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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 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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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 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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Method Comparison:
  • Serum: N = 104
  • Urine: N = 115
• Imprecision: For each of the two instruments and four control levels/serum pools, N = 80 measurements were performed (this implies 20 days x 2 replicates x 2 runs, or similar, over the course of the study).
• Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It does refer to "patient samples" for the method comparison, suggesting real-world samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is an in-vitro diagnostic test for cortisol levels, not an imaging device requiring expert interpretation of results for ground truth. The "ground truth" for comparison and performance evaluation is generally established by the predicate device's measurements and reference methods.

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

This information is not applicable for this type of in-vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies between assessors need to be resolved. For quantitative laboratory tests, "ground truth" is typically established by comparing against established reference methods or predicate devices.

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 information is not applicable as the device is an in-vitro diagnostic test for cortisol levels, not an AI-assisted diagnostic tool for human readers.

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

This concept is not directly applicable in the same way it would be for an AI algorithm. The Access Cortisol assay on the DxC 500i Clinical Analyzer is an automated in-vitro diagnostic system. The "standalone" performance is essentially what is being evaluated in the method comparison, linearity, imprecision, and detection capability studies, where the system itself generates the quantitative results without subjective human interpretation as part of the core measurement. Human operators are involved in running the instrument and interpreting the numerical results, but the measurement itself is automated.

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

The "ground truth" in these studies is established by:

• Predicate Device Measurements: For the method comparison study, the Access Cortisol assay run on the predicate Access 2 Immunoassay System serves as the comparator or "reference" for evaluating the candidate device (Access Cortisol assay on the DxC 500i Clinical Analyzer).
• Reference Materials/Established Protocols: For linearity, imprecision, and detection capability, the ground truth is often tied to known concentrations in control materials, spiked samples, and established analytical performance specifications derived from CLSI guidelines. The calibrators use "Human serum containing cortisol (purified chemical compound) at levels of 0 and approximately 2, 5, 10, 25, and 60 µg/dL," with traceability to "USP Reference Material."

8. The sample size for the training set

This information is not provided and is likely not explicitly documented in the submission for an IVD device of this nature. The instrument doesn't explicitly 'train' in the machine learning sense on a dataset. Its operational parameters are set during its development and validated through studies like those described.

9. How the ground truth for the training set was established

As there's no explicitly mentioned "training set" in the context of machine learning, this question is not directly applicable. The device's operational characteristics and performance specifications are established through rigorous analytical verification and validation using known standards, controls, and patient samples, rather than a "training set" in the AI sense.

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The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay Amalyzer for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Dxl 9000 Access Immunoassay Analyzer.

Here's a breakdown of the acceptance criteria and study information for the Access BR Monitor device, based on the provided FDA document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison: N = 163 samples.
  • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
• Imprecision:
  • Sample 1, 2: N = 126
  • Sample 3, 4, 5, 6, 7: N = 120
  • Data Provenance: Not specified.
• Linearity, LoB, LoD, LoQ: Sample sizes not explicitly stated for these specific studies, beyond the "N" for method comparison and imprecision.
  • Data Provenance: Not specified.

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

There is no mention of experts or ground truth establishment for the test set in the provided document. The studies described are analytical performance studies (method comparison, imprecision, linearity, limits) of an immunoassay device, which typically compare the device's measurements against a reference method or predetermined values, not against expert consensus on clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as the studies are analytical performance assessments of an immunoassay, not studies involving human interpretation or adjudication of clinical cases.

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

No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for measuring CA 15-3 antigen levels, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

Yes, the studies described (Method Comparison, Imprecision, Linearity, LoB, LoD, LoQ) are all examples of standalone performance evaluations of the immunoassay system. The device itself (Access BR Monitor on the Dxl 9000 Access Immunoassay Analyzer) operates as an "algorithm only" in the sense that it automates the measurement of the analyte; there is no human-in-the-loop for the measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" for these analytical studies is either:

• Reference method/Predicate device results: For the method comparison study, the Access 2 Immunoassay System served as the reference (predicate) for comparison.
• Known concentrations/values: For studies like Imprecision, Linearity, LoB, LoD, and LoQ, calibrated samples or controls with known or expected analyte concentrations are used as the reference against which the device's measurements are assessed. The document refers to "predetermined values" or "calculated estimates" based on established statistical methods (e.g., CLSI guidelines).

