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The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the ARCHITECT i System.

The ARCHITECT CMV IgG assay is to be used as an aid in the diagnosis of infection with cytomegalovirus and as an aid in the determination of serological status to cytomegalovirus in individuals including women of child-bearing age.

The ARCHITECT CMV IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.

The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibodies to cytomegalovirus. The reagent kit contains microparticles coated with CMV virus lysate, murine anti-human IgG acridinium-labeled conjugate, and assay diluent. The assay is performed on the ARCHITECT i System. The presence or absence of anti-CMV IgG is determined by comparing the chemiluminescent relative light unit (RLU) in the reaction to a cutoff RLU from an active calibration.

Here's an analysis of the acceptance criteria and study information for the ARCHITECT CMV IgG device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, based on the non-clinical and clinical performance summaries, we can infer performance goals for the device's accuracy and precision. The "Predicate Device" (ADVIA Centaur CMV IgG Assay, K181213) serves as a benchmark for substantial equivalence.

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

• Within-Laboratory Precision (20-Day): 117-120 replicates per panel/control across 3 reagent lots/calibrator lot combinations.
• Analytical Specificity (Interference): Not explicitly stated, but each substance was tested at 3 analyte levels.
• Analytical Specificity (Other Conditions): 187 specimens.
• CDC Panel Agreement: 80 samples (either CMV IgG negative or CMV IgG positive). Data provenance is the Centers for Disease Control and Prevention (CDC). The document doesn't specify if this was retrospective or prospective, but the description "masked, characterized serum panel" suggests it was a curated, retrospective panel.
• Clinical Percent Agreement:
  • Routine Order: 591 specimens collected in the US and 198 specimens collected outside of the US.
  • Pregnant Females: 200 specimens collected in the US.
  • Further Evaluation: 4 specimens (3 routine order, 1 pregnant female) with equivocal/grayzone results by the comparator assay.
  • Data provenance for the clinical study is multi-site (Indianapolis Indiana, Lewisville Texas, and Palo Alto California) for the US samples, and unspecified international locations for the "outside of the US" routine order specimens. This was a clinical study (method comparison), suggesting prospective collection relative to the comparison against the investigational assay.

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

There is no information provided about experts being used to establish a ground truth for the test set in the conventional sense (e.g., for image interpretation).

• For the CDC Panel Agreement, the CDC provided "their result interpretation for each sample," implying the CDC's own characterization (likely by reference methods/consensus) served as the ground truth. No specific number or qualifications of experts are given.
• For the Clinical Percent Agreement, the ground truth was established by a "current, FDA-cleared, commercially available anti-CMV IgG assay" (the comparator assay), essentially establishing a reference standard from an already approved diagnostic device. For 4 equivocal/grayzone samples, "consensus testing" with "2 additional current, FDA-cleared, commercially available anti-CMV IgG assays" was used. The document does not mention human experts establishing ground truth for these studies.

4. Adjudication Method for the Test Set

• CDC Panel Agreement: The results were compared directly to CDC's result interpretation. No explicit adjudication method is described beyond this direct comparison.
• Clinical Percent Agreement: The primary comparison was against a single comparator assay. For specific equivocal/grayzone cases (4 specimens), a form of adjudication was used where the result was "negative by consensus testing" or "negative based on the consensus result from the comparator assay and 2 additional current, FDA-cleared, commercially available anti-CMV IgG assays." This implies a form of multi-comparator consensus for ambiguous cases, but not necessarily human expert adjudication in the traditional sense.

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 MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic (IVD) assay (chemiluminescent microparticle immunoassay), not an AI-powered diagnostic imaging device or tool that assists human readers. Therefore, the concepts of human readers, AI assistance, and effect size in improving human reader performance are not applicable.

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

The device itself, the ARCHITECT CMV IgG assay on the ARCHITECT i System, is a standalone algorithm/device for qualitative detection. Its performance is evaluated entirely as an automated system without human interpretation in the loop influencing the direct output of IgG antibody detection. The "human-in-the-loop" would be the clinician interpreting the result provided by the device (e.g., Reactive, Nonreactive, Grayzone/Equivocal) in the context of a patient's overall clinical picture, but not in generating the result itself.

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

• CDC Panel Agreement: Ground truth was based on CDC's own "result interpretation" of their characterized serum panel. This likely represents a highly robust reference method or internal consensus.
• Clinical Percent Agreement: Ground truth was primarily established by a "current, FDA-cleared, commercially available anti-CMV IgG assay" (comparator assay). For a few ambiguous cases, consensus results from multiple FDA-cleared comparator assays were used. This is a form of reference method comparison.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. As this is a traditional immunoassay, it undergoes development and validation using various biological samples. However, no specific number is provided for samples used during the development or optimization phases that could be analogized to a training set. The clinical study samples described are specifically for performance evaluation (test set).

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

As no explicit training set is defined (because it's not an AI/ML device), this question is not applicable. The assay's parameters (e.g., cutoff values) would have been established during product development using a large set of characterized samples and optimized for performance, but this is a different process than establishing ground truth for an AI training set.

