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The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System.

The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.

The ARCHITECT HSV-2 IgG assay is an automated, two-step immunoassay for the qualitative detection of IgG antibodies to HSV-2 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

The kit contains different components: Reagent (microparticles, conjugate and assay diluent), Calibrator, and external Controls (reactive and nonreactive).

The document describes the ARCHITECT HSV-2 IgG assay, a diagnostic device for detecting specific IgG antibodies to herpes simplex virus type 2 (HSV-2). The study aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.

While the document does not explicitly state "acceptance criteria" in the format of a separate table setting thresholds beforehand, the performance summary sections detail the studies and the observed performance. The key performance metrics demonstrated are:

• Clinical Performance (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA): This is the primary measure of the device's accuracy in correctly identifying positive and negative samples for HSV-2 IgG antibodies.
• Precision (Within-Laboratory and Reproducibility): These studies evaluate the consistency and reliability of the assay results across different runs, days, and sites.
• Analytical Specificity (Interference and Cross-reactivity): These studies assess the device's ability to accurately measure HSV-2 IgG without being affected by other substances or related conditions.
• Specimen Collection Types: This confirms the assay's performance across various accepted sample types.
• Carry-Over: Verifies that prior samples do not affect subsequent sample results.

Here's an interpretation of the implied acceptance criteria and reported performance based on the provided document:

Acceptance Criteria and Reported Device Performance

• PPA: 96.54% (223/231) with 95% CI: 93.32% to 98.24%
• NPA: 96.90% (375/387) with 95% CI: 94.66% to 98.22%

Pregnant Population:

• PPA: 95.12% (78/82) with 95% CI: 88.12% to 98.09%
• NPA: 98.60% (212/215) with 95% CI: 95.98% to 99.52%

CDC Panel Agreement:

• PPA (Reactive samples): 100% (30/30)
• NPA (Nonreactive samples): 97.14% (68/70) |
  | Precision (Within-Laboratory) | Low %CV for different panels and controls, demonstrating consistent results within the laboratory. | 20-Day Within-Laboratory Precision:
• Positive Control: Mean S/CO 3.01, Within-Laboratory %CV 3.9
• Serum Panel 2: Mean S/CO 1.60, Within-Laboratory %CV 6.8
• Serum Panel 3: Mean S/CO 2.47, Within-Laboratory %CV 11.6
• Plasma Panels: %CVs ranging from 3.3 to 5.7

12-Day Within-Laboratory Precision (Higher Analyte Levels):

• Serum Panel 4: Mean S/CO 7.14, Within-Laboratory %CV 5.2
• Serum Panel 5: Mean S/CO 14.73, Within-Laboratory %CV 4.6
• Plasma Panel 4: Mean S/CO 7.85, Within-Laboratory %CV 4.5
• Plasma Panel 5: Mean S/CO 14.90, Within-Laboratory %CV 5.0 |
  | Precision (Reproducibility) | Low %CV across multiple sites/instruments, demonstrating consistent results regardless of testing location. | Reproducibility (3 testing sites):
• Positive Control: Mean S/CO 2.98, Reproducibility %CV 5.2
• Serum Panel 2: Mean S/CO 1.56, Reproducibility %CV 4.0
• Serum Panel 3: Mean S/CO 2.52, Reproducibility %CV 4.3
• Plasma Panels: %CVs ranging from 5.2 to 5.4 |
  | Analytical Specificity (Interference) | Minimal impact (

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The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IqG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

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The provided text describes the performance of the ADVIA Centaur EBV-EBNA IgG assay, an in vitro diagnostic device for the qualitative detection of IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA).

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ADVIA Centaur EBV-EBNA IgG assay are primarily demonstrated through its agreement with an FDA-cleared reference EBV EBNA IgG assay. While explicit "acceptance criteria" are not listed with numerical thresholds in a dedicated table, the clinical study results (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA) are implicitly compared against an expectation of substantial equivalence to the predicate device.

For precision and reproducibility, specific targets are mentioned.

