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For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella.

The Mago 4S Automated EIA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

The MAGO 4S is an automated laboratory instrument designed to automate the processing of enzyme-linked immunoabsorbent assays (EIA) as well as Immunofluorescence Assay (IFA) slides. The MAGO 4S is designed to minimize manual operations associated with performing routine laboratory analysis by mechanizing and computerizing the test process.

The provided document describes the MAGO 4S, an automated laboratory instrument for processing enzyme-linked immunoabsorbent assays (EIA) and immunofluorescence assay (IFA) slides, specifically for the detection of IgG antibodies to rubella in human serum. The study aims to demonstrate substantial equivalence to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for precision, linearity, or agreement percentages before the study was conducted. Instead, it presents the results obtained and implies that these results are deemed acceptable for substantial equivalence. For the purpose of this table, I will infer the acceptance from the presented "Pass" results and the general expectation for such assays.

*   **CDC Performance Panel:** 100 sera provided by the CDC.
*   **CDC Biological Standard:** CDC Biological Standard, Low-Titer Anti Rubella Human Reference Serum, used with a dilution series.

• Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of performance testing for a new device, it is likely prospective, with samples collected or acquired specifically for this study. The country of origin for general samples is not mentioned, but the CDC performance panel samples are from the US.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of external human experts to establish ground truth for the test set that directly compares the MAGO 4S to a reference.
• For the "Positive and Negative Agreement with Comparator" test, the "manual" method acts as the comparative standard. The expertise for establishing the results of the manual method would rely on the laboratory personnel performing those tests, presumably qualified medical technologists or similar professionals.
• For the CDC Performance Panel, the "CDC Target" is used as the ground truth. This implicitly relies on the expertise and established reference methods of the CDC.

4. Adjudication Method

• The document does not describe a formal adjudication method (like 2+1 or 3+1) involving multiple human readers/reviewers for the test set.
• For the "Positive and Negative Agreement with Comparator," it seems a single manual test result was compared to a single MAGO 4S result for each sample. Equivocal results were specifically addressed in a retest zone assessment.

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

• No MRMC comparative effectiveness study was done. This study focuses on the performance of the automated instrument itself (standalone performance) against manual methods or established standards, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire submission details the performance of the MAGO 4S automated instrument (algorithm only, without human-in-the-loop performance) in various aspects such as precision, linearity, and agreement with established methods/standards.

7. Type of Ground Truth Used

• Existing Legally Marketed Devices/Manual Methods: For precision, linearity, and positive/negative agreement, the "Diamedix test kit" (manual method) serves as the comparator, and its results are implicitly considered ground truth for comparison.
• Reference Standards/Panels:
  • CDC Performance Panel: The "CDC Target" results for the 100 sera served as the external ground truth.
  • CDC Biological Standard: The expected IU/ml values for the various dilutions of the Low-Titer Anti Rubella Human Reference Serum served as the reference ground truth.

8. Sample Size for the Training Set

• The document does not provide information on a specific "training set" or sample sizes used for training the MAGO 4S in the context of machine learning or AI. This device appears to be an automated instrument following predefined protocols for assays (EIA/IFA) rather than a system requiring extensive machine learning model training on large datasets in the way modern AI devices do. Its "development" would involve engineering and calibration rather than algorithm training on a separate dataset.

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

• As noted in point 8, the document does not describe a "training set" in the context of machine learning. Therefore, methods for establishing ground truth for such a set are not applicable or described within this submission. The "ground truth" for the device's operational parameters would have been established during its engineering, calibration, and internal validation processes based on reference materials and established assay principles.

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For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassayas an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-Rheumatoid Factor Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum.

Acceptance Criteria and Device Performance for Is-Rheumatoid Factor Test System

This document outlines the acceptance criteria and the results of studies demonstrating the performance of the Diamedix Is-Rheumatoid Factor Test System, an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgM-class Rheumatoid Factor (RF) in human serum.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Is-Rheumatoid Factor Test System were established through comparative studies against another commercially available EIA kit and nephelometry, as well as an assessment of linearity, cross-reactivity, precision, and expected values in normal and clinical populations.

