clinical isolates tested at multiple sites) elements.

3. Experts Used for Ground Truth and Qualifications

This section does not directly apply as the device is an in vitro diagnostic (IVD) for antimicrobial susceptibility testing, not an imaging AI device requiring expert interpretation of images. The "ground truth" for antimicrobial susceptibility is established by a standardized laboratory method (broth microdilution) rather than human expert consensus on subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1, etc.) are typically used in studies involving human interpretation or subjective assessments. For this AST device, the ground truth is established by a quantitative, objective laboratory method (CLSI broth microdilution guidelines). Therefore, no human adjudication method was employed for establishing the ground truth of the MIC values. Minor discrepancies or errors between the device and the reference method are simply categorized as such (major, minor, very major errors).

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

An MRMC study is not applicable to this type of device. The MTS Sulbactam-Durlobactam is a manual antimicrobial susceptibility test system that determines the MIC directly. It is not an AI-assisted diagnostic imaging system where human readers interpret data with or without AI assistance. The performance is assessed by comparing the device's MIC readings to a gold standard laboratory method, not by comparing human reader performance.

6. Standalone (Algorithm Only) Performance

This concept is applicable, and the study provided details on the standalone performance of the MTS Sulbactam-Durlobactam device. The "performance data" table (Essential Agreement, Category Agreement, and Error Rates) directly refers to the device's ability to accurately determine MIC values and susceptibility categories when compared to the reference method, essentially its "algorithm-only" performance in the context of an IVD. There is no "human-in-the-loop" component for interpretation; the user manually reads the MIC from the strip.

7. Type of Ground Truth Used

The ground truth used for this study was reference broth microdilution MIC method, conducted according to CLSI M7-A11 guidelines. This is a well-established and standardized laboratory method for determining antimicrobial minimum inhibitory concentrations, considered the gold standard for AST.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the development of the MTS Sulbactam-Durlobactam device. For IVDs like AST systems, the "training" typically refers to the initial development and optimization of the test strip's design, antimicrobial gradient, and manufacturing process to reliably produce specific drug concentrations and diffusion patterns. This is primarily a chemical and engineering development process, not a machine learning training process with a distinct data set. The 588 isolates discussed are for the performance validation (test set) rather than initial model training.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" and associated "ground truth establishment" in the machine learning sense are not described for this type of medical device. The "ground truth" for the performance validation was established by the CLSI broth microdilution reference method. For the initial development and optimization phase of such a device, the "ground truth" would implicitly be the accurate and precise measurement of drug concentration gradients and their biological effect on various bacterial strains, guided by established AST principles and drug properties.

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The MicroScan Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial daptomycin at concentrations of 0.06-32 µg/mL to the test panel. Testing is indicated for Enterococcus faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) has demonstrated acceptable performance with the following organisms:

• Enterococcus faecium
• Enterococcus spp. other than E. faecium (Enterococcus faecalis, Enterococcus avium, Enterococcus raffinosus, Enterococcus casseliflavus and Enterococcus durans)
• Staphylococcus spp. (Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus capitis, Staphylococcus haemolyticus, Staphylococcus lugdunensis, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus simulans, Staphylococcus saprophyticus, Staphylococcus intermedius, and Staphylococcus sciuri)

MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.

The principle of MicroScan panels with antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

This product is single-use and intended for laboratory professional use.

The provided text specifies the performance validation of the MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP). Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics against a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel. The primary metrics are Essential Agreement (EA) and Categorical Agreement (CA).

Note: The document states "acceptable performance" without defining specific numerical thresholds for EA and CA as explicit "acceptance criteria." However, the reported values are presented as meeting this "acceptable performance." In antimicrobial susceptibility testing, typical FDA guidance for acceptable EA is generally $\geq$90% and for CA is general $\geq$90% to 95%, depending on the organism/drug combination and resistance rates.

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

The document mentions "external evaluations" conducted with:

• Fresh and stock Efficacy isolates
• Stock Challenge strains

It does not explicitly state the numerical sample size (number of isolates/strains) used for the test set.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the mention of "external evaluations," it implies that the testing was performed, but the location and study design (retrospective/prospective) are not detailed. Standard AST studies typically involve prospective collection of clinical isolates and/or the use of well-characterized reference strains.

