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Ask a specific question about this device

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 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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Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Unicel DxI Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).

The Access hsTnI is a two–site immunoenzymatic ("sandwich") assay. Monoclonal anti–cTnI antibody conjugated to alkaline phosphatase is added to a reaction vessel along with a surfactant–containing buffer and sample. After a short incubation, paramagnetic particles coated with monoclonal anti–cTnI antibody are added. The human cTnI binds to the anti–cTnI antibody on the solid phase, while the anti–cTnI antibody–alkaline phosphatase conjugate reacts with different antigenic sites on the cTnI molecules. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

Here's a breakdown of the acceptance criteria and study information for the Access hsTnI device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a study primarily focused on demonstrating the substantial equivalence of the Access hsTnI assay when run on the UniCel DxI 800 Immunoassay System compared to its predicate device (Access hsTnI on the Access 2 Immunoassay System). This is achieved through performance testing of various analytical aspects.

1. Sample Size Used for the Test Set and Data Provenance:

   • Method Comparison: 239 samples (119 Lithium Heparin Plasma and 120 Serum).
   • Data Provenance: Not specified (e.g., country of origin). The document indicates it's a retrospective comparison between the "IVD Access hsTnI (Current Assay Protocol File (APF))" and the "proposed Access hsTnI (Proposed APF)" on the UniCel DxI 800 instruments, implying existing samples or previously collected data.

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

   • Not Applicable. This device is an in-vitro diagnostic (IVD) immunoassay for quantitative determination of cTnI levels. The "ground truth" for the test set in this context refers to the measured cTnI values, which are inherently quantitative and determined by the predicate device's method and the proposed device's method, not by expert consensus or interpretation of images/clinical findings.

3. Adjudication Method for the Test Set:

   • Not Applicable. As noted above, this is a quantitative analytical method comparison, not a diagnostic interpretation or clinical outcome study that would require adjudication.

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:

   • Not Applicable. This is an in-vitro diagnostic device, not an AI-based image interpretation or diagnostic aid system involving human readers.

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

   • Yes, implicitly. The studies described (Method Comparison, Imprecision, Linearity, LoB/LoD, LoQ, Carryover) evaluate the performance of the analytical instrument and assay without human intervention in the measurement process. The device itself is an automated immunoassay system that produces quantitative results.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context refers to the quantitative measurements of cTnI levels themselves. For the method comparison, the predicate device (Access hsTnI on the Access 2 Immunoassay System, or the "Current Assay Protocol File (APF)" on the DxI 800) essentially serves as the reference for comparison against the "Proposed APF" on the UniCel DxI 800. Therefore, it's a comparison against an established, legally marketed reference measurement method.

7. The Sample Size for the Training Set:

   • Not specified. This documentation primarily focuses on the validation of the device's analytical performance. While there would have been internal development and optimization (which could be considered "training"), the document does not distinguish a formal "training set" (as might be seen with AI/ML models) from "internal validation" data. The tested datasets described are for analytical validation.

8. How the Ground Truth for the Training Set Was Established:

   • Not specified / Not applicable in the traditional sense. As an IVD assay, the "ground truth" for developing such a test is the accurate quantitative measurement of the analyte (cTnI) in biological samples, requiring highly controlled reference methods and materials. The document indicates the device's principle is a "two-site immunoenzymatic ('sandwich') assay," which is a well-established biochemical technique. The development process would involve extensive characterization against reference standards and known concentrations, rather than establishing ground truth through, for example, expert labeling of clinical data.

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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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Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).

The Access hsTnI assay is a two–site immunoenzymatic ("sandwich") assay. Monoclonal anti–cTnI antibody conjugated to alkaline phosphatase is added to a reaction vessel along with a surfactant–containing buffer and sample. After a short incubation, paramagnetic particles coated with monoclonal anti–cTnI antibody are added. The human cTnI binds to the anti–cTnI antibody on the solid phase, while the anti–cTnI antibody–alkaline phosphatase conjugate reacts with different antigenic sites on the cTnI molecules. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The provided text describes the 510(k) clearance for the Beckman Coulter Access hsTnI device, specifically focusing on demonstrating its equivalence when run on the DxC 500i Clinical Analyzer compared to the previously cleared Access 2 Immunoassay System. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the analytical performance characteristics required to show substantial equivalence between the new platform (DxC 500i) and the cleared predicate platform (Access 2) for the Access hsTnI assay.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the "Platform Equivalency" and "Clinical Performance" studies are largely the same (slope 1.00 ± 0.10 and r ≥ 0.90), indicating the central intent was to show the DxC 500i performs equivalently to the Access 2 for this assay.