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The Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IgG test was ordered, including pregnant women.

Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This test is not intended for use in screening blood and plasma donors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys CMV IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined using a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent bar code. Results greater than or equal to 1.0 U/mL are considered reactive CMV IgG antibody. The test system contains the human serum-based calibrators intended for use with the system.

Elecsys PreciControl CMV lgG contains liquid control serum. The controls are used for monitoring the accuracy of the Elecsys CMV IgG immunoassay.

Note: The reagent and calibrators are packaged together in the Elecsys CMV lgG assay kit, while the associated is packaged separately.

Here's an analysis of the provided text regarding the Elecsys CMV IgG device, structured according to your requested information:

Elecsys CMV IgG Device Acceptance Criteria and Supporting Study

The provided 510(k) summary details the performance evaluation of the updated Elecsys CMV IgG assay.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a quantitative "acceptance criteria" table with specific thresholds (e.g., "sensitivity ≥ X%", "specificity ≥ Y%"). Instead, it describes various studies conducted and concludes that "All performance specifications were met." and "The analytical studies demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device with improved biotin tolerance level up to 1200 ng/mL."

However, based on the studies described, we can infer performance aspects and reported outcomes:

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

• Precision Study:
  • Sample Size: "3 levels of controls and 5 human serum samples per run, 2 runs per day for 21 days." This totals (3 controls + 5 samples) * 2 runs * 21 days = 336 individual measurements (or 21 days of testing on 8 distinct samples).
  • Data Provenance: The text states "human serum samples" and "native human serum pools" for interference studies, implying human origin. No specific country of origin is mentioned. The studies are described as internal performance evaluations, which are typically prospective for the device under development.
• Biotin Interference Study:
  • Sample Size: "three serum samples (negative, positive close to cut-off, positive)" were used, each subjected to "11 dilution steps." This amounts to 3 samples * 11 dilutions = 33 individual sample preparations for testing.
  • Data Provenance: "Native human serum pools" and "a single serum donor." No specific country of origin or retrospective/prospective nature is stated, but it's an analytical study, likely prospective.
• Method Comparison to Predicate:
  • Sample Size: "A total of 280 samples."
  • Data Provenance: Not specified, but likely human serum/plasma samples. The study is analytical and likely prospective.

General Note on Data Provenance: For all studies, the document does not specify the country of origin of the data or explicitly state if the studies were retrospective or prospective, though the nature of these analytical performance studies suggests they were conducted prospectively as part of the device development and validation.

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

The device is an in vitro diagnostic (IVD) for the detection of IgG antibodies to CMV. The "ground truth" for such assays typically relies on established reference methods, a "gold standard" laboratory test result, or classification based on a patient's clinical status (e.g., infected vs. uninfected based on a battery of tests or clinical history).

The provided text does not mention the use of experts (like radiologists) to establish ground truth for any of the studies. For IVDs, "ground truth" is usually analytical (e.g., a sample spiked with a known concentration, or a sample with a confirmed status by a highly sensitive and specific reference method).

4. Adjudication Method for the Test Set

Since the studies described are analytical performance studies for an IVD, and not clinical studies involving interpretation by multiple human readers, there is no mention of an adjudication method like 2+1 or 3+1. Ground truth for these types of studies is typically established by the analytical reference method or preparation of known samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret results, sometimes with and without AI assistance, to assess the impact of AI on reader performance. The Elecsys CMV IgG is an automated immunoassay, not an imaging device requiring human interpretation of results in the same manner.

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

Yes, the studies described are essentially standalone performance evaluations of the device (Elecsys CMV IgG assay). As an automated immunoassay, the "algorithm" (the assay's chemical reactions and instrument's detection/calculation) provides a result directly. The studies like precision, biotin interference, and method comparison assess the performance of the assay itself without human intervention in the result determination process. The output is a quantitative (U/mL) or qualitative (reactive/non-reactive) result.

7. The Type of Ground Truth Used

The types of "ground truth" implicitly used in the analytical studies are:

• Known Sample Status/Concentration: For the precision study, controls and samples with a certain expected concentration or qualitative status were used.
• Known Biotin Concentration: For the biotin interference study, samples were "spiked with the interfering endogenous substance" (biotin) to known concentrations.
• Predicate Device Results: For the method comparison study, the results from the legally marketed predicate device (Elecsys CMV IgG K131605) served as a comparative "ground truth" to demonstrate equivalence.

The document does not mention pathology, expert consensus, or outcomes data as ground truth, which are more common for diagnostic imaging or clinical decision support AI devices.

8. The Sample Size for the Training Set

The Elecsys CMV IgG assay is an immunoassay, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" for model development. The assay relies on established biochemical reactions (electrochemiluminescence immunoassay "ECLIA"), calibration curves, and reagent lot-specific master curves. Therefore, there is no "training set" in the context of typical AI/ML algorithm development.

