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For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.

This document describes the performance characteristics of the Is-H. pylori IgG ELISA Kit, an in vitro diagnostic (IVD) device used for the qualitative determination of IgG antibodies to Helicobacter pylori antigen in human sera.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance metrics, demonstrating the device's accuracy and precision.

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

• Sample Size for Sensitivity and Specificity Study (Section A): 249 patients.
  • 121 sera characterized as positive for H. pylori.
  • 128 sera characterized as negative for H. pylori.
• Sample Size for Relative Agreement Study (Section B): 249 patients (same samples as in Section A).
• Data Provenance: The sera were frozen retrospective samples from patients. The country of origin is not explicitly stated in the provided text.

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

The ground truth for characterizing H. pylori infection in the test set (Section A) was established using "biopsy with culture, stain and CLO results for H.pylori". While these are considered reference standard clinical tests, the document does not specify the number of experts (e.g., pathologists, microbiologists) who interpreted these results or their specific qualifications (e.g., years of experience as a pathologist). The interpretation of such tests inherently involves expert judgment, but the level of detail is not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for resolving discrepancies in the biopsy, culture, stain, or CLO results that formed the ground truth. It states that "Based on the results of this testing, the patient sera were characterized." This implies that a consensus or a defined decision rule based on these multiple tests was used to establish the positive or negative status for each patient, but the specific adjudication process is not detailed. Equivocal results from the device under test were excluded from calculations, but this is a different kind of exclusion from an adjudication of ground truth.

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 mentioned. This device is an immunoassay kit, not an AI-based image analysis or interpretation tool that would typically involve human readers and AI assistance for interpretation. Therefore, this section is not applicable.

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

For the sensitivity and specificity study (Section A), the device (Is-H. pylori IgG Test Kit) was tested on sera, and its results were compared to the biopsy-based ground truth. This represents standalone performance, as the interpretation of the ELISA results would be direct based on the established cut-off, without a human "reader" making a subjective judgment in the same way a radiologist reads an image.

The section on "Correlation of Manual and MAGO Plus Results" (Section D) and "MAGO Plus Precision" (Section E) studies the performance of the device when used with an automated EIA processor. This also represents standalone performance of the device in either manual or automated modes, where the device directly produces a result.

7. The Type of Ground Truth Used

The primary ground truth used for the sensitivity and specificity study (Section A) was based on biopsy with culture, stain, and CLO results for H. pylori. These are objective laboratory and histopathological methods considered gold standards for H. pylori infection diagnosis.

For the "Relative Agreement Versus Another ELISA" study (Section B), the "ground truth" was the results from "another commercially available kit for H. pylori IgG antibodies." However, the notice explicitly states: "Please be advised that 'relative' refers to the comparison of the 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's accuracy to predict disease." This clarifies that the predicate ELISA was used for relative performance comparison, not as a true gold standard for disease presence.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay kit (ELISA), which is a biochemical test, not an algorithm that requires a separate training set. The various studies described (Sensitivity/Specificity, Relative Agreement, Precision) are all validation studies for the device's performance.

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

As this is an immunoassay and not an AI/ML algorithm requiring a training set, this question is not applicable. The device itself produces a result based on a biochemical reaction and predefined interpretation rules.

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For the qualitative and semi-quantitative determination of IgGi antibodies to Mumps virus m human serum of adults over cighteen vears of age by indirect enzyme immunoassay as an aid in the diaunosis at Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antihody itel can also aid in the diagnosis of acute infection by seroconversion through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children

The & Mumps IgG ELISA Kit is an Enzyme-Linked ImmunoSorbent Assay (E.I.S.A) (6) the detection of IgG antibodies to Mumps antigen in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mumps IgG ELISA Kit:

