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EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.

EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.

The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The provided text describes a submission for an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set size, expert adjudication, etc.) are not applicable and cannot be extracted from this document.

However, I can extract information regarding acceptance criteria and device performance from the provided text, focusing on the clinical study that supports its intended use.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the form of a table. However, it implies that the device's performance needs to be comparable to the predicate device and show appropriate results with clinically defined sera and normal populations.

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

• Sample Size: The document does not explicitly state the specific number of samples for the test set used in the comparison study, clinically defined sera, or normal population. It mentions "a data set including results obtained within a comparison study," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)."
• Data Provenance: Not specified in terms of country of origin. The study appears to be retrospective, using existing "clinically defined sera" and "samples from apparently healthy subjects."

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

Not applicable. This is an immunoassay, not an AI/ML device requiring expert interpretation of images or other complex data for ground truth establishment. The "ground truth" for this type of device would typically be the clinical diagnosis of primary biliary cirrhosis, likely established by standard clinical criteria, not by individual experts assessing the samples themselves for ground truth.

4. Adjudication method for the test set

Not applicable. This is an immunoassay. The concept of adjudication for a test set typically applies to areas where human interpretation or labeling is involved, such as image analysis.

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

Not applicable. This is an immunoassay, not an AI/ML device, and no human reader interpretation is described.

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

This refers to the performance of the immunoassay device itself. The study described focuses on the comparison of the new immunoassay device (EliA M2) to a predicate device (Quanta Lite M2 EP (MIT3), INOVA K052262), and its performance with clinically defined sera and healthy subjects. The entire system (reagents, instrument Phadia 100/250, and software for evaluation) constitutes the "standalone" performance of the diagnostic test.

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

The ground truth for the "clinically defined sera" and "samples from apparently healthy subjects" would be based on the established clinical diagnosis of Primary Biliary Cirrhosis (PBC) for positive cases and the absence of PBC for healthy subjects, determined through a combination of clinical findings and other laboratory tests. The document implies a clinical diagnosis.

8. The sample size for the training set

Not applicable. This is an immunoassay, not an AI/ML device that requires a training set in the conventional sense. The "training" of the device is inherent in its design and calibration, not through data learning.

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

Not applicable for the same reasons as point 8.

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EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 100.

EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 250.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 100.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 250.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 100.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 250.

EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method.

EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ß-D-Galactoside as substrate.

The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The Phadia US, Inc. EliA™ PR3s, EliA™ MPOs, and EliA™ GBM immunoassays are intended for the semi-quantitative measurement of IgG antibodies to PR3, MPO, and alpha3 chain of collagen IV, respectively. These tests aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA), microscopic polyangitis (MPA), and Goodpasture syndrome when used in conjunction with other laboratory and clinical findings. The EliA ANCA/GBM Positive Controls are for monitoring the performance of these immunoassays.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) for the new devices (EliA PR3s, EliA MPOs, EliA GBM). Instead, it focuses on demonstrating "laboratory equivalence" to predicate devices.

The study indicates:

• Results obtained within a comparison study between new and predicate device.
• Results obtained for clinically defined sera.
• Results obtained for samples from apparently healthy subjects (normal population).

The overarching conclusion is: "In summary, all available data support that the new devices are substantially equivalent to the predicate devices."

Without explicit quantitative criteria, a table like the one requested cannot be fully populated. However, if we infer "equivalence" as the acceptance criterion, the reported performance is that this equivalence was supported by the comparison studies.

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

The document mentions "a data set including results obtained within a comparison study between new and predicate device, results obtained for clinically defined sera, and results obtained for samples from apparently healthy subjects (normal population)."

• Test Set Sample Size: The document does not specify the exact sample sizes used for the comparison study, clinically defined sera, or healthy subjects.
• Data Provenance: The document does not specify the country of origin for the data. It also does not explicitly state if the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic, it is highly probable that the "clinically defined sera" and "samples from apparently healthy subjects" would be retrospective collections, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document describes the devices as "intended for the in vitro semi-quantitative measurement of IgG antibodies... to aid in the clinical diagnosis... in conjunction with other laboratory and clinical findings." The "clinically defined sera" implies that the cases likely had their diagnosis confirmed by clinical experts.

