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Immunoassays for the in vitro quantitative determination of the soluble fms like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio in human serum.

The sFlt-1/PlGF ratio is indicated as an aid in the risk assessment of pregnant women, with a singleton pregnancy (23+0 to 34+6/7 weeks' gestation) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension), to develop preeclampsia with severe features within two weeks from testing. The sFit-1/PlGF ratio should be used in conjunction with clinical assessment and routine laboratory testing.

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

The Elecsys sFlt-1 and Elecsys PlGF assays employ a sandwich principle using electrochemiluminescence immunoassay "ECLIA" technology. The total duration of each assay is 18 minutes. Samples are incubated with biotinylated and ruthenium-labeled monoclonal antibodies specific to sFlt-1 or PlGF, forming a sandwich complex. Streptavidin-coated microparticles are added, binding the complex to the solid phase. The microparticles are magnetically captured, unbound substances are removed, and a voltage is applied to induce chemiluminescent emission, which is measured by a photomultiplier. Results are determined via a calibration curve generated by 2-point calibration and a master curve provided via the reagent barcode. The reagents for each assay are combined in a "rackpack".

Here's a breakdown of the acceptance criteria and study information for the Elecsys sFlt-1 and Elecsys PlGF assays, based on the provided document.

Acceptance Criteria and Device Performance

• Sensitivity: 91.40% (95% CI: 86.41, 95.00)
• Specificity: 77.30% (95% CI: 72.68, 81.47)
• NPV (ratio ≤ 38): 94.70% (95% CI: 91.54, 96.94)
• PPV (ratio > 38): 66.93% (95% CI: 60.77, 72.68) |
  | Non-Clinical Performance | Precision: Low coefficients of variation (CV) for repeatability (within-run) and intermediate precision (within-laboratory). | Elecsys PlGF (N=84 per sample type):
• Repeatability CV: 1.0% - 5.7%
• Intermediate precision CV: 1.4% - 9.9%
  Elecsys sFlt-1 (N=84 per sample type):
• Repeatability CV: 0.9% - 2.4%
• Intermediate precision CV: 1.7% - 3.7%
  Ratio (N=84 per sample type):
• Repeatability CV: 1.1% - 4.9%
• Intermediate precision CV: 1.4% - 7.0% |
  | | Linearity/Assay Reportable Range: Measurements are linear across the claimed measuring range. | - Elecsys sFlt-1: 80-85000 pg/mL (claimed range)
• Elecsys PlGF: 10-5400 pg/mL (claimed range)
  (Study concludes measurements are linear across these ranges) |
  | | Limit of Blank (LoB): ≤ 2 pg/mL for PlGF and 26.4 mg/dL can cause up to 10% decrease in ratio.
• Hemoglobin, Intralipid, Rheumatoid Factors, Biotin (up to 1200 ng/mL): No significant interference reported (implies within acceptable limits though quantitative data not listed).
• Common Drugs (15 tested): No interference.
• Additional Substances (13 tested): No interference.
• Heparin: Interference with Elecsys PlGF for concentrations > 500 U/L. |
  | | Analytical Specificity/Cross-Reactivity: Highly specific for sFlt-1 and PlGF, with minimal cross-reactivity with related substances. | - sFlt-1 cross-reactivity:

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The Atellica® IM High-Sensitivity Troponin I (TnIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) using the Atellica® IM Analyzer. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).

The Atellica IM TnIH assay can be used as an aid in prognosis for 30-, 182-, and 365-day all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS). MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.

The Atellica® IM TnIH assay is a 3-site sandwich immunoassay using direct chemiluminescent technology. The Solid Phase reagent consists of magnetic particles conjugated with streptavidin with 2 bound biotinylated capture monoclonal antibodies, each recognizing a unique cTnl epitope.

The Lite Reagent comprises a conjugate with an architecture consisting of a proprietary acridinium ester and a recombinant anti-human cTnl sheep Fab covalently attached to bovine serum albumin (BSA) for chemiluminescent detection.

A direct relationship exists between the amount of cTnl present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The provided document is a 510(k) summary for the Atellica® IM High-Sensitivity Troponin I (TnIH) assay, detailing its substantial equivalence to a predicate device and supporting the addition of a prognostic indication for use. However, it does not explicitly define acceptance criteria as a separate, quantitative table with pass/fail metrics. Instead, the "Performance Characteristics – Clinical Study" section presents the study objective and results that demonstrate the device's performance for the new prognostic indication, implicitly serving as the validation for meeting the FDA's requirements for substantial equivalence.