• Clinical Sera (18 samples): Sensitivity 50% (9/18 Positive) for Latex; Sensitivity 100% (18/18 Positive) for Is-RF.
• Other Sera (13 samples): Latex 4/13 Positive; Is-RF 10/13 Positive. Higher sensitivity for Is-RF compared to Latex. |
  | Linearity (WHO Standard) | High correlation coefficient (r) with serial dilutions. | Correlation Coefficient (r) = 0.9557. |
  | Linearity (In-House Standard) | High correlation coefficient (r) with serial dilutions. | Correlation Coefficient (r) = 0.9634. |
  | Lack of Cross-reactivity with other ANA | Minimal or no positive results from RF-negative samples containing other ANAs. | Out of 21 RF-negative samples with various ANAs (SSA, Sm, RNP, Scl-70, Jo-1, dsDNA, SSB), only one sample containing anti-SSB gave a very low positive result (21.2 IU/ml), all others were negative. This demonstrates minimal cross-reactivity. |
  | Lack of Prozone/High-Dose Hook Effects | No evidence of prozone or high-dose hook effects across a range of RF concentrations. | No prozone or high-dose hook effects were evidenced in 8 sera (4 high concentrated, 2 mid-range, 2 negative) tested with serial dilutions. |
  | Correlation of Manual and MAGO Plus Results | Strong positive correlation between manual and automated (MAGO Plus) testing. | Correlation Coefficient (r) = 0.9933 (95% CI: 0.9916 to 0.9946) for 303 normal and clinical serum samples. |
  | Precision (Intra-assay and Inter-assay) | Acceptable coefficient of variation (%CV) for various RF levels, within generally accepted laboratory standards. | Manual: Intra-assay %CV generally

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The Diamedix Is anti-β,Glycoprotein I Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is anti B, Glycoprotein I Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to ß, glycoprotein I in human serum

The provided text describes the performance characteristics of the "Is anti-β₂Glycoprotein I Screen Test System". This device is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM, and IgA antibodies to β₂ glycoprotein I in human serum, intended as an aid in the diagnosis of certain autoimmune thrombotic disorders in patients with SLE or SLE-like disorders.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for relative sensitivity, specificity, or overall agreement as a specific numerical threshold that the device must meet to be considered acceptable. Instead, it reports the observed performance and implicitly expects it to be within a reasonable range for an equivalent device. However, for clinical sensitivity and specificity, specific percentages are reported for different patient groups.

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The Diamedix Is anti-β ,Glycoprotein | IgG/IgM Test Kit is indications for OSS inmunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to ßglycoprotein I in human serum as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patlents with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is anti-β, Glycoprotein I IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to ß, glycoprotein in human serum

The Diamedix Is anti-β₂Glycoprotein I IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of IgG or IgM antibodies to β₂-glycoprotein in human serum. It is intended for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders in patients with SLE or SLE-like disorders.

Acceptance Criteria and Device Performance

The provided document describes several performance characteristics of the device, including:

1. Relative Sensitivity and Specificity (compared to commercially available ELISA kits)

2. Clinical Sensitivity and Specificity (against clinically characterized sera)

3. Precision (Intra-assay and Inter-assay Coefficient of Variation - CV%)

No explicit acceptance criteria for CV% are stated. However, typical expectations for ELISA precision would be CV% values generally below 15-20%, especially for higher concentration samples. The reported precision values are generally within acceptable ranges for immunoassays.