• Number of Experts: The document does not specify the number of experts used to establish the ground truth for the clinically defined sera.
• Qualifications of Experts: The document does not specify the qualifications of these experts. However, for "clinically defined" cases, it would typically involve physicians specializing in the relevant diseases (e.g., rheumatologists, nephrologists) who use a combination of clinical symptoms, imaging, and other laboratory tests for diagnosis.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth for the test set.

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

• Was an MRMC study done? No, the devices are immunoassays, which are laboratory tests that produce a quantitative or semi-quantitative result. They are not image-based AI tools interpreted by human readers, so an MRMC comparative effectiveness study involving human readers is not applicable to this type of device.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, the described "comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects" represent the standalone performance of the immunoassay system. The device itself (the immunoassay) produces the semi-quantitative measurement of antibodies. There is no human-in-the-loop component for interpreting the direct output of these specific diagnostic tests, although a clinician then uses these results in conjunction with other findings for diagnosis.

7. Type of Ground Truth Used

The ground truth for the clinical cases appears to be "clinically defined diagnoses." The document specifically mentions "clinically defined sera," implying that patients were diagnosed with GPA, MPA, or Goodpasture syndrome based on established clinical criteria, which would likely include a combination of clinical symptoms, other laboratory tests, and potentially biopsy results (e.g., pathology for kidney biopsies in Goodpasture syndrome). For the "healthy subjects," the ground truth is the absence of these diseases.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size. For an immunoassay, the "training" analogous to machine learning often involves assay development, optimization, and establishment of referent ranges and cut-offs. The sample sets described ("comparison study," "clinically defined sera," "healthy subjects") are typically used for validation or verification of performance, not explicitly for "training" in the AI sense.

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

As no explicit "training set" is described in the context of machine learning, the establishment of its ground truth is not applicable. For the performance studies, as mentioned in point 7, the ground truth was based on clinically defined diagnoses.

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EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.

EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.

Not Found

This document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on the "Indications for Use" and the substantial equivalence determination rather than a comprehensive description of acceptance criteria and a deep dive into the study details. However, based on the provided text, here's what can be extracted and inferred:

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

The provided text does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics in a structured table format. The EliA™ SmDP Immunoassay is an "Antinuclear Antibody Immunological Test System" (21 CFR §866.5100), and its performance would typically be evaluated based on its ability to detect IgG antibodies directed to Sm with acceptable sensitivity and specificity for aid in the clinical diagnosis of systemic lupus erythematosus (SLE).

Without a dedicated section on performance data, it's impossible to create the requested table from the provided text.

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

The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for any test set. For immunological assays like this, the "ground truth" often involves clinical diagnosis of SLE based on established ACR or SLICC criteria, which might involve expert physicians, but this isn't detailed here.

4. Adjudication method for the test set

The document does not mention any adjudication method used for a test set.

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

This device, the EliA™ SmDP Immunoassay, is an in vitro diagnostic (IVD) assay designed to semi-quantitatively measure antibodies. It is not an AI-based device that would typically involve "human readers" or "AI assistance" in the way a medical imaging AI device would. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable to this type of device, and no such study is mentioned.

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

This is an IVD immunoassay, essentially a laboratory test system. Its "performance" is inherently standalone in the sense that the assay results are generated by the instrument (Phadia 100 or Phadia 250) based on the sample, without real-time human interpretation affecting the raw measurement. The human-in-the-loop comes in when a clinician interprets the results in conjunction with other clinical findings. The document doesn't provide a specific study abstract, but the nature of an immunoassay implies standalone analytical performance.

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

Given the "Indications for Use" state "as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings," the ground truth for evaluating the device's performance would most likely be established based on clinical diagnosis of SLE, potentially using established classification criteria (e.g., American College of Rheumatology (ACR) criteria or Systemic Lupus International Collaborating Clinics (SLICC) criteria), which implicitly involves a form of expert consensus and possibly other laboratory and pathology findings. The document itself doesn't explicitly state the methodology for establishing this ground truth for the studies conducted.