Based on the information provided, here's a breakdown of the requested elements:

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

The document does not provide a formal table of acceptance criteria with quantitative thresholds for "pass/fail". The study's objective was to demonstrate the ability of the device to predict future mortality or adverse cardiac events. The reported performance focuses on:

• Hazard Ratios (Unadjusted and Adjusted): Showing the increased risk of ACM/MACE for patients with cTnI levels >99th percentile compared to those ≤99th percentile.
• Post-test risk: The cumulative incidence of ACM/MACE for the two troponin level groups.
• Kaplan-Meier Curves: Visually representing the absolute risk of events over time for the two groups.

The implicit acceptance criteria for this prognostic indication would be that the device's measurements (specifically, cTnI levels > 99th percentile) demonstrate a statistically significant association with increased future risk of all-cause mortality (ACM) and major adverse cardiac events (MACE) across the specified follow-up periods (30, 90, 182, and 365 days) in the relevant patient populations.

Reported Device Performance (Excerpted from the document, focusing on statistically significant findings):

Note: Bolded Hazard Ratios indicate statistically significant findings (95% CI does not cross 1.0). Italicized Hazard Ratios (e.g., serum at 30, 90, 365 days for Population 2) are explicitly marked as "Not Statistically Significant" in the document.

The overall conclusion states: "The results of the clinical study provided in this submission support the addition of an indication for use as an aid in prognosis for all-cause mortality (ACM) and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome (ACS)." This implies that the observed effects (higher risk for cTnI > 99th percentile) were deemed sufficient, particularly for the statistically significant findings.

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

• Test Set Sample Size:
  • Population 1: 2064 patients
  • Population 2:
    • Lithium Heparin Plasma: 1190 patients
    • Serum: 1214 patients
  • Population 3: 874 patients
• Data Provenance: The document states, "This prognostic risk analysis utilized the same emergency department cohort previously described in K171566." It does not explicitly state the country of origin. The study was prospective in terms of follow-up for outcomes after initial presentation, as patients were "followed up for 30-, 90-, 182-, and 365-day progression to ACM and MACE."

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

The ground truth for Adjudicated AMI was mentioned ("Entire Population Excluding Subjects with Adjudicated AMI"). The document does not specify the number or qualifications of experts used for establishing this adjudication or for the MACE/ACM outcomes. It says "a detailed symptom history was obtained for each subject" and "the following information was collected from each subject's medical chart." This suggests medical record review, but the specific adjudicators are not detailed.

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

The document mentions "adjudicated AMI" and the collection of outcome data (ACM/MACE events). However, it does not describe the specific adjudication method (e.g., how many reviewers, conflict resolution) for AMI or the MACE/ACM outcomes. It implies that MACE consisted of clearly defined clinical events (myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization) which are typically obtained from medical records.

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. This is an in vitro diagnostic (IVD) assay for measuring a biomarker (Troponin I). It is not an AI-assisted imaging device or a device involving "human readers" in the typical sense of an MRMC study. The study assesses the prognostic performance of the cTnI assay result itself, not human interpretation enhanced by AI.

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

Yes, in a sense. The performance evaluated is that of the assay (the Atellica® IM High-Sensitivity Troponin I (TnIH) measurement) as a standalone prognostic indicator, reported as a quantitative value. It's the "algorithm" of the assay (producing the cTnI value) that is assessed for its ability to predict outcomes in patient populations, without direct human cognitive input being part of the primary performance metric. Clinical decision-making would then incorporate this result.

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

The ground truth for the prognostic indication was outcomes data, specifically:

• All-Cause Mortality (ACM)
• Major Adverse Cardiac Events (MACE): Consisting of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
  This long-term outcome data was collected from patient follow-up over 30, 90, 182, and 365 days.

8. The sample size for the training set

The document describes a clinical performance study for the new prognostic indication. It does not mention a separate "training set" for model development, implying that this was a single-cohort validation study using the full collected dataset (the test set described above). The purpose of the submission is to expand the intended use of an already existing device (cleared under K171566), suggesting the core assay technology was already established.

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

As no separate "training set" is explicitly mentioned for the prognostic model development (if one occurred), this question is not fully answerable from the provided text. The ground truth for the clinical validation (the "test set") was established through prospective follow-up for clinical outcomes (ACM/MACE) as described in point 7.

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Binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Elecsys Folate III is a binding assay that makes use of a competitive test principle using a ruthenium labeled folate-binding assay.
Elecsys Folate III is a binding assay for the in vitro quantitative determination of folate in erythrocytes (red blood cells, RBC). Folate measurements are used in the diagnosis and treatment of anemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Whole blood treated with anticoagulants (heparin or EDTA) is mixed with ascorbic acid solution and incubated for approximately 90 minutes at 20-25 °C. Lysis of the erythrocytes takes place, with liberation and stabilization of the intracellular folate. The resulting hemolysate sample is then used for subsequent measurement.
Results are determined via a calibration curve, which is instrument-specifically generated by 2point calibration, and a master curve provided via the cobas link.