Manual Intra-assay and Interassay Precision for Is-anti-B₂-Glycoprotein I IgG (Selected CV% Values):

• Intra-assay (Range): 0.22% - 14.09%
• Interassay (Range): 2.26% - 9.82%

MAGO Plus - Intra-assay and Interassay Precision for Is-anti-B₂-Glycoprotein I IgG (Selected CV% Values):

• Intra-assay (Range): 1.12% - 22.35%
• Interassay (Range): 4.84% - 24.13%

Manual Intra-assay and Interassay Precision for Is-anti-B₂-Glycoprotein IgM (Selected CV% Values):

• Intra-assay (Range): 0.00% - 19.52%
• Interassay (Range): 3.92% - 17.15%

MAGO Plus - Intra-assay and Interassay Precision for Is-anti-B₂-Glycoprotein IgM (Selected CV% Values):

• Intra-assay (Range): 1.93% - 20.33%
• Interassay (Range): 9.89% - 19.77%

Study Details

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

• 3-point vs 6-point calibration:
  • 178 samples for IgG
  • 187 samples for IgM
• Relative Sensitivity and Specificity:
  • 172 frozen retrospective sera for IgG antibodies.
  • 161 frozen retrospective sera for IgM antibodies.
  • Data Provenance: Retrospective, no country of origin specified.
• Clinical Sensitivity and Specificity:
  • 388 frozen retrospective, clinically characterized sera. These included:
    • 248 normal sera
    • 57 sera from patients with diagnosed anti-phospholipid syndrome (APS)
    • 33 sera from patients with systemic lupus erythematosus (SLE)
    • 35 sera from patients with other autoimmune diseases (Sjogren's Syndrome, scleroderma, polymyositis/dermatomyositis)
    • 15 samples from patients with positive RPR titers
  • Data Provenance: Retrospective, no country of origin specified.
• Cross-Reactivity:
  • 50 samples reactive to various autoantibodies (SSA/SSB, Scl-70, Jo-1, dsDNA, RF, RPR positive).
• Linearity:
  • "Several highly positive samples" serially diluted.
• Correlation of Manual and MAGO Plus results:
  • 153 serum samples for anti-B₂ glycoprotein I IgG antibodies.
  • 163 sera for anti-B₂ glycoprotein I IgM antibodies.
• Precision:
  • 6 serum samples of varying reactivity tested in triplicate in three separate runs for both manual and MAGO Plus methods.
• Expected Values (Normal Population):
  • 148 S. Florida blood donors.
  • Data Provenance: Prospective (presumably from healthy donors), South Florida, USA.
• Expected Values (Clinical Population):
  • 57 sera from patients with a diagnosis of anti-phospholipid syndrome (APS).

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 of experts or their qualifications for establishing ground truth.
• For "Relative Sensitivity and Specificity," a "refereed EIA method" was used to resolve discordant samples, implying expert interpretation or confirmation of the referee test results, but without specifying the number or qualifications of experts.
• For "Clinical Sensitivity and Specificity," samples were described as "clinically characterized sera," implying a diagnosis by medical professionals, but again, without details on the number or specific qualifications of these clinicians.

4. Adjudication method for the test set:

• For "Relative Sensitivity and Specificity," discordant samples (between the test device and the "other EIAs") were sent for "further resolution" by a "referee EIA method." This implies an adjudication process where a third, presumably more definitive, method was used for discordant results. No specific "X+Y" adjudication rule is mentioned for expert review.

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 (IVD) assay, not an AI or imaging device involving human readers for interpretation. Its performance is evaluated biochemically, not through human reader interpretation of images or other data.

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

• Yes, the device was evaluated in a standalone manner. It is an ELISA test system that directly measures antibodies in serum. Its performance characteristics (sensitivity, specificity, precision, linearity, etc.) are inherent to the assay and its components, functioning "algorithm only" in the sense of a biochemical procedure. The document discusses both "manual" and "MAGO Plus Automated EIA Processor" usage, with the latter being automated, further supporting the standalone evaluation of the device's technical performance.