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

The ground truth for the test set was established by comparison with a CLSI frozen Reference Panel. This implies that the reference standard, and thus the "ground truth," is determined by a highly standardized and validated laboratory method (broth microdilution or similar CLSI-recognized standard).

The document does not mention human experts being used directly to establish the ground truth for individual cases in the test set. Instead, the CLSI frozen Reference Panel itself serves as the gold standard.

4. Adjudication Method for the Test Set

No human adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the ground truth is established by the CLSI frozen Reference Panel, not by human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable to this device. This device is an Antimicrobial Susceptibility Test (AST) panel, which determines the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against bacteria. It does not involve human readers interpreting images, and therefore, an MRMC study is not relevant. The device measures a quantitative result (MIC) which is then interpreted categorically (susceptible, intermediate, resistant) based on established breakpoints.

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

Yes, this study represents a standalone performance evaluation of the device. The "MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin" is a diagnostic test system. Its performance is evaluated against a recognized reference method (CLSI frozen Reference Panel) to determine its accuracy in reporting MIC values and categorical interpretations. While human operators inoculate and read the panels (either visually or with MicroScan instrumentation), the "performance" being assessed here is the device's ability to produce accurate results compared to the reference standard, not an AI algorithm's ability to interpret data without human input.

7. The type of Ground Truth Used

The ground truth used was comparison to a CLSI frozen Reference Panel. This is a laboratory-based gold standard for antimicrobial susceptibility testing, representing the accepted accurate measurement of MIC. It is a highly controlled and standardized method.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is an AST panel, not an AI/ML diagnostic algorithm that requires a training set. The performance validation is based on a comparison to a reference standard using a test set of bacterial isolates/strains.

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

As there is no concept of a training set for this type of device (AST panel based on traditional microbiological principles), this question is not applicable.

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The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial aztreonam at concentrations of 0.5-64 µg/mL to the test panel. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Yersinia enterocolitica)

Pseudomonas aeruginosa

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

The principle of MicroScan panels with antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

This product is single-use and intended for laboratory professional use.

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test (AST) system, specifically the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam. It is not an AI/ML medical device. Therefore, many of the requested criteria regarding AI-specific study design (like MRMC studies, number of experts for AI ground truth, training set details) are not applicable to this type of device and study.

However, I can extract the relevant acceptance criteria and performance data for this AST device based on the provided document.

Acceptance Criteria and Device Performance (for an AST System)

The study proves the device's performance through comparison with a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel. The criteria primarily revolve around "Essential Agreement (EA)" and "Categorical Agreement (CA)" between the new device and the reference method.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly refers to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. This guidance typically defines the statistical acceptance criteria for EA and CA for AST systems. The document states the device "demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document..." meeting "acceptable performance."

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

• The document mentions "external evaluations were conducted with contemporary and stock Efficacy isolates and stock Challenge strains."
• Specific numerical sample sizes for the test set (number of isolates/strains) are not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin. It indicates the use of "contemporary and stock Efficacy isolates and stock Challenge strains," which suggests a mix of clinical and laboratory strains. The study appears to be prospective in nature, as new data was generated for this specific submission to demonstrate performance against a reference standard.

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

• This is an AST system, not an AI/ML device requiring expert radiological annotation.
• Ground Truth Establishment: The ground truth (reference MIC values and categorical interpretations) for the test set was established by a CLSI frozen Reference panel. This is a recognized standard method for AST device validation. The "experts" in this context are the established CLSI methodologies and laboratories that produce these reference panels, not individual human readers or annotators in the typical AI/ML sense.

4. Adjudication Method for the Test Set

• Adjudication, as typically described (e.g., 2+1, 3+1), is not applicable here because the ground truth is established by a standardized laboratory method (CLSI frozen Reference panel), not by consensus among human experts annotating medical images. The comparison is objective, based on measured MIC values.

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 specific to diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
• This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test system, where the output is a MIC value and a categorical interpretation for a bacterial isolate, not an image interpretation by a human observer.

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

• This question is framed for AI/ML algorithms. While the device automation ("MicroScan instrumentation," "WalkAway instrument") is a component, the "standalone performance" here refers to the device's ability to accurately determine MIC and categorize susceptibility when compared to the CLSI reference method.
• The study did evaluate the device's performance independently of human interpretation, as it explicitly states panels can be "read either visually or with MicroScan instrumentation." The reported EA and CA numbers reflect the system's performance, including automated reading where applicable.