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning or AI model that requires a "training set." Its calibration is established through a stored calibration curve, as mentioned in the "Comparison of Technological Characteristics" table.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this immunoassay device. The "calibration curve" for the immunoassay is established using calibrators, which are materials with known concentrations of the analyte, manufactured and tested according to quality control standards.

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

The Access hsTnI is a two-site immunoenzymatic ("sandwich") assay. Monoclonal anti-cTnl antibody coniugated 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-cTnl antibody are added. The human cTnl binds to the anti-cTnl antibody on the solid phase, while the anti-cTnl antibody-alkaline phosphatase conjugate reacts with different antigenic sites on the cTnl 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 details for the Access hsTnI device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • Method Comparison: 92 samples (41 Lithium Heparin Plasma and 51 Serum).
  • Precision (within-laboratory): Not explicitly stated, but results are given for concentrations ≥ 11.5 pg/mL and < 11.5 pg/mL.
  • Linearity: Not explicitly stated how many samples were used, but it mentions "each sample concentration range."
  • LoB/LoD/LoQ: Not explicitly stated.
  • Carryover: Not explicitly stated.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The samples were "human serum and plasma," suggesting patient samples were collected, but the specific details are not provided in this summary.

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

This device is an in-vitro diagnostic (IVD) immunoassay for the quantitative determination of cardiac troponin I (cTnl). The "ground truth" for such devices is established by the analytical measurement of the analyte itself, not typically by expert consensus of images or clinical assessments in the same way as, for example, an AI diagnostic tool for radiology.

Therefore, the concept of "experts establishing ground truth for the test set" (e.g., radiologists) is not directly applicable here. The "truth" is based on the highly controlled and validated measurements of cTnl concentrations using established laboratory methods.

4. Adjudication Method for the Test Set

Since the ground truth for this type of device is established by analytical measurement rather than subjective interpretation, an adjudication method like 2+1 or 3+1 (common in image-based diagnostic studies) is not applicable. The measurements are taken directly and compared to a reference method or validated analytical ranges.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of an AI system on human reader performance, especially in image-based diagnostics. The Access hsTnI is a standalone immunoassay directly measuring a biomarker, not an AI-assisted diagnostic tool that aids human interpretation.

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

Yes, the studies conducted (precision, linearity, LoB/LoD/LoQ, carryover, method comparison) evaluate the standalone performance of the Access hsTnI device (the immunoassay system itself) without human-in-the-loop interaction for interpretation, other than standard laboratory procedures for running the assay. The device provides a quantitative measurement directly.

7. Type of Ground Truth Used

The ground truth used is analytical measurement of cardiac troponin I (cTnl) concentrations. This is established through highly precise and accurate laboratory methods, often using reference standards and validated instrumentation. For the method comparison, the "IVD Access hsTnl (Current Assay Protocol File (APF))" likely served as the reference or comparative method against the "proposed Access hsTnl (Proposed APF)".

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, which typically relies on chemical reactions and signal detection, not a machine learning model that requires a training set. The term "training set" is not applicable in this context. The "calibration" mentioned ("Analyte concentration is automatically determined from a stored calibration") implies a process by which the instrument is set up to accurately measure concentrations, but this is distinct from an AI training set.

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

As noted above, a "training set" in the AI sense is not applicable. For instrument calibration, the ground truth (e.g., known concentrations of cTnl) is established using certified reference materials or highly characterized standards with defined concentrations. These known concentrations are then used to generate a calibration curve that allows the instrument to quantify cTnl in unknown samples.

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The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goter, and Graves' disease.

The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.

The Access Thyroglobulin Antibody II assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The assay is run on Access 2 Immunoassay Analyzers.

The device modifications described in this submission impact the Access Thyroqlobulin Antibody II reagent pack only; they do not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.