Acceptance Criteria and Device Performance for Is-Mumps IgG Test Kit

• Positive Sera (A, B, C, D): CV% generally in the range of 4-9% (Interassay CV% 6.36%-8.70%).
• Negative Sera (E, F): CV% generally in the range of 21-40% (Interassay CV% 32.18%-39.03%).
  Intra-Assay/Interassay CV% (Site #2):
• Positive Sera (A, B, C, D): CV% generally in the range of 4-10% (Interassay CV% 8.92%-9.63%).
• Negative Sera (E, F): CV% generally in the range of 4-18% (Interassay CV% 13.02%-18.06%).
  Intra-Assay/Interassay CV% (Site #3):
• Positive Sera (A, B, C, D): CV% generally in the range of 2-10% (Interassay CV% 4.06%-8.04%).
• Negative Sera (E, F): CV% generally in the range of 8-35% (Interassay CV% 17.49%-35.19%). |
  | Correlation (Manual vs. MAGO Plus) | Strong correlation between manual assay results and results obtained using the MAGO® Plus Automated EIA Processor. (Implicitly, a high Pearson Correlation Coefficient is expected). | Pearson Correlation Coefficient: 0.954 (indicating good correlation, as stated). |
  | Reproducibility (MAGO Plus) | Acceptable intra-assay and interassay coefficients of variation (CV%) for both positive and negative sera when performed on the MAGO® Plus. (No explicit numerical targets are given for CV%). | Intra-Assay/Interassay CV% (MAGO Plus - Site #2):
• Positive Sera (A, B, C, D): CV% generally in the range of 6-13% (Interassay CV% 8.84%-11.50%).
• Negative Sera (E, F): CV% generally in the range of 0-28% (Interassay CV% 21.19%-23.79%). |

Study Details:

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

   • Accuracy (Comparison Study): 173 fresh sera samples.
     • Provenance: "a clinical commercial laboratory, located in the Mid-Atlantic area" (United States, retrospective).
   • Reproducibility (Manual & MAGO Plus): 6 sera (4 positive, 2 negative) for each site, assayed 10 times in 3 runs. This means for each Reproducibility section (Manual, MAGO Plus), a total of (6 sera * 10 replicates * 3 runs) + (interassay variability) were evaluated at each site. This refers to the number of measurements/replicates rather than unique patient samples like in the accuracy study.
     • Provenance: Not explicitly stated for the source of these 6 sera, but the testing was done at "the manufacturer, a research and development laboratory, and a clinical laboratory."

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

   • The ground truth for the comparison study was established by a "commercially available kit for Mumps IgG antibodies" (the predicate device), not by human experts. The study clarifies: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease."

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by another ELISA test, not by human interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) assay, not a medical imaging or interpretation device that would typically involve multiple human readers.

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

   • Yes, the performance characteristics (accuracy against a predicate, reproducibility) are reported for the device as a standalone test system, both in manual operation and when automated with the MAGO® Plus. Human "readers" are not part of the performance evaluation beyond performing the lab procedures.

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

   • Comparative Device Results: The primary "ground truth" for the accuracy study was the results from a predicate, commercially available Mumps IgG ELISA kit.
   • IFA Reference: The footnotes in Table 1 mentioned "313 sera were positive by IFA" and "373 sera were positive by II/A", suggesting that some samples may have also been referenced against Immunofluorescence Assay (IFA), but the main comparison was with the predicate ELISA. The report explicitly states it was not correlated with disease presence/absence.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" for the device itself. For IVDs, the development process typically involves internal validation and optimization, but the performance data presented here are usually from a "test set" demonstrating the final product's characteristics.

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

   • Not applicable, as a distinct training set with established ground truth is not detailed in the provided information. If there were a training phase, it would likely involve similar methods as the test set (e.g., comparison to a reference method, known positive/negative samples).

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The TPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and quantitation of antibodies against the thyroid peroxidase antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

The & TPO IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to thyroid peroxidase in human serum.

Acceptance Criteria and Study for Is-anti-TPO IgG ELISA Test Kit

This document describes the acceptance criteria and the studies performed to demonstrate the safety and effectiveness of the Is-anti-TPO IgG ELISA Kit.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• Relative Sensitivity and Specificity Study: 255 frozen retrospective sera.
• Clinical Sensitivity and Specificity Study: 207 frozen retrospective, characterized sera.
• Precision Study: 4 positive sera and 2 negative sera, each assayed 10 times in 3 different runs at 2 different sites. For MAGO Plus precision, 6 sera were assayed 10 times each in 3 different runs.
• Correlation of Manual and MAGO Plus Results: 104 serum samples.

Data Provenance: All data appears to be retrospective. The country of origin of the data is not explicitly stated in the provided text, but given the context of a US regulatory submission, it is likely the data was collected in the USA or a region with comparable clinical practices.

