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The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.

The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The Trinity Biotech plc. Adenovirus Antigen Detection ELISA Test System underwent several performance studies to establish its effectiveness. The acceptance criteria and reported device performance are summarized below, followed by details of each study.

1. Table of Acceptance Criteria and Reported Device Performance

*Note: Specific numerical acceptance criteria were not explicitly stated in the provided text, so they are inferred based on general expectations for diagnostic device performance. The reported performance values met the implicit high standards for sensitivity, specificity, and agreement compared to predicate methods and for reliability in precision within the context of an ELISA assay.

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

• Study 1 (Relative to Cell Culture):
  • Sample Size: 120 fecal specimens.
  • Data Provenance: Retrospective, frozen fecal specimens sent to a University Virus Reference Laboratory in Ireland for routine testing. 90% of specimens were from adults.
• Study 2 (Relative to Alternate EIA):
  • Sample Size: 481 sera (likely a typo and should be fecal specimens given the device description)
  • Data Provenance: Retrospective, frozen fecal specimens from a large public health lab in the UK. 57% of samples were from patients less than 5 years old and 43% from patients greater than five years old.
• Precision Study:
  • Sample Size: 6 samples (containing Type 2 adenovirus from cell culture), plus positive and negative controls. Each was run in triplicate over three days at three sites, totaling 216 determinations.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples for internal validation.

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

The studies do not mention the use of "experts" in the traditional sense for establishing ground truth, such as radiologists or pathologists making diagnoses. Instead, the ground truth was established by established laboratory methods:

• Study 1: Ground truth was established by cell culture isolation, with positive cultures confirmed by electron microscopy (EM) using a standard negative staining technique (considered presumptive for adenovirus types 40 and 41).
• Study 2: Ground truth was primarily established by a commercially available alternate adenovirus EIA. For discordant samples, Electron Microscopy (EM) was used for confirmation.

No specific number or qualifications of "experts" (e.g., a board-certified virologist with X years of experience) were provided for interpreting these laboratory results; it is assumed that these benchmark methods were performed by qualified laboratory personnel following standard procedures.

4. Adjudication Method for the Test Set

• Study 1: No specific adjudication method was described beyond the initial cell culture and EM confirmation. "Equivocals" (2 samples) were excluded from the final calculations but not explicitly adjudicated further.
• Study 2: For samples where the device ELISA and the alternate EIA produced discordant results, these discrepant samples were re-tested, and any remaining discordant samples (15 in total) were then tested by Electron Microscopy (EM) for resolution. This implies a form of sequential adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic ELISA test, not an AI-assisted diagnostic tool that involves human readers interpreting images or data alongside an AI.

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

• Yes, the performance characteristics described (Sensitivity, Specificity, Limit of Detection, Precision, Cross-Reactivity) represent the standalone performance of the ELISA test system itself, without human-in-the-loop performance considerations beyond standard laboratory procedures for running the assay and interpreting the quantitative optical density readings against a cut-off.

7. The Type of Ground Truth Used

• Study 1: The ground truth was based on a predicate laboratory method (cell culture isolation), confirmed by electron microscopy (EM). This is a form of laboratory gold standard for detecting the presence of adenovirus.
• Study 2: The primary comparison was against an alternate commercially available adenovirus EIA. For discordant results, electron microscopy (EM) served as the confirmatory ground truth.

8. The Sample Size for the Training Set

No explicit "training set" is mentioned in the context of machine learning. For an ELISA test, the development process involves identifying antibodies and optimizing assay parameters. The performance studies detailed are validation studies for the finalized assay.

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

As this is an ELISA diagnostic kit and not an AI/machine learning device, the concept of a "training set" and establishing ground truth for it in the AI context does not directly apply. The development of the antibody and assay would have relied on known positive and negative controls and characterized samples to establish appropriate binding and detection parameters, but these are not referred to as a "training set" in the document.

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The Mycoptasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.

The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semiquantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.

The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

K971393 Mycoplasma IgG ELISA Test Kit: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mycoplasma IgG ELISA Test Kit are primarily defined by its "relative" performance against a predicate commercial IFA kit, rather than absolute diagnostic accuracy against a confirmed disease state.

Note on "Relative" Performance: The report explicitly states, "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. 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 is crucial context for interpreting the results.