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

As there is no "training set" for an AI/ML algorithm, this question is not applicable to the Elecsys CMV IgG device as described. The assay's performance is driven by its chemical formulation, reagents, and instrument calibration, not by a learned model from a training dataset.

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Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semiautomated methods, NEO Iris® and Galileo NEO®.

Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV).
The CMV assay is to be used with NEO Iris® and the Galileo NEO® instruments. The NEO Iris®/Galileo NEO® is a microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions for the associated assays. The instrument is designed to automate, in addition to the CMV assay, standard immunohematology assays using a microplate-based platform. The originally cleared Galileo NEO® (BK100033) was updated with the following modifications in the current submission:

• The Digi CCD camera module was replaced with an IDS CMOS camera module
• Galileo NEO® software was replaced with NEO Iris® Install Set 3.0.1.0 U software and configuration files
• Galileo NEO® versions of the files OiBxEngl.dll and GalileoLogo.bmp were installed to preserve Galileo NEO® branding in the User Interface and on Reports

The provided text describes the regulatory clearance of the Immucor Capture-CMV® assay for use on an upgraded Galileo NEO® instrument. The core of the submission is to demonstrate that the upgraded Galileo NEO® is functionally identical to the NEO Iris® instrument, on which the Capture-CMV® assay was previously cleared. Therefore, no new primary studies were conducted for this specific submission; instead, data from the previous K183571 clearance for the NEO Iris® were presented.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance metrics comparing the NEO Iris® (the predicate for the current submission and the reference for the data) to the original Galileo NEO® or the "FDA cleared assay." The key performance metrics are Sensitivity and Specificity.

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

• Test Set for Method Comparison (Clinical Performance):

  • Patient Specimens: N=501 total.
  • Breakdown by type: Not fully specified if all 501 were unique patients or if it includes serum/plasma duplicates. The table shows 26, 0, 195, and 280 patient specimens collected across 4 sites, summing to 501.
  • Breakdown by specimen type: Of the 501, 300 were serum and 201 were plasma.
  • Data Provenance: The studies were performed at "four clinical sites, three external sites and internally at Immucor, Inc. for donor specimens and at two external sites and internally at Immucor, Inc. for patient specimens." The specific country of origin is not explicitly stated, but Immucor Inc. is based in Norcross, Georgia, implying US-based studies. The studies are retrospective as the data was from a previously cleared device (K183571).

• Test Set for Reproducibility:

  • Panel of Coded Samples: 10 samples (5 CMV antibody positive, 5 CMV antibody negative).
  • Total Tests: 1200 (10 samples * 3 sites * 2 operators * 2 runs * 5 days = 1200 total tests). This implies each sample was run multiple times.

• Test Set for Specificity and Cross-reactivity:

  • Various numbers of samples for each category of lgG antibodies. For example, 16 for EBV, 23 for HSV, 5 for Hepatitis A, 11 for ANA, etc. The total number of unique samples for this section is the sum of these values.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For the method comparison study, discordant specimens were further tested with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" which served as the reference method or "ground truth resolver" for discordant results.

4. Adjudication Method for the Test Set

For the method comparison study, the adjudication method for discordant results was further testing with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV." This acts as a reference standard to resolve differences between the two systems being compared (NEO Iris® and original Galileo NEO®). This is a form of "tie-breaker" or "ground truth resolution" rather than expert consensus adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay system and does not involve human readers interpreting images, so the concept of human readers improving with AI assistance is not applicable. The study focuses on the agreement between two automated instrument platforms (NEO Iris® and Galileo NEO®) and their performance against a reference assay.

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

Yes, this is essentially a standalone performance study. The Capture-CMV® assay, run on the NEO Iris® (and thus, by extension, the upgraded Galileo NEO®), provides a qualitative result (positive or negative) without human intervention in the interpretation of the primary result. The comparison is between two automated systems (NEO Iris® and Galileo NEO®).

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment (sensitivity and specificity) was established using:

• The results from the original Galileo NEO® instrument as a comparator, specifically for concordance.
• For discordant specimens, a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" was used as the reference standard or "FDA cleared assay." This implies a laboratory-based reference standard or established diagnostic assay as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML device. The Capture-CMV® assay is an in vitro diagnostic test system based on a solid phase red cell adherence principle, not an AI/ML algorithm that requires training data in the conventional sense. The "development" and "verification" activities referenced are typical for IVD device development, not AI model training. Therefore, a sample size for a training set (as understood for AI/ML) is not applicable or provided.

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

As this is not an AI/ML device, the concept of a training set and its ground truth establishment does not apply in the same way. The development and verification process for IVD assays involves establishing performance characteristics against known positive and negative samples, and the consistency of these characteristics across manufacturing lots and instrument platforms.