• NPA: 92.8% (95% CI: 89.6% - 95.1%)
• PPA: 99.4% (95% CI: 98.8% - 99.7%)

Population 2 (Known EBV EBNA IgG negative individuals)

• NPA: 98.2% (95% CI: 94.9% - 99.4%)

Pediatric Population (Population 1 - symptomatic)

• NPA: 97.3% (95% CI: 94.3% - 98.8%)
• PPA: 98.4% (95% CI: 96.0% - 99.4%)

Pediatric Population (Population 2 - known negative)

• NPA: 100% (95% CI: 94.9% - 100%) |
  | Precision | Not explicitly stated as a single value, but individual sample CVs are presented. | Serum Samples: Total Precision CVs range from 4.4% to 13.3%.
  Plasma, EDTA Samples: Total Precision CVs range from 4.3% to 9.5%.
  Controls: Control 1 (0.32 Index) Total Precision SD 0.014; Control 2 (3.16 Index) Total Precision CV 4.1%. |
  | Reproducibility | - Concentration $\le$ 0.80 Index: N/A (for CV)
• Concentration > 0.80 Index: $\le$ 20.0% CV | Serum Samples:
• Serum A (0.77 Index): SD 0.048, CV N/A (within $\le$ 0.80 Index)
• Serum B-E (1.07 to 8.85 Index): CVs range from 4.0% to 9.8% (all $\le$ 20.0%)
  Plasma, EDTA Samples:
• Plasma A (0.78 Index): SD 0.044, CV N/A (within $\le$ 0.80 Index)
• Plasma B-E (1.06 to 8.75 Index): CVs range from 5.0% to 10.7% (all $\le$ 20.0%)
  Controls: Control 1 (0.36 Index) SD 0.022, CV N/A; Control 2 (3.31 Index) CV 4.0%. |
  | Specimen Equivalency | Regression equation close to y=x, high correlation coefficient (r). | EDTA Plasma vs. Serum: y = 1.00x - 0.01 Index; r = 1.00
  Lithium Heparin Plasma vs. Serum: y = 0.98x - 0.01 Index; r = 0.99
  Conclusion: EDTA Plasma and Lithium Heparin Plasma are equivalent matrixes to Serum. |
  | Interferences | ±10% bias for reactive samples and ±0.10 Index for nonreactive samples. | The listed substances (Hemoglobin, Bilirubin, Lipemia, Biotin, Cholesterol, Protein, etc.) do not interfere at the indicated concentrations. |
  | Cross-reactivity | Not explicitly stated as a numerical criterion, but demonstrated by testing against various viral antibodies and disease states. | Data presented for 330 samples across 29 clinical categories, showing agreement or defined discrepancies with the comparative assay. For HCV, Mycoplasma pneumoniae IgG, HSV-1 IgG, and HSV-2 IgG, possible cross-reactivity cannot be excluded for a few discordant samples and should be interpreted clinically. |
  | Onboard Stability | 28 days for reagents, 28 days for calibration. | Reagents: 28 days. Calibration: 28 days. |
  | Calibrator Stability (Opened Vial) | 60 days when stored at 2-8ºC. | 60 days when stored at 2-8ºC. |
  | Unopened Reagents/Calibrators Stability | Until expiration date when stored at 2-8°C. | Until expiration date when stored at 2-8°C. |

2. Sample Size and Data Provenance

Clinical Study (Test Set):

• Total Study Population (Population 1): 1428 leftover samples.
  • Provenance: Collected over a contiguous time period from individuals for whom an EBV test was ordered. The document does not specify the country of origin but implies a clinical setting ("symptoms and signs for whom an EBV antibody test was ordered"). It is a retrospective collection of leftover samples.
• Known EBV EBNA IgG Negative Population (Population 2): 167 samples.
  • Provenance: Samples with a known EBV EBNA IgG negative result, used to supplement numbers for negative EBV EBNA IgG. Retrospective.
• Pediatric Population: Subsets of Population 1 (479 samples including 84 unclassified serostatus individuals) and Population 2 (72 samples including 6 unclassified serostatus individuals).
• Cross-reactivity Study: 330 samples across various clinical categories.
• Specimen Equivalency Study: 97-98 sets of matched samples (SST, EDTA plasma, lithium heparin plasma).
  • Provenance: Commercial sources.

3. Number of Experts and Qualifications for Ground Truth

The document explicitly states that the ground truth for the clinical study was established by an "FDA cleared EBV EBNA IgG reference assay."
It also states: "Equivocal reference assay results were resolved by 2 other comparative assays."

• Number of 'Experts' (resolving assays): 2 (for equivocal cases from the primary reference assay).
• "Qualifications" of these 'experts': These were "comparative assays" rather than human experts. The document does not specify if these were other FDA-cleared assays or the nature of their qualification, but the implication is that they served as a consensus mechanism to resolve indeterminate results from the primary reference assay.