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

The document does not explicitly state the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., radiologist with X years of experience).

• For the "Relative Sensitivity and Specificity" study, a "commercially available ELISA kit for TPO antibodies" was used as the comparator, implying its results served as the reference for ground truth in that comparison.
• For the "Clinical Sensitivity and Specificity" study, "characterized sera" were used. This suggests that the ground truth for these samples (e.g., normal, Grave's Disease, Hashimoto's Disease) was previously established through clinical diagnosis, but the method and expert involvement are not detailed.

4. Adjudication Method (Test Set)

The document does not describe an adjudication method for the test set, such as 2+1 or 3+1. The ground truth appears to be based on results from a comparative device or pre-characterized clinical diagnoses.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an in-vitro diagnostic (ELISA kit), not an imaging or AI-assisted diagnostic tool that typically involves human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Relative Sensitivity and Specificity" and "Clinical Sensitivity and Specificity" sections, along with the "Precision" studies, evaluate the performance of the "Is-anti-TPO IgG Test Kit" as a standalone device. The correlation study with the MAGO Plus demonstrates the performance of the kit both manually and when integrated with an automated processor, but these are still evaluations of the algorithm/kit itself.

7. Type of Ground Truth Used

• Relative Sensitivity and Specificity Study: The "ground truth" was established by the results of a commercially available ELISA kit for TPO antibodies. This is a form of comparative reference standard.
• Clinical Sensitivity and Specificity Study: The "ground truth" was based on characterized clinical diagnoses (Normals, Grave's Disease, Hashimoto's Disease). This can be categorized as clinical diagnosis/outcomes data, although the specific methods of characterization are not detailed.

8. Sample Size for the Training Set

The document does not mention a "training set" or "validation set" in the context of device development. The studies described are performance evaluations of the final device. This type of in-vitro diagnostic development typically focuses on analytical and clinical performance studies rather than machine learning model training.

9. How Ground Truth for Training Set Was Established

As no training set is described, the method for establishing its ground truth is not applicable or provided.

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For the qualitative presumptive detection of total (IgG/IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

The & Borrelia burgdorferi IgG/IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG/IgM to Borrelia burgdorferi antigen in human serum.

The provided 510(k) summary for the "Borrelia burgdorferi IgG/IgM ELISA Kit" details performance characteristics but does not explicitly state specific acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or precision that the device had to meet for clearance. Instead, it presents the device's performance results across various studies and implies that these results were considered acceptable by the FDA for substantial equivalence to a predicate device.

However, based on the presented data, we can infer the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria were not explicitly stated, the reported performance is presented as demonstrated.

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For the qualitative presumptive detection of IgM antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease. The test can be performed either manually or in conjunction with the MAGO TM PLUS Automated EIA Processor.

The Is-anti-Borrelia burgdorferi IgM Test Kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to develop IgG antibodies. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

The & Borrelia burgdorferi IgM ELISA Kit is an enzyme-finked immunosorbent assay (ELISA) for the detection of IgM to Borrelia burgdorferi antigen in human serum.

Here's a breakdown of the acceptance criteria and study information for the Borrelia burgdorferi IgM ELISA Kit, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative or numerical format (e.g., "Sensitivity must be >X%"). Instead, it presents performance data for comparison against other methods or expected clinical behavior. For example, it provides agreement percentages with characterized serum panels and precision values.

Therefore, the table below will summarize the provided performance characteristics rather than predefined acceptance criteria. The implied acceptance is that these performance characteristics are adequate for the intended use and comparable to similar devices (as suggested by the substantial equivalence to "Zeus Lyme Elisa").

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The TG IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroglobulin (TG) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated ETA processor.

The TG IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Thyroglobulin in human serum.

Here's a breakdown of the acceptance criteria and the study details for the anti-TG IgG ELISA Kit, based on the provided 510k summary:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds that the device must meet in a table. Instead, it presents performance characteristics from studies that demonstrate its capabilities. I will infer the implied acceptance criteria from the reported values, particularly in comparison to a commercially available ELISA kit mentioned in the "Relative Sensitivity and Specificity" section.

