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The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system.

The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age.

The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors.

The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.

The Alinity i Rubella IgG assay is an automated, two-step immunoassay for the quantitative determination of anti-rubella IgG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

Sample, partially purified rubella virus-coated paramagnetic microparticles, and assay diluent are combined and incubated. The anti-rubella IgG present in the sample bind to the rubella virus coated microparticles. The mixture is washed. Anti-human IgG acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.

The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-rubella IgG in the sample and the RLU detected by the system optics.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for the Alinity i Rubella IgG assay.

Overview of the Device and its Purpose:

The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to the rubella virus. It's intended to aid in determining the immune status to rubella, particularly in women of child-bearing age. It is a diagnostic device, not an AI/ML-driven one, so some of the requested points regarding AI/ML studies (like MRMC studies, training set details, expert ground truth establishment for AI) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a diagnostic assay and not an AI/ML device, the acceptance criteria are related to the analytical and clinical performance of the immunoassay itself rather than metrics like AUC, sensitivity/specificity for object detection, or F1 scores inherent to AI. The key performance indicators are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a composite comparator method.

Acceptance Criteria (Implied by Performance Targets in Context of 510(k) Equivalence):

For a 510(k) substantial equivalence determination, the new device must demonstrate performance that is as safe and effective as a legally marketed predicate device. While explicit numerical acceptance criteria for PPA and NPA are not stated in the summary, typical expectations for diagnostic assays like this are high agreement rates (e.g., >90% or 95%) with the comparator method, especially in categories such as "Reactive" and "Nonreactive." The confidence intervals should also demonstrate a reasonable level of certainty around these agreement rates. The acceptance of the listed performance values below implies that these meet the FDA's criteria for substantial equivalence to the predicate.

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The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age.

The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay.

The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.

The LIAISON® Rubella IgM assay is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral. The assay configuration for the LIAISON® Rubella IgM assay allows for the performance of 100 tests.

Reagent Integral Composition:

• a. Magnetic particles mouse monoclonal antibody IgG to human IgM
• b. Calibrator 1 human serum or defibrinated plasma containing low level of Rubella IqM
• c. Calibrator 2 human serum or defibrinated plasma containing high level of Rubella laM
• d. Antigen Inactivated rubella viral particles (HPV 77 strain)
• c. Specimen diluent buffer with BSA added
• d. Conjugate -- mouse monoclonal antibodies to rubella virus conjuqated to an isoluminol derivative

The LIAISON® Control Rubella IgM is an in vitro diagnostic device consisting of 2 levels of controls to monitor the performance of the LIAISON® Rubella IgM assay

Controls (2 vials of each level):

Negative control - human serum or defibrinated plasma non-reactive for Rubella IgM Positive control - human serum or defibrinated plasma reactive for Rubella IgM

Acceptance Criteria and Device Performance Study for LIAISON® Rubella IgM

This document describes the acceptance criteria and the study conducted to demonstrate the performance of the LIAISON® Rubella IgM assay.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various analytical performance characteristics. While explicit "acceptance criteria" for all metrics (e.g., precision %CV thresholds) are not stated in a dedicated table, the studies were conducted to demonstrate acceptable performance for the intended use. The LIAISON® Rubella IgM performance is compared against these implicit standards and the FDA-cleared predicate device.

*Precision calculations for these samples were based on signal (RLU) as the dose was below the reading range.
^1 The lower positive agreement in the prospective study is likely due to the small number of positive samples in that cohort (only 10 identified as positive by the comparator assay). The retrospective study (designed for positive samples) shows much higher positive agreement.

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

• Precision/Reproducibility Study Test Set: A coded panel was tested. The specific number of individual samples in the panel is not explicitly stated, but it was tested with two replicates per run, in two runs per day for 20 operating days across three sites.
  • Data Provenance: The study was conducted at two external laboratories and DiaSorin Inc. The origin of the samples in the coded panel is not specified (e.g., country of origin). The study design (testing over 20 days) implies a prospective collection for the study itself, although the source of the panel samples could be retrospective.
• Cross-reactivity Study Test Set: 261 individual samples, each sero-positive for a specific cross-reactant and sero-negative for Rubella IgM by a commercially available Rubella IgM assay.
  • Data Provenance: Not specified (retrospective or prospective, country of origin).
• High Dose Hook Effect Study Test Set: 3 samples with Rubella IgM levels > 400 AU/mL.
  • Data Provenance: Not specified.
• IgM Specificity Study Test Set: 10 samples containing Rubella IgM antibodies covering the assay range.
  • Data Provenance: Not specified.
• Interference Study Test Set: Two matched sample pools near the clinical decision point were tested neat and spiked with each interferent. The specific number of individual samples contributing to the pools or number of independent tests is not detailed beyond the two pools.
  • Data Provenance: Not specified.
• Comparative Testing (Clinical Studies) Test Set:
  • Prospective study: 448 samples from individuals sent to the laboratory for Rubella IgM testing.
  • Retrospective study: 178 samples from individuals who had a positive Rubella IgM result (pre-selected population).
  • Data Provenance: The clinical studies were conducted in the United States, as indicated by the mention of "validated in the United States during clinical studies" and the context of FDA submission. Both prospective and retrospective data were used.