Here's a summary of the acceptance criteria and study details for the Elecsys Folate III device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Precision (Repeatability & Intermediate Precision): Not explicitly stated, but typically involves multiple replicates over several days/runs with multiple instruments. Specific sample types are "Hemolysate 1" to "Hemolysate 5".
• Lot-to-lot Reproducibility: "three reagent lots" were used.
• Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, but determined according to CLSI EP17-A2, which involves specific numbers of blank and low-concentration samples.
• Linearity and Dilution: "At least seven concentrations using hemolysate samples" for linearity. Dilution study used "high concentration hemolysate samples".
• Endogenous Interferences: Not explicitly stated, but "various endogenous substances" were evaluated.
• Analytical Specificity/Cross-Reactivity: Not explicitly stated.
• Exogenous Interferences: "17 commonly and 1 specially used pharmaceutical" compounds.
• Sample Matrix Comparison: "Whole blood samples were drawn into Na-Heparin and K3-EDTA tubes." (Number not specified).
• Method Comparison to Predicate: 119 samples with concentrations between 132 and 618 ng/mL.
• Reagent Stability (On-board), Lot Calibration Stability, On-board Calibration Stability: Tested on "one cobas e 801 analyzer".

Data Provenance: The document states "NON-CLINICAL PERFORMANCE EVALUATION" and refers to CLSI (Clinical and Laboratory Standards Institute) guidelines, which are standard for in-vitro diagnostic device performance studies. The data is internal to Roche Diagnostics, a company with global operations. The specific country of origin for the studies is not stated, but given the submission is to the U.S. FDA, the studies are expected to meet international and U.S. regulatory standards. These are retrospective studies in the context of device development and validation.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is an in-vitro diagnostic (IVD) assay that produces quantitative measurements of folate. It does not involve human interpretation of images or other subjective data. Therefore, the "ground truth" for its performance is established by reference methods, calibrated standards, and accurate measurement principles, rather than human expert consensus. No human experts were used to establish ground truth in the way one would for an AI imaging device.

4. Adjudication Method (Test Set)

Not applicable, as this is an IVD device producing quantitative results, not an AI imaging device requiring expert adjudication.

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

Not applicable. This is an in-vitro diagnostic device, not an AI device assisting human readers with interpreting cases.

6. Standalone (Algorithm Only) Performance

Yes, the studies described are standalone performance evaluations of the Elecsys Folate III assay (the "algorithm" in a broad sense for an IVD) without human intervention in the measurement process. The device performs the quantitative determination of folate using its defined binding assay and electrochemiluminescence immunoassay (ECLIA) method.

7. Type of Ground Truth Used

The ground truth for evaluating the Elecsys Folate III's performance is established through:

• Reference materials/standards: For analytical sensitivity (LoB, LoD, LoQ) and linearity, where known concentrations are used.
• Performance against a predicate method: For method comparison, the results are compared to a previously cleared, established method (Elecsys Folate RBC).
• CLSI guidelines: Adherence to established scientific and statistical methodologies for validating assay performance, implying well-defined benchmarks for accuracy, precision, and interference.

8. Sample Size for the Training Set

Not explicitly stated. For an IVD like the Elecsys Folate III, a traditional "training set" as understood in machine learning is not directly applicable. The "training" for such a system would involve the development and optimization of the reagent formulations, assay parameters, and calibration curve algorithms, using various samples and experiments during the research and development phase. However, a specific training set size with corresponding ground truths is not documented in the same way as an AI algorithm.

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

As above, a formal "training set ground truth" isn't directly applicable in the machine learning sense. The "ground truth" during the development and optimization (analogous to training) would have been established through:

• Known concentrations: Using purified folate standards or spiked samples.
• Reference methods: Comparing early-stage assay performance against established, often more labor-intensive or gold-standard methods for folate determination.
• Clinical correlation: (Though "clinical testing" is marked Not Applicable for this 510(k), early development might involve correlation with clinical status or outcomes).
• Statistical optimization: Adjusting reagent ratios, incubation times, and instrument settings to achieve optimal analytical performance characteristics (sensitivity, specificity, precision, linearity) based on these known values and reference method comparisons.

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The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.

The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.

The FLC Kappa and FLC Lambda test kits are intended for the quantification of free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure utilizing specific antibodies targeting anti-Lambda free light chains.