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Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

Capture-CMV is a solid phase red cell adherence antibody detection system based on procedures of Plapp et al. This procedure is a modification of the mixed agglutination tests for antigen and antibody detection of Coombs et al. and Hogman employing anti-IgG and IgM-coated red cells as the indicator system. Serum or plasma samples are added to the viral-coated wells. The samples are incubated for five minutes; during which antibodies specific for CMV proteins bind to immobilized viral proteins. Unbound immunoglobulins are washed from the wells and replaced with a suspension of anti-IgG plus anti-IgM-coated indicator red cells. Centrifugation brings the indicator red cells in contact with antibodies bound to the immobilized viral proteins. In the case of a positive test, the migration of the indicator cells to the bottom of the well is impeded as the anti-IgG and anti-IgM bridges are formed between the indicator red cells and the viral-bound antibodies. As a consequence, the indicator red cells adhere over the surface of the test well. In contrast, in the absence of viral antigen-antibody interactions (i.e. a negative test) the indicator red cells are not impeded during their migration, and pellet to the bottom of the well as a packed, well-defined cell button. CMV antigen from cytomegalovirus strain AS 169 grown in human foreskin fibroblast cells is inactivated and coated onto microtitration wells and dried.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving the device meets them:

Device: Capture-CMV®
Intended Use: An in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Intended for use in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

The document describes the performance of the Capture-CMV assay specifically when run on the NEO Iris instrument, comparing it to the predicate device (Capture-CMV on Galileo Neo). The "acceptance criteria" here are implied by the clinical performance targets for sensitivity and specificity necessary to demonstrate substantial equivalence to the predicate device and suitability for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate table with quantified thresholds before presenting the results. Instead, it presents the results of clinical performance studies (sensitivity and specificity) and reproducibility, which implicitly demonstrate that the device meets the required performance for its intended use and substantial equivalence to the predicate. The performance of the predicate device (Galileo Neo) serves as the de facto benchmark.

Based on the "CMV Resolved Results" and "Concordance by Site" tables, the performance targets appear to be very high agreement with the predicate and high sensitivity/specificity.

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

• Test Set Sample Size: N=501 patient samples were used for the method comparison study (sensitivity and specificity analysis). For reproducibility, 10 coded samples (5 positive, 5 negative) were tested for 400 total tests per site across 3 sites, totaling 1200 tests.
• Data Provenance: The studies were conducted at three clinical sites: two external sites and internally at Immucor, Inc. The document does not specify the country of origin but implies a US context given the FDA submission. The study appears to be retrospective as it uses existing patient samples and compares the new device to a predicate device and a commercial particle agglutination assay.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

However, the ground truth for discordant results was established by further testing with a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV. This implies that the accepted "gold standard" or reference method for CMV antibody detection served as the arbiter, rather than human experts reviewing raw data. For reproducibility, "Expected Positive" and "Expected Negative" values were used for the coded samples, implying a pre-established ground truth for these control samples.

4. Adjudication Method for the Test Set

• For the sensitivity and specificity comparison: Discordant results between the NEO Iris and Galileo Neo were adjudicated using a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV. This acts as an objective, third-party reference method for reconciliation.
• For reproducibility: The reproducibility study used "coded samples" with "Expected Positive" and "Expected Negative" results, implying that these samples had a predetermined ground truth. No further adjudication method is described beyond comparing the device's output to these expected results.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay that produces a qualitative (positive/negative) result, not an imaging device requiring human interpretation. Therefore, a multi-reader study is not applicable. The comparison here is between different automated analyzer platforms run by presumably trained lab technicians.

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

Yes, the performance presented is inherently standalone (algorithm/device only). The Capture-CMV assay on the NEO Iris instrument is an automated system that produces a result (positive/negative for CMV antibodies). The performance metrics (sensitivity, specificity, reproducibility) reflect the device's ability to correctly classify samples based on its internal processes, without direct human intervention in the result determination beyond loading samples and running the assay.

7. The Type of Ground Truth Used

• For the method comparison (sensitivity/specificity): The initial ground truth seems to be established by the predicate device (Capture-CMV on Galileo Neo), and discordant results were then resolved using an alternative commercial reference assay (particle agglutination assay). This is a form of reference standard test result.
• For reproducibility: The ground truth was based on pre-defined "expected" results for coded positive and negative control samples.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is typical for a traditional IVD device like this, which is validated through performance studies rather than developed using machine learning with distinct training and test sets in the same way an AI/ML algorithm would be. The "training" in this context would likely refer to the iterative development and optimization of the assay's biochemical components and the instrument's operational parameters, which is not usually quantified as a "training set" in regulatory submissions for non-AI devices.

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

As noted above, a distinct "training set" in the AI/ML sense is not described. The device's performance is validated against clinical samples and known control materials. Any "ground truth" during the development phase would have been established through a combination of well-characterized clinical samples, reference laboratory methods, and known concentrations of analytes, analogous to how IVD assays are traditionally developed and optimized.

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The ADVIA Centaur® CMV IgG (CMV IgG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human pediatric and adult serum and plasma (dipotassium EDTA, lithium heparin) using the ADVIA Centaur XP system. The assay is used to determine CMV IgG serological status and as an aid in the diagnosis of CMV infection in individuals for whom a CMV IgG test was ordered, including pregnant women. The ADVIA Centaur CMV IgG assay is not intended for blood and tissue donor screening.