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

• For the clinical comparative studies (prospective and retrospective): The ground truth was established by an "FDA-cleared predicate device" (ADVIA Centaur Rubella IgM Assay, K010668). No human experts were explicitly mentioned as establishing the ground truth for the test set samples in these comparative studies. The predicate device's results were considered the reference.
• For setting the assay cut-off: Ground truth was established based on consensus between "several comparison methods" and "available clinical and serological data". This implies the involvement of experts who interpreted these data, but the number and qualifications of these experts are not specified in the document. The European studies for cutoff establishment mention "subjects never infected by rubella virus, subjects affected by autoimmune diseases, patients affected by various infectious diseases with similar symptomology, subjects with past rubella infector or vaccine recipients, patients affected by acute rubella infection and subjects with long-lasting rubella virus IgM," which would require expert clinical and serological diagnosis to categorize.

4. Adjudication Method for the Test Set

• For the clinical comparative studies, the LIAISON® Rubella IgM assay results were compared directly against the results of the predicate device. There is no mention of an independent adjudication method (like 2+1, 3+1, etc.) for discrepancies between the new device and the predicate. The predicate device's classification was used as the reference.

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

• No, an MRMC comparative effectiveness study was not done. The studies described are focused on comparing the performance of the new device (assay) against a predicate device, and analytical characteristics, not on the improvement of human readers with AI assistance.

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

• Yes, this is a standalone device performance study. The LIAISON® Rubella IgM assay is an in vitro diagnostic device (a lab test system) that provides a qualitative result (Positive, Equivocal, Negative). The studies assess the analytical and clinical performance of this assay itself, generating results without human interpretive input into the device's determination. Human laboratory personnel would operate the instrument and interpret the final quantitative result based on the defined cut-offs to a qualitative diagnosis, but the core performance evaluation is of the assay's output.

7. The Type of Ground Truth Used

• Predicate Device/Reference Methods and Clinical Data Consensus.
  • For the comparative clinical studies, the FDA-cleared predicate device (ADVIA Centaur Rubella IgM Assay) served as the primary ground truth for comparison.
  • For establishing the assay cut-off, the ground truth was derived from "consensus between several comparison methods as well as the available clinical and serological data." This falls under a form of expert consensus and reference method agreement based on clinical and laboratory findings.
  • For analytical studies (e.g., cross-reactivity, IgM specificity), the ground truth was based on known characteristics of the samples (e.g., known sero-positivity for a cross-reactant, known Rubella IgM presence/absence, DTT treatment effect).

8. The Sample Size for the Training Set

• Not explicitly specified for a distinct "training set" in the context of machine learning. As an immunoassay, the device's "training" involves the development and calibration of reagents and the establishment of cut-offs.
• The assay cut-off was established based on studies including "1662 subjects from different populations" (subjects never infected by rubella virus, subjects affected by autoimmune diseases, patients affected by various infectious diseases with similar symptomology, subjects with past rubella infector or vaccine recipients, patients affected by acute rubella infection and subjects with long-lasting rubella virus IgM) in European studies. This large cohort of 1662 subjects would serve as the primary dataset used to "train" or optimize the assay's interpretive criteria (i.e., the cut-off values).

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

• The ground truth for the 1662 subjects used to establish the cut-off was determined by:
  • "several comparison methods" (implying other established serological tests for Rubella IgM), and
  • "available clinical and serological data" (suggesting a comprehensive evaluation of patient history, symptoms, and other laboratory findings).
  • The "consensus between the methods as well as the available clinical and serological data" was applied to define the expected results for these subjects. This indicates a robust method involving multiple lines of evidence and expert review.

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For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.

The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.

The provided document describes the MAGO 4S, an automated laboratory instrument for processing enzyme-linked immunoabsorbent assays (EIA) and immunofluorescence assay (IFA) slides, specifically for the detection of IgG antibodies to rubella in human serum. The study aims to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for precision, linearity, or agreement percentages before the study was conducted. Instead, it presents the results obtained and implies that these results are deemed acceptable for substantial equivalence. For the purpose of this table, I will infer the acceptance from the presented "Pass" results and the general expectation for such assays.