4. Adjudication Method for the Test Set

The adjudication method for equivocal results from the primary reference assay was by "2 other comparative assays." This is a form of 2+0 or 1+2 (primary reference + 2 comparative). If the two comparative assays agreed, that likely established the reconciled ground truth for the equivocal samples. The document does not describe what happened if the two comparative assays disagreed.

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

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, which typically does not involve human readers interpreting images or data alongside AI. The device is evaluated for its analytical and clinical performance against a reference method. Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm only without human-in-the loop performance)

Yes, a standalone performance study was done. The entire clinical study, precision, reproducibility, specimen equivalency, and interference studies evaluate the performance of the ADVIA Centaur EBV-EBNA IgG assay as a standalone device (algorithm/assay only) against a reference method or predetermined analytical specifications. There is no human-in-the-loop component described for its primary intended use and evaluation.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on an FDA-cleared EBV EBNA IgG reference assay, with equivocal results resolved by 2 other comparative assays. This indicates a reference method or comparative assay-based ground truth.

8. Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic assay. It does not provide information regarding a "training set" in the context of machine learning or AI models.
The samples mentioned are for performance evaluation (clinical study, precision, etc.) and are analogous to test or validation sets. For IVD devices, a "training set" might refer to samples used during the development and optimization of the assay's reagents and parameters, but this information is not typically disclosed in a 510(k) summary in this format.

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

As there is no "training set" described in the context of an AI/ML model for this IVD assay according to the provided document, this information is not applicable and not available.

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The ADVIA Centaur EBV-VCA IgM (EBVM) assay is for in vitro diagnostic use in the qualitative detection of lgM antibodies to the viral capsid antigen (VCA) of the Epstein-Barr virus (EBV) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

The ADVIA Centaur EBV-VCA IgM assay is a fully automated 2-step sandwich immunoassay using acridinium ester chemiluminescent technology. The specimen is incubated with the Ancillary Well Reagent and the Solid Phase, which contains an EBV-VCA IgM specific antigen. Antigen-antibody complexes will form if anti EBV-VCA IgM antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgM labeled with acridinium ester and is used to detect EBV-VCA IgM in the specimen.

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

Device: ADVIA Centaur EBV-VCA IgM

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the reported performance metrics. For a diagnostic device intended to aid in the diagnosis of infection, common acceptance criteria would include achieving certain levels of Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a reference method, especially in relevant clinical populations (e.g., primary acute infection). Precision and reproducibility are also key acceptance criteria for laboratory assays.

2. Sample Size and Data Provenance:

• Clinical Study Test Set:
  • Total Study Population: 1428 leftover samples (Population 1) + 202 samples with known EBV VCA IgM positive result (Population 2). Total = 1630 samples.
    • Population 1: Collected over a contiguous time period from individuals for whom an EBV test was ordered.
    • Population 2: Samples with a known EBV VCA IgM positive result.
  • Pediatric Population: 479 samples (from Population 1) + 155 samples (from Population 2). Total = 634 samples.
  • Data Provenance: The document states "leftover samples were collected over a contiguous time period" and "multisite clinical study," suggesting diverse geographical sources and a real-world setting. It does not explicitly state country of origin but implies a clinical laboratory setting. The samples are retrospective (leftover samples).

3. Number of Experts and Qualifications for Ground Truth:

• This information is not explicitly provided in the document. The comparison is made against an "FDA-cleared EBV VCA IgM reference assay."
• For equivocal reference assay results, the ground truth was "resolved by 2 other comparative assays." This implies an algorithmic or rule-based resolution rather than human expert consensus for these specific cases.

4. Adjudication Method for the Test Set:

• The document states: "Equivocal reference assay results were resolved by 2 other comparative assays." This indicates a form of algorithmic or rule-based adjudication rather than a human expert consensus method (like 2+1 or 3+1). If the two additional comparative assays agreed, that would constitute a form of resolution. If they disagreed, the method for final resolution is not detailed.

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 in vitro diagnostic (IVD) assay, not an imaging device or a device requiring human interpretation as part of its primary function where reader performance would be a direct outcome. The performance is assessed by comparing the assay's output to a reference method, not by how human readers improve with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

• Yes, a standalone performance study was done. The entire clinical and analytical performance evaluation describes the ADVIA Centaur EBV-VCA IgM assay's performance independently (as an algorithm/assay) against a reference standard or for its inherent analytical characteristics (precision, reproducibility). There is no "human-in-the-loop" component described for the assay's function itself; it is an automated immunoassay.