2. Sample Size and Data Provenance

• Test Set (Comparative Studies):

  • Study 1: 187 frozen retrospective sera.
  • Study 2: 176 frozen retrospective sera.
  • Data Provenance: From two R&D laboratories at commercial companies in Maryland and New York, affiliated with the manufacturer. Sera in Study 1 were from "normal individuals of various ages, gender, from Lyme diseases endemic and non-endemic areas." Sera in Study 2 were "randomly selected sera from normal individuals of various ages, gender, and geographical location." Crucially, none of the performance characteristics were established with specimens from patients having documented mycoplasma infections.

• Test Set (Linearity): 20 positive sera (serially diluted).

• Test Set (Paired Sera Evaluation): 56 pairs of sera (acute sera with ISR < 2.18).

• Test Set (Complement Fixation Paired Serum Study): 11 serum pairs from patients suspected of having acute Mycoplasma pneumoniae infection (7 usable pairs).

• Test Set (Reproducibility Study): 50 different sera with various levels of activity.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the context of expert review for image-based diagnostics. The "ground truth" for the comparative studies was the result of a commercial IFA kit (predicate device).
• Qualifications of Experts: Not specified, as the comparison was against another diagnostic test, not expert clinical judgment of individual cases solely.

4. Adjudication Method for the Test Set

• No adjudication method described for establishing the primary ground truth (IFA results). The IFA results were taken as the reference.
• In the comparative studies (Tables 2 and 3), "equivocals were not included in the above calculations" for sensitivity and specificity, indicating a simple exclusion rather than an adjudication process for those specific cases.
• For the 20 sera found positive by IFA but negative by the Wampole ELISA in both studies, it is noted that "* All 20 sera were found to be positive by an alternate ELISA." This suggests a secondary verification, but not a formal adjudication process involving multiple independent readers to establish a definitive consensus ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This report describes the performance of a diagnostic kit against a predicate device and its internal consistency, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The entire submission details the performance of the "Mycoplasma IgG ELISA Test Kit" (an assay, not an algorithm in the modern AI sense) as a standalone diagnostic device. The reported sensitivity, specificity, agreement, linearity, paired sera detection, precision, and reproducibility demonstrate its performance without human-in-the-loop assistance for interpretation beyond reading the assay results.

7. Type of Ground Truth Used

• Comparative Reference Standard: The primary "ground truth" for the relative sensitivity and specificity studies was the results from a commercial IFA kit (predicate device).
• Internal Consistency: For linearity, precision, and reproducibility, the ground truth was derived from the expected behavior of serially diluted samples, repeated measurements, and inter-site comparisons.
• Clinical Correlation (Limited): For the paired sera analysis, the "ground truth" was a four-fold increase in antibody level or comparison against Complement Fixation (CF) results for a subset. However, the report explicitly states that there was no attempt to correlate the assay's results with disease presence or absence.

8. Sample Size for the Training Set

• Not Applicable. This is an ELISA test kit, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The development of the kit involved internal optimization and validation, but this is distinct from training a statistical or AI model.

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

• Not Applicable. As noted above, there is no training set for this type of device. The development process would have involved establishing the optimal antigen coating, reagent concentrations, incubation times, and cutoff values through internal technical validation, rather than an ML-style "ground truth" establishment for training.

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The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.

The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera. The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG, M, A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Acceptance Criteria and Device Performance for PR-3 ELISA Test Kit

This document describes the acceptance criteria and a detailed study supporting the performance of the PR-3 ELISA test kit for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera.

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PR-3 ELISA test kit are derived from its stated intended use as an aid in the diagnosis of Wegener's granulomatosis and its substantial equivalence to IFA (Indirect Immunofluorescence Assay). The study primarily focuses on demonstrating the analytical performance (sensitivity, specificity, precision, linearity, and cross-reactivity) of the device.

II. Sample Size and Data Provenance for the Test Set

• Sample Size for Sensitivity and Specificity (relative to IFA):

  • Patient with Wegener's granulomatosis/microscopic polyangiitis (IFA Positive): 54 sera
  • Normals and other patients (IFA Negative): 181 sera
  • Total: 235 sera

• Sample Size for Sensitivity and Specificity (relative to Alternate ELISA):

  • Total: 235 sera (same group as for IFA comparison)

• Sample Size for Clinical Sensitivity and Specificity:

  • Wegener's granulomatosis: 40 sera
  • Microscopic polyangiitis: 40 sera
  • Other autoimmune sera: 21 sera (containing antibodies to Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA)
  • Normals: 155 sera
  • Total: 256 sera

• Sample Size for Precision: 9 different sera, each tested 10 times on 3 different assays (total 270 measurements).

