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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 Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.

The Diagnostic Hybrids, Inc. D3 DFA VARICELLA-ZOSTER IDENTIFICATION KIT includes a DFA Reagent that contains a blend of two fluorescein-labeled murine monoclonal antibodies directed against VZV antigens. The kit includes the following components: VZV DFA Reagent, Mounting Fluid, VZV Antigen Control Slides, PBS Concentrate.

Here's a breakdown of the acceptance criteria and study information for the Diagnostic Hybrids, Inc. D3 DFA Varicella-zoster Virus Identification Kit, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device rather than defining strict, pre-specified acceptance criteria with numerical targets. Instead, the performance is reported as agreement with the predicate device.

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

• Test Set Sample Size: 251 specimens (after excluding 3 specimens due to toxic cell culture monolayers from an initial 254 prospectively collected specimens).
• Data Provenance: Prospectively collected specimens. The country of origin is not explicitly stated, but it was collected at "three laboratory sites" which typically implies within the country of submission (USA for FDA approval).

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

The ground truth for the test set was established by comparison to a currently marketed Varicella-zoster virus identification kit (the predicate device) which serves as the reference method. No independent experts are mentioned as having adjudicated or established ground truth in this particular type of study (method comparison). The "experts" in this context would be the technicians and microbiologists performing and interpreting the predicate device's results. Their specific qualifications are not detailed in the summary, but it's implied they are qualified laboratory personnel accustomed to these types of assays.

4. Adjudication Method for the Test Set

The adjudication method was a direct comparison between the D3 DFA VZV Identification Kit and a predicate device, serving as the "comparison device." There is no mention of an independent expert adjudication process for discordant results. The table presented shows agreement and disagreement between the two kits.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison study between two diagnostic kits, not an evaluation of human reader performance with or without AI assistance.

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

Yes, a standalone performance study was done. The study evaluates the performance of the D3 DFA Varicella-zoster Virus Identification Kit itself (using immunofluorescence read by a human under a microscope) against a predicate device. This is the "algorithm only" in the context of a laboratory assay, where the "algorithm" is the entire test procedure and the interpretation criteria provided. There is no automated image analysis or AI component involved in the reading of this specific device; it relies on human observation through a fluorescence microscope.

7. Type of Ground Truth Used

The ground truth used was established by comparison to a legally marketed predicate device (Light Diagnostics Varicella-zoster (VZV) Direct Immunofluorescence Assay or Light Diagnostics Simulfluor HSV/VZV Immunofluorescence Assay) which also uses immunofluorescence for VZV detection in cell cultures. This is a form of "reference method" ground truth.

8. Sample Size for the Training Set

The 510(k) summary does not explicitly describe a separate "training set" as would be common for machine learning applications. This is a traditional diagnostic kit submission. The "training" for such a kit involves the development and optimization of the antibodies and reagents by the manufacturer. The data presented in the performance characteristics section (Analytical performance, Analytical Specificity, Comparison Studies) are primarily for validation and demonstrate the kit's performance, not for training a model.

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

As noted above, a distinct "training set" and associated ground truth establishment in the context of statistical model training is not applicable to this type of device (an immunofluorescence assay kit). The development of the kit itself involves internal R&D and quality control, ensuring the antibodies correctly bind to VZV antigens. This developmental process would involve testing against known positive and negative VZV samples, where "ground truth" would be established by standard microbiological techniques (e.g., cell cultures, PCR, viral isolation) for VZV positivity. However, this is part of product development, not a separate "training set" study as described for AI/ML devices.

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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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Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay is a direct immunofluorescence test intended for the simultaneous detection and identification of HSV 1 and 2 and varicella-zoster virus (VZV) from patients with vesicular, oral, genital, or skin lesions, and following amplification of virus in culture. Specimens found to be negative on direct specimen examination should be tested by cell culture.

Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay utilizes a single reagent for the simultaneous detection and identification of HSV and VZV. The primary component, specific for both HSV 1 and 2 will bind to 155kD major capsid protein in HSV-infected cells. The secondary component, specific for VZV, will bind to glycoprotein gp I and the immediate early antigen in VZV-infected cells. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. When a FITC filter set is used, the HSV antigen-antibody complex will exhibit an apple green fluorescence and the VZV antigen-antibody complex will fluoresce yellow-gold. Uninfected cells stain a dull red due to the presence of Evans blue in the reagent.

A blend of monoclonal antibodies directed against HSV and VZV is used in the Light Diagnostics SimulFluor™ HSV/VZV reagent. The use of monoclonal antibodies ensures increased specificity of the reagent and reduces the risk of non-specific background or interference.

Here's a summary of the acceptance criteria and study details for the Light Diagnostics SimulFluor™ HSV/VZV Immunofluorescence Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve a sensitivity of at least X%"). Instead, it reports the performance of the device and concludes that it is "substantially equivalent" to predicate devices, thus demonstrating safety and effectiveness. The reported performance metrics are presented below.

Study Details

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

   • Site 1 (Northeast US): 203 specimens tested for HSV or VZV.
   • Site 2 (West Coast US): 283 specimens submitted for HSV and/or VZV testing; 236 specimens tested for HSV and VZV in direct specimens.
   • Data Provenance: Clinical evaluations were conducted at two separate hospital laboratories in the US (Northeast and West Coast). The data is retrospective, as it involves the comparison of direct patient specimens and cell cultures.

2. 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. The ground truth was established by "culture confirmation."

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

   • The document does not describe any specific adjudication method for discrepancy resolution. Ground truth was determined solely by "culture confirmation."

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, this was not a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI. This is a study evaluating an immunofluorescence assay (a laboratory test) against predicate devices and culture.

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

   • This device is a direct immunofluorescence assay, which inherently requires human observation (fluorescence microscopy). Therefore, a "standalone algorithm only" performance is not applicable in the context of this device. The performance reported is the performance of the assay as read by a human.

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

   • The primary ground truth used for the clinical evaluation was culture confirmation.

7. The sample size for the training set:

   • The document does not describe a "training set" in the context of machine learning. The non-clinical evaluations involved characterization of monoclonal antibodies using "reference viral strains and clinical isolates," but a specific sample size for this characterization is not provided, nor is it analogous to a machine learning training set.

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

   • Not applicable, as there is no mention of a traditional machine learning training set. The characterization of antibodies involved testing against "reference viral strains and clinical isolates," implying known or well-characterized viral types.

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