7. Type of Ground Truth Used:

• The primary ground truth was established by an "FDA-cleared EBV VCA IgM reference assay."
• For cases where the reference assay was equivocal, "2 other comparative assays" were used for resolution.
• For defining "primary acute infection," the presence of "either EBV IgM or heterophile antibodies, and the absence of EBNA IgG" was used – this relies on a combination of other serological markers/tests.

8. Sample Size for the Training Set:

• The document does not provide information on the training set for the ADVIA Centaur EBV-VCA IgM assay. As a chemical immunoassay, its "training" involves the development and optimization of its chemical components, reagents, and detection parameters, using internal development studies that are typically not detailed as "training sets" in the same way as machine learning models. The reported studies are for validation/testing.

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

• As the document does not mention a "training set" in the context of machine learning, this question is not applicable/not addressed by the provided text. The development process for such an immunoassay typically involves extensive R&D, analytical characterization, and optimization using well-characterized samples, but this is distinct from establishing ground truth for a machine learning training dataset.

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The ARCHITECT HSV-1 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System.

The ARCHITECT HSV-1 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-1 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.

NOTE: The performance of the ARCHITECT HSV-1 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.

This assay is an automated, two-step immunoassay for the qualitative detection of specific IgG antibodies to HSV-1 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample, HSV-1 specific recombinant gG1 antigen coated paramagnetic microparticles, and assay diluent are combined and incubated. The IgG antibodies to HSV-1 (HSV-1 IgG) present in the sample bind to the HSV-1 specific recombinant gG1 antigen 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 relationship between the amount of HSV-1 IgG in the sample and the RLU detected by the system optics. The presence or absence of HSV-1 IgG in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration.

Here's a breakdown of the acceptance criteria and the studies performed for the ARCHITECT HSV-1 IgG assay, based on the provided document:

Acceptance Criteria and Device Performance

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Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric.

The provided document outlines the acceptance criteria and study results for the Quantia IgE assay, a device for quantitatively determining total IgE in human serum or plasma. It's important to note that this document is a 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device after a modification, rather than a comprehensive de novo approval study. Therefore, some information typically found in a de novo clinical trial report (e.g., specific details on training set size, number of experts for training ground truth) might not be explicitly detailed.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance characteristics presented and their comparison to the predicate device or established clinical standards (e.g., CLSI guidelines). The document focuses on demonstrating that the modified device performs as well as the predicate and meets relevant analytical performance metrics.

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The ADVIA Centaur® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum and plasma (EDTA and lithium heparin).

The ADVIA Centaur Herpes-2 IgG (HSV2) assay is a fully automated two-step sandwich immunoassay using indirect chemiluminometric technology. The specimen is incubated with the Solid Phase, which contains HSV-2-specific recombinant-gG2 antigen. Antigen-antibody complexes will form if anti-HSV-2 antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgG labeled with acridinium ester, and is used to detect HSV-2 IgG in the specimen.

The provided document describes the performance of the ADVIA Centaur Herpes-2 IgG (HSV2) assay, which is an in vitro diagnostic device. The study aims to demonstrate that the device meets acceptance criteria for substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics and compares them against design requirements or expected outcomes.

2. Sample Size and Data Provenance

• Precision Study: 6 samples and Negative/Positive Controls. Each material tested in duplicate, twice a day for 20 days.
  • N = 80 replicates per level for within-lab precision.
• Sample Matrix Study: 68 sets of matched samples (serum, serum separator tube, EDTA plasma, lithium heparin plasma).
• Panel Testing:
  • ToRCH-mixed Zeptometrix panel: 24 characterized HSV samples.
  • CDC panel: 100 blind characterized HSV samples.
• Cross-Reactivity Study: 522 specimens across various clinical categories.
• Multi-site Reproducibility: 6 samples and Negative/Positive Controls.
  • N = 90 replicates per level (from 3 external sites, 5 days, 2 runs/day, 3 replicates/run).
• Clinical Study:
  • Total: 864 specimens (≥ 18 years of age), including 274 pregnant women.
  • Data Provenance: Specimens collected within the United States. The study was conducted at 3 independent external laboratories. The nature of the specimen collection implies it was prospective for the purpose of this study, although the individual samples may have been sourced retrospectively from biobanks or collected prospectively for the study itself. The document does not explicitly state "retrospective" or "prospective" for the clinical sample collection, but "collected within the United States" and tested at external labs suggests purpose-collected samples for the study.