7. The Type of Ground Truth Used

• Reference Standard: The ground truth used was a CLSI frozen Reference Panel. This is considered the gold standard for comparing the performance of new antimicrobial susceptibility test devices. It provides "true" Minimum Inhibitory Concentration (MIC) values for the bacterial isolates against the antimicrobial agent.

8. The Sample Size for the Training Set

• This is an IVD device, not an AI/ML system that undergoes a separate "training" phase with a large dataset in the sense of machine learning. The device's underlying "knowledge" is built into its design, chemistry, and reading algorithms (for automated methods).
• Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this device.

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

• As the concept of a "training set" as in AI/ML does not apply here, this point is not applicable. The device's development involved standard microbiological and analytical chemistry principles, validated against established reference methods.

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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 ciprofloxacin in the dilution range of 0.002-64 ug/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for 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 Ciprofloxacin in the dilution range of 0.002-64 ug/mL demonstrated acceptable performance with the following organisms:

Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter (K250990) for "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL" does not include detailed information about the acceptance criteria or the specific study that proves the device meets those criteria. The letter primarily serves as a notification of substantial equivalence and outlines regulatory requirements.

However, based on the nature of the device (Antimicrobial Susceptibility Test) and the context of FDA clearance for such products, we can infer the typical types of acceptance criteria and studies that would have been conducted. Please note that the specific numerical values for acceptance criteria and study details are not present in the provided document and would normally be found in the manufacturer's 510(k) submission summary.

Here's a breakdown of the requested information, with inferred details for sections not explicitly stated:

Acceptance Criteria and Device Performance

Note: The specific acceptance criteria (e.g., % Essential Agreement, % Category Agreement) and the reported device performance for the Sensititre system with Ciprofloxacin are not provided in the FDA clearance letter. For an AST device, these usually revolve around agreement with a reference method.

Inferred Acceptance Criteria and Hypothetical/Typical Reported Performance for AST Devices:

Explanation of Terms (for AST devices):

• Essential Agreement (EA): The Minimum Inhibitory Concentration (MIC) result of the test device is within ±1 doubling dilution of the reference method's MIC result.
• Category Agreement (CA): The interpretive category (Susceptible, Intermediate, Resistant) assigned by the test device matches the interpretive category assigned by the reference method.
• Minor Errors (mE): One method (test or reference) interprets as Intermediate, and the other interprets as Susceptible or Resistant.
• Major Errors (ME): The test device interprets as Susceptible, but the reference method interprets as Resistant. This is a critical error as it could lead to ineffective treatment.
• Very Major Errors (VME): The test device interprets as Resistant, but the reference method interprets as Susceptible. This is also a critical error as it could lead to unnecessary use of broader-spectrum antibiotics.

Study Details (Inferred/Typical for AST Devices)

1. Sample size used for the test set and the data provenance:

   • Sample Size (Test Set): Not specified in the clearance letter. For AST devices, test sets typically involve hundreds to thousands of unique isolates for each organism-antibiotic combination to ensure statistical significance across various resistance mechanisms and phenotypes. This would include both common and challenging strains.
   • Data Provenance: Not specified. For FDA submissions, the data provenance is usually a mix of prospective and retrospective clinical isolates, often collected from diverse geographical regions (e.g., multiple centers across the United States) to represent a broad range of clinically relevant strains. The clearance letter mentions testing for "Enterobacterales" and "Pseudomonas aeruginosa," indicating a focus on these specific bacterial groups.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified. For AST devices, ground truth is typically established by reference laboratory personnel highly experienced in microbiology, particularly in performing and interpreting reference AST methods (e.g., broth microdilution or agar dilution as per CLSI guidelines). These are not usually "experts" in the sense of clinicians reading images, but rather highly skilled microbiologists.
   • Qualifications of Experts: Clinical microbiologists, medical technologists, or laboratory scientists with extensive experience (e.g., 5-10+ years) in a clinical microbiology reference laboratory, proficient in CLSI (Clinical and Laboratory Standards Institute) methodologies for antimicrobial susceptibility testing.

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

   • Adjudication Method: Not applicable in the traditional sense for AST devices when comparing to a recognized reference method. The "ground truth" (reference method results) is considered definitive. If initial discrepancies occur between the test device and the reference method, these are typically re-tested by the reference method for confirmation rather than adjudicated by human readers. The reference method (e.g., CLSI broth microdilution) is itself the gold standard.