• Sample Size for Linearity: 5 positive sera, serially diluted twofold.

• Sample Size for Cross-reactivity: 21 sera containing antibodies to potentially cross-reactive antigens (Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA).

• Data Provenance: The document does not explicitly state the country of origin. The data appears to be retrospective, as patient sera were "from patients diagnosed with" specific conditions, implying collection prior to the study.

III. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used or their specific qualifications (e.g., radiologist with 10 years of experience).
• The ground truth for IFA results (used as a comparator for relative sensitivity/specificity) is implicitly established by the performance of the IFA assay itself, which is a predicate device.
• The ground truth for patient diagnoses (Wegener's granulomatosis, microscopic polyangiitis) and the presence of other autoimmune conditions/antibodies are stated as prior diagnoses, but the process of establishing these diagnoses by experts is not detailed within this document.

IV. Adjudication Method for the Test Set

• No explicit adjudication method is described for the test set. The study relies on pre-existing diagnoses and comparator assay results (IFA, alternate ELISA) as the ground truth.

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

• No MRMC comparative effectiveness study was done. This study evaluates an in vitro diagnostic (IVD) device, which typically assesses the analytical and clinical performance of the assay itself rather than the improvement of human reader performance with AI assistance. The device is a laboratory test, not an AI interpretation tool for human readers.

VI. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The entire study analyzes the performance of the PR-3 ELISA kit (the algorithm/device) in isolation, without human intervention in the interpretation of the raw assay data (though human technical skill is involved in performing the assay). The reported sensitivities, specificities, precision, and linearity are all measures of the device's standalone performance.

VII. Type of Ground Truth Used

• Comparator Assay Results: For relative sensitivity and specificity, the ground truth was established by the results of the Indirect Immunofluorescence Assay (IFA) for ANCA and an alternate legally marketed ELISA device.
• Clinical Diagnosis: For clinical sensitivity and specificity, the ground truth was based on patient diagnoses of Wegener's granulomatosis and microscopic polyangiitis, as well as the presence of other autoimmune conditions/antibodies (e.g., Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA) and serological status of normals.

VIII. Sample Size for the Training Set

• The document does not specify a training set sample size. As this is a traditional ELISA assay and not a machine learning or AI algorithm in the modern sense, the concept of a "training set" for model development as typically understood in AI/ML is not directly applicable. The device's parameters (e.g., cutoff values) would have been established during earlier development and validation phases, but these details are not provided here.

IX. How Ground Truth for the Training Set Was Established

• Given that this is a conventional immunoassay, the concept of a distinct "training set" with ground truth in the AI/ML context isn't relevant. The "ground truth" for establishing assay parameters (like cutoff values) would typically involve internal studies using well-characterized clinical samples and comparison against reference methods (like IFA) to optimize performance, but the specifics of this process are not described in this summary.

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The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of microscopic polyangiitis. FOR IN VITRO DIAGNOSTIC USE.

The MPO EIA test is an enzyme-linked immunosorbent assay (EIA) for the detection and semi-quantitation of antibodies to myeloperoxidase in human sera. The MPO EIA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to myeloperoxidase. Purified MPO is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG. M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Here's an analysis of the provided text regarding the MPO EIA Test Kit, structured according to your request:

In this document summary, the "device" refers to the MPO EIA Test Kit. The "acceptance criteria" can be inferred from the performance characteristics reported, as these values are presented as demonstrating the device's acceptable function. The primary study described is a comparative analysis against IFA and an alternate ELISA, as well as a clinical sensitivity and specificity study.

Acceptance Criteria and Reported Device Performance

Note on Precision Acceptance Criteria: The document states, "With proper technique the user should obtain C.V.'s of less than 15%." While most reported C.V. values for samples 1-4, 8, and 9 meet this, samples 5, 6, and 7 consistently show C.V.s significantly above 15% in both intra- and inter-assay measurements, indicating that this acceptance criterion was not met for all tested samples. This discrepancy is important for a full safety and effectiveness evaluation.