3. Number of Experts and Qualifications for Ground Truth

• The document implies the use of "reference assay 1" for the ToRCH-mixed Zeptometrix panel and "results provided by the CDC" for the CDC panel, as well as a "Comparative Assay" and "validated Western Blot reference confirmatory test (University of Washington, Seattle)" for the clinical study and cross-reactivity assessment.
• Number of Experts: Not explicitly stated how many individual experts established the ground truth for these reference methods. The description refers to "characterized HSV samples" for panels and "validated Western Blot" from a university, which implies expert consensus or highly standardized laboratory procedures.
• Qualifications of Experts: Not explicitly stated (e.g., "radiologist with 10 years of experience" is not applicable here as it's an in vitro diagnostic test for antibodies). However, the use of "validated Western Blot" from a reputable institution (University of Washington, Seattle) and "CDC" as sources for ground truth implies the highest level of expertise and validated methodologies in serological testing.

4. Adjudication Method for the Test Set

• For the clinical study: Of the 864 specimens, 22 were equivocal with the Comparative Assay. These 22 samples were resolved by Western Blot testing. 20 were resolved to be negative, and 2 remained equivocal. This describes a form of adjudication where an equivocal result from one reference method is adjudicated by a more definitive reference method (Western Blot).
• No multi-reader consensus (e.g., 2+1, 3+1) is mentioned, as this is an in vitro diagnostic assay, not an image-reading task.

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

• No MRMC comparative effectiveness study was done. This type of study is typically performed for AI/CAD systems that assist human readers in interpreting medical images, not for in vitro diagnostic assays like this one which provides a quantitative or qualitative result directly.

6. Standalone (Algorithm Only) Performance

• This device is an automated immunoassay (ADVIA Centaur HSV2 assay). Its performance is inherently "standalone" in the sense that it directly measures antibodies without human interpretation in the loop to generate the initial result. The reported sensitivity and specificity values are for the device (algorithm) itself against the established ground truth.

7. Type of Ground Truth Used

• Expert Consensus / Highly-validated Reference Methods:
  • For panels: "characterized HSV samples," "reference assay 1," and "results provided by the CDC."
  • For clinical and cross-reactivity studies: A Comparative Assay (likely another FDA-cleared or well-established commercial immunoassay) and a validated Western Blot reference confirmatory test (University of Washington, Seattle). Western Blot is generally considered a highly specific and confirmatory test for antibody presence in serology. The use of a confirmatory test like Western Blot for equivocal results strengthens the ground truth.

8. Sample Size for the Training Set

• The document describes a 510(k) submission for an in vitro diagnostic device (immunoassay). Immunoassays are based on biochemical reactions and established calibration curves, not typically on machine learning models requiring large "training sets" in the same sense as AI/ML software. Therefore, a "training set" for an algorithm, as understood in AI/ML, isn't applicable or mentioned for this device. The development process would involve characterization, optimization, and validation using various samples, but not "training data" for a learnable algorithm.

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

• As explained in point 8, the concept of a "training set" with ground truth establishment in the AI/ML sense does not apply to this immunoassay. The device's performance is driven by its reagent chemistry and instrumentation, not by a trained algorithm.

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The ADVIA Centaur® Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatic patients or matrices other than human serum and plasma (EDTA and lithium heparin).

Not Found

The provided text describes the performance study for the ADVIA Centaur Herpes-1 IgG (HSV1) assay, an in vitro diagnostic device. This device is intended for the qualitative determination of IgG antibodies to HSV-1 in human serum and plasma, aiding in the presumptive diagnosis of HSV infection and serological status determination.

The study aims to demonstrate that the device meets its performance requirements, which can be interpreted as acceptance criteria for precision, matrix equivalency, panel agreement, interference, cross-reactivity, and clinical accuracy (sensitivity and specificity).

Here is a breakdown of the requested information:

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

The document implicitly defines acceptance criteria through its "Design Requirement" for precision and agreement percentages for panels, interference, cross-reactivity, and clinical studies.