The ADVIA Centaur® CMV IgG) Quality Control material is for in vitro diagnostic use for monitoring the performance of the ADVIA Centaur CMV IgG (CMV IgG) assay on ADVIA Centaur systems.

CMV IgG Assay Kit (100-Tests) consists of 1 ReadyPack containing ADVIA Centaur CMV IgG Lite Reagent and Solid Phase reagent, and 1 ReadyPack ancillary reagent pack that contains ADVIA Centaur CMV IgG Diluent, and a set of Calibrators (1 vial each of Low and High, with fill volume of 2 mL each). The reagents and calibrators are packaged together in the ADVIA Centaur CMV IgG Assay kit, while the associated ADVIA Centaur CMV IgG Quality Control is packaged separately.

The ADVIA Centaur CMV IgG assay is a fully automated, 2-step sandwich immunoassay using indirect chemiluminometric technology.

Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur CMV IgG assay, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally inferred from the "Assay Cut-off" section, where the cutoff value was set to achieve a certain agreement with a comparator device. The performance is then demonstrated in the clinical studies.

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

• Initial Cut-off Study: 389 remnant clinical samples (negative: 196, positive: 186, equivocal: remainder - exact number not specified but implied to be few).
• Method Comparison (Primary Test Set): A total of 1842 samples
  • Prospective Study: 1699 specimens
    • 684 general population subjects
    • 348 pregnant subjects
    • 229 pediatric subjects (2-21 years old)
    • 44 HIV-positive subjects
    • 394 transplant-patient subjects
    • Provenance: 6 collection sites in the United States.
  • Retrospective Study: 143 HIV-positive specimens
    • Provenance: 1 site (implied to be in the US, given the overall context of the submission).
• CDC Panel: 80 previously characterized serum samples.
  • Provenance: Centers for Disease Control (CDC).

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

This information is not explicitly provided in the document. The ground truth for the comparison studies was established by a "comparator CMV IgG assay" (bioMerieux VIDAS CMV IgG (CMVG) Assay, K920661). For equivocal samples, additional testing was done on "2 other CMV IgG comparator assays" to achieve a "two out of three consensus result."

There is no mention of human experts (e.g., radiologists, pathologists) establishing ground truth for the primary clinical studies. The ground truth for the CDC panel samples was "previously characterized" by the CDC, implying expert determination at some point in the past, but details are absent.

4. Adjudication Method for the Test Set

• For the primary method comparison, the comparator CMV IgG assay served as the reference.
• For samples that tested equivocal on the comparator assay, an adjudication method of "two out of three consensus result" was used, comparing the initial comparator result with results from two other CMV IgG comparator assays.

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 is not applicable. The device is an in-vitro diagnostic (IVD) assay for detecting antibodies, not an AI-assisted diagnostic imaging or pathology device that involves human readers interpreting cases. Therefore, no MRMC study or effect size for AI assistance is provided or expected.

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

Yes, this is a standalone device. The ADVIA Centaur CMV IgG assay is a fully automated immunoassay that generates a qualitative result (reactive or non-reactive) based on an Index value. Its performance is evaluated entirely without human interpretation of raw assay data. The results are reported directly by the system.

7. The Type of Ground Truth Used

The primary ground truth for the clinical studies was established by a comparator CMV IgG assay. This is a surrogate ground truth based on the performance of an already legally marketed and accepted diagnostic test. For equivocal samples, an expert consensus of other comparator assays (two out of three consensus) was used. For the CDC panel, the ground truth was previously characterized serological status provided by the CDC.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate training set for the device in the context of machine learning or AI. The term "training set" is typically used in the development of AI algorithms. This device is an immunoassay, and its development would involve optimization and calibration rather than distinct "training" in the AI sense.

However, the "Assay Cut-off" section describes a study performed to determine the cutoff value:

• A comparison study involving 389 remnant clinical samples was used to determine the placement of the cutoff value. While not a "training set" in the AI sense, these samples were used to establish a critical decision-making parameter for the assay.

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

As discussed above, there isn't a "training set" in the AI context. For the 389 samples used to establish the cut-off value:

• The ground truth for these samples was established by a comparator CMV IgG assay. The aim was to set the cutoff such that the new device's results agreed with the comparator.

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The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin).

The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age.

This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.

Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.

The BioPlex 2200 ToRC IgM Calibrator Set is intended for the BioPlex 2200 ToRC IgM Reagent Pack.

The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.

BioPlex ToRC IgM Reagent Pack includes the following components:

• One (1) 10 mL vial, containing dyed beads coated with lysates of T. gondii, Rubella and CMV ● plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine and caprine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device's performance, as requested.