                           | a benchmark kit, with a lower bound within the 95% CI that indicates acceptable detection)                                                                                                                                              | 83.3% (95% CI: 67.2-93.0)                                                                            |

| Relative Specificity | High specificity to correctly identify negative cases (implied: comparable to a benchmark kit, with a lower bound within the 95% CI that indicates acceptable rejection of negatives) | 97.2% (95% CI: 93.5-99.1) |
| Overall Agreement | High overall agreement with a benchmark kit (implied: overall performance nearing 90% or above, with a lower bound within the 95% CI that indicates acceptable consistency) | 94.8% (95% CI: 90.9-97.4) |
| Clinical Specificity (Normals) | High specificity in a normal population. Specific numerical criteria are not specified, but a high percentage is expected to avoid false positives in healthy individuals. | 97.7% (95% CI: 94.3-99.4) |
| Clinical Sensitivity (Grave's Disease) | Moderate to high sensitivity in Grave's Disease patients; while not an explicit threshold, the reported value (38.5%) should be considered clinically acceptable for an aid in diagnosis based on the device's role. | 38.5% (95% CI: 13.9-68.4) |
| Clinical Sensitivity (Hashimoto's Disease) | Moderate to high sensitivity in Hashimoto's Disease patients; similar to Grave's, the reported value (64.3%) should be acceptable for diagnostic aid. | 64.3% (95% CI: 35.1-87.2) |
| Precision (Intra-assay & Inter-assay CV%) | Low Coefficient of Variation (CV%) for both positive and negative samples across different runs and sites. Although no explicit threshold is given, typically CVs below 15-20% are considered acceptable, especially for quantitative assays. | Max Intra-assay CV%: 61.85% (F, NEG, Site 1, Run 1)
Max Inter-assay CV%: 98.47% (F, NEG, Site 1)

(Values for positive samples generally much lower, e.g., ~10-15%) |
| Correlation (Manual vs. MAGO Plus) | High correlation between manual and automated methods. The Pearson Correlation Coefficient (r) should be close to 1. | 0.988 (Pearson Correlation Coefficient) |

2. Sample Size and Data Provenance:

• Relative Sensitivity and Specificity:
  • Test Set Sample Size: 227 (Frozen retrospective sera). The table provided specifies N=213 for calculation after excluding equivocal results.
  • Data Provenance: Retrospective sera. Country of origin is not specified but is implied to be relevant to the market the device is seeking approval for, likely the US.
• Clinical Sensitivity and Specificity:
  • Test Set Sample Size: 207 (Frozen retrospective, clinically characterized sera). The table breaks this down into:
    • Normals: 176 (175 used for calculation)
    • Grave's Disease: 12 (13 used for calculation)
    • Hashimoto's Disease: 16 (14 used for calculation)
  • Data Provenance: Retrospective sera. Clinically characterized. Country of origin not specified.
• Precision:
  • Test Set Sample Size: 6 sera (4 positive, 2 negative) tested 10 times in 3 different runs at 2 different sites.
  • Data Provenance: Not specified; likely laboratory samples.
• Correlation of Manual and MAGO Plus Results:
  • Test Set Sample Size: 91 serum samples.
  • Data Provenance: Not specified; likely laboratory samples.
• MAGO Plus Precision:
  • Test Set Sample Size: 6 sera (implied same a precision study data set).
  • Data Provenance: Not specified; likely laboratory samples.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not specify the number of experts used to establish the ground truth or their qualifications for any of the studies.
• For the "Relative Sensitivity and Specificity" study, the comparison is made to "a commercially available ELISA KIT." The "ground truth" here is essentially the results of this comparator kit.
• For the "Clinical Sensitivity and Specificity" study, the "ground truth" for patient groups (Normals, Grave's Disease, Hashimoto's Disease) is established through "clinically characterized sera." How this clinical characterization was performed (e.g., by a panel of endocrinologists, by a single specialist for each patient, based on a gold standard diagnostic) is not detailed.

4. Adjudication Method for the Test Set:

• The document does not explicitly describe an adjudication method for the test set in the context of expert review.
• For the "Relative Sensitivity and Specificity" study, "Equivocal results were excluded from calculations." This acts as a form of exclusion, but not a multi-expert adjudication to reconcile discrepant results.
• For "Clinical Sensitivity and Specificity," "Equivocal results were excluded from calculations" as well.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) ELISA kit, not an imaging or interpretation device that would involve multiple human readers. The studies focus on the analytical and clinical performance of the assay itself.