7. The type of ground truth used:

• Relative Sensitivity and Specificity: The ground truth was established by comparing the device's results against "commercially available ELISA kits" and, for discordant samples, a "referee EIA method." This is a comparative ground truth based on other established assay methods.
• Clinical Sensitivity and Specificity: The ground truth was based on "clinically characterized sera" from patients with diagnosed conditions (APS, SLE, other autoimmune diseases) or normal individuals. This represents a clinical diagnosis ground truth, implying that patients' disease status was determined by standard medical diagnostic procedures and clinical presentation.
• Cross-Reactivity: Ground truth was based on samples "reactive to various autoantibodies."
• Expected Values: Ground truth was based on "normal, healthy population" (blood donors) and "patients with a diagnosis of anti-phospholipid syndrome (APS)."

8. The sample size for the training set:

• The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional IVD device. The samples used for calibration (3-point vs 6-point) and for various performance studies (relative sensitivity/specificity, clinical sensitivity/specificity, precision, etc.) serve as validation data for the assay's performance characteristics. The assay is likely developed with internal validation data, but these details are not provided in a summary for regulatory submission.

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

• As this is not an AI/ML device, the concept of a "training set" with ground truth in that specific context does not apply. The development of the assay would involve internal R&D with characterized samples and controls to optimize reagents and procedures, which implicitly establishes "ground truth" for the internal optimization process. However, the document focuses on the validation studies for regulatory submission, as outlined in point 7.

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The Diamedix Is anti-Cardiolipin IgG/IgM Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is anti-Cardiolipin IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG or IgM antibodies to cardiolipin in human serum

Here's a breakdown of the acceptance criteria and study details for the Diamedix Is-anti-Cardiolipin IgG/IgM Test System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria with specific numerical targets. Instead, it describes performance characteristics and then presents the results. The implicit acceptance criteria are that the device demonstrates comparable performance to a commercially available predicate device and satisfactory analytical and clinical performance.

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The Diamedix Is anti-Cardiolipin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is anti-Cardiolipin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum

The provided submission K012450 describes the "Is anti-Cardiolipin IgA Test System," an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum. The results are intended to aid in assessing the risk of thrombosis in patients with SLE or SLE-like disorders.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria with numerical targets in the "Performance Characteristics" section. However, the studies presented imply that the observed performance values were considered acceptable for demonstrating substantial equivalence. The predicate device's performance would serve as an implicit benchmark.

Based on the provided data, the following table summarizes the reported device performance:

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

• 3-point vs 6-point calibration:
  • Sample Size: 190 samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). Implied to be retrospective as they are "results of 190 samples tested."
• Relative Sensitivity and Specificity:
  • Sample Size: 237 frozen retrospective sera.
  • Data Provenance: Retrospective, provenance not specified (e.g., country of origin).
• Clinical Sensitivity and Specificity:
  • Sample Size: 354 frozen retrospective, clinically characterized sera.
  • Data Provenance: Retrospective, provenance not specified (e.g., country of origin).
• Cross Reactivity:
  • Sample Size: 36 samples.
  • Data Provenance: Not explicitly stated, context implies retrospective.
• Linearity:
  • Data Provenance: Not explicitly stated, likely laboratory-prepared dilutions of highly positive samples.
• Manual and MAGO Plus results correlation:
  • Sample Size: 190 serum samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin). Implied to be retrospective.
• Precision:
  • Sample Size: 6 serum samples of varying reactivity. Each tested in triplicate in three separate runs (total of 9 measurements per sample for inter-assay).
  • Data Provenance: Not explicitly stated, likely laboratory samples.
• Expected Values (Normal Population):
  • Sample Size: 148 sera from a "normal, healthy population."
  • Data Provenance: South Florida, likely prospective collection of healthy individuals.
• Expected Values (Clinical Population - APS):
  • Sample Size: 57 sera from patients with a diagnosis of anti-phospholipid syndrome (APS).
  • Data Provenance: Not explicitly stated, likely retrospective collection from a clinical setting.