*   **CDC Performance Panel:** 100 sera provided by the CDC.
*   **CDC Biological Standard:** CDC Biological Standard, Low-Titer Anti Rubella Human Reference Serum, used with a dilution series.

• Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of performance testing for a new device, it is likely prospective, with samples collected or acquired specifically for this study. The country of origin for general samples is not mentioned, but the CDC performance panel samples are from the US.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of external human experts to establish ground truth for the test set that directly compares the MAGO 4S to a reference.
• For the "Positive and Negative Agreement with Comparator" test, the "manual" method acts as the comparative standard. The expertise for establishing the results of the manual method would rely on the laboratory personnel performing those tests, presumably qualified medical technologists or similar professionals.
• For the CDC Performance Panel, the "CDC Target" is used as the ground truth. This implicitly relies on the expertise and established reference methods of the CDC.

4. Adjudication Method

• The document does not describe a formal adjudication method (like 2+1 or 3+1) involving multiple human readers/reviewers for the test set.
• For the "Positive and Negative Agreement with Comparator," it seems a single manual test result was compared to a single MAGO 4S result for each sample. Equivocal results were specifically addressed in a retest zone assessment.

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

• No MRMC comparative effectiveness study was done. This study focuses on the performance of the automated instrument itself (standalone performance) against manual methods or established standards, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire submission details the performance of the MAGO 4S automated instrument (algorithm only, without human-in-the-loop performance) in various aspects such as precision, linearity, and agreement with established methods/standards.

7. Type of Ground Truth Used

• Existing Legally Marketed Devices/Manual Methods: For precision, linearity, and positive/negative agreement, the "Diamedix test kit" (manual method) serves as the comparator, and its results are implicitly considered ground truth for comparison.
• Reference Standards/Panels:
  • CDC Performance Panel: The "CDC Target" results for the 100 sera served as the external ground truth.
  • CDC Biological Standard: The expected IU/ml values for the various dilutions of the Low-Titer Anti Rubella Human Reference Serum served as the reference ground truth.

8. Sample Size for the Training Set

• The document does not provide information on a specific "training set" or sample sizes used for training the MAGO 4S in the context of machine learning or AI. This device appears to be an automated instrument following predefined protocols for assays (EIA/IFA) rather than a system requiring extensive machine learning model training on large datasets in the way modern AI devices do. Its "development" would involve engineering and calibration rather than algorithm training on a separate dataset.

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

• As noted in point 8, the document does not describe a "training set" in the context of machine learning. Therefore, methods for establishing ground truth for such a set are not applicable or described within this submission. The "ground truth" for the device's operational parameters would have been established during its engineering, calibration, and internal validation processes based on reference materials and established assay principles.

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

The BioPlex 2200 Rubella and CMV 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 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 Rubella and CMV IgM assays have not been evaluated in immunosupressed 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 Rubella and CMV IgM Calibrator Set is intended for calibration of the BioPlex 2200 Rubella and CMV IgM Reagent Pack.

The BioPlex 2200 Rubella and CMV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex Rubella and CMV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV IgM Control Set has not been established with any other Rubella or Cytomegalovirus (CMV) IgM antibody assays.

The BioPlex® 2200 Rubella and CMV IgM kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. Rubella and CMV IgM test is to detect antibodies to Rubella and Cytomegalovirus (CMV).

Two (2) different populations of dyed beads are coated with cell lysates bearing Rubella or CMV antigens. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel; the mixture is incubated at 37°C. After a wash cycle, anti-human IgM antibody, conjugated to phycoerythrin (PE), is added to the dyed beads, and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data are reported as relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma.

The instrument is calibrated using a set of three (3) distinct serum based calibrators. A negative and CMV IgM calibrator is used to calibrate CMV assay, and a negrative and rubella IgM calibrator is used to calibrate the rubella IgM assay, The cul-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard. For Rubella and CMV, results of ≤ 0.8 Al are negative, 0.9 and 1.0 Al are equivocal and results of ≥ 1.1 Al are reported as positive.

The BioPlex 2200 Rubella and CMV IgM Control Set includes a negative control as well as a CMV IgM positive control and a Rubella IgM positive control. The BioPlex Rubella and CMV IgM Positive Controls are manufactured to give positive results, with values above the cut-off for each specific analyte. The BioPlex Rubella and CMV IgM Negative Control are manufactured to give negative results, with values below the cut-off for each specific analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

Here's an analysis of the provided text regarding the BioPlex® 2200 Rubella and CMV IgM kit, focusing on acceptance criteria and the supporting studies:

Summary of Acceptance Criteria and Device Performance (Based on Method Comparison Studies)