6. Standalone Performance Study:

• Yes, standalone performance was done for the algorithm (the ELISA kit). The primary studies (Relative Sensitivity and Specificity, Clinical Sensitivity and Specificity, Precision) all evaluate the performance of the anti-TG IgG ELISA Kit in isolation. The "Correlation of Manual and MAGO Plus Results" and "MAGO Plus Precision" evaluate its performance when integrated with an automated system, but the core analytical performance is still inherent to the kit itself.

7. Type of Ground Truth Used:

• For Relative Sensitivity and Specificity: The "ground truth" was established by comparison to a "commercially available ELISA KIT" designed for detecting anti-TG IgG antibodies. This is a comparator device ground truth.
• For Clinical Sensitivity and Specificity: The "ground truth" was based on clinical characterization of the patient sera (categorized as Normals, Grave's Disease, Hashimoto's Disease). This can be considered clinical diagnosis/outcomes data ground truth, although the specific diagnostic criteria and methods for this characterization are not elaborated upon.
• For Precision, Correlation, and MAGO Plus Precision: The ground truth is the inherent concentration or presence/absence of the analyte in the tested sera, with consistency and correlation being the metrics of interest against established values or the manual method.

8. Sample Size for the Training Set:

• The document does not specify a separate "training set" for the ELISA kit. ELISA kits are typically developed and optimized through iterative R&D processes, but the performance studies described here are for validation rather than training a machine learning model. If any optimization involved specific sample sets, it is not detailed as a formal "training set" in this summary.

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

• As a formal "training set" is not described, the method for establishing its ground truth is not applicable/not provided in this summary.

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For the qualitative determination of IgM antibodies in human serum to Epsien Barr Virus (recombinant) Nuclear antigen (EBNA-1) antigen. The 78 EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS TM Automated EIA Processor.

The & EBNA-1 IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Nuclear antigen-1 in human serum.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Test Set Sample Size and Data Provenance:

   • Sample Size: 176 sera.
   • Data Provenance: Frozen retrospective sera from patients.
   • Country of Origin: Not specified.

2. Experts Used for Ground Truth and Qualifications:

   • The text does not specify the number of experts used to establish the ground truth or their qualifications.
   • The "ground truth" was established by characterizing the sera using commercially available kits for VCA IgM, VCA IgG, EBNA-1 IgG, and heterophile antibodies, and then classifying them into "convalescent," "current infection," or "seronegative" based on the results of this testing.

3. Adjudication Method for the Test Set:

   • The text does not describe an adjudication method for the test set. The characterization of sera appears to be based on the results of multiple commercial assays rather than a human consensus process.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test, and the study evaluated its performance against established serological markers, not against human readers with and without AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Yes, a standalone performance study was done. The entire clinical performance section evaluates the device (the EBNA-1 IgM ELISA Kit) directly against the characterized sera without human-in-the-loop assistance for the interpretation of the EBNA-1 IgM ELISA results. Human interpretation was part of the "ground truth" establishment using other assays, but the device's output (positive, negative, equivocal) was directly compared.

6. Type of Ground Truth Used:

   • Expert Consensus (indirectly) / Reference Comparator Assay Results: The ground truth was established by classifying patient sera based on the results of multiple commercially available EBV serology kits (VCA IgM, VCA IgG, EBNA-1 IgG, and heterophile antibodies). This is a form of reference standard based on accepted laboratory diagnostics.

7. Training Set Sample Size:

   • The document does not specify a training set sample size. This is typical for traditional ELISA kits, where optimization and assay development are performed, but a distinct "training set" for an algorithm in the modern AI sense is not applicable. The device's parameters (e.g., cut-offs) would have been established during its development phase.

8. How Ground Truth for Training Set Was Established:

   • As there is no distinct "training set" in the AI sense for this device, the concept of establishing ground truth for it is not directly applicable. The development of the assay (e.g., determining optimal concentrations, incubation times, and cut-off values) would have involved extensive experimentation and standardization using characterized samples, similar to how the ground truth for the test set was established using comparator assays.