• Serum Separator Tube vs Serum: r=0.996
• EDTA Plasma vs Serum: r=0.998
• Lithium Heparin Plasma vs Serum: r=0.998 |
  | Commercial Panel Agreement | Not explicitly stated as a numerical criterion, but high agreement expected. | - Seracare Diagnostics: 92% total agreement with reference assay 1 (25 samples)
• ToRCH-mixed Zeptometrix: 96% total agreement with reference assay 1 (24 samples)
• CDC panel: 100% total agreement with CDC results (100 samples) |
  | Interferences | ≤ 10% change in results with interfering substances | Confirmed ≤ 10% change for various substances up to specified concentrations (e.g., Biotin 3500 ng/mL, Hemoglobin 500 mg/dL) |
  | Cross-reactivity | Not explicitly stated as a numerical criterion, but high agreement expected. | 95.8% total agreement (413/431) against Comparative Assay/Western Blot across various clinical categories. |
  | Clinical Sensitivity (Overall) | Not explicitly stated, but common for diagnostic tests to aim for high sensitivity/specificity. | 97.5% (507/520) with 95% CI of 95.8%-98.5% |
  | Clinical Specificity (Overall) | Not explicitly stated. | 96.2% (331/344) with 95% CI of 93.6%-97.8% |
  | Clinical Sensitivity (Pregnant Women) | Not explicitly stated. | 98.7% (155/157) with 95% CI of 95.5%-99.7% |
  | Clinical Specificity (Pregnant Women) | Not explicitly stated. | 98.3% (115/117) with 95% CI of 94.0%-99.5% |

2. Sample sizes used for the test set and the data provenance

• Precision Study: 80 replicates per level (for 2 controls and 6 samples). The data provenance is not explicitly stated beyond "performed according to CLSI EP05-A3," suggesting controlled laboratory conditions.
• Sample Matrix Study: 68 sets of matched samples (serum, SST, EDTA plasma, lithium heparin plasma) from "commercial sources." Provenance not explicitly country-specific, but generally implies a controlled study.
• Panels Study:
  • Seracare Diagnostics panel: 25 characterized HSV samples.
  • ToRCH-mixed Zeptometrix panel: 24 characterized HSV samples.
  • CDC panel: 100 blind characterized HSV samples.
  • Provenance: Commercial sources and CDC (likely US-based).
• Interferences Study: Not specified, but involved testing at three levels of samples for each interfering substance.
• Cross-reactivity Study: 431 specimens across various clinical categories. Provenance not specified.
• Clinical Study:
  • Sample Size: 864 specimens (total enrollment)
  • Provenance: "Collected within the United States" and tested at "3 independent external laboratories." This indicates a prospective collection for the clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts or their qualifications for establishing ground truth.

• For the panel studies, "characterized HSV samples" from commercial sources and "blind characterized HSV samples" from the CDC were used. This implies that the ground truth for these samples was established by the respective commercial supplier or the CDC, likely through a validated reference method, but the specific expertise of those who characterized them is not detailed.
• For the cross-reactivity study, the HSV-1 IgG status of specimens was verified using a "Comparative Assay" (a commercially available anti-HSV-1 IgG immunoblot method) and, for equivocal cases, a "validated Western Blot reference confirmatory test (University of Washington, Seattle)." This points to a recognized reference laboratory (University of Washington) for confirmatory testing, but the specific experts (e.g., medical technologists, scientists, physicians) and their qualifications involved in interpreting these reference methods are not stated.
• For the clinical study, the ground truth was established by comparing the device's performance to a "commercially available anti-HSV-1 IgG immunoblot method (Comparative Assay)" and a "validated Western Blot reference confirmatory test (University of Washington, Seattle)" for equivocal results. Again, the specific experts involved in the interpretation of these reference methods are not detailed.

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

The document states that for the clinical study, 22 "equivocal" results from the Comparative Assay were "further tested by the Western Blot test." This serves as a form of adjudication, where a higher-level, confirmed reference method (Western Blot) resolves uncertain or equivocal results from the primary comparative method. It's not a multi-reader, consensus-based adjudication, but rather a hierarchical resolution using a more definitive test.

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 not a multi-reader multi-case (MRMC) comparative effectiveness study. The device reviewed is an in vitro diagnostic assay (HSV-1 IgG antibody test), not an AI-based imaging or interpretive software that would be used by human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this device.