The acceptance criteria for the BioPlex® 2200 Rubella and CMV IgM kit are not explicitly stated as numerical targets in the provided document, but rather implied through comparison to predicate devices and general performance metrics like Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The document implies that "comparable performance" or "performed according to its specifications" is the acceptance criterion for many aspects. For quantitative measurements like reproducibility and matrix comparison, specific numerical targets (e.g., %CV ranges, slope 1.0 +/- 0.2, r >= 0.98) are explicitly mentioned and met.
• The PPA values for the prospective study, especially for Rubella IgM (66.7%) and CMV IgM (53.8%), seem low initially. However, these are based on a very small number of positive samples (3 for Rubella IgM and 13 for CMV IgM), which leads to wide confidence intervals. The larger retrospective study with presumptive positive samples shows much higher PPA values (96.3% for Rubella IgM and 91.3% for CMV IgM), suggesting strong overall positive agreement when sufficient positive samples are present. The low positive counts in the prospective study are likely due to the low prevalence of acute infections in the "test ordered" population.

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

• Reproducibility (Internal): 3 panels (serum, EDTA plasma, heparinized plasma). Assayed 2 times in 2 separate daily runs over 20 days (n=80).
• Reproducibility (External): 3 panels (serum, EDTA plasma, heparinized plasma). Tested in quadruplicate over 5 days at 3 sites (n=60 replicates per panel member).
• Interfering Substances: Specific substances tested at varying concentrations. Number of samples not explicitly stated per substance, but implied to be sufficient to observe interference if present.
• Cross-Reactivity: Varied numbers of samples (typically 9-10) for each potential cross-reactant. Samples were known positive for the given cross-reactant and negative by predicate devices.
• IgM Detection (DTT treatment): 10 Rubella IgM-positive samples and 10 CMV IgM-positive samples.
• Seroconversion Testing: 3 commercial Rubella IgM seroconversion panels (RP001, RP011, RP014) and 1 commercial CMV IgM seroconversion panel (RP003). Each panel consists of multiple bleeds over time.
• Expected Values:
  • Rubella IgM: 300 samples (US origin).
  • CMV IgM: 400 samples (300 US, 100 Europe).
• Method Comparison (Prospective Study):
  • Rubella IgM: 300 samples (US origin), including 71 pregnant women.
  • CMV IgM: 400 samples (300 US, 100 Europe).
• Method Comparison (Retrospective Study - Presumptive Positive):
  • Rubella IgM: 107 samples.
  • CMV IgM: 229 samples.
• Matrix Comparison: 20 individual donors for matched serum, potassium EDTA plasma, and sodium heparin plasma samples. Evaluated in replicates of 10.

Data Provenance:

• US and Europe: Explicitly mentioned for some Expected Values and Method Comparison studies for CMV IgM. Rubella IgM samples are predominantly US.
• Retrospective/Prospective:
  • Prospective: Method Comparison study for general population and pregnant women.
  • Retrospective: Method Comparison study for presumptive positive samples. Seroconversion panels, interfering substances, and cross-reactivity studies are inherently retrospective in their selection (i.e., using pre-characterized samples). Reproducibility studies used panels.

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

The document does not specify the direct involvement of human experts (e.g., radiologists, pathologists) in establishing the ground truth for this device. Instead, the ground truth for most comparative studies is established by:

• Predicate Devices: The ADVIA Centaur® Rubella IgM (K010668) and bioMeriéux VIDAS® CMV IgM (K933549) are used as the reference standard ("predicate results as the standard") for determining cut-off values and for method comparison studies.
• FDA Cleared Devices: For the cross-reactivity study, samples were pre-tested by "FDA cleared devices." For adjudication, "two out of three FDA cleared devices" were used.
• Commercial Seroconversion Panels: Bio-Rad Laboratories Liquichek™ Rubella IgM and CMV IgM seroconversion panels were used, which are typically well-characterized.

Therefore, the ground truth is based on established, FDA-cleared commercial assays and recognized diagnostic panels, rather than direct expert consensus on individual cases.

4. Adjudication Method for the Test Set

• Adjudication by Multiple FDA Cleared Devices: For samples that showed equivocal results by the predicate device in the Method Comparison (Prospective Study), an adjudication method was used: "One sample that was equivocal by the predicate device was adjudicated by two out of three FDA cleared devices." and "Two samples that were equivocal by the predicated by two out of three HDA cleared devices." This is a form of 2-out-of-3 or 3-out-of-3 adjudication against external reference methods.
• No explicit 2+1, 3+1, or similar human expert adjudication is mentioned in the context of interpretation of images or clinical cases. The adjudication is against other laboratory tests.

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 mentioned or performed. This device is an in vitro diagnostic (IVD) immunoassay kit, not an AI-assisted diagnostic imaging device or tool that involves human "readers" in the traditional sense of interpreting complex data like medical images. Its performance is evaluated against other laboratory assays.