4. 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:

   • MRMC Study: Not applicable. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. The Sensititre system is an in vitro diagnostic device for antimicrobial susceptibility testing, which directly measures bacterial growth inhibition at various antibiotic concentrations (MICs). It does not involve human "readers" interpreting output in the same way as an imaging device, nor does it typically involve AI assistance in its core mechanism for determining MICs.

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

   • Standalone Performance: Yes, the core evaluation of an AST device like Sensititre is a standalone performance study. The device, when operated according to its instructions for use, generates MIC results and interpretive categories. These results are then compared directly to the reference method. There isn't typically a "human-in-the-loop" for the determination of the MIC or category by the device itself, although human laboratory personnel perform the setup and interpretation of the result in the clinical workflow. The performance data presented in the 510(k) submission would reflect this intrinsic performance of the device.

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

   • Type of Ground Truth: For AST devices, the ground truth is established by a recognized reference method, typically the CLSI (Clinical and Laboratory Standards Institute) reference broth microdilution method or agar dilution method. This is considered the "gold standard" for determining MICs and susceptibility categories. It is a highly standardized and reproducible laboratory procedure.

7. The sample size for the training set:

   • Sample Size (Training Set): Not applicable in the same way as for AI/machine learning algorithms. The Sensititre system is a phenotypic AST system, not an AI-based diagnostic algorithm that requires a "training set" of data. Its "training" is inherent in its design and manufacturing, based on established microbiological principles for detecting bacterial growth and inhibition. Any "development" data would be internal to the manufacturer for optimizing plate format, reagent concentrations, and reading algorithms, but not a "training set" in the context of deep learning.

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

   • Ground Truth for Training Set: Not applicable for this type of device. As explained above, the device does not use a "training set" with established ground truth in the AI sense. Its underlying principles are based on microbiological standards and reference methods.

Summary of Information from the FDA Letter:

• Device Name: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 µg/mL
• Intended Use: In vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for Ciprofloxacin in the stated dilution range against Enterobacterales (C. freundii, C. koseri, E. cloacae complex, E. coli, K. aerogenes, K. oxytoca, K.pneumoniae, M. morganii, P. mirabilis, P. rettgeri, P. stuartii, P. vulgaris, S. marcescens) and Pseudomonas aeruginosa.
• Performance: "demonstrated acceptable performance" (no specific metrics or values provided in the clearance letter).

To obtain the detailed acceptance criteria and study specifics, one would need to review the manufacturer's 510(k) summary, which is typically a public document available through the FDA's 510(k) database.

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

This 510(k) is for ceftobiprole in the dilution range of 0.008-16 µg/mL for testing fastidious isolates on the Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System. Testing is indicated for Streptococcus pneumoniae and Streptococcus pyogenes, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC (HP) or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL demonstrated acceptable performance with the following organisms:

• Streptococcus pneumoniae
• Streptococcus pyogenes

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain the detailed information necessary to answer your request regarding acceptance criteria and the study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA has determined the device is substantially equivalent to a previously cleared device, rather than requiring the submission of a de novo study including specific acceptance criteria and detailed study results. The letter does not describe the specific study design, sample sizes, expert qualifications, or ground truth methods used to establish the performance of the device itself against predefined acceptance criteria. Instead, it focuses on the administrative aspects of the 510(k) clearance process, regulatory compliance, and the device's intended use.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample sizes used for the test set and data provenance: Not detailed in the letter.
3. Number of experts used to establish ground truth and their qualifications: Not detailed in the letter.
4. Adjudication method: Not detailed in the letter.
5. MRMC comparative effectiveness study details or effect size: This type of study is typically for AI/imaging devices, not for an antimicrobial susceptibility test system as described. Even if it were relevant, the information is not present.
6. Standalone (algorithm only) performance: Not applicable to this type of device and not mentioned.
7. Type of ground truth used: Not detailed in the letter.
8. Training set sample size: Not detailed in the letter.
9. How ground truth for the training set was established: Not detailed in the letter.

The primary purpose of this FDA letter is to inform the manufacturer of the clearance and the associated regulatory requirements, not to disseminate the specifics of the underlying performance studies that led to the substantial equivalence determination.

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