It is carried out in 8 successive steps:

• Incubation of the previously diluted samples and calibrators, in the wells of the microplate, where specific free light chain antibodies are fixed.
• Washing of the wells to remove elements that have not been fixed by the anti-free light chain antiserum.
• Incubation with an anti- light chain antiserum (Kit specific) conjugated to peroxidase.
• Washing of the wells to remove the excess of antiserum conjugated to peroxidase.
• Incubation with peroxidase substrate.
• Stopping of the enzymatic reaction with an acidic solution.
• Reading of the optical density by absorbance spectrophotometry at 450 nm of the colored product.
• Calculation of the free light chain concentration of the sample using a calibration curve obtained with calibrators that have been analyzed on the same microplate.

The provided document is an FDA 510(k) clearance letter and associated summary for the Sebia FLC Kappa and FLC Lambda kits. These kits are in vitro diagnostic (IVD) devices used for quantifying free light chains in human serum. They are immunoassay-based tests, not AI/ML-driven devices.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document. The concepts of "test set," "training set," "experts to establish ground truth," "adjudication methods," "MRMC studies," and "standalone performance" are relevant to AI/ML device evaluations, but they do not apply to the traditional IVD assay described here.

The document discusses analytical and clinical studies for the immunoassay, focusing on performance characteristics such as:

• Clinical Study: Evaluates the concordance of FLC Kappa and FLC Lambda kit results with clinical assessment and other tests for monitoring Multiple Myeloma and AL Amyloidosis.
  • Sample size:
    • Multiple Myeloma: 551 follow-up samples from 235 unique subjects.
    • AL-amyloidosis: 190 follow-up samples from 87 unique subjects.
  • Data Provenance: Subjects had "expanded racial and ethnic diversity (Caucasian, African American, Hispanic, Asian)". No specific country of origin is mentioned, but the manufacturer is based in France and the submission is to the US FDA. The studies appear to be retrospective analyses of follow-up samples.
  • Ground Truth: Clinical assessment and other tests based on criteria from the IMWG (International Myeloma Working Group) for Multiple Myeloma and consensus guidelines (Comenzo et al., 2012; Palladini et al., 2012; Kumar et al., 2022 NCCN guidelines) for AL-Amyloidosis.
  • No mention of experts establishing ground truth or adjudication methods in the context of human readers for an AI system, as this is a laboratory assay.
  • No MRMC study, as this is not an image-based or AI-assisted diagnostic.
  • No separate "standalone" algorithm performance because the device itself is the diagnostic assay.
  • No specific training set or how its ground truth was established is mentioned, as this is a traditional laboratory assay, not a machine learning model.
• Stability Studies: Determined shelf-life for the kits and controls.

In summary, this document describes a traditional immunoassay, not an AI/ML device. Thus, the requested AI/ML-specific information is not applicable and not present.

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The LIAISON® VZV IgG HT assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum (with gel and without gel-SST), dipotassium EDTA (K2- EDTA), lithium heparin and sodium heparin plasma samples. This assay is intended as an aid in the determination of previous infection of varicella- zoster virus. The test must be performed on the LIAISON® XL Analyzer. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.

The LIAISON® VZV IgG HT is an indirect chemiluminescence immunoassay (CLIA) for qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum and plasma.

The LIAISON® Control VZV IgG HT are liquid ready-to-use controls based in human serum and 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 assay and controls are designed for use with DiaSorin LIAISON® analyzer family

Here's an analysis of the provided text regarding the DiaSorin LIAISON® VZV IgG HT device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily expressed as Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a predicate device, as well as satisfactory performance in interference, cross-reactivity, precision, and high-dose saturation studies.

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

• Test Set Sample Size:
  • Total Clinical Agreement Study: 1544 clinical human serum samples (1543 used in analysis due to one sample with insufficient volume).
  • Breakdown: 125 known positive, 200 known negative, 135 pregnant women, and 1084 routine lab specimens.
  • Specific sub-studies:
    • Interfering Substances: Not specified, but involved VZV IgG antibody negative, around the cut-off, low positive, and high positive samples.
    • Cross-Reactivity: 226 samples from various conditions.
    • Precision (Within-Lab): 7 samples (panel of coded samples) tested 240 times each.
    • Reproducibility (Multi-site): 7 samples tested 90 times each across sites.
    • High-dose saturation: 3 high-titer samples.
    • Analytical sensitivity: Not a sample size of patient specimens, but derived from serial dilutions of WHO International Standard on 3 assay lots.
• Data Provenance: The general clinical samples were collected within the United States. The study was prospective in execution as it involved testing these samples with the new device and comparing them to a predicate, conducted at three independent external laboratories.