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For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) Viral Capsid antigen (EBV-VCA) antigen. The EBV-VCA IgM assay should be used in conjunction with other Epstein-Barr serologies (EBV-VCA IgG, EBNA-1 IgG, EA-D IgG, EA-D IgM, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious monomucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS ™ Automated EIA Processor.

The & EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Viral Capsid antigen in human serum.

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

Acceptance Criteria and Device Performance

Device Name: EBV-VCA IgM ELISA Kit (also referred to as Is-EBV-VCA IgM Test Kit and 7 VCA IgM ELISA)

Study Details Proving Acceptance Criteria

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

   • Clinical Sensitivity and Specificity: 176 frozen retrospective sera. The provenance (country of origin) is not explicitly stated, but it's referred to as "sera from one hundred and seventy-six patients" which suggests human samples. The study explicitly states it was a "pre-selected, retrospective, population."
   • Precision:
     • Intra-assay and Interassay Precision: Four positive and two negative sera (6 unique sera) were assayed 10 times each, in 3 different runs. This was done at 3 different sites.
     • Inter-Site Precision: The document mentions n=90 for serum samples A-F (presumably 90 total measurements across sites for each serum type, or 3 sites * 3 runs * 10 replicates = 90 total for each serum type), and n=36 for CAL (Calibrator), n=18 for LPC (Low Positive Control), n=18 for NC (Negative Control).
   • Specificity with Potentially Cross-Reactive Sera: 13 sera.
   • Correlation of Manual and MAGO Plus Results: 120 serum samples.
   • MAGO Plus Precision: Six sera were assayed 10 times each in 3 different runs (similar to the manual precision study).

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

   • For the "Clinical Sensitivity and Specificity Using Characterized Sera" section, the sera were "characterized using commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies." This implies an established laboratory testing method rather than human expert opinion directly establishing ground truth for individual cases. No human experts are explicitly mentioned for ground truth establishment.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by comparing to results from "commercially available kits" for other EBV serologies.

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:

   • This is not an MRMC study. The device is an ELISA kit, which is an in vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers. There is no mention of human readers or AI assistance in this context. The comparison is between the new EBV-VCA IgM ELISA Kit and existing commercial kits/methods.

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

   • Yes, for the EBV-VCA IgM ELISA Kit, the performance data provided (sensitivity, specificity, precision, cross-reactivity) represents the standalone performance of the diagnostic assay. This assay is a laboratory test, and its results are read and interpreted, but the performance characteristics apply to the kit itself.
   • The "Correlation of Manual and MAGO Plus Results" section compares the standalone performance of the kit when processed manually versus using an automated EIA processor (MAGO Plus). Both are "standalone" in the sense of the chemical assay's performance.

6. The type of ground truth used:

   • Clinical Performance: "EBV Serological Status" derived from other "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies." This is a lab result-based ground truth (or predicate method comparison) rather than pathology, clinical outcome, or expert consensus on a subjective measure. The document explicitly states: "There was not an attempt to correlate the assay's results with disease presence or absence."
   • Precision: Ground truth for positive/negative samples was pre-established (e.g., "four positive and two negative sera").
   • Cross-Reactivity: Sera "reactive for IgM antibodies to varicella zoster, cytomegalovirus and herpes simplex virus by EIA". This is again a lab result-based ground truth to check for specific antibody interference.
   • Correlation: Comparison between the manual and MAGO Plus results on the same samples.

7. The sample size for the training set:

   • The document does not explicitly describe a "training set" in the context of machine learning or AI. This is an in vitro diagnostic (IVD) assay. The development of such assays typically involves research and development where reagents and protocols are optimized. The "Characterized Sera" mentioned in the clinical performance section serves as the test set for the final validation of the device.

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

   • As no "training set" in the AI sense is explicitly mentioned, this question is not fully applicable. For the development and optimization of the ELISA kit itself, ground truth for sample characterization would have been established through well-characterized reference materials, clinical samples with known serological status using predicate methods, or samples from a disease registry. The "Characterized Sera" in the performance study were characterized using "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies," which indicates the method used to establish the "ground truth" for those specific samples relative to established serological definitions.

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For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) early antigen diffuse (EA-D) antigen. The & EA-D IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EBNA-1 IgG, EBNA-1 IgM, EA-D IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS The Automated EIA Processor.

