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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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The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. 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 DiaSorin LIAISON® Control VZV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assay or instrument platforms different from LIAISON® and LIAISON® XL.

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

The LIAISON® Control VZV IqG are liquid ready-to-use controls based in human serum. 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 familv.

This document describes modifications to the LIAISON® VZV IgG assay and LIAISON® Control VZV IgG, and provides a summary of performance data to support the substantial equivalence to the predicate device.

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

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

The document does not explicitly present a table of acceptance criteria with reported numerical performance values against them. Instead, it states that "Non-clinical verification and validation testing conducted with the LIAISON® VZV IgG and LIAISON® Control VZV IgG demonstrate that the modified devices met predetermined acceptance criteria".

The types of claims supported by testing are listed:

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

• LIAISON® VZV IgG Serum Storage Freeze-Thaw Cycles: "Twelve samples with different reactivity underwent five (5) freeze-thaw cycles."
• Other tests: The exact sample sizes for other tests (stability, commutability, precision, control value assignment, control range definition) are not explicitly stated in this summary.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states "Non-clinical verification and validation testing conducted...".

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

This information is not provided in the document. The LIAISON® VZV IgG is a chemiluminescence immunoassay (CLIA) for detecting specific IgG antibodies to VZV in human serum. Its performance relies on the assay's chemical and biological properties, not on human interpretation by experts in the context of this specific regulatory submission for modifications. The "ground truth" for VZV IgG assays is typically established through reference methods or well-characterized clinical samples, not by expert readers.

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

This information is not applicable and therefore not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as imaging studies where multiple readers might interpret images. This device is an in-vitro diagnostic assay.

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

This information is not applicable and therefore not provided in the document. The LIAISON® VZV IgG is an automated in-vitro diagnostic assay and does not involve human readers or AI assistance in its direct operation or interpretation for a comparative effectiveness study as described.

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

The device itself (LIAISON® VZV IgG) is an automated standalone assay for qualitative detection of VZV IgG antibodies. The performance data presented (stability, precision, etc.) are inherent to the device's operational characteristics without human intervention influencing the assay's result generation. This aligns with the concept of "standalone performance" for an IVD device.

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

The document does not explicitly state the specific "ground truth" method used for the initial assays or for validating the modified claims. For an immunoassay like this, the ground truth would typically be established by:

• Reference methods: Comparison to a gold standard VZV IgG assay.
• Well-characterized clinical samples: Samples from individuals with confirmed VZV infection history or vaccination status, or known serological status.

The purpose of this submission is to demonstrate equivalence of modifications to a previously cleared device, not to re-establish the fundamental clinical validity against a primary ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided in the document. This is a traditional immunoassay, not a machine learning or AI-based device that would require a distinct "training set." The development of such assays involves reagent formulation, optimization, and extensive verification and validation studies.

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

This information is not applicable and therefore not provided in the document, as there is no "training set" in the context of this traditional immunoassay.

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The Zeus Scientific Varicella Zoster Virus (VZV) IgM ELISA Test System is intended for the qualitative detection of IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation.

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 assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.

The Zeus Scientific VZV IgM ELISA Test System is an enzyme linked immunosorbent assay intended for the qualitative detection of distict IgM antibody to the Varicella-zoster virus.

The test is designed to detect IgM antibody using inactivated VZV antigen: strain, Ellen.

This submission describes the Zeus Scientific VZV IgM ELISA Test System, an in-vitro diagnostic device. As such, acceptance criteria and performance are typically measured in terms of diagnostic accuracy metrics (sensitivity, specificity, agreement) against a comparator method, rather than effect sizes of human reader improvement or standalone algorithm performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" as clear numerical thresholds for performance. However, it presents the "Agreement Summary" with a commercially distributed ELISA assay as the primary evidence of performance. The performance metrics are Positive % Agreement and Negative % Agreement.

Note: The reported performance for "Prospective Samples: Combined Sites" also provides similar figures: Positive % Agreement = 100% (95% CI: 54.1% to 100.0%) and Negative % Agreement = 95.6% (95% CI: 92.6% to 97.6%). The table above uses the combined prospective and retrospective data as it represents a larger and more comprehensive dataset for agreement.

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

• Sample Size for Test Set:
  • Prospective samples: 302
  • Retrospective samples: 36
  • Total combined samples: 338 (used for the primary agreement summary)
• Data Provenance: Retrospective and Prospective. The document does not specify the country of origin of the data.

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

• The ground truth for the test set was established by comparison to a "commercially distributed VZV IgM ELISA test system" (predicate device). There is no mention of human experts establishing ground truth for the test set.

4. Adjudication Method for the Test Set

• The document implies a direct comparison method, where the results of the Zeus Scientific VZV IgM ELISA Test System were compared against the results of the "commercially distributed VZV IgM ELISA test system." There is no mention of an adjudication process (like 2+1 or 3+1). The commercial ELISA served as the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of 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 assay (ELISA kit), not an AI-assisted diagnostic tool involving human readers. Therefore, this section is not applicable.