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

The document does not explicitly state the number of experts used and their qualifications for establishing the ground truth of the test set.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). The "ground truth" for the clinical agreement study appears to be defined by the results of the FDA cleared predicate device (LIAISON® VZV IgG, K150375), which is referred to as the "comparator." It notes that "Specimens which were repeatedly equivocal by the predicate device were graded against the performance of the LIAISON® VZV IgG HT assay which does not have an equivocal zone." This implies a direct comparison to the predicate's results rather than an independent expert adjudication process for the clinical samples. For cross-reactivity, samples were "pre-screened with another commercially available VZV IgG assay" and then confirmed for the presence of potential cross-reactants using "US-marked assays."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay (CLIA technology) for qualitative detection of antibodies, not an imaging device requiring human reader interpretation or AI assistance in the human-in-the-loop context.

6. Standalone (Algorithm Only) Performance Study

Yes, the entire clinical performance evaluation described (Clinical Agreement, Interfering Substances, Cross-Reactivity, Precision, Reproducibility, High-dose saturation, Analytical Sensitivity) is essentially a standalone algorithm-only performance study. The LIAISON® VZV IgG HT assay is an automated system run on the LIAISON® XL Analyzer, meaning its performance is evaluated without human interpretation of results beyond reading the automated output.

7. Type of Ground Truth Used

The primary ground truth for the clinical agreement study was established by the FDA cleared predicate device (LIAISON® VZV IgG, K150375). For the "known positive" and "known negative" specimens, their status was pre-determined, likely by previous clinical diagnosis or established VZV serology results (though the exact method for this is not detailed beyond being "known"). For cross-reactivity studies, ground truth was based on positive results from "US-marked assays" for the specific cross-reacting agent.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is typical for in vitro diagnostic (IVD) assays like this one. While there is an "algorithm" (the CLIA technology and interpretation logic), it's not a machine learning model that undergoes a separate training phase with a distinct dataset in the way a medical imaging AI would. The "development" and "optimization" of such assays usually happen using internal samples and established chemical/biological principles, not a formalized, reported training set size like in AI/ML submissions.

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

Since a formalized "training set" for a machine learning algorithm isn't explicitly mentioned or directly applicable in the typical sense for this type of IVD, the concept of establishing ground truth for it is also not directly addressed. The assay's performance characteristics are developed and validated based on its underlying chemical and biological reactions and internal testing, which ensures it correctly identifies VZV IgG antibodies.

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B·R·A·H·M·S™ CgA II KRYPTOR™ is an automated immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE™) technology for quantitative determination of Chromogranin A concentration in human serum.

B·R·A·H·M·S™ CgA II KRYPTOR™ is to be used in conjunction with other clinical methods as an aid in monitoring of disease progression during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors (GEP-NETs, grade 1 and grade 2).

The B-R-A-H-M-S CgA II KRYPTOR assay is based on the formation of a complex comprised of a Chromogranin A (CgA) analyte "sandwiched" between two monoclonal mouse anti-CgA antibodies. One of the antibodies (537/H2) is directed at the epitope AA124–144 and labelled with DiSMP cryptate, the other antibody (541/E2) binds to AA280-301 and is labelled with Alexa Fluor®647.

The measurement principle is based on a non-radiative energy transfer from a donor (cryptate) to an acceptor (Alexa Fluor™647) when they are part of an immunocomplex (TRACE technology (Time-Resolved Amplified Cryptate Emission)).

The fluorescent signal is proportional to the concentration of the analyte to be measured.

With this principle B-R-A-H-M-S CgA II KRYPTOR is a homogenous one-step immunoassay for the quantification of CgA II in human serum. The linear direct measuring range of the assay is from 20-3,000 ng/mL, going up to 1,000,000 ng/mL with automated dilution. Results can be retrieved after a 29 min incubation time.

Here's an analysis of the acceptance criteria and study findings for the B.R.A.H.M.S CgA II KRYPTOR device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The provided document primarily describes analytical performance criteria and clinical performance measures (sensitivity, specificity) rather than explicit "acceptance criteria" in a pass/fail format for clinical decision-making. However, the sensitivity and specificity values obtained from the clinical study serve as the reported device performance against which implicit clinical acceptance would be judged. The analytical performance metrics are generally presented as numerical results meeting industry standards (CLSI guidelines).

Study Details:

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

   • Clinical Study (for Sensitivity and Specificity): 153 adult GEP-NET patients (grade 1 and 2), with 459 total observations (likely reflecting multiple monitoring visits per patient). The study was described as a prospective study.
   • Clinical Cut-off Derivation: 102 patients with diagnosed well-differentiated G1 and G2 GEP-NETs. This was a retrospective, bicentric observational pilot study.
   • Reference Range Determination: 206 samples from self-declared healthy individuals. Data provenance is USA.
   • Analytical studies: Various sample sizes were used, often involving replicates of pooled or individual human serum samples. For example, LoQ used 420 total replicates from 7 different pools of human serum samples.
   • Provenance for analytical samples: Not explicitly stated but generally implied to be from human subjects, for instance, "human serum samples".