Study Details:

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

   • Relative Sensitivity and Specificity (vs. IFA):
     • Test Set Size: 235 sera (40 from patients with Wegener's granulomatosis, 40 from patients with microscopic polyangiitis, and 155 from normals). However, the table data on page 2 shows a total of 233 sera evaluated against IFA.
     • Data Provenance: Not explicitly stated, but the mention of "various ages, gender, and geographical areas" for normals suggests a broader, though unspecified, geographical origin. The data appears retrospective, as it's a collection of existing patient sera.
   • Comparison to Alternate ELISA:
     • Test Set Size: 233 sera. This is the "same group of clinical sera" as used for the IFA comparison.
     • Data Provenance: Same as above – not explicitly stated, likely retrospective.
   • Clinical Sensitivity and Specificity:
     • Test Set Size: 254 sera (40 Microscopic polyangiitis, 40 Wegener's granulomatosis, 21 Other autoimmune sera, 153 Normals). This appears to be a grouped analysis of the "clinical sera and the potentially cross-reactive sera".
     • Data Provenance: Not explicitly stated, likely retrospective.
   • Precision:
     • Test Set Size: 9 different sera, each tested 11 times on 3 different assays (for a total of 33 tests per serum for inter-assay precision).
     • Data Provenance: Not specified.
   • Linearity:
     • Test Set Size: 5 positive sera.
     • Data Provenance: Not specified.
   • Cross-Reactive Data:
     • Test Set Size: 21 sera with high levels of antibodies to potentially cross-reactive antigens.
     • Data Provenance: Not specified.

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):

   • The "ground truth" for the primary study (Sensitivity and Specificity) is established by IFA (Immunofluorescence Assay) for ANCA detection. For clinical performance, it's based on patient diagnoses (Wegener's granulomatosis, microscopic polyangiitis, other autoimmune diseases, normals).
   • The document does not specify the number or qualifications of experts who performed the IFA tests or established the clinical diagnoses.

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

   • There is no mention of an adjudication method used for either the IFA results or the clinical diagnoses. The IFA is presented as the reference standard itself.

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

   • No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test kit, not an AI-powered image analysis tool requiring human readers. The comparison is between different assay methodologies (ELISA vs. IFA, and MPO ELISA vs. Alternate ELISA).

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

   • Yes, this is an inherent standalone performance study. The MPO EIA Test Kit is an in vitro diagnostic assay. Its performance (sensitivity, specificity, precision, linearity, cross-reactivity) is measured by its chemical and biological reactions, without human interpretation of complex images or data needing AI assistance. The results (optical density, index value) are read by a photometer, and interpretation rules (e.g., Index ≥ 1.10 for Positive) are applied directly.

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

   • For Relative Sensitivity/Specificity: The primary ground truth is the IFA (Immunofluorescence Assay) result for ANCA.
   • For Clinical Sensitivity/Specificity: The ground truth is based on clinical diagnoses (e.g., microscopic polyangiitis, Wegener's granulomatosis, other autoimmune diseases, and "normals"). The method of confirming these diagnoses (e.g., pathology, clinical criteria, etc.) is not detailed.

7. The sample size for the training set:

   • This document describes performance studies, which are typically conducted on test sets. There is no mention of a separate "training set" for an algorithm, as this device is a laboratory assay kit and not an AI/ML model. The development of such a kit would involve initial research and optimization, but standard "training set" terminology doesn't directly apply here in the context of AI.

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

   • As there's no explicitly defined "training set" in the AI/ML sense, this question is not applicable. The development and optimization of the MPO EIA Test Kit would have involved various experimental runs and validations, but the details of those processes are not provided in this summary of safety and effectiveness.

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The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.