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

The BioPlex® 2200 system operates as a standalone automated immunoassay. The performance studies described (reproducibility, interfering substances, cross-reactivity, seroconversion, method comparison) inherently evaluate its "algorithm only" or automated performance without human intervention in the interpretation process of individual test results. The device provides quantitative results (RFI) which are then interpreted qualitative (negative, equivocal, positive) based on predefined cut-offs.

7. The Type of Ground Truth Used

The ground truth primarily used is "predicate devices" or "FDA cleared devices."

• For method comparison studies, the results from the ADVIA Centaur® Rubella IgM and bioMeriéux VIDAS® CMV IgM predicate devices served as the gold standard.
• For cross-reactivity, samples confirmed positive for specific conditions by other FDA cleared devices were used.
• For seroconversion, commercial seroconversion panels were used, which have well-characterized profiles.
• The calibration itself uses concordance and Receiver Operator Characteristic (ROC) analysis with predicate device results.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or AI algorithm development. This is an immunoassay kit, where the "training" involves the development and calibration of the assay.

• The calibration process is described using "a set of three (3) distinct serum based calibrators." The cut-off values are determined by "performing concordance and Receiver Operator Characteristic (ROC) analysis using the Centaur Rubella IgM and VIDAS CMV IgM predicate results as the standard." While not a "training set" in the AI sense, this calibrator set and the analysis with predicate results serve a similar function in establishing the assay's operational parameters.

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

As noted above, there isn't a "training set" in the typical AI sense. For the establishment of assay calibration and cut-offs:

• Predicate Device Results: The ground truth for defining the cut-off values and calibrators was established by comparing the BioPlex 2200's performance against the established results of the predicate devices (ADVIA Centaur® Rubella IgM and bioMeriéux VIDAS® CMV IgM) using concordance and ROC analysis. This means the clinical and analytical performance of those predicate devices, which are already FDA cleared, serve as the reference for tuning the BioPlex 2200's output.

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The Elecsys Rubella IgM immunoassay is for the in vitro qualitative determination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been cleared/approved by the FDA for blood/plasma donor screening.

Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Rubella IgM Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgM is composed of a biotin-labeled monoclonal antibody-against-human IgM, a Rubella-like particle and a ruthenium-labeled anti-Rubella antibody. A relationship exists between the concentration of the IgM antibody targets present in a patient sample and the level of signal count detected by the system. The IgM assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values equal to or greater than 1.0 are considered positive for the presence of anti-Rubella IgM antibody. Results are determined using a 2 point calibration. The test system contains the human serum-based calibrators intended for use with the system.
(2) The Elecsys PreciControl Rubella igM contains two levels of human serum. The positive control contains native, inactivated Rubella IgM antibodies.

Here's a breakdown of the requested information based on the provided text for the Elecsys Rubella IgM Test system.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it presents performance data (e.g., agreement percentages) as part of the method comparison with predicate devices.

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

• Test Set Sample Sizes:
  • Method Comparison (Elecsys vs. Zeus Scientific/Abbott AxSym and DPC Immulite):
    • Pregnant Subjects: 132 (131 negative, 0 positive)
    • Non-Pregnant Subjects: 369 (368 negative, 1 positive)
    • This totals 501 samples for the method comparison.
  • Analytical Specificity: 60 specimens.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the data was retrospective or prospective.

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

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The "ground truth" for the method comparison appears to be established by the results of the predicate devices (Zeus Scientific Rubella IgM ELISA Test System, Abbott AxSym, and DPC Immulite).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1). The comparison is directly made against the results of the predicate devices.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or conducted. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool for human readers.

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

Yes, the performance data presented (e.g., method comparison, analytical specificity, precision) represents the standalone performance of the Elecsys Rubella IgM Immunoassay system. Since it's an automated immunoassay, its performance is inherently "standalone" without direct human-in-the-loop interaction in the diagnostic step (though human operators initiate and interpret the results).

7. The Type of Ground Truth Used

The primary "ground truth" used for evaluating the Elecsys Rubella IgM Immunoassay appears to be:

• Predicate Device Results: For the method comparison, the results from the legally marketed predicate devices (Zeus Scientific Rubella IgM ELISA Test System, Abbott AxSym, and DPC Immulite) served as the reference for determining agreement.
• The document also implies other laboratory methods were used for the "analytical specificity" though more detail is not provided.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" size. As an immunoassay, the device is developed and validated through analytical studies and clinical comparisons, rather than a machine learning approach that typically involves distinct training and test sets.

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

Since a "training set" is not mentioned in the context of this immunoassay's development, the document does not describe how ground truth for a training set was established. The development of such assays typically involves optimizing reagents and protocols to achieve desired analytical performance and then validating that performance against established methods and clinical samples.