8. The sample size for the training set

The document does not provide details about a training set or its sample size. For an immunoassay, the concept of a "training set" in the context of machine learning (where this question typically applies) is not directly relevant. Instead, the assay's parameters would be established during development and analytical validation, which involves calibration and analytical studies, not a "training set" as understood in AI/ML.

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

As in point 8, the concept of a "training set" and its ground truth establishment, as typically applied to AI/ML, isn't directly applicable for this type of immunoassay. The clinical "ground truth" for evaluating its diagnostic utility would be established through clinical studies, as described in point 7.

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EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100.

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The provided text describes the regulatory submission for the EliA™ Cardiolipin IgA Immunoassay and associated control devices. However, it does not contain any information about acceptance criteria or specific study results that prove the device meets such criteria.

The document primarily focuses on:

• 510(k) Summary details: Manufacturer, contact, device names, common name, classification, and date.
• Intended Use Statements: Explicitly stating what the EliA Cardiolipin IgA device is designed to measure (IgA antibodies to cardiolipin) and its purpose (aiding in diagnosis of APS and thrombotic disorders related to SLE) on Phadia 100 and Phadia 250 instruments.
• Special Conditions for Use: Prescription use only.
• Special Instrument Requirements: Phadia 100/250 automated immunoassay analyzers.
• General Description and Test Principle: Explains the fluorescence-immunoassay system, antigen coating, and methodology.
• Device Comparison: States that the new device and predicate (Quanta Lite IgA ACA (HRP), K953366) are both non-competitive solid phase ELISAs used for similar diagnostic aids.
• Laboratory Equivalence: Mentions that comparability is supported by a comparison study, clinically defined sera, and samples from healthy subjects, concluding with a statement of substantial equivalence.
• FDA Correspondence: Official letter acknowledging receipt and approval of the 510(k) submission, confirming substantial equivalence and providing regulatory information.
• Indications for Use Forms: Repeated forms for the main device and its associated positive and negative controls, reiterating their intended uses.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document states that a "comparison study between new and predicate device" and "results obtained for clinically defined sera" were used to support laboratory equivalence, but it does not present the data, the specific acceptance criteria, or the methodology of these studies.

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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500, Phadia 5000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance Study

The provided document describes the submission of new ImmunoCAP Allergen Components to be added to an existing ImmunoCAP Specific IgE assay, a quantitative in vitro assay for measuring allergen-specific IgE antibodies. The submission asserts that the safety and effectiveness of the cleared device ImmunoCAP Specific IgE system have already been established in previous 510(k) submissions. This current submission focuses on demonstrating that the new allergen components maintain the performance characteristics of the established system.

The "acceptance criteria" are implied by the nature of the performance characteristics studied, which are typical for in vitro diagnostic devices. Since the device is an in vitro quantitative assay and the new components are additions to an existing system, the acceptance criteria would revolve around ensuring these new components perform similarly and reliably to established ones.

No explicit table of acceptance criteria with numerical targets is provided. Instead, the document states that performance characteristics were "established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the analytical specificity of the allergen components." The reported device performance is that these studies were conducted and the conclusion drawn is that the new components are suitable additions to the existing assay.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical values for precision, linearity, LoD, or the results of the comparative study. It only states that these studies were performed and that the new components are acceptable.

2. Sample Size and Data Provenance

• Sample Size for the test set: Not explicitly stated. The document mentions "clinical samples, as well as samples from healthy, nonatopic donors" were used for comparison with predicate devices. The exact number of samples for each type is not provided.
• Data Provenance: Not explicitly stated. Given that Phadia AB is located in Sweden and Phadia US Inc. is the distributor, it's possible the clinical samples originated from either country or other regions. The document does not specify whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement. The ground truth for such devices is typically established through analytical methods, reference standards, and correlation with clinical diagnoses, not usually through a panel of human expert readers adjudicating images or cases in the same way as an AI-powered image analysis system would.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring specific IgE levels, there isn't a "test set" in the context of human expert adjudication. The comparison was against established extract-based predicate devices using clinical and non-atopic samples.

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

Not applicable. This is an in vitro diagnostic device, not an AI-powered image analysis system or a decision support system that involves human readers interpreting results in an MRMC study setup.