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

• Yes, the performance presented is standalone for the assay. ELISA tests are inherently standalone, as they provide a direct result based on chemical reactions, without human interpretation other than reading the optical density and interpreting it against a cut-off (which is part of the assay's design).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth Type: Comparison to a predicate commercial ELISA test system. This is a common method for establishing the performance of new in-vitro diagnostic assays, where a well-established and legally marketed assay serves as the reference standard.

8. The Sample Size for the Training Set

• The document mentions smaller sets of samples used for various non-clinical performance aspects:
  • Cut-off Establishment: 25 known negative samples and a minimum of 5 known positive samples (total at least 30 samples). These were confirmed by a commercially distributed ELISA assay.
  • Interfering Substances: 3 samples (positive, borderline, negative) were tested with various interfering substances.
  • Cross-Reactivity: A minimum of 10 samples for each cross-reactive substance (EBV, CMV, Lyme, RF, Mumps, Toxo, Measles, Rubella) were tested (total at least 80 samples). These were confirmed negative for VZV IgM using the predicate device.
  • Precision: 6 samples were used, tested at three sites, over three days.
• It's important to note that for IVDs like ELISA kits, the concept of a "training set" as understood in machine learning (where an algorithm learns from data) isn't directly applicable in the same way. These studies are for establishing performance characteristics rather than "training" an algorithm. The samples listed above are used to define the assay's characteristics and validate its function.

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

• For studies like cut-off establishment and cross-reactivity, the ground truth was established by confirmation using a commercially distributed ELISA assay (the predicate device). For other studies like linearity, limits of detection, interfering substances, and precision, the ground truth is inherent to the experimental design (e.g., known dilutions, spiked samples, or reproducibility across replicates/sites).

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The LIAISON® VZV IgG Assay uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.

The method for the qualitative determination of specific IgG to varicella- zoster virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer.

Varicella-zoster virus antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgG is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-VZV IgG antibodies, present in calibrators, samples or controls, bind to the solid phase. After each incubation, the unbound material is removed with a wash cycle. During the second incubation, the antibody conjugate reacts with anti-VZV IgG already bound to the solid phase. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is induced. The light signal, directly related to the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-VZV IgG in calibrators, samples or controls.

Here's a breakdown of the acceptance criteria and study information for the DiaSorin LIAISON® VZV IgG device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical trial results. The device aims to demonstrate substantial equivalence to the predicate device.

Reproducibility (3-site, 5-day study with 3 kit lots):

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The Zeus Scientific, Inc. AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-based immunoassay intended for the quantitative determination of IgG class antibodies to Varicella-Zoster Virus in human serum. The AtheNA Multi-Lyte® VZV IgG Test System is intended for the qualitative determination of a previous infection with Varicella-Zoster Virus.

Not Found

I am sorry, but the provided text does not contain the detailed study information required to fulfill your request. The document is an FDA 510(k) clearance letter for a medical device (AtheNA Multi-Lyte® VZV IgG Test System), which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

While it mentions the "Indications For Use" and the type of immunoassay, it does not include:

• A table of specific acceptance criteria.
• Reported device performance metrics (sensitivity, specificity, accuracy, etc.) against those criteria.
• Details about the study design that would prove the device meets acceptance criteria (e.g., sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set sample sizes).

Such details are typically found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

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The VZV IgG ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgG-class antibody to VZV in human serum. The test is intended to be used to aid in the determiation of immune status, and/or aid in the diagnosos of VZV infections, and is for in vitro diagnostic use.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Aptus (automated) Application for the VZV IgG ELISA Test System". This document grants clearance based on substantial equivalence to a predicate device and describes the intended use of the device, but it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance, not the specifics of the clinical study that would have supported the 510(k) submission.

To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical study, which are not provided in the given text.

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For the qualitative and semi-quantitative detection of IgG antibodies to Varicella-Zoster Virus (VZV) in human serum by indirect immunoassay to determine a prior exposure to VZV and, when evaluating paired sera, to aid in the determination of acute or convalescent stage of VZV infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-VZV IgG Test System is an enzyme immunoassay (EIA) for the detection and semi-quantitation of IgG antibodies to VZV antigen in human serum

The Diamedix Is-VZV IgG Test System is an enzyme immunoassay (EIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to VZV antigen in human serum. Its purpose is to determine prior exposure to VZV and, when evaluating paired sera, to assist in identifying the acute or convalescent stage of VZV infection. The device can be used manually or with the MAGO Plus Automated EIA Processor.

Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Is-VZV IgG Test System are implicitly demonstrated through its "relative" performance compared to other commercially available EIA test kits. While explicit numerical acceptance targets are not stated, the study demonstrates satisfactory performance within specific ranges for sensitivity, specificity, and agreement. The table below summarizes the reported performance for each site and method.