The provided text describes the performance characteristics of the BioPlex 2200 ToRC IgM kit, which is a multiplex flow immunoassay for detecting IgM antibodies to Toxoplasma gondii, Rubella, and Cytomegalovirus (CMV).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a section titled "Acceptance Criteria" with pass/fail metrics. Instead, the document presents various analytical and clinical performance studies, and the results of these studies implicitly represent the device's acceptable performance. For the purpose of this response, I will infer the acceptance criteria from the reported performance, particularly where quantitative results are presented.

1. Table of Acceptance Criteria and Reported Device Performance

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Immunoassay for the in vitro qualitative detection of IgM antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the diagnosis of recent or current CMV infection in individuals for which a CMV IgM test was ordered, including pregnant women.

Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This test is not intended for use in screening blood and plasma donors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys CMV IgM is a qualitative assay for the detection of IgM antibodies to CMV in human serum and plasma for use on the cobas e 801 immunoassay analyzer. The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.

The document describes the Elecsys CMV IgM assay on the cobas e 801 analyzer, which is a qualitative immunoassay for the detection of IgM antibodies to CMV. The submission (K163569) seeks to demonstrate substantial equivalence to a predicate device, the Elecsys CMV IgM on the cobas e 601 (K142133).

Here's an breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a "table of acceptance criteria" with corresponding performance values in every section, but rather states "All results met predefined acceptance criteria" for various performance characteristics. I will compile the relevant performance data points that were provided.

• HSP 1: 1.2%
• HSP 2: 1.3%
• HSP 3: 1.6%
• HSP 4: 1.0%
• HSP 5: 1.0%
• PC CMV IgM 1: 0.9%
• PC CMV IgM 2: 1.9% |
  | | | Intermediate Precision (CV)
• HSP 1: 2.8%
• HSP 2: 1.8%
• HSP 3: 1.8%
• HSP 4: 1.4%
• HSP 5: 1.8%
• PC CMV IgM 1: 2.6%
• PC CMV IgM 2: 2.2% |
  | Analytical Sensitivity | Implicit: LoD below cut-off. | Limit of Blank (LoB): 0.243 COI
  Limit of Detection (LoD): 0.276 COI (well below cut-off of 0.7 COI) |
  | High Dose Hook Effect | Implicit: No high-dose hook effect observed. | "All results met the predefined acceptance criteria demonstrating no high dose hook effect for the Elecsys CMV IgM assay." |
  | Endogenous Interferences | Implicit: No significant interference from tested substances. | No interference from:
• Hemoglobin up to 500 mg/dL
• Intralipid up to 1500 mg/dL
• Bilirubin up to 20 mg/dL
• Biotin up to 100 ng/mL
• Rheumatoid factor up to 899 IU/mL |
  | Exogenous Interferences (Anticoagulants) | Implicit: Acceptable sample types. | Serum, serum with separating gel, Li-heparin plasma, K2EDTA plasma, K3EDTA plasma are acceptable. |
  | Exogenous Interferences (Drugs) | Implicit: No significant interference from tested drugs. | No interference from 18 common drugs, Ganciclovir, and Valganciclovir. |
  | Method Comparison (Platform Equivalence) | Implicit: High positive and negative agreement. | Negative Percent Agreement (NPA): 100% (142/142)
  Positive Percent Agreement (PPA): 100% (73/73)
  Agreement rate for Indeterminate: 75% (6/8) |

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

The document focuses on the technical performance of the device and its equivalence to a predicate. It does not clearly define a "test set" in the context of clinical cohorts but rather describes samples used for various analytical performance studies.

• Precision Study: 84 runs for repeatability and intermediate precision for each of the 7 samples (HSP 1-5, PC CMV IgM 1-2). The samples are referred to as "serum samples." Provenance is not specified (e.g., country of origin, retrospective/prospective).
• Method Comparison (Between Analyzer Platforms): 142 negative plasma samples, 73 positive plasma samples, and 8 indeterminate plasma samples. This totals 223 plasma samples. Provenance (e.g., country, retrospective/prospective) is not specified.
• Interference Studies: Number of samples not explicitly stated; typically involves spiking substances into a limited number of samples.
• Analytical Sensitivity (LoB/LoD): Number of runs/replicates used for determination is not specified, but the methodology (CLSI EP17-A2) implies a structured approach.

Data Provenance: The document generally lacks explicit details on the country of origin for the samples used in these performance studies or whether they were retrospective or prospective. It refers to "in-house studies" and "external clinical studies" for cutoff validation, but specifics are missing from this summary.

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

This device is an in vitro diagnostic immunoassay, not an imaging device. Therefore, the concept of "experts" (like radiologists) establishing ground truth for a "test set" in the traditional sense of image interpretation is not directly applicable.

For this type of device:

• The "ground truth" for the test samples (e.g., positive, negative, indeterminate) would typically be established by known clinical status (e.g., confirmed CMV infection or absence of infection based on various clinical and laboratory parameters, potentially using a "gold standard" or reference assay).
• The document implies that the "cutoff was established with in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays" and "validation of the assay cutoff was performed by external clinical studies." This suggests the ground truth (or referent status) for the samples was determined by established laboratory methods, not expert consensus on qualitative interpretation.