6. Standalone (Algorithm Only) Performance

Yes, in a sense. The ImmunoCAP Specific IgE system (including these new components) is an automated quantitative assay. Its performance is evaluated independently of human interpretation of the raw reaction directly. The "algorithm" here refers to the instrument's processing of results and calculation of concentrations based on a calibration curve. The studies on precision, linearity, LoD, and analytical specificity assess this standalone performance of the assay itself.

7. Type of Ground Truth Used

For the analytical performance studies (precision, linearity, LoD, specificity), the ground truth is established using:

• Reference materials/standards: For linearity and LoD, known concentrations of IgE antibodies or spiked samples would typically serve as the ground truth.
• Established analytical methods: For specificity, the ability to selectively detect the target allergen is the ground truth.
• Clinical correlation: While not explicitly detailed for the new components, the overall ImmunoCAP Specific IgE assay is intended "as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings." This implies a connection to clinical outcomes or diagnoses for the broader system. For the comparative study, the performance of the extract-based predicate devices served as a comparative reference.

8. Sample Size for the Training Set

Not applicable. This device is an in vitro diagnostic assay. It does not use a "training set" in the context of machine learning algorithms. The "training" in this context would refer to the development and optimization of the assay reagents and protocols, which is a laboratory R&D process, not a machine learning training process with a distinct "training set."

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

Not applicable, as there is no "training set" in the machine learning sense. The assay development process involves analytical validation using standards and reference materials to ensure the assay accurately measures the target analyte.

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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Instrument System - Phadia 100. Phadia 250 and Phadia 1000 instruments with built-in software process all steps of the assay and print results automatically after the assay is completed.

ImmunoCAP Specific IgE, Test Principle: The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

The provided text describes a 510(k) submission for new ImmunoCAP Allergen Components and refers to the performance characteristics established in previous 510(k) submissions for the ImmunoCAP Specific IgE system. Therefore, the acceptance criteria and study details are largely summarized rather than exhaustively detailed for this specific submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format for this 510(k) submission. Instead, it states that "The performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the immunological specificity of the allergen components."

The conclusion states: "The safety and effectiveness of the cleared device ImmunoCAP Specific IgE system for the determination of specific IgE antibodies have been established in previous 510(k) submissions." This implies that the new allergen components meet the same performance standards as the existing system.

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

• Sample Size: The document states that the new ImmunoCAP Allergen Components were compared with predicate devices using "clinical samples, as well as samples from healthy, nonatopic donors." Specific numbers for the sample size are not provided.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though "clinical samples" often implies retrospective use of existing samples.

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

This information is not provided in the document. The device is a laboratory assay measuring IgE antibodies; the "ground truth" for such assays typically refers to agreement with established methods or clinical diagnosis, not expert image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. Given it's a quantitative assay, adjudication in the sense of resolving conflicting interpretations is typically not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation where human readers are involved. This document describes an in vitro diagnostic (IVD) assay where the instrument provides quantitative results.

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

Yes, the performance described is inherently standalone, as it refers to the device and its components generating quantitative results without human-in-the-loop performance influencing the assay's measurement. The instruments (Phadia 100, Phadia 250, and Phadia 1000) process all steps and print results automatically.

7. The Type of Ground Truth Used

The "ground truth" for this type of in vitro diagnostic assay would be the actual concentration of allergen-specific IgE antibodies or correlation with clinical diagnosis of allergic disorders. The document implies that the performance was established by comparison with "extract based predicate devices" using "clinical samples" and "samples from healthy, nonatopic donors," suggesting a comparison against established methods and clinical status. More specific details on how this "ground truth" was rigorously defined are not present in this summary.

8. The Sample Size for the Training Set

The document describes premarket notification for new allergen components being added to an existing system. It does not mention a "training set" as would be relevant for machine learning algorithms. Performance characteristics were evaluated with "clinical samples" and "healthy, nonatopic donors" for the purpose of demonstrating substantial equivalence, not for training an algorithm. Therefore, no distinct training set sample size is provided.

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

Since there is no mention of a training set for an algorithm, this question is not applicable. The ground truth for evaluating the performance of the assay itself would be based on the established clinical or laboratory standards as mentioned in point 7.

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EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein 1 IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-specific, method-specific and general reagents that are packaged as separate units.