The & EA-D IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Early antigen diffuse in human serum.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EA-D IgM ELISA Kit:

The document does not explicitly state pre-defined acceptance criteria for the device's performance. Instead, it presents the results of its performance characteristics study. The acceptance for market clearance seems to be based on "substantial equivalence" to legally marketed predicate devices, implying that the observed performance falls within an acceptable range compared to those predicates, even if specific numerical targets aren't listed here.

However, we can infer the "reported device performance" from the study results.

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

As stated, explicit acceptance criteria are not presented in the document. The table below outlines the reported performance from the study, which would have been evaluated against a benchmark for substantial equivalence.

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

• Test Set Sample Size: 176 patient sera were used for the clinical performance study.
• Data Provenance: The data used was from retrospective sera from patients. The country of origin is not explicitly stated, but given the applicant and reporting of a 510(k) to the FDA, it is highly likely to be from the USA.

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

The ground truth for the test set was established by characterizing the 176 frozen retrospective sera using "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies."

• Number of Experts: Not applicable, as the "ground truth" (or reference standard) was established using other commercial serological assays, not by expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

The concept of an "adjudication method" as typically applied in scenarios involving multiple human readers (e.g., 2+1, 3+1 for discrepancies) is not relevant here. The ground truth for the test set was determined by the results of other commercial serological assays, which are considered objective measurements, not subjective interpretations requiring 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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not done.
• Effect Size of Human Readers Improvement with/without AI: Not applicable, as this is an in vitro diagnostic device for antibody detection, not an imaging analysis or interpretive AI system that assists human readers.

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

Yes, the primary clinical performance study (Section A) evaluates the device in standalone mode. The results of the Is-EBV-EA-D IgM Test Kit were directly compared to the classification of patient sera based on other commercial EBV serologies. While a technician performs the test, the result (positive, negative, equivocal) is generated by the kit itself, making it a standalone assessment of the device's diagnostic capability. The section on manual vs. MAGO Plus correlation also demonstrates standalone performance for both methods.

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

The ground truth for the clinical performance study was established using a combination of commercially available serological assays for Epstein-Barr Virus (EBV) antibodies. This allowed for the classification of sera into "convalescent," "current infection," and "seronegative" categories based on established serological patterns for EBV infection. It's a form of clinical reference standard based on established serology.

• Specifically:
  • Convalescent (past infection): Positive for VCA IgG and/or EBNA IgG antibodies; negative for VCA IgM and heterophile antibody.
  • Seronegative: Negative for VCA IgG, VCA IgM, EBNA IgG, and heterophile antibody.
  • Current (recent) infection: Positive for VCA IgM and/or heterophile antibody; negative for EBNA IgG.

8. The sample size for the training set

The document does not explicitly describe a separate "training set" for the development of the EA-D IgM ELISA Kit. The provided studies focus on the performance evaluation of the developed device. For in vitro diagnostic kits, the "training" (development and optimization) phase is usually internal and not detailed in 510(k) summaries in the same way as machine learning models. Therefore, the sample size for a training set (in the ML sense) is not reported.

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

As there is no distinct "training set" described in the context of machine learning model development, the method for establishing its ground truth is not applicable/not reported in this 510(k) summary. The development of an ELISA kit involves biochemical optimization and formulation, rather than algorithmic training on labeled data in the way an AI/ML model would.

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The & MPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Myeloperoxidase antigen in serum as an aid in the diagnosis of Microscopic polyangiitis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

The & MPO IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Myeloperoxidase in human serum.

Here's an analysis of the provided text regarding the anti-MPO IgG ELISA Kit, focusing on acceptance criteria and study details:

Device: anti-MPO IgG ELISA Kit

Intended Use: Qualitative detection and semi-quantitation of antibodies against Myeloperoxidase antigen in serum as an aid in the diagnosis of Microscopic polyangiitis. Can be performed manually or with the Mago Plus automated EIA processor.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the relative sensitivity, specificity, or clinical performance. Instead, it reports the calculated performance characteristics. However, based on the presentation and the context of a 510(k) submission, the reported values serve as the de facto "met" criteria for demonstrating substantial equivalence to a predicate device. For precision, the document reports the CV% values. For the correlation study, a Pearson coefficient of 0.983 is reported, which is indicative of a strong correlation.