No specific number or qualification of "experts" is mentioned for establishing the ground truth of the performance study samples.

4. Adjudication Method for the Test Set

Since this is an immunoassay and "ground truth" is established by laboratory methods rather than subjective expert interpretation, the concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. The results are quantitative (COI values) and then categorized based on predefined cut-offs.

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 specifically designed for evaluating diagnostic aids (like AI algorithms in imaging) that assist human readers. The Elecsys CMV IgM assay is a standalone laboratory diagnostic test.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the performance data presented (precision, sensitivity, interference, method comparison) represents the standalone performance of the Elecsys CMV IgM assay on the cobas e 801 analyzer. This device does not have a human-in-the-loop component for its primary diagnostic function.

7. The Type of Ground Truth Used

The ground truth used for establishing performance characteristics and assay cut-offs appears to be:

• For Method Comparison: The results from the predicate device (Elecsys CMV IgM on cobas e 601) and potentially other established/commercial CMV IgM assays. The document states "Positive and negative agreement of the results between the two platforms were calculated."
• For Assay Cut-off: "in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays." Additionally, "Validation of the assay cutoff was performed by external clinical studies on the Elecsys 2010." This implies a combination of reference assay results and potentially clinical outcomes/established disease status for the samples used in those studies.

It's not explicitly stated as "pathology" or "outcomes data" in this summary, but rather defined by comparison to other commercial assays and clinical studies.

8. The Sample Size for the Training Set

This document describes the validation of a commercial in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the same way. The principles for developing diagnostic assays involve extensive research and development phases where reagents, protocols, and cutoffs are refined. The "training" in this context refers to the development and optimization studies that led to the final assay characteristics.

The specific sample sizes for these development/optimization phases are not provided in this 510(k) summary, as the summary focuses on the final analytical and comparative performance data for the substantial equivalence determination.

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

Again, applying the term "training set" directly to a traditional immunoassay is not precise. However, for the establishment of the assay cut-off (which is analogous to setting decision boundaries in an algorithm), the summary states:

• "The cutoff was established with in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays."
• "Validation of the assay cutoff was performed by external clinical studies on the Elecsys 2010."

This indicates that the "ground truth" for determining the assay cut-offs was established through a combination of results from other established commercial CMV assays and samples from clinical studies, which would have had their CMV status determined by other means (e.g., patient history, other diagnostic tests, or clinical follow-up). The exact "how" for these broader clinical studies is referenced as being included in the predicate device's K-submission (K142133).

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The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.

The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON® Analyzer family *. The performance characteristics of the LIAISON® CMV IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum.

The LIAISON® CMV IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® CMV IgG assay on the LIAISON® Analyzer family.

Here's a summary of the acceptance criteria and study information for the LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or specific numerical reported device performance values for the LIAISON® CMV IgG assay (which remains unchanged from the predicate device). However, it focuses on the performance of the LIAISON® CMV IgG Serum Control Set. The acceptance criteria for the controls are described qualitatively:

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes used for the "Test Set" in the context of commutability, precision, control value assignment, or control range definition. It mentions "samples and controls" for precision equivalence. For stability testing, it states "Real time stability testing," implying a duration-based study rather than a fixed sample count of individual specimens.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal to the manufacturer (DiaSorin Inc.). The document implies these are non-clinical verification and validation studies. It does not clarify if the data is retrospective or prospective, but real-time stability testing would be prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The device is an immunoassay for detecting antibodies, which typically relies on laboratory-defined cut-offs and established reference methods for "ground truth", rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant for an immunoassay that doesn't involve subjective interpretation or a panel of experts.

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

A MRMC comparative effectiveness study was not done, as this type of study is relevant for imaging devices or algorithms that involve human interpretation and reader variability. The LIAISON® CMV IgG is an automated immunoassay.

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

The LIAISON® CMV IgG assay is a standalone algorithm/device for its performance. It measures IgG antibodies to hCMV in human serum automatically. The controls are also designed to monitor this automated performance. The study described focuses on the performance characteristics of the controls and their impact on the assay itself, rather than comparing its performance with or without human intervention for result interpretation.

7. Type of Ground Truth Used

The ground truth for immunoassay performance is typically established by:

• Reference methods/panels (e.g., CDC reference panels).
• Clinically characterized samples (e.g., samples from known CMV-positive and CMV-negative individuals).
• Comparison to a legally marketed predicate device (as in this 510(k), where the assay's performance is stated as "No Change" from the cleared predicate, K040290).

The document states that the studies demonstrate the modified device (Control Set) meets "predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." This strongly implies the ground truth for establishing acceptance and equivalency relies on the established performance characteristics and values of the predicate device and/or defined laboratory standards.

8. Sample Size for the Training Set

The document does not specify a training set sample size, as this filing is for a modification to an already cleared device (the control set for an existing assay). The primary focus is on validating the new control set, not on developing or training a new algorithm from scratch.