Here's a breakdown of the acceptance criteria and study information for the EliA™ ß2-Glycoprotein I IgA Immunoassay, based on the provided 510(k) summary:

The provided 510(k) summary primarily focuses on establishing "substantial equivalence" to a predicate device for this in vitro diagnostic (IVD) immunoassay, rather than presenting a performance study with detailed acceptance criteria in the manner one might see for an AI/software device or a medical imaging device. The "performance" here relates to how well the new device compares to the predicate and its ability to detect the target antibodies.

1. Table of Acceptance Criteria and the Reported Device Performance

• Comparison study between new and predicate device
• Results from clinically defined sera
• Results from samples of apparently healthy subjects (normal population)
  Overall Finding: All available data support the new device is substantially equivalent to the predicate device. |
  | Intended Use | Semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I to aid in diagnosis of antiphospholipid syndrome (APS) and thrombotic disorders related to systemic lupus erythematosus (SLE). | The device's performance supports its intended use as described. |
  | Method | Uses EliA IgA method on Phadia 100 and Phadia 250 instruments. | The device is designed to operate with these instruments and methods. |
  | Calibration | IgA calibration based on six WHO-standardized IgA Calibrators; initial calibration curve valid for up to 28 days; includes calibrator (curve) controls with defined recovery ranges. | The system incorporates this calibration method to ensure validity and accuracy. |

Explanation of "Acceptance Criteria" for IVDs in a 510(k) context: For an in vitro diagnostic device seeking 510(k) clearance, acceptance criteria often revolve around demonstrating analytical and clinical performance comparable to a legally marketed predicate device. This typically involves studies on precision, accuracy (comparison to a reference method or predicate), linearity, detection limits, interference, and agreement studies for clinical samples. The provided summary is very high-level and only states that data supports equivalence, rather than detailing specific numerical criteria used in those studies (e.g., "agreement rate >90%").

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

The summary does not provide specific sample sizes for the "test set" or explicit data provenance (e.g., country of origin). It generally refers to:

• "results obtained within a comparison study between new and predicate device"
• "results obtained for clinically defined sera"
• "results obtained for samples from apparently healthy subjects (normal population)"

This indicates the data was collected retrospectively from various sample sources to facilitate comparison. Without more detail, it's not possible to determine if the samples were prospective.

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

This information is not provided in the summary. For an IVD, "ground truth" (or clinical truth) for samples used in method comparison or clinical concordance studies would typically be established by combining patient clinical diagnoses (e.g., diagnosed with APS or SLE by a rheumatologist/hematologist) with results from established, often predicate, diagnostic tests. The summary implies "clinically defined sera" were used, meaning these samples had a known clinical status, but the process of establishing that status (e.g., number and qualifications of clinicians) is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the summary. For IVDs, adjudication isn't typically used in the same way as for imaging devices where multiple readers interpret images. Instead, the "ground truth" for clinical samples is based on a patient's overall clinical presentation and diagnosis, typically accepted as definitive for the study.

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 done. This type of study is relevant for medical imaging AI devices where human readers interpret images. The EliA™ ß2-Glycoprotein I IgA Immunoassay is an in vitro diagnostic (IVD) serological test, not an imaging device, and does not involve human "readers" interpreting results in a way that an MRMC study would be applicable.

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

This refers to the performance of the immunoassay system itself. The device is described as a "fully integrated and automated system for immunodiagnostic testing" and requires operation on the "Phadia 100/Phadia 250" instruments which include "software for evaluation of test results." Therefore, its performance is inherently "standalone" in the sense that the instrument-software system processes the sample and yields a result without direct human interpretation of a raw signal. The comparison studies described are essentially evaluating this standalone performance against the predicate.

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

The summary implies two types of "ground truth" for the performance studies:

• Predicate Device Results: For the "comparison study between new and predicate device," the predicate device's results (Varelisa ß2-Glycoprotein I IgA Antibodies, K040450) would serve as a comparative ground truth.
• Clinical Diagnoses: For "clinically defined sera," the ground truth would be the clinical diagnosis of the patient (e.g., presence or absence of APS or SLE-related thrombotic disorders), presumably based on a combination of clinical symptoms, other laboratory findings, and expert physician assessment. The "samples from apparently healthy subjects" provide a "negative" ground truth based on their healthy status.