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

• Platform Equivalency Study (Method Comparison - Representative) Sample Size:
  • Serum: N = 106
  • Plasma: N = 122
• Clinical Performance (Method Comparison) Sample Size:
  • "More than 200 discrete lithium heparin plasma samples" per site for a total of three sites (2 external, 1 internal). This implies a total sample size of >600 for this specific study.
• Imprecision, Linearity, Detection Capability, and Carryover studies: Sample sizes are not explicitly stated for these, but they are implied to be sufficient for the CLSI standards cited (EP05-A3, EP06-2nd Edition, EP17-A2).
• Data Provenance: The studies were conducted at "two external tests sites and one internal test site." The specific country of origin is not mentioned, but "Beckman Coulter, Inc." is based in California, USA. The data is prospective as it involves controlled studies and analyses to demonstrate performance on the new platform.

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

This section is Not Applicable to this device. The Access hsTnI assay is an in vitro diagnostic (IVD) test that quantitatively measures a biomarker (cardiac troponin I). The "ground truth" for method comparison and analytical performance studies of IVDs is typically established by comparative analysis against a reference method or a legally marketed predicate device, as seen here. It does not involve human expert interpretation of images or signals that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This section is Not Applicable. As stated above, this is an IVD device for quantitative measurement. The "test set" in this context refers to patient samples with varying concentrations of the analyte, measured by both the candidate and predicate devices. There is no human interpretation or subjective assessment that would require adjudication.

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 section is Not Applicable. The device is a quantitative immunoassay, not an AI-powered diagnostic imaging or interpretation tool that assists human readers. Therefore, an MRMC study is not relevant.

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

This section is Not Applicable in the context of an "algorithm only" being evaluated for standalone performance. The Access hsTnI device on the DxC 500i is a laboratory instrument system performing a chemical assay. Its "performance" is inherently "standalone" in the sense that the instrument provides a quantitative result without immediate human-in-the-loop assistance for that specific measurement. The "comparison testing" essentially evaluates its standalone performance against a predicate standalone device.

7. The Type of Ground Truth Used

The "ground truth" for the test set was essentially:

• Measurement by the legally marketed predicate device (Access hsTnI on Access 2 Immunoassay System): This is the gold standard against which the performance of the Access hsTnI on the DxC 500i Clinical Analyzer is compared to demonstrate substantial equivalence.
• Definitions within CLSI guidelines: For parameters like precision, linearity, and detection capability, the "ground truth" is adherence to statistical and analytical performance models defined by the specified CLSI (Clinical and Laboratory Standards Institute) guidelines.

8. The Sample Size for the Training Set

This section is Not Applicable. The Access hsTnI is a reagent and instrument system for an immunoassay. It is not an AI/ML algorithm that requires "training data" in the typical sense. The term "training set" is usually associated with machine learning models. The development and validation of such IVD assays involve extensive R&D, method development, and verification on an internal set of samples, but these are not referred to as a "training set" in the context of AI.

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

This section is Not Applicable for the reasons stated in point 8.

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The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and may be used to assess the immune status of pregnant women.

This product is not FDA cleared/approved for the screening of blood or plasma donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens or infants.

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative detection of Toxoplasma gondii-specific IgG antibody in adult human serum using the Access Immunoassay Systems.

The Access Toxo IgG assay consists of the reagent pack, calibrators, and quality controls (OCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

This document describes the premarket notification (510(k)) for the Beckman Coulter Access Toxo IgG assay, a chemiluminescent immunoassay for detecting IgG antibodies to Toxoplasma gondii in human serum. This product is intended to aid in the diagnosis of Toxoplasma gondii infection and assess the immune status of pregnant women.

The submission claims substantial equivalence to a legally marketed predicate device, the Access Toxo IgG assay (K080869). The primary difference highlighted is the instrument used: the new device runs on the DxI 9000 Access Immunoassay Analyzer, while the predicate runs on the Access 2 Immunoassay System.