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The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.

The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. The individual kit components are described in detail on the following pages.

All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the Rubella antigen fixed onto the interior wall of the SPR to capture the Rubella antibodies present in the sample. After dilution, the sample is incubated with the SPR. Rubella IgG antibodies present in the specimen bind to the Rubella antigen coating the interior of the SPR. Unbound components are eliminated during the preliminary wash step.

A second incubation step is then performed using alkaline phosphatase labeled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step.

During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm.

The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

This submission describes the VIDAS® RUB IgG Assay, an in vitro diagnostic device for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum, intended as an aid in determining immune status to rubella. The study presented aims to demonstrate substantial equivalence to the predicate device, the Abbott's AxSYM Rubella IgG Antibody Assay.

Here's an analysis of the acceptance criteria and study detailed in the provided documentation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum percentage agreement for positive or negative results). Instead, it presents the performance data and implies that these results are considered acceptable for demonstrating substantial equivalence to the predicate device.

For the purpose of this analysis, we will infer the "reported device performance" directly from the clinical performance tables provided. The study compares the VIDAS® RUB IgG assay's results against a "2/3 Consensus" method, which serves as the ground truth.

Note: The wide confidence intervals for negative agreement, especially in prospective populations and retrospective pregnant women, suggest small sample sizes for negative cases in those cohorts. The "Worst Case CI Lower Bound" is used as a conservative measure, as the actual point estimate for agreement is higher in most cases.

2. Sample Sizes and Data Provenance

The study utilized a combination of prospective and retrospective samples from various populations.

• Prospective Pregnant Women: 325 samples
• Prospective General Population: 179 samples (1 sample was QNS and excluded from analysis)
• Retrospective Pregnant Women: 200 samples
• Retrospective General Population: 291 samples (5 samples were QNS and excluded from analysis)
• Pre-selected Pregnant Women Population: 127 samples (2 samples were QNS and excluded from analysis)

Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's address in Hazelwood, MO, USA, and the FDA's regulatory context, it is highly probable that the studies were conducted in the United States or followed U.S. regulatory guidelines for data collection. The data included both retrospective and prospective samples.

3. Number of Experts and Qualifications for Ground Truth

The document states that the ground truth for the clinical performance evaluation was established using a "2/3 Consensus" method. This implies that at least three reference methods or expert readers were used, and the final classification (Positive, Equivocal, or Negative) was based on agreement from at least two out of three.

Qualifications of Experts: The document does not explicitly state the qualifications of the "experts" or the nature of the "reference methods" used to form the consensus. Typically, for serological assays, this consensus would involve results from established reference assays or expert interpretation of multiple existing test results, rather than human "readers" in the context of imaging.

4. Adjudication Method

The adjudication method used for establishing the ground truth for the test set was a "2/3 Consensus". This means that for a sample to be classified as Positive, Equivocal, or Negative, at least two out of three independent comparators (presumably other rubella IgG assays or a panel with known status) had to agree on that classification.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or presented in the provided text. This type of study typically involves human readers (e.g., radiologists, pathologists) interpreting medical images or data, with and without AI assistance, to measure the impact of AI on their performance. The VIDAS® RUB IgG Assay is an automated immunoassay, designed to directly provide quantitative and qualitative results, rather than assisting human interpretation of complex medical cases. Therefore, an MRMC study is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study was done. The clinical performance data presented (Prospective, Retrospective, and Pre-selected populations) directly reflects the algorithm's (VIDAS® RUB IgG Assay) performance in classifying samples as Positive, Equivocal, or Negative, compared to the established "2/3 Consensus" ground truth. The tables explicitly show the agreement rates of the VIDAS® assay alone against the consensus.

7. Type of Ground Truth Used

The type of ground truth used for the test set was expert consensus, specifically a "2/3 Consensus" method. While the specifics of what constituted this consensus (e.g., comparison to a gold standard assay, multiple predicate assays, or a well-characterized reference panel) are not detailed, it implies an agreement among a minimum of two out of three established methods or experts.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. Immunoassays like the VIDAS® system are typically developed and optimized through extensive R&D, including reagent formulation, calibration curve development, and internal validation, rather than "training" in the same sense as machine learning algorithms. If any computational models were involved in the assay's development or calibration, the training data for those are not described. The provided data is for the validation or test sets used to demonstrate clinical performance.

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

As no training set information is provided, the method for establishing its ground truth is also not described. For laboratory assays, "ground truth" during development often comes from well-characterized reference materials, spiked samples, or comparison to established gold standard methods.