A description of the reagent pack is provided below.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the "Access Thyroglobulin Antibody II" device:

Device: Access Thyroglobulin Antibody II

The study in the document focuses on the modified Access Thyroglobulin Antibody II assay and compares it to the previously cleared predicate device (Access Thyroglobulin Antibody II Assay, FDA 510(k) Number K112933). The goal is to demonstrate substantial equivalence of the modified device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a dedicated table format. Instead, it describes performance characteristics and the results obtained. I've reconstructed a table based on the implicit criteria derived from the reported performance, especially where a target value or range is given (e.g., for imprecision, biases, or correlation).

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

• Method Comparison: n = 123 samples. Data provenance not specified (country of origin, retrospective/prospective).
• Imprecision: Not specified, but involved reagent lots and instrument details suggest laboratory testing.
• Reproducibility: Not specified, but involved reagent lots and instrument details suggest laboratory testing.
• High-dose Hook Effect: Not specified how many samples were tested, but concentrations up to 50,000 IU/mL were used.
• Linearity: Not specified how many samples were tested, but both serum and plasma samples were used.
• Sensitivity (LoB, LoD, LoQ): Not specified how many samples were used, but involved 2 reagent lots and 2 instruments over a minimum of 3 days (LoB) or 5 days (LoD, LoQ).
• Analytical Specificity:
  • Cross-reactive disease states: "Samples with potential cross-reactive disease states were tested." Number of samples not specified.
  • Potential interferents: "Patient serum samples containing two levels of thyroglobulin antibody at clinically relevant concentrations of approximately 4 IU/mL and 100 IU/mL." Number of samples not specified, but specific interferents (like biotin at 3510 ng/mL) were tested.
• Matrix Comparison: Fifty (50) matched sets of serum, lithium heparin plasma, and EDTA plasma samples.

Data Provenance: The document does not specify the country of origin for any of the samples used in these studies, nor does it explicitly state if the studies were retrospective or prospective, though "patient samples" implies retrospective collection or prospective enrollment for the study.

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

This device is an in vitro diagnostic (IVD) immunoassay, not an imaging device typically requiring expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in the traditional sense of clinical diagnosis (e.g., radiologists, pathologists) does not directly apply here.

For IVDs, "ground truth" is typically established by:

• Reference methods/devices.
• Certified reference materials.
• Pathology or histopathology (for certain tests).
• Clinical outcomes/diagnosis (for certain tests).
• Known concentrations in spiked samples or characterized panels.

In this document:

• The "Method Comparison" used a "commercially available immunoassay" as a comparator, which serves as a de facto reference for comparison.
• Analytical specificity testing used "potential cross-reactive disease states" and "potential interferents" for which the expected results (presence/absence of Thyroglobulin Antibody, or known interference levels) would be pre-established or determined by a reference method.
• Sensitivity studies (LoB, LoD, LoQ) involve statistical calculations based on repeated measurements of samples with very low or zero analyte concentrations, not expert consensus.
• Concentration ranges for linearity were established using characterized samples.

Therefore, no information on human experts establishing ground truth is provided, as it's not relevant for this type of device validation.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret medical images or complex data, and their interpretations need to be reconciled to establish a ground truth.

Since this is an in vitro diagnostic device measuring an analyte concentration, and the gold standard for comparison typically involves laboratory methods or reference materials, an adjudication method for a test set is not applicable or described in this document. The "ground truth" for the various performance characteristics is established by analytical methods and comparisons to reference standards or predicate devices.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for medical imaging devices where the performance of human readers, with and without AI assistance, is evaluated using a set of cases. This document describes an in vitro diagnostic device, an immunoassay, which does not involve human interpretation of images or complex data in a way that MRMC studies would be applicable.

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

Yes, the studies described are all standalone performance evaluations of the Access Thyroglobulin Antibody II assay. This means the studies assess the device's ability to measure thyroglobulin antibody levels independent of human intervention in the interpretation of the result in the context of the device's analytical performance. The Access Immunoassay Systems are automated, and the assay's performance metrics (imprecision, linearity, sensitivity, specificity, etc.) are solely based on the analytical capabilities of the device itself.