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

Yes, the studies presented (precision, matrix, panels, interference, cross-reactivity, and clinical sensitivity/specificity) reflect the standalone performance of the ADVIA Centaur HSV1 assay as an automated in vitro diagnostic device. Its output (qualitative determination of IgG antibodies) is directly provided by the instrument based on its chemical reactions and detector, without a human-in-the-loop directly influencing the test result. Human intervention would be for specimen handling, loading, and result review, but not for the determination of the assay's output itself.

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

The ground truth for this in vitro diagnostic device was established primarily through:

• Reference Assays/Methods:
  • A "reference assay 1" for commercial panels.
  • "Results provided by the CDC" for the CDC panel.
  • A "commercially available anti-HSV-1 IgG immunoblot method (Comparative Assay)" and a "validated Western Blot reference confirmatory test (University of Washington, Seattle)" for the clinical and cross-reactivity studies.
  • This falls under the category of reference standard comparison using established laboratory methods believed to be highly accurate.

8. The sample size for the training set

The document describes performance studies for regulatory submission (510(k)). It does not provide information about a "training set" in the context of machine learning, as this is an immunoassay, not an AI/ML-based device. If "training set" refers to samples used during the assay's development or optimization prior to these validation studies, that information is not provided in this regulatory summary. The presented data represents the validation/test set.

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

As there is no mention of a "training set" in the context of an AI/ML device, this question is not applicable. The assay's performance relies on its biochemical design and manufacturing controls, not on a machine learning model that requires a ground-truth-labeled training set.

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The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.

The ARCHITECT SHBG assay is a two-step immunoassay to determine the presence of SHBG in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex. In the first step, sample, assay diluent, and anti-SHBG coated paramagnetic microparticles are combined. SHBG present in the sample binds to anti-SHBG coated microparticles. After washing, the SHBG binds to the anti-SHBG acridinium-labeled conjugate that is added in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of SHBG in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of SHBG in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT SHBG calibration.

This document is primarily a 510(k) summary for a labeling change to the ARCHITECT SHBG assay. It is not about a new device or an AI/ML device, but rather an update to the "Free Testosterone Index (FTI) / Free Androgen Index (FAI)" expected values section of the existing device's labeling. Therefore, many of the requested categories for acceptance criteria and study details for AI/ML devices are not applicable.

Here's an interpretation based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device itself (ARCHITECT SHBG assay) was previously cleared. The current submission is for a labeling change to update expected values for the Free Testosterone Index (FTI) or Free Androgen Index (FAI). Therefore, there are no new performance acceptance criteria for the device itself as part of this submission. The performance of the underlying assay remains as established in K060818.

However, the "study" described in the document is the generation of new FTI/FAI expected values. The implicit acceptance criterion for this study is that the calculated FTI/FAI values are representative of the studied populations and are suitable for inclusion in the device labeling. The "reported device performance" in this context refers to the generated expected value ranges.

SHBG Expected Values (nmol/L)

Testosterone Expected Values

% FTI or % FAI Expected Values

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

• Sample sizes:
  • Males (21-49 years of age): 163 samples
  • Males (≥ 50 years of age): 144 samples
  • Females (Premenopausal, 21-49 years of age): 174 samples
  • Females (Postmenopausal, ≥ 50 years of age): 175 samples
  • Total samples: 163 + 144 + 174 + 175 = 656 samples
• Data Provenance: The document states "A new study was conducted in 2014 to calculate FTI or FAI..." It specifies "individuals in the following categories: normal males... normal females..." without explicitly stating the country of origin. The study appears to be prospective in nature, as it was specifically conducted to establish these new expected values.

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

• This is not applicable as the study involves quantitative measurements using an immunoassay device, not subjective expert assessment of images or clinical findings that would require ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable for a quantitative in vitro diagnostic assay. The results are raw numerical measurements from the ARCHITECT i System.

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

• Not applicable. This is an immunoassay, not an imaging device or an AI/ML algorithm requiring human reader performance evaluation.

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

• Not applicable as this is not an AI/ML algorithm. The "standalone" performance here refers to the ARCHITECT SHBG and ARCHITECT 2nd Generation Testosterone assays themselves, which provide quantitative results directly from the instrument.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the quantitative determination of SHBG and Testosterone concentrations in human serum/plasma samples using the respective ARCHITECT assays. These are measured values, not a 'ground truth' in the sense of a consensus diagnosis or pathology result. For FTI/FAI, the ground truth is derived calculation based on these assay results.