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

   • For the clinical study, tumor progression was classified by RECIST 1.1 criteria. This implies that experts (typically radiologists or oncologists) were involved in interpreting imaging (CT/MRI) according to these established criteria to determine the ground truth for tumor progression.
   • The document does not specify the direct number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, RECIST 1.1 is an internationally recognized standard for evaluating cancer treatment response based on imaging, implying adjudication by qualified personnel.

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

   • The ground truth for tumor progression in the clinical studies was established using RECIST 1.1 criteria based on standard imaging (CT/MRI).
   • The document does not explicitly state an adjudication method like "2+1" or "3+1" for discordant interpretations if multiple readers were involved in RECIST assessment. However, RECIST guidelines themselves are designed to standardize interpretation, and clinical trials often employ independent central review or consensus panels for definitive RECIST ratings, though this specific detail is not provided here.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for quantitative determination of Chromogranin A concentration in human serum, intended to be used in conjunction with other clinical methods as an aid in monitoring. It is not an AI-assisted imaging device or a device that directly aids human readers in interpreting images.

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

   • This is an IVD assay, which functions as a "standalone" measurement of a biomarker in serum. The results are generated by the automated instrument (B.R.A.H.M.S KRYPTOR compact PLUS analyzer) without direct human interpretation of the measurement itself. However, the device's output (CgA concentration) is explicitly stated to not be used for standalone diagnosis or monitoring but "in conjunction with other clinical methods." So while the analytical measurement is standalone, the clinical interpretation for decision-making is not.

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

   • For the clinical performance evaluation (sensitivity and specificity for tumor progression), the ground truth was imaging-based tumor assessment using RECIST 1.1 criteria. This is a form of expert assessment based on a standardized methodology, often relying on radiologists and oncologists to interpret imaging studies.

7. The sample size for the training set:

   • This document describes an IVD device submission, not a machine learning/AI device. Therefore, the concept of a "training set" for an algorithm in the typical AI sense does not directly apply. The development and validation of the assay itself would have involved numerous samples for optimization and establishment of analytical performance characteristics, but these are not referred to as a "training set" here.

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

   • As addressed above, the concept of a "training set" in the context of machine learning/AI is largely inapplicable here. The development of the assay's analytical characteristics (e.g., linearity, precision, detection limits) would be established through standard laboratory practices and reference materials, for which "ground truth" is defined by known concentrations or established analytical methods.

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Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.

Results are determined via a calibration curve which is instrument-specifically generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.

The provided text describes the performance evaluation of the Elecsys Anti-Tg immunoassay, a diagnostic device, and its acceptance criteria. Here's a breakdown of the requested information based on the text:

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

The document does not explicitly present a single table labeled "Acceptance Criteria" with corresponding "Reported Device Performance" in a direct side-by-side format. Instead, it describes various performance evaluations and states whether "All predefined acceptance criteria was met" for each. However, we can reconstruct a table based on the provided details for the non-clinical performance evaluation.

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

• Test Set Sample Sizes:
  • Precision: Not explicitly stated, but includes "Human serum 1-5" and "PC THYRO1-2" (presumably replicates for each, as per CLSI EP05-A3 which requires sufficient replicates).
  • Lot-to-lot Reproducibility: "three reagent lots" (number of samples per lot not specified).
  • Analytical Sensitivity (LoB, LoD, LoQ): Not explicitly stated, determined according to CLSI EP17-A2 which has sample size recommendations.
  • Linearity: "Six dilution series" using "native human serum samples and sample pools" (number of samples/pools not specified).
  • Endogenous Interferences: Not explicitly stated per substance, but mentions "Six endogenous substances."
  • Analytical Specificity/Cross-Reactivity: Not explicitly stated (for anti-TPO).
  • Exogenous Interferences: "17 commonly and 14 specially used pharmaceutical compounds" (number of samples not stated).
  • Sample Matrix Comparison: "blood from 13 donors" (tested across serum, K2-EDTA, K3-EDTA plasma, and serum separation tubes from 3 manufacturers).
  • Method Comparison to Predicate: "total of 129 human serum samples."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is a "510(k) Summary" for an FDA submission, reporting on laboratory performance studies. Given they are "non-clinical performance evaluation," these are typically controlled laboratory studies.

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

This device is an in-vitro diagnostic (IVD) immunoassay. The ground truth for such devices is established through analytical testing against reference materials, established methods, and clinical samples with known characteristics, not typically by expert consensus in the same way as an imaging AI. The "ground truth" here is the precise concentration or presence/absence of the analyte (thyroglobulin antibodies) as determined by the study's reference method or expected values for standards/controls.