7. The Type of Ground Truth Used

The type of "ground truth" used varies depending on the specific study:

• Method Comparison: A "commercially available immunoassay" served as the comparative standard. The results from this predicate/reference immunoassay formed the basis for comparing the new device's measurements.
• Imprecision & Reproducibility: Ground truth is implicit in the known characteristics of the control materials or spiked samples used, and the statistical variability observed from repeated measurements defines the performance.
• High-dose Hook Effect & Linearity: Ground truth is established by using samples with known or precisely characterized concentrations, often prepared by dilution or spiking.
• Sensitivity (LoB, LoD, LoQ): Statistical models are used based on repeated measurements of blank samples and samples with very low (but known) analyte concentrations.
• Analytical Specificity:
  • Cross-reactive disease states: Likely involved samples from patients with these conditions, where the presence/absence of TgAb would have been characterized by a reference method or clinical diagnosis. The "ground truth" then is the expected TgAb status based on the sample's origin.
  • Potential interferents: Involved adding known concentrations of interfering substances to samples with known TgAb concentrations. The "ground truth" is the expected TgAb concentration without interference.
• Matrix Comparison: Used matched samples from different matrices (serum, plasma), where the inherent TgAb concentration within a given patient sample is the ground truth against which each matrix measurement is compared.

In summary, the ground truth for this IVD device is primarily established through comparisons to established reference methods/predicate devices, known concentrations in characterized samples (spiked or diluted), and statistical analysis of performance with control materials.

8. The Sample Size for the Training Set

The document describes studies for validation of a modified device, demonstrating substantial equivalence to a predicate. It does not mention a "training set" in the context of developing an algorithm or AI model. This is an immunoassay, not a machine learning model that typically requires a large training dataset. The studies focus on analytical performance rather than diagnostic accuracy determined by a machine learning pipeline.

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

As noted above, there is no mention of a "training set" or "ground truth" established for training in this document, as the device is an immunoassay not based on a trainable algorithm.

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The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and lithium heparin plasma or red blood cells using the Access Immunoassay Systems.

The provided text describes the Beckman Coulter Access Folate Assay, a chemiluminescent immunoassay for the quantitative determination of folic acid levels. The submission is a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison: 123 samples. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Linearity: The number of samples/levels used is not explicitly stated, but it's a verification study.
• Serum Imprecision: 5 serum samples with varying concentrations. Each sample was assayed in duplicate with two runs per day, over 20-22 days, meeting a minimum requirement of 80 replicates per sample on each instrument and reagent lot combination. This implies a total of (5 samples * 80 replicates/sample) = 400 replicates (for one instrument and reagent lot combination, multiplied by 3 instruments and 3 reagent lots, so 3600 replicates in total across all combinations). Data provenance is not specified.
• RBC Imprecision: 6 whole blood hemolysate samples with varying concentrations. For each sample, N=80 replicates were collected for imprecision calculations. Data provenance is not specified.
• LoB/LoD/LoQ: Verification studies were performed but sample sizes are not explicitly stated, though CLSI EP17-A2 is mentioned as the protocol, which specifies methodologies for determining these limits.

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

Not applicable. This is a laboratory diagnostic assay for measuring analyte concentrations, not an interpretation task typically requiring expert consensus on ground truth like image analysis. The "ground truth" for method comparison and imprecision studies typically refers to the reference method (predicate device) results and the true concentration of controls/samples, respectively.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative laboratory assay, there is no expert adjudication process in the traditional sense. The comparisons are against the predicate device or established analytical performance criteria.

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

No. This is an in-vitro diagnostic device (IVD) that quantitatively measures a biomarker (folic acid). MRMC studies are typically performed for devices that involve human interpretation, such as imaging devices, to evaluate the impact of AI assistance on reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the studies described (Method Comparison, Linearity, Imprecision, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Folate Assay on the DxI 9000 Access Immunoassay Analyzer. This device is an automated immunoassay system; its output is a quantitative measurement, not an interpretation that involves human-in-the-loop interaction in the same way as, for example, an AI-powered diagnostic imaging tool. The "performance" refers to the analytical accuracy, precision, and range of the automated system itself.