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

The submission does not mention the use of experts to establish ground truth for any of the test sets. The ground truths were established by:

• Comparative method: For relative sensitivity/specificity (using a "commercially available ELISA kit for detecting cardiolipin IgA antibodies" and a "referee EIA method").
• Clinical diagnosis: For clinical sensitivity/specificity ("patients with diagnosed antiphospholipid syndrome (APS)", "patients with systemic lupus erythematosus (SLE)", "patients with other autoimmune diseases", "patients with positive RPR titers").
• Established serological reactivity: For cross-reactivity ("samples which were reactive to various autoantibodies (SSA/SSB, Scl-70, Jo-1, dsDNA and RF)").

4. Adjudication method for the test set:

No adjudication method is mentioned for the establishment of ground truth in any of the studies. All ground truths appear to be based on existing clinical diagnoses or results from other established assays. For the "Relative Sensitivity and Specificity" study, "Further resolution of the discordant samples" was done using a "referee EIA method," which acts as a secondary resolution mechanism rather than an expert adjudication.

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

No, this device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.

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

The device itself is a standalone assay. The performance characteristics described (relative sensitivity/specificity, clinical sensitivity/specificity, precision, linearity, correlation with automated platform) all represent the "algorithm only" or device-only performance without human interpretation being a variable in the primary performance measures. The "Manual vs MAGO Plus" correlation study demonstrates the device's performance across two modes of operation (manual vs. automated), both of which are standalone in their result generation.

7. The type of ground truth used:

• Other ELISA kit and a referee EIA method: Used for "Relative Sensitivity and Specificity."
• Clinical diagnosis: For "Clinical Sensitivity and Specificity" (e.g., diagnosed APS, SLE, other autoimmune diseases, RPR positive).
• Serological reactivity to specific autoantibodies: For "Cross Reactivity."
• Established concentrations/dilutions: For "Linearity" and "Precision."
• Healthy population status and APS diagnosis: For "Expected Values."

8. The sample size for the training set:

The submission does not explicitly define a "training set" in the context of machine learning or AI development, as this is an ELISA assay. Therefore, there is no specified sample size for a training set in that sense. The studies described are performance evaluation studies, not algorithm training studies.

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

Not applicable, as there is no mention of an AI/ML training set in the context of this traditional IVD assay.

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The Diamedix Is anti-Gliadin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor

The Is anti-Gliadin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific threshold percentages for sensitivity, specificity, or agreement. Instead, it presents the calculated performance metrics and implies their acceptance through the 510(k) clearance.

Here's a table summarizing the reported performance, with implied "acceptance criteria" being the demonstrated values:

2. Sample Sizes and Data Provenance

• Relative Sensitivity and Specificity Study (Comparison to predicate device):
  • Sample Size: 190 frozen retrospective sera.
  • Data Provenance: Not explicitly stated by country, but mentions "samples submitted to a large reference laboratory for celiac disease evaluation." This suggests a clinical laboratory setting, likely within the US given the submission to the FDA. The data is retrospective.
• Clinical Sensitivity and Specificity Study:
  • Sample Size: 484 frozen retrospective, clinically characterized sera.
  • Data Provenance: Not explicitly stated by country, but sourced from "214 normal sera, 72 sera from patients with possible celiac disease... 61 sera from patient with diagnosed celiac disease, 54 sera from patients with other gastrointestinal diseases, etc." This suggests a clinical setting, likely within the US. The data is retrospective.
• Correlation of Manual and MAGO Plus results:
  • Sample Size: 177 serum samples.
  • Data Provenance: Not specified, but implied to be from the same development/testing location.
• Precision Study:
  • Sample Size: 6 serum samples tested in triplicate in three separate runs (total of 9 measurements per sample for inter-assay determination).
  • Data Provenance: Not specified.
• Expected Values (Normal Population):
  • Sample Size: 148 S. Florida blood donors.
  • Data Provenance: South Florida, USA; prospective (testing for prevalence in a specific healthy population).
• Expected Values (Clinical Population):
  • Sample Size: 61 sera from patients with celiac disease.
  • Data Provenance: Not explicitly stated, likely related to the clinical sensitivity study samples.