8. The Sample Size for the Training Set

• Not applicable as this is not an AI/ML device that undergoes a training phase. The study involved collecting new data to establish expected values for FTI/FAI, effectively acting as a validation/reference range study, not a training set for an algorithm.

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

• Not applicable.

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The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

For in vitro diagnostic use.

The Lp (a) Calibrators are a set of 5 levels required to establish the calibration curve of the Quantia Lipoprotein (a) reagents (K050487) for the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma using immunoturbidimetry technology on the ARCHITECT c Systems.

The Lp (a) Control are a set of 2 levels used to monitor the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma with the Quantia Lipoprotein (a) reagents (K050487) using immunoturbidimetry technology on the ARCHITECT c Systems.

Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone:

• Reference 7K00-40 Quantia Lp(a) Reagent (US) -
• Reference 7K00-01 Quantia Lp(a) Reagent (EX-US)

Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products.

The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

Here's a breakdown of the acceptance criteria and study information for the Lp(a) Calibrators and Lp(a) Control, based on the provided 510(k) summary:

Description of Device

The Lp(a) Calibrators and Lp(a) Control are for in vitro diagnostic use to assist in measuring Lipoprotein (a) concentration in human serum or plasma.

Device Components:

• Lp(a) Calibrators: A set of 5 levels used to establish the calibration curve for the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.
• Lp(a) Control: A set of 2 levels (Control I and Control II) used to monitor the quantitative measurement of Lipoprotein (a) concentration with the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size for Test Set:
     • Calibrator Value Assignment: 30 replicates for each level of the new manufactured calibrator lot, the Master lot, and the previously released calibrator lot.
     • Control Value Assignment: Data generated from multiple runs (specific number not provided) on the ARCHITECT c8000 System.
   • Data Provenance: Not explicitly stated, but the applicant's address is in Llica d'Amunt, Barcelona, Spain, suggesting the studies were conducted there. The studies appear to be prospective for product development and validation.

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)

   • This is a clinical chemistry device, not an imaging device that relies on expert interpretation. The ground truth (assigned values for calibrators and controls) is established through analytical methods and comparisons to a Master lot, not by human experts in the traditional sense of image adjudication.

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

   • Not applicable. This is not an imaging or diagnostic device that requires human adjudication of results. The "adjudication" is based on statistical analysis of quantitative measurements against established criteria and comparison to a Master lot.

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

   • Not applicable. This is a calibrator and control material for an automated clinical chemistry analyzer. It does not involve human readers or AI assistance in interpretation.

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

   • The device (calibrators and controls) operates in conjunction with the Quantia Lp(a) reagents on the ARCHITECT c Systems. The performance described is essentially the "standalone" analytical performance of the calibrators and controls to provide accurate values. There's no human-in-the-loop component for the calibrators/controls themselves; they are reagents used by the automated system.

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

   • The ground truth for the calibrators and controls is established via assigned values. These assigned values are determined:
     • For calibrators: By comparing to an "existing Master lot" of calibrators.
     • For controls: By repeated measurements on the ARCHITECT c8000 System using the Quantia Lp(a) Reagent, generating a mean value and acceptance ranges.
     • Traceability to a commercial EIA (Enzyme Immunoassay) method was used for in-house reference material establishment, as no international reference material exists for Lp(a) in mg/dL.

7. The sample size for the training set

   • Not explicitly defined as a "training set" in the context of an AI/ML device. For value assignment and stability studies:
     • Value Assignment Test: 30 replicates were used for each calibrator level.
     • Stability Studies: Involved comparing results over time to assigned values. The number of samples for the initial assignment and subsequent stability checks is not specified in detail beyond the 30 replicates for value assignment.

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

   • As noted above, this device doesn't have a "training set" in the AI/ML sense. The "ground truth" (assigned values for calibrators and controls) was established through:
     • Comparison to a Master lot for calibrators.
     • Multiple runs on the ARCHITECT c8000 System for controls to calculate their mean values and acceptance ranges.
     • In-house reference materials were value-assigned using a commercial EIA method due to the lack of an international reference standard for Lp(a) in mg/dL.

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The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT i Vancomycin assay is a device for the quantitative measurement of vancomycin in human serum or plasma. The device is a chemiluminescent microparticle immunoassay (CMIA) for in vitro diagnostic use, intended to aid in the diagnosis and treatment of vancomycin overdose and in monitoring its levels to ensure appropriate therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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