Here's an analysis of the provided information, focusing on the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document does not present "acceptance criteria" in a separate table with yes/no compliance. Instead, it details specific performance metrics and their measured values. The implicit acceptance criterion for most analytical performance studies (like imprecision and method comparison) is that the new device's performance is acceptable for its intended use and comparable to or better than the predicate. For Linearity, LoB, LoD, and LoQ, the acceptance criterion is that the study supports the claimed values.

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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only.

The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting.

The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.

The provided text describes the Beckman Coulter Access Cortisol assay on the DxC 500i Clinical Analyzer and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

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The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.

The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection in males and pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

Note: This assay has not been cleared/approved by the FDA for the screening of blood or plasma donors in the United States.

The Access Toxo IgM II assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems. The Access Toxo IgM II QC is intended for monitoring system performance of the Access Toxo IgM II assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay callorators, Access QCs, along with the UniCel DxI Wash Buffer II are designed for use with the DxI 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The provided text is a 510(k) premarket notification summary for the Access Toxo IgM II assay, a diagnostic immunoassay, not an AI/ML-driven device. Therefore, many of the requested criteria (e.g., sample size for training set, number of experts for ground truth, MRMC study, AI assistance effect size) are not applicable to this type of medical device submission.

However, I can extract and present the relevant information regarding the device's acceptance criteria and the study proving it meets these criteria based on the provided text.

Acceptance Criteria and Device Performance for Access Toxo IgM II Assay

This document describes the validation of the Access Toxo IgM II assay on the DxI 9000 Access Immunoassay Analyzer, demonstrating its substantial equivalence to the previously cleared Access Toxo IgM II assay on the Access 2 Immunoassay System. The primary performance metrics reported are Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Imprecision (CV%).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results presented, which showed 100% agreement for both positive and negative samples, and the imprecision results were well within the design specification.

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

• Method Comparison Study: 152 samples.
  • Data Provenance: Samples were "collected from the intended use population." The study was "performed at an internal site." No specific country of origin or whether the data was retrospective or prospective is mentioned, but "intended use population" generally implies clinical samples.
• Imprecision Studies (Within-Laboratory & Reproducibility):
  • For each of the 4 samples tested: N = 240 (for within-laboratory precision) and N = 225 (for reproducibility). These represent the number of individual measurements.
  • The study involved testing multiple samples in duplicate (for precision) or in replicates of 5 (for reproducibility) over multiple days, across three reagent/calibrator lots and three analyzers.

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

N/A. This is a laboratory diagnostic immunoassay, not an image-based AI/ML device where expert consensus for ground truth is typically required. The "ground truth" for the method comparison study was the result from the FDA-cleared predicate device (Access Toxo IgM II on the Access 2 Immunoassay System).

4. Adjudication Method for the Test Set

N/A. The comparison was directly between the candidate device (DxI 9000) and the predicate device (Access 2). There was no human adjudication process involved in settling discrepancies between results from different analyzers beyond standard laboratory procedures for confirming unexpected results.

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

No, an MRMC study was not done. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for an automated immunoassay.

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

Yes, the studies evaluate the standalone performance of the device/assay system (Access Toxo IgM II on the DxI 9000) against a reference standard (predicate device or established precision metrics). The system itself performs the measurement and provides a qualitative (Reactive, Equivocal, Non-Reactive) result. There isn't an "algorithm only" in the AI/ML sense, but the device operates autonomously to produce results.

7. The Type of Ground Truth Used

• Method Comparison: The results obtained from the FDA-cleared predicate device (Access Toxo IgM II on the Access 2 Immunoassay System) served as the reference for determining agreement.
• Imprecision: The consistency of the device's own measurements provided the "ground truth" for precision relative to established statistical methods (CLSI EP05-A3).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a distinct "training set." The device is a chemical immunoassay system. The development of such assays involves extensive R&D, reagent formulation, and analytical validation, but not "training data" in the machine learning sense.

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

N/A. As stated above, there is no "training set" or corresponding ground truth establishment in the context of an AI/ML model. The assay's analytical performance relies on validated biochemical reactions and instrument calibration.

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