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

• Relative Sensitivity and Specificity Study:
  • Ground truth was based on a "commercially available ELISA kit for detecting gliadin IgA antibodies" (the predicate device) and "a referee EIA method" for discordant samples. No human experts are explicitly mentioned for establishing ground truth in this section, as it's a comparison to other assays.
• Clinical Sensitivity and Specificity Study:
  • The sera were "clinically characterized," and for "Diagnosed Celiac Disease," it implies a prior clinical diagnosis. For "Normals," it's understood they are healthy individuals based on clinical assessment.
  • The document does not specify the number or qualifications of experts involved in establishing the clinical characterization or diagnosis for the retrospective samples.

4. Adjudication Method for the Test Set

The adjudication methods for establishing ground truth for the test sets are as follows:

• Relative Sensitivity and Specificity Study: Discordant samples between the investigational device and the predicate device were adjudicated using "a referee EIA method." This implies an independent, tertiary test for conflict resolution rather than human expert consensus.
• Clinical Sensitivity and Specificity Study: The "clinically characterized sera" implies that patients were categorized based on established clinical diagnostic criteria for celiac disease or other conditions, potentially involving biopsies, clinical symptoms, and other serological markers, but a specific "adjudication method" (e.g., 2+1 physician review) is not detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The device is a diagnostic assay (ELISA), not an imaging or interpretive AI system that typically involves human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire performance evaluation (Relative Sensitivity/Specificity, Clinical Sensitivity/Specificity, Precision, Correlation with automation) assesses the algorithm's performance (in this case, the assay's performance) as a standalone diagnostic tool without human-in-the-loop assistance in the interpretation of the primary result. The output is a semi-quantitative measurement of IgA antibodies.

7. Type of Ground Truth Used

The types of ground truth used are:

• Relative Sensitivity and Specificity Study: Comparison against a predicate commercial ELISA kit for anti-gliadin IgA antibodies and a "referee EIA method" for discordant samples. This is a form of comparative ground truth against established assays.
• Clinical Sensitivity and Specificity Study: Clinical characterization/diagnosis of patients (e.g., "Diagnosed Celiac Disease," "Normals," "Other Gastrointestinal Diseases"). This relies on a combination of clinical outcomes, other diagnostic tests, and physician diagnosis, which can be considered a form of clinical ground truth or patient outcomes ground truth.

8. Sample Size for the Training Set

The document does not mention or specify a separate training set for the device. This device is an in-vitro diagnostic (IVD) ELISA assay, not a machine learning or AI algorithm that typically requires a distinct training phase on a large dataset. The performance studies evaluate its diagnostic capabilities on test sets.

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

Since a distinct "training set" is not described for this type of device, the method for establishing its ground truth is not applicable. The development and optimization of such assays typically involve internal R&D validation using characterized samples, but this is not explicitly outlined as a "training set" in the context of this 510(k) submission.

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The Diamedix Is anti-Gliadin IgG Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-anti-Gliadin IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG antibodies to gliadin in human serum.

Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in a quantitative format (e.g., "sensitivity must be >X%"). Instead, it presents performance characteristics and implies that these results are deemed acceptable for substantial equivalence to the predicate device and for the intended use.

Based on the provided data, we can infer the following performance metrics:

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The Diamedix Is anti-Cardiolipin Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor

The Is anti-Cardiolipin Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum

Here's a breakdown of the acceptance criteria and the study details for the Is anti-Cardiolipin Screen Test System, based on the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets. Instead, the submission demonstrates the device's performance through comparison to a similar device and its clinical utility in specific patient populations. The "acceptance criteria" can be inferred as achieving satisfactory levels of agreement and correlation with established methods, along with demonstrating clinical sensitivity and specificity.