Note on Precision CV%: The CV% for negative samples (E and F) is very high (e.g., 194.37%, 161.02%, 100.23%). This is common for values close to zero, where small absolute variations lead to large percentage changes. The CV% for positive samples is much lower and generally acceptable (e.g., 4.49-19.90%).

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

• Relative Sensitivity and Specificity Study:
  • Sample Size: 264 frozen retrospective sera from patients.
  • Data Provenance: Not explicitly stated, but common for such studies in 510(k) submissions to be from a single or few clinical sites within the country of the applicant (USA, based on address). The term "retrospective sera" indicates samples collected in the past.
• Clinical Sensitivity and Specificity Study:
  • Sample Size: 256 frozen retrospective, clinically characterized sera.
  • Data Provenance: Not explicitly stated, but "retrospective, clinically characterized" implies samples from a clinical setting.
• Correlation of Manual and MAGO Plus Results:
  • Sample Size: 100 serum samples.
  • Data Provenance: Not specified, but likely from the same clinical context as the other studies.

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

• Relative Sensitivity and Specificity Study: The ground truth was established by another "Other ELISA" kit. There is no mention of human experts defining the ground truth for this comparison.
• Clinical Sensitivity and Specificity Study: The samples were "clinically characterized." This implies that patient diagnoses (Normals, Wegener's Granulomatosis, Microscopic Polyangiitis) were established through standard clinical evaluation, which would involve medical professionals (e.g., physicians, specialists). However, the number and qualifications of these experts are not mentioned in the document.
• Training Set Ground Truth: No specific "training set" or "ground truth for training set" details are provided, as this is a traditional ELISA kit, not an AI/machine learning device. The design and validation of ELISAs rely on established biochemical principles and purified antigens/antibodies, rather than iterative machine learning training.

4. Adjudication Method for the Test Set

• Relative Sensitivity and Specificity Study: The ground truth was based on the results of an "Other ELISA" kit. There was no human adjudication process described. "Equivocal results were excluded from calculations."
• Clinical Sensitivity and Specificity Study: The samples were "clinically characterized." This implies a clinical diagnosis process, which often involves multiple clinicians or a consensus, but no specific adjudication method (e.g., 2+1, 3+1) is detailed in the document. "Equivocal results were excluded from calculations."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay, and such studies are typically performed for imaging devices or AI-assisted diagnostic tools where human readers interpret results. The "MAGO Plus" is an automated processor, not a human reader. The correlation study between manual and MAGO Plus results assesses the equivalence of the method of processing, not the improvement of human readers.

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

Yes, the device operates as a standalone assay for detecting MPO IgG antibodies. The "algorithm" in this context refers to the chemical reactions and spectrophotometric measurement, not a computational algorithm. The performance of the test, both manually and with the MAGO Plus automated EIA processor, is the standalone performance of the assay to detect the target analyte.

7. The Type of Ground Truth Used

• Relative Sensitivity and Specificity Study:
  • Ground Truth: Results from a "similar assay" (other ELISA).
• Clinical Sensitivity and Specificity Study:
  • Ground Truth: "Clinically characterized" patient diagnoses (e.g., Normals, Wegener's Granulomatosis, Microscopic Polyangiitis). This is effectively a form of clinical diagnosis/outcomes data as established by medical professionals.

8. The Sample Size for the Training Set

The concept of a "training set" as understood in artificial intelligence and machine learning is not applicable to this traditional immunoassay device. ELISA kits are developed based on established biochemical principles (antigen-antibody binding) and calibrated using standards and controls, not trained on vast datasets of patient samples in the same way an AI model would be. Therefore, there is no discrete "training set" in the context of this device.

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

As noted above, there is no "training set" in the context of AI/ML for this device. The development and calibration of the ELISA kit would involve a different process:

• Antigen and Antibody Validation: Ensuring the MPO antigen used is pure and reactive, and the anti-human IgG conjugate is specific.
• Assay Optimization: Determining optimal reagent concentrations, incubation times, wash steps, and developing cut-offs or calibration curves using known positive and negative control materials. These controls and calibrators serve a role analogous to "ground truth" for assay performance characterization, but it's fundamentally different from training an ML algorithm.

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