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

As no training set is explicitly mentioned for a new algorithm development, this information is not applicable in the context of this 510(k) submission for a control set modification. For the original assay (K040290), ground truth would have been established using methods mentioned in point 7.

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(1) Immunoassay for the in vitro qualitative detection of IgM antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the diagnosis of recent or current CMV infection in individuals for which a CMV IgM test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This assay is not intended for use in screening blood and plasma donors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys immunoassay analyzers.

(2) PreciControl CMV IgM is used for quality control of the Elecsys CMV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) Elecsys CMV IgM is a u-capture immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined using a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent bar code. The test system contains the human serum-based calibrators intended for use with the system.

The CMV IgM assay begins with an automatic 1:20 predilution of sample with Elecsys Diluent Universal and the addition of biotinylated monoclonal anti-h-IgM-specific antibodies.

During the second incubation, CMV-specific recombinant antigen labeled with a ruthenium complex and streptavidin-coated microparticles are added. Anti-CMV IgM antibodies present in the sample react with the ruthenium-labeled CMV-specific recombinant antigen. The complex becomes bound to the solid phase via interaction of biotin and streptavidin.

The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode induces chemiluminescent emission which is measured by a photomultiplier.

The analyzer automatically calculates the cutoff based on the measurement of Cal 1 and Cal2. The result of the samples is given either as reactive or non-reactive as well as in the form of a cutoff index (signal samples/cutoff). Samples with a cutoff index (COI)

Here's a breakdown of the acceptance criteria and the study details for the Elecsys CMV IgM Immunoassay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating that the device met its predefined acceptance criteria rather than explicitly listing the criteria in a single table with performance. However, I can construct a table summarizing the performance metrics and their implicit acceptance criteria from the "Analytical Performance Data" and "Clinical Performance Data" sections.

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Elecsys CMV IgG:
The Elecsys CMV IgG immunoassay is a test for the in vitro semi-quantitative determination of IgG class antibodies to CMV in human serum, lithium-heparin plasma, K2 -EDTA plasma, and K3 -EDTA plasma. The test is intended for adults, including expectant mothers, as an aid in presumptive diagnosis of CMV infection. Results with this assay are used to indicate past infection with CMV.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
This test is not FDA cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
Elecsys PreciControl CMV IgG:
Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMV IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) Elecsys CMV IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined using a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent bar code. Results greater than or equal to 1.0 U/mL are considered reactive CMV IgG antibody. The test system contains the human serum-based calibrators intended for use with the system.
(2) Elecsys PreciControl CMV IgG contains liquid control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys CMV IgG immunoassay.
Note: The reagent and calibrators are packaged together in the Elecsys CMV IgG assay kit, while the associated PreciControl is packaged separately.

The Elecsys CMV IgG Test System was evaluated through a clinical trial to demonstrate its performance characteristics.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Elecsys CMV IgG Immunoassay are not explicitly stated as numerical targets in the provided text. Instead, the study reports the "Percent Agreement" values (often referred to as sensitivity and specificity for agreement studies) against a reference method (the predicate device, Diamedix Is-CMV IgG).

2. Sample Size and Data Provenance

The study included several cohorts for performance evaluation:

• Routine Cohort: n=500
• Expectant Mother Cohort: n=98
• CMV IgM Positive Cohort: n=119
• Cross-Reactivity Cohort: 249 samples positive for various cross-reactants.

The document does not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human experts or their qualifications for establishing ground truth for the clinical trial comparing the Elecsys CMV IgG immunoassay with the predicate device. The performance is assessed based on agreement with the predicate device results.

4. Adjudication Method

No adjudication method is mentioned in the provided text, as the comparison is made directly against the predicate device's results.

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

No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed, as this device is an in vitro diagnostic immunoassay, not an AI software intended for human interpretation assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone study was performed. The Elecsys CMV IgG Immunoassay's performance metrics (Positive Percent Agreement, Negative Percent Agreement) were directly evaluated against the predicate device's results in various clinical cohorts, representing its standalone performance. Additional analytical performance characteristics like precision, LoB/LoD, hook effect, and cross-reactivity were also evaluated for the Elecsys CMV IgG assay itself.

7. Type of Ground Truth Used

The ground truth for the clinical performance evaluation appears to be established by the results of the predicate device, the Diamedix Is-CMV IgG Test System (K981163). The study reports "Percent Agreement" with this predicate device. For the cross-reactivity study, the ground truth was the known positive status for specific cross-reactants.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an algorithm or machine learning model for the Elecsys CMV IgG Immunoassay. This device is an immunoassay, and its development likely involves laboratory optimization and validation studies, rather than machine learning training sets. Therefore, a sample size for a training set is not applicable or provided.

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

As noted in point 8, the concept of a "training set" and associated ground truth establishment is not typically applicable to the development of an immunoassay like the Elecsys CMV IgG Test System. The document describes standard laboratory validation procedures and clinical performance evaluation against a predicate device.

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