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(1) The Elecsys Rubella IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to rubella virus in human serum and Li-heparin, K3-EDTA and sodium citrate plasma.
This assay may be used as an aid in the assessment of immune status to rubella in individuals including women of childbearing age.
The electrochemiluminescence immunoassay "ECLIA" is intended for use or Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Rubella IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgG assay contains: a biotin labeled monoclonal antibody against human IgG, a ruthenium-labeled anti-Rubella antibody fragment , biotin- and ruthenium-labeled Rubella-antigens and a Rubella-like particle. A relationship exists between the concentration of the IgG antibody targets present in a patient sample and the level of signal count detected by the system. The IgG assay is quantitative and is standardized against WHO materials. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The test kit contains the human serum-based calibrators intended for use with the system.
(2) The Elecsys Precicontrol Rubella IgG contains two levels of human serum with Rubella IgG antibodies.

Here's an analysis of the acceptance criteria and supporting studies for the Elecsys Rubella IgG Immunoassay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. However, we can infer performance goals based on the presented data and the comparison to the predicate device.

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The LIAISON® Rubella IgG uses chemiluminescencc immunoussay (CLIA) technology on the LIAISON Analyzer for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women.

The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum. Likewise, performance has not been established for population(s) of immunocompromised or immunosuppressed individuals.

The LIAISON® Rubella IgG Tri-Control kit is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgG assay.

The method for qualitative determination of specific IgG to Rubella virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with Rubella antigen and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, Rubella virus antibodies present in the calibrators, specimens or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with Rubella virus IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU).

The provided document describes the DiaSorin LIAISON® Rubella IgG Assay, a chemiluminescence immunoassay (CLIA) for the qualitative determination of IgG antibodies to rubella virus in human serum, intended as an aid in determining immune status, including in pregnant women.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the provided text. Instead, the document presents comparative study results against a "commercially available rubella chemiluminescence test kit" and consensus testing with three FDA-cleared ELISA devices for equivocal samples, as well as an evaluation using a CDC performance panel. The reported device performance is as follows:

*c: Number of samples too low to reliably calculate % negative agreement for this group.

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

• Comparative Study (Non-selected subjects):
  • Total: 2806 prospectively collected frozen specimens.
  • Routine Rubella IgG Testing: 2159 samples.
  • Pregnant Women: 449 samples.
  • Data Provenance: Prospectively collected specimens from U.S. subjects. The "routine rubella IgG testing" and "pregnant women" samples were part of this overall set. Samples were divided randomly, and testing sites were blinded to populations and comparator results.
• Comparative Study (Pre-selected Negative Subjects):
  • Total: 198 pre-selected negative subjects.
  • Routine Rubella IgG Testing: 98 subjects.
  • Pregnant Women: 100 subjects.
  • Data Provenance: Prospectively collected from U.S. subjects. These were pre-selected based on initial negative results from predicate device testing.
• CDC Performance Panel: 100 specimens (50 pairs of sera, 18 negative, 82 positive).
  • Data Provenance: Obtained from the CDC (Centers for Disease Control and Prevention), a masked, characterized serum panel.

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

The document does not explicitly state the number or specific qualifications (e.g., "radiologist with 10 years of experience") of experts used to establish the ground truth.

For the comparative study, the ground truth was established by:

• "a commercially available rubella chemiluminescence test kit" (predicate device).
• For equivocal samples from the predicate device, a consensus of 2 out of 3 results from three FDA-cleared ELISA devices was used.
• For the pre-selected negative subjects, the initial predicate device testing (rubella antibody testing performed by the laboratories) was used to define samples as negative. For the 100 pregnant women, no equivocal results were found in the initial predicate test, so no consensus was needed for this cohort.

For the CDC Performance Panel, the samples were a "masked, characterized serum panel" with known status (titered by HI), implying the ground truth was established by the CDC through their characterization methods.

4. Adjudication Method for the Test Set

• For equivocal samples from the predicate device: A "2 out of 3 rule using 3 additional FDA cleared assays" was applied. If a sample had concordant results by at least two of the three methods, the consensus defined the result. If discordant or concordant equivocal, the sample remained classified as equivocal.
• For the pre-selected negative subjects: The initial predicate test results were used as the basis for definition (no explicit "adjudication" beyond that initial classification is mentioned in the context of validating the LIAISON device).

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 assay that provides an objective measurement (Index value) and qualitative result (Positive, Negative, Equivocal) rather than relying on human interpretation of images or other subjective data. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

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

Yes, the studies presented are standalone performance evaluations of the DiaSorin LIAISON® Rubella IgG Assay. The output is a numerical Index and a qualitative classification (Positive, Equivocal, Negative) generated by the automated LIAISON Analyzer based on the chemiluminescence immunoassay technology. There is no human-in-the-loop interpretation that impacts the device's direct output.