Additional Performance Metrics:

• Correlation of Manual and MAGO Plus Results:
  • Correlation Coefficient (r): 0.972 (demonstrating good correlation between manual and automated methods for 253 serum samples).
• Linearity/Dynamic Range:
  • R values for serial dilutions: 0.972 to 0.999.
  • Reportable range: 20-100 EU/ml.
• Semi-Quantitative Data (Ratios for Dilutions):
  • Overall mean ratio for 4-fold dilutions: 3.13 (SD 0.35).
  • Overall mean ratio for 2-fold dilutions: 1.77 (SD 0.15).
  • Estimated ratio for significant increase: 2.8-fold or greater (mean ratio minus 1 SD).
• Cross-Reactivity: No cross-reactivity observed with IgG antibodies to HSV, Measles, Rubella, or CMV in samples negative for VZV.
• Precision (Interassay CV%):
  • Site #1 (Manual): Range from 2.20% (Serum F) to 12.50% (Negative Control).
  • Site #2 (Manual): Range from 5.45% (Calibrator) to 28.89% (Negative Control).
  • Site #3 (Manual): Range from 4.40% (Positive Control) to 12.35% (Negative Control).
  • Site #3 (MAGO Plus): Range from 7.03% (Serum F) to 45.93% (Negative Control).
• Inter-Site Precision (Manual): Range from 2.67% (Calibrator) to 20.00% (Negative).

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

A total of 652 sera were tested across three independent sites:

• Site #1 (Miami, FL): 200 sera (all frozen). Samples obtained from the S. Florida area.
• Site #2 (Salt Lake City, Utah): 198 sera (all fresh). Samples obtained from the Mid-West region.
• Site #3 (Diamedix Corp., Miami FL): 254 samples (all frozen) tested manually, and 253 of these samples tested using the MAGO Plus. Samples were selected, with 74 specifically chosen for negative or near-cutoff values, and the remainder from the normal S. Florida blood donor population.

The data provenance is retrospective, as existing serum samples were used. The country of origin for the data is the United States (S. Florida area, Mid-West region).

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

The study does not specify the number or qualifications of experts used to establish a ground truth. Instead, the performance of the Diamedix Is-VZV IgG Test Kit is compared to "another commercially available EIA test kit" (referred to as "Other EIA"). Referee EIA methods were used for discordant samples. The document explicitly states: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This indicates that the "ground truth" was essentially the result of a comparative reference assay rather than clinical expert consensus or pathology.

4. Adjudication Method for the Test Set

The adjudication method involved testing discordant samples with a "referee EIA method."

• For Site #1, the single discordant sample was equivocal by the referee EIA.
• For Site #2, discordant sera were not available for further resolution.
• For Site #3 (manual testing), two samples positive by Is-VZV IgG and negative by the other EIA were negative by the referee EIA. For three samples negative by Is-VZV IgG and positive by the other EIA, one was negative, one equivocal, and one positive by the referee method.
• For Site #3 (MAGO Plus testing), five samples positive by Is-VZV IgG and negative by the other EIA were negative by the referee EIA. The one sample negative by Is-VZV IgG and positive by the other EIA was negative by the referee EIA.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The device is an automated in vitro diagnostic (IVD) test for detecting antibodies in human serum. It is not an AI-assisted diagnostic device that would involve human readers or image interpretation. Therefore, an MRMC study with human readers and AI assistance was not performed.

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

The primary performance studies (comparison testing) evaluate the Is-VZV IgG Test System in a standalone capacity (i.e., the performance of the test kit itself) against another commercially available EIA. The manual method and the MAGO Plus Automated EIA Processor are both standalone in terms of the test's output. There is no "human-in-the-loop" interaction for interpretation or further decision-making as would be seen with an AI diagnostic. The studies compare the device's results to a reference method's results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was the result obtained from "another commercially available EIA test kit" and, for discordant samples, a "referee EIA method." There is no mention of expert consensus, pathology, or outcomes data being used to establish a definitive ground truth for VZV infection status. The studies are explicitly described as "relative" comparisons to other assays, not correlations with disease presence or absence.

8. The Sample Size for the Training Set

This information is not provided. The document describes a performance evaluation of a medical device (an IVD kit), not a machine learning or AI algorithm that would typically involve a separate training set. The comparison testing utilized the described 652 sera as a test set for performance validation.

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

This information is not provided and is not applicable given that this is a performance evaluation of an IVD kit, not an AI or machine learning model that requires a distinct training set with established ground truth.

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• 1. For in vitro diagnostic use only.
• 2. For the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay.
• 3. Individual specimens may be used for the determination of immune status.
• Paired (acute / convalescent) sera, may be used to demonstrate seroconversion 4. or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV.
• For manual use, or for use with the HyPrep System Plus semi-automated fluid 5. handler.

Not Found

I am sorry, but based on the text provided, I cannot answer the request as there is no information about the acceptance criteria and study that proves the device meets the acceptance criteria. The text consists of a letter from the FDA regarding the 510(k) premarket notification for the SeraQuest VAV IgG device and its indications for use. It does not contain any details about performance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

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