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

Not applicable for this type of IVD analytical performance study. Adjudication methods like 2+1 or 3+1 are common in clinical trials or imaging studies where expert readers interpret results, but not for direct quantitative measurements from an immunoassay. The acceptance criteria are based on statistical analysis of quantitative results (e.g., precision, linearity, recovery, regression).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an immunoassay for determining antibody levels, not an imaging device or an AI intended to assist human readers. Hence, no MRMC study was performed, and human reader improvement with AI assistance is not relevant to this device's evaluation.

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

This entire non-clinical performance evaluation section (4. NON-CLINICAL PERFORMANCE EVALUATION) describes the standalone performance of the Elecsys Anti-Tg immunoassay (a device, not an AI algorithm). The measurements are performed by the "cobas e 411 immunoassay analyzer," which acts as the "algorithm" or automated system. There's no human "in the loop" for the direct measurement results themselves, though human operators are involved in running the tests and interpreting the results in a clinical setting.

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

The ground truth for the analytical performance studies (precision, linearity, sensitivity, interferences, stability) is based on:

• CLSI guidelines: The studies adhere to specific Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP05-A3, EP17-A2, EP06-Ed2), which define how such analytical characteristics are determined using reference materials, spiked samples, and statistical methods.
• Reference Standards/Materials: Implied in sections like "Traceability/Standardization" against the NIBSC 65/93 Standard, and the use of calibrators (Anti-Tg CalSet) and controls (PreciControl ThyroAB).
• Known Sample Characteristics: For linearity, samples with varying known concentrations are typically used. For interference studies, samples spiked with known interferents are used.
• Predicate Device Comparison: For method comparison, the predicate device's results serve as a comparative reference.

8. The sample size for the training set

Not applicable in the context of an immunoassay. This device is an in-vitro diagnostic test kit (reagents) used on an existing analyzer. It does not involve a "training set" in the machine learning sense. The "development" or "training" of such a diagnostic involves optimizing the chemical and biological components of the assay (reagents, antibodies, detection method) and calibrating the system across a range of known concentrations.

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

As there is no "training set" in the AI/machine learning sense, this question is not applicable. The development process for an immunoassay involves extensive research and development to create reagents that accurately quantify the target analyte. Calibration is done using reference materials with assigned values, and the assay's performance characteristics (as detailed in section 4) are then rigorously validated.

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The EasyStat 300 is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbances.

Blood gases (p02, pCO2) and pH measurements in blood are used in the diagnosis and treatment of life-threatening acidbase disturbances.

The EasyStat 300 is a system for use by health care professionals to rapidly analyze whole blood samples. The analyzer incorporates a Reagent Module containing the "calibrating" solutions A2, B2, and a "conditioning" solution C2, which is also use a calibrant for the Oxygen sensor. Calibrations are performed automatically or on-demand by the user to establish the "slope" of each sensor used in the calculation of the patient sample. The EasyStat 300 uses 175μL of whole blood in the "Syringe" mode and 100μL of whole blood in the "Capillary" mode to analyze patient samples. The EasyStat 300 reports results for blood Gases (PCO2, PO2), and pH. Additionally, it provides a number of calculated parameters based on the reported results and a number of input parameters as described in the Operator's Manual. The EasyStat 300 is a microprocessor-controlled device with a touch sensitive screen that guides the operator through the different menu options and proper operation. It also incorporates a thermal printer to record all reported results and patient information as described in the Operator's Manual. The device software has incorporated routines to assist the end-user with maintenance, cleaning, and troubleshooting activities also outlined in the manual. The incorporated USB port may be used to download data and also to update the software version based on detailed instructions by Medica Corporation. The blood gas and pH sensors require calibration and cleaning after a predefined number of samples are analyzed as described in the Operator's Manual. The pH and PCO2 sensors are based on potentiometric sensor design, generating a small voltage that is dependent on the concentrations of these analytes in the patient sample. The PO2 sensor is based on amperometric sensor design that generates a small current that is dependent on the concentration of oxygen in the patient sample. Medica's EasyQC materials are specifically formulated for the EasyStat 300. The EasyStat 300 may be equipped with a Medica provided barcode scanner via a USB port to automatically enter patient sample and EasyQC material info. To maintain the performance of the analyzer Medica provides a cleaning solution and a troubleshooting kit.

Here's a breakdown of the acceptance criteria and the study that proves the EasyStat 300 device meets these criteria, based on the provided FDA 510(k) summary.