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

• Relative Sensitivity and Specificity Study:
  • Sample Size: 203 frozen, retrospective sera.
  • Data Provenance: Not explicitly stated, but implied to be from a general population from which frozen sera were collected.
• Clinical Sensitivity and Specificity Study:
  • Sample Size: 345 frozen, retrospective, clinically characterized sera.
  • Data Provenance: Not explicitly stated, but includes "Normals," "patients with diagnosed anti-phospholipid syndrome (APS)," "patients with systemic lupus erythematosus (SLE)," "patients with other autoimmune diseases," and "patients with positive RPR titers." These are clinical samples.
• Correlation of Manual and MAGO Plus results:
  • Sample Size: 152 serum samples.
  • Data Provenance: Not explicitly stated, but implies routine clinical samples tested by both methods.
• Precision Study:
  • Sample Size: Six serum samples (two negative, four positive), tested in three separate runs, generally in triplicate per run for intra-assay, leading to 9 replicates for interassay (n=9).
  • Data Provenance: Not explicitly stated.
• Expected Values Study (Normal Population):
  • Sample Size: 148 S. Florida blood donors.
  • Data Provenance: Prospective collection from "S. Florida blood donors."
• Expected Values Study (Clinical Population):
  • Sample Size: 57 sera from patients with a diagnosis of anti-phospholipid syndrome (APS).
  • Data Provenance: Retrospective, clinically characterized sera.

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

There is no mention of experts being used to establish a ground truth for the test sets in the traditional sense of consensus reading or clinical adjudication.

• For the "Relative Sensitivity and Specificity" study, the ground truth was established by comparison to a "commercially available ELISA kit" and further resolved by a "referee EIA method."
• For the "Clinical Sensitivity and Specificity" study, the ground truth was based on "clinically characterized sera" and "diagnosed" patient populations (APS, SLE, etc.). This implies medical diagnosis as the ground truth.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method like 2+1 or 3+1. The studies rely on comparison to existing commercial assays or established clinical diagnoses. In the "Relative Sensitivity and Specificity" study, there was "further resolution of the discordant samples" using a referee EIA method, which acts as a form of adjudication but not involving human readers/experts.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in the provided text. This device is an immunoassay kit, not an AI-powered diagnostic system involving human readers.

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

This refers to an immunoassay kit. The "standalone" performance is assessed by its analytical characteristics (sensitivity, specificity, precision, correlation to other methods) and clinical performance without human interpretation being the primary variable. The device itself generates a semi-quantitative result. The "MAGO Plus Automated EIA Processor" represents an automated, "algorithm-only" (i.e., machine-only) method for running the assay, and its correlation with manual performance was specifically studied.

7. The Type of Ground Truth Used

• Relative Sensitivity and Specificity Study: Comparison to a commercially available ELISA kit and a "referee EIA method." This is a form of reference standard comparison (another validated test).
• Clinical Sensitivity and Specificity Study: Clinical diagnosis of specific conditions (e.g., diagnosed Anti-phospholipid Syndrome (APS), Systemic Lupus Erythematosus (SLE), normal status). This is a form of outcomes data/clinical characterization.
• Expected Values Study:
  • Normal population: Healthy blood donor status (absence of disease).
  • Clinical population: Clinical diagnosis of Anti-phospholipid Syndrome (APS).

8. The Sample Size for the Training Set

There is no mention of a separate "training set" in the context of machine learning or AI. This is a traditional immunoassay kit. Method development and optimization would have involved internal lab work, but not a distinct "training set" as understood in AI/ML. All samples mentioned in the summaries above would typically be considered "test sets" or "validation sets" for the final device performance.

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

As there is no mention of a training set in the AI/ML context, this question is not applicable. The development of the assay itself would have involved establishing the optimal conditions and reagents, but not "ground truth" for a training set in the AI sense.

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