7. The Type of Ground Truth Used

• Comparative Studies:
  • Comparator Assay / Predicate Device: A commercially available rubella chemiluminescence test kit.
  • Consensus Testing: For equivocal samples, results from "three FDA cleared devices" (ELISA assays) using a 2 out of 3 rule.
  • Pre-selected Negatives: Initial negative classification by existing laboratory rubella IgG testing.
• CDC Performance Panel: Characterized serum panel with known rubella IgG status, likely established through a combination of serological methods, including HI (Hemagglutination Inhibition).

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning or AI development. Since this is an immunoassay, the device's "training" would typically involve optimization and calibration during development using internal panels, but these are not explicitly detailed as a distinct "training set" in a manner typical for AI algorithms in this regulatory submission. All the sample sizes mentioned (2806 for comparative, 100 for CDC) are used for performance evaluation/testing.

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

As no explicit "training set" in the AI sense is provided, the method for establishing its ground truth is not applicable or detailed in this document. The assay's parameters would have been established and optimized during its development using various internal reference materials and panels, but these are not outlined as a formal "training set" with established ground truth in the context of this 510(k) summary.

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The Zeus Scientific, Inc. AtheNA Multi-Lyte Rubella IgG Test System is intended for the qualitative detection of IgG class antibody to Rubella virus in human sera by microparticle immunoassay testing on the AtheNA Multi-Lyte Instrument. The results of the AtheNA Multi-Lyte Rubella IgG Test System may be used to determine the serological status of individuals including women of childbearing age.

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This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting.

The letter acknowledges that the device, "AtheNA Multi-Lyte Rubella IgG Test System," is substantially equivalent to a legally marketed predicate device for the qualitative detection of IgG class antibody to Rubella virus in human sera.

Therefore, I cannot extract the information requested as it is not present in the provided text.

To answer your questions, I would need access to the actual study report or relevant sections of the 510(k) submission that contain the performance data and methodology.

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For in vitro diagnostic use only.

The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.

The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.

The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic Products Rubella IgG Reagent Pack and VITROS Immunodiagnostic Products Rubella IgG Calibrators on the VITROS Immunodiagnostic System for the qualitative and quantitative determination of rubella IgG antibodies to rubella virus in human serum and plasma. An immunometric technique is used. This involves the reaction of antirubella IgG present in the sample with rubella antigen coated onto the wells. After a wash step a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-human IgG) is added and this complexes with bound anti-rubella IgG. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of antirubella IgG present.

Here's a breakdown of the acceptance criteria and study information for the VITROS Rubella IgG Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a numerical target format (e.g., "Sensitivity must be >95%"). Instead, it compares the performance of the new device to a predicate device. The "acceptance" is implied by demonstrating substantial equivalence to the predicate device.

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

The document does not specify the exact sample size for the test sets (i.e., the number of samples used to determine Positive % Agreement and Negative % Agreement). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not provide information about the number of experts, their qualifications, or how they established the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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 study is an in-vitro diagnostic device (IVD) for laboratory use and does not involve human readers interpreting results. Inter-rater variability studies are more applicable to imaging or subjective interpretations rather than quantitative immunoassay results.

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

Yes, this is implicitly a standalone performance study. The "device performance" refers to the output of the VITROS Immunodiagnostic System itself, without a human in the loop for interpretation beyond running the assay and reading the quantitative results. The output of the device is a quantitative determination of IgG antibodies, which is then used by laboratory personnel to aid in determining immunity.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of "ground truth" used for the studies that generated the Positive % Agreement and Negative % Agreement. However, given that it's an immunoassay for rubella IgG, the ground truth would typically be established by:

• Reference Methods: Highly sensitive and specific laboratory reference assays for rubella IgG antibodies.
• Clinical Status: Correlation with confirmed rubella infection history or vaccination status for clinical immunity determination.
• CDC Panel Evaluation: The mention of "CDC Panel evaluation" indicates that standardized panels from the Centers for Disease Control and Prevention were likely used, which represent well-characterized samples with established rubella IgG status.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for a training set. This is typical for in-vitro diagnostic assays, where a "training set" in the context of machine learning isn't usually a separate, explicitly defined component in the same way it would be for a typical AI/ML medical device. Instead, the assay's design, calibration, and optimization (which can be considered analogous to "training") are performed using a range of characterized samples during the development phase.

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

Since an explicit "training set" as understood in AI/ML is not described, the method for establishing its "ground truth" is also not detailed. However, for the development and optimization of such an immunoassay, the manufacturer would use precisely characterized samples with known concentrations or presence/absence of rubella IgG antibodies, likely derived from reference materials, clinical samples with confirmed status, and potentially fortified samples.

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