Key Findings from the Document:

• Device: EasyStat 300 Blood Gas Analyzer
• Purpose: Measures pO2, pCO2, and pH in whole blood.
• Comparison: Substantially equivalent to its predicate device, the EasyStat Blood Gas Analyzer (K021515).
• Studies Conducted: Precision (Repeatability, Reproducibility), Linearity, Method Comparison, Sensitivity, and Selectivity (Interference).
• Ground Truth for Analytical Studies: Primarily based on pre-assayed whole blood samples, aqueous QC materials, and tonometered whole blood, with comparisons against results from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table labeled "Acceptance Criteria," but rather presents "Performance Specs" within the precision studies and "Status" (PASS) for linearity and method comparison, indicating adherence to pre-defined criteria. The interference study uses a "Conclusion" column based on a predefined percentage change. Based on the data provided, the acceptance criteria are inferred from the "Performance Specs" headers and the overall "PASS" status for each test.

• System 1 PO2 Level 1: 1.39 SD (vs 2.5 SD)
• System 1 PCO2 Level 1: 0.9 CV (vs 5.0% CV)
• System 1 pH Level 1: 0.002 SD (vs 0.020 SD)

Aqueous Controls (Capillary Mode): All results "within specification." Examples:

• Unit 1 PO2 Level 1: 2.70 SD (vs 3 SD)
• Unit 1 PCO2 Level 1: 1.5 CV (vs 5.0% CV)
• Unit 1 pH Level 1: 0.004 SD (vs 0.020 SD) |
  | Reproducibility | pO2: Level 1: 2.5mmHg; Level 2: 2.5mmHg; Level 3: 3.0% CV | 5-day w. Blood Study (Syringe Mode): All results "within specification." Examples:
• PO2 Level 1: 0.6 SD (vs 2.5mmHg)
• PCO2 Level 1: 0.5 SD (vs 2.0% CV, implied from table structure)
• pH Level 1: 0.007 SD (vs 0.015 units)

5-day w. Blood Study (Capillary Mode): All results "within specification." Examples:

• PO2 Level 1: 0.9 SD (vs 2.4mmHg)
• PCO2 Level 1: 2.5 CV (vs 4.0% CV)
• pH Level 1: 0.008 SD (vs 0.015 units) |
  | Linearity | "met all device specifications" (implied criteria typically high R^2 values, slope ~1) | Data shown (e.g., for ES300-P7):
• PO2 (Syringe): R² 0.999, Slope 1.016 (PASS)
• PCO2 (Syringe): R² 0.999, Slope 1.066 (PASS)
• pH (Syringe): R² 0.996, Slope 1.008 (PASS)
  Conclusion: "all analytes... are linear within the advertised reportable range." |
  | Method Comparison | "linear regression slope, the coefficient of variation, and the calculated predicted bias at the decision levels for each analyte were within specifications." (implied) | Exemplified by PO2 Syringe Mode:
• n=272, Slope=1.001, R²=0.999
• Predicted Bias for PO2 (30.0, 45.0, 60.0): All PASS ("within specifications," typically close to 0 bias and CI within allowable error).
  Conclusion: "all analytes... are favorably correlated to the predicate/reference device... within specifications." |
  | Sensitivity | LoQ

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The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The FLC Kappa and FLC Lambda test kits are intended for the quantification of free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure utilizing specific antibodies targeting anti-Lambda free light chains. It is carried out in 8 successive steps: Incubation of the previously diluted samples and calibrators, in the wells of the microplate, where specific free light chain antibodies are fixed. Washing of the wells to remove elements that have not been fixed by the anti-free light chain antiserum. Incubation with an anti- light chain antiserum (Kit specific) conjugated to peroxidase. Washing of the wells to remove the excess of antiserum conjugated to peroxidase. Incubation with peroxidase substrate. Stopping of the enzymatic reaction with an acidic solution. Reading of the optical density by absorbance spectrophotometry at 450 nm of the colored product. Calculation of the free light chain concentration of the sample using a calibration curve obtained with calibrators that have been analyzed on the same microplate.

Here's a breakdown of the acceptance criteria and study details for the Sebia FLC Kappa and FLC Lambda kits, based on the provided FDA 510(k) summary.

Note: This document describes an in vitro diagnostic (IVD) device, which measures specific analytes (free light chains) in human serum using a laboratory assay (ELISA). The concepts of "AI assistance," "human readers," "radiologist," and "image" are not relevant to this type of device. Therefore, sections pertaining to these concepts (like MRMC studies) are not applicable and will be marked as such. The "ground truth" for an IVD kit is established through various analytical performance studies demonstrating its accuracy and reliability compared to established methods, and clinical studies correlating its results with disease states.

Acceptance Criteria and Device Performance for Sebia FLC Kappa and FLC Lambda Kits

1. Table of Acceptance Criteria & Reported Device Performance

The FDA 510(k) summary does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds. Instead, it details various performance studies and their results, which implicitly form the basis for acceptance. The reported device performance is indicated by the successful execution of these studies and the obtained values meeting recognized clinical laboratory standards (e.g., CLSI guidelines).

General Performance Categories and Key Findings:

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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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