7. Type of Ground Truth Used

• Method Comparison: The predicate device's results (Access Folate assay on Access 2 Instrument) served as the comparator for showing substantial equivalence.
• Linearity, Imprecision, LoB/LoD/LoQ: The "true" concentrations of control materials and samples, as determined by highly controlled experimental conditions and accepted statistical methods (e.g., CLSI guidelines), serve as the basis for evaluating performance against pre-defined analytical criteria.

8. Sample Size for the Training Set

The document does not provide information about a "training set." This type of IVD, an immunoassay, is typically developed and characterized through analytical verification and validation studies rather than machine learning training sets. While there is an "algorithm" (the immunoassay process), it's based on chemical reactions and detection, not a learned model from a large dataset. Therefore, the concept of a training set as used in AI/ML is not directly applicable here.

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

Not applicable, as a training set, in the machine learning sense, is not described for this device.

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The MicroScan Prompt® Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility tests.

The MicroScan Prompt Inoculation System-D is an accessory to the MicroScan Gram Negative and Gram Positive MIC/Combo Panels. Indications for use organisms are specific for each antimicrobial agent on the panel.

The MicroScan Prompt Inoculation System-D is a method for obtaining standardized bacterial inoculum while eliminating the need for incubation and turbidity adjustment with inocula prepared according to the CLSI procedure. It consists of an inoculation wand and a bottle of diluent. The wand is a polypropylene rod with a breakaway collar that serves as a wiping mechanism. The rod is attached to a stopper. At the tip of the wand is a groove designed to hold a specific amount of bacteria equivalent to a 0.5 McFarland standard. Thirty (30) ml of diluent (Pluronic is used as the surfactant) are provided in the plastic bottle. Each kit contains 60 plastic bottles, each containing 30 ml of stabilized aqueous Pluronic surfactants and 62 inoculation wands.

The provided text is a 510(k) Premarket Notification from the FDA for the Beckman Coulter MicroScan Prompt Inoculation System-D. While it discusses the device's intended use, description, and comparison to a predicate device, it does not contain the detailed study results, acceptance criteria, or specific performance metrics (like sensitivity, specificity, accuracy, or effect sizes) that would typically be found in a study report proving a device meets acceptance criteria.

The document states that "Clinical performance data obtained with the Prompt Inoculation System-D were evaluated in previously conducted studies described in recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels for each antimicrobial agent." It further notes that "Performance of the MicroScan MIC/Combo panels were evaluated using the Prompt inoculation method and the turbidity method against the CLSI broth microdilution reference method and results were analyzed based on the recommended guidelines in the AST Class II Special Controls Guidance Document issued on August 28, 2009."

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document refers to other 510(k) decision summaries and a guidance document for the actual performance data and acceptance criteria.

To answer your request thoroughly, I would need access to those referenced documents, specifically the "recent 510(k) decision summaries for the MicroScan Dried Gram negative and Gram positive MIC/Combo panels" and the "AST Class II Special Controls Guidance Document issued on August 28, 2009."

Without those, the most I can infer is that the acceptance criteria are based on the CLSI broth microdilution reference method, and the performance analysis follows the AST Class II Special Controls Guidance Document. The device's performance is likely evaluated in terms of its ability to standardize bacterial inocula for Antimicrobial Susceptibility Tests (AST) such that the AST results are consistent and accurate compared to the reference method.

Regarding your specific points, here's what the provided text does not contain:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present. It mentions "previously conducted studies" but no details on sample size or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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: Not applicable, as this is an inoculation system, not an AI-assisted diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an inoculation system; its "performance" is in consistently producing a standardized inoculum, which then feeds into a downstream AST process (MicroScan MIC/Combo panels). The text mentions results were read both manually and with instruments, but doesn't detail a "standalone" algorithm performance study in the way it might for an AI diagnostic.
7. The type of ground truth used: It references the "CLSI broth microdilution reference method" as the comparative standard, which serves as the ground truth for AST results.
8. The sample size for the training set: Not applicable/not present. This is a physical device/reagent system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable/not present.

In summary, the provided document describes the regulatory submission for an inoculation system, outlining its purpose and comparison to a predicate device. It specifically references other documents where the detailed performance data and acceptance criteria would be found, rather than including them directly.

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