The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

This document describes the performance characteristics of the Immuno Probe EBNA-1 IgG EIA Test Kit (K951549) and presents studies to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EBNA-1 IgG EIA Test Kit are not explicitly stated as distinct, pre-defined thresholds in the provided text. Instead, the document presents performance characteristics and demonstrates that the device's results are in line with a predicate device and expected clinical serological profiles for EBNA-1 IgG. Based on the "Performance Characteristics" section, we can infer the following performance metrics and observed results:

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

• Relative sensitivity and specificity (vs. predicate):
  • Sample Size: 350 total specimens (276 positive, 74 negative). 8 equivocal results were excluded.
  • Data Provenance: The study was conducted at three different sites: two R&D laboratories at commercial companies (Maryland and New York) and one large commercial lab (Pennsylvania). The data is retrospective, as it compares the new device's performance against an "alternate commercially available EIA assay" implying existing specimens.
• Precision:
  • Sample Size: For each of the four sera (High Positive, Mid Positive, Low Positive, Negative) and two controls (Calibrator, High Positive Control), samples were tested 3 times, twice a day for 20 days at 3 sites.
    • This totals to 3 * 2 * 20 * 3 = 360 individual assay points for each serum type across all sites (though the table states n=360 for "Inter Site Precision", implying this is the total number of data points aggregated for the CV calculation, not necessarily 360 distinct patient samples).
    • Calibrator: n=240
    • High Positive Control: n=120
  • Data Provenance: Three different sites (locations not specified beyond "different sites"). Likely prospective as these were controlled runs of known sera/controls.
• Linearity:
  • Sample Size: 5 different sera were serially diluted and tested.
  • Data Provenance: Not specified, but likely laboratory-generated data as it involves controlled serial dilutions.
• Cross-Reactivity:
  • Sample Size: 5 sera known to contain antibodies to HSV I & II, CMV, and VZV.
  • Data Provenance: Not specified, but likely laboratory-generated data from specific known-positive samples.
• Evaluation of paired sera:
  • Sample Size: 20 high positive sera were serially diluted to create 68 paired samples with a four-fold dilution.
  • Data Provenance: Not specified, but likely laboratory-generated from existing high-positive samples.
• Sensitivity and Specificity Based on Serum Characterization:
  • Sample Size: 150 specimens (95 seropositive, 24 acute, 31 seronegative). 8 equivocal results were excluded.
  • Data Provenance: The serum was from "the first study site" which implies one of the sites mentioned in the relative sensitivity/specificity study. The characterization (seronegative, acute, seropositive) suggests these were clinical samples. The study is likely retrospective, using samples with pre-established serological profiles.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

• For Relative Sensitivity/Specificity: The ground truth for the comparison was an "alternate commercially available EIA assay." It is implied that the results from this predicate device are considered the truth for this comparison. The "experts" would implicitly be the developers and users of this predicate device, whose qualifications are not detailed.
• For Sensitivity/Specificity Based on Serum Characterization: The ground truth was established by classifying sera as "seronegative," "acute," or "seropositive" based on "other Epstein-Barr serologies (VCA IgG, VCA IgM)." This implies a determination made by laboratory personnel or serologists who follow established diagnostic protocols. No specific number or qualifications are provided.

4. Adjudication method for the test set

The document does not describe an adjudication method involving multiple readers for the test sets. The results appear to be based on direct laboratory measurements and comparisons to a predicate device or established serological profiles. "Equivocals were not included in the calculations" for the relative sensitivity/specificity and the serum characterization studies, which acts as a form of exclusion rather than an adjudication process to assign true status.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is an in vitro diagnostic test, not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

Yes, the studies presented are all standalone performance evaluations of the assay itself. The results (e.g., optical density readings converted to index values) are generated by the kit components and detected instrumentally, without a human-in-the-loop interpretation step that influences the primary measurement outcome beyond standard laboratory procedures for running an ELISA.

7. The type of ground truth used

• For Relative Sensitivity and Specificity: The ground truth was based on the results of a "commercially available EIA assay" (predicate device).
• For Sensitivity and Specificity Based on Serum Characterization: The ground truth was based on serological characterization using other established EBV serologies (VCA IgG, VCA IgM) to classify samples as seronegative, acute, or seropositive. This falls under the category of established diagnostic criteria.
• For Precision, Linearity, Cross-Reactivity, Paired Sera: The ground truth was based on known characteristics of the samples used (e.g., known positive/negative samples for precision, serially diluted samples for linearity, samples with known viral antibodies for cross-reactivity).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The device is a traditional immunoassay kit, not an AI/ML algorithm. Therefore, no specific training set data is described for this type of device. The extensive testing described in the document serves as performance validation.

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

As there is no AI/ML algorithm and thus no explicit "training set" described, this question is not applicable. The performance characteristics were established by testing against established serological methods and clinical classifications, which serve as the reference standard or "ground truth" for validation.

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