8. The Sample Size for the Training Set

The summary does not mention a training set in the context of machine learning or AI. This device is an immunoassay, not an AI or machine learning device that requires a separate training phase. The "calibration" of the device is based on a set of WHO-standardized IgA Calibrators, which is distinct from a machine learning training set.

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

As no training set (in the machine learning sense) is discussed, this question is not applicable. The "ground truth" for the calibration is established by using "WHO-standardized IgA Calibrators derived from human serum," implying these calibrators have a known and certified IgA concentration.

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ImmunoCAP Tryptase is an in vitro semi-quantitative assay for measurement of tryptase in human serum or plasma (EDTA, lithium heparin or sodium heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.

ImmunoCAP Tryptase is to be used with the instruments Phadia 100, Phadia 250, or Phadia 1000.

ImmunoCAP Tryptase is a fluorescence immunoassay for the measurement of human tryptase based on ImmunoCAP solid phase. ImmunoCAP Tryptase measures the total tryptase levels including all forma of a-tryptase and B-tryptase. ImmunoCAP Tryptase concentrations are quantitatively reported in microgram/L (ug/L).

ImmunoCAP Tryptase consists of assay specific reagents to be used as part of Phadia Laboratory Systems along with already cleared instruments (including instrument and data management software) and system reagents (system reagents were cleared in K051218).

ImmunoCAP Tryptase kits (for the Phadia 100, Phadia 250, and Phadia 1000) contain the following reagents:

• ImmunoCAP Tryptase Conjugate
• ImmunoCAP Tryptase Anti-Tryptase bound to ImmunoCAP carrier
• Development solution
• Stop solution
• Washing solution
• IgE/ECP/Tryptase sample diluent (available separately, not included in the ImmunoCAP Tryptase kit)
• ImmunoCAP Tryptase Control (prepared from selected pooled human serum and lyophilized)

In addition, the Phadia 100 kit includes the following reagents:

• Tryptase calibrators (1, 5, 12.5, 50, and 200 µg/L human tryptase in buffer)
• Tryptase Curve Control 1 (single dose vials of human tryptase in buffer)

In addition, the Phadia 250 and Phadia 1000 kits include the following reagents:

• ImmunoCAP Tryptase Calibrator Strip (1, 5, 12.5, 50, and 200 µg/L human tryptase in buffer)
• Tryptase Curve Control Strip (human tryptase in buffer)

The IMMUNOCAP TRYPTASE device is a fluorescence immunoassay for the measurement of human tryptase, intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis. The device's performance was evaluated through various studies, including precision, linearity, recovery, stability, detection limit, hook effect, analytical specificity, and clinical studies for sensitivity and specificity.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for precision were defined as a maximum total CVtotal% that would be met for all samples. The exact numerical criteria are obscured in the provided document (b)(4).

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

• Precision (Phadia 100): 10 serum samples.
• Precision (Phadia 250): 16 serum samples.
• Precision (Phadia 1000): 15 serum samples.
• Linearity: 6 serum samples.
• Hook Effect: 5 samples (two serum, one EDTA plasma, one lithium heparin plasma, one sodium heparin plasma).
• Analytical Specificity: Two studies each with two serum samples (13.2 µg/L and 1.8 µg/L tryptase) and three serum samples (with tryptase levels (b)(4)). Heparin interference tested with blank and tryptase-spiked samples. HAMA tested with serum samples.
• Matrix Comparison:
  • Serum and EDTA Plasma: 21 healthy patients.
  • Serum, Lithium Heparin Plasma, and Sodium Heparin Plasma: 20 healthy patients.
• Instrument Comparison: 50 individual samples, 3 pooled internal control samples, and two lots of ImmunoCAP Tryptase Control.
• Clinical Studies (Adults): 138 adult patients. Data provenance: Samples collected at one site in Spain over a 3-year period (retrospective/prospective not explicitly stated, but "over a 3-year period" suggests collection over time).
• Clinical Studies (Pediatric): 156 pediatric patients. Data provenance: Samples collected at one site in Spain over an eight-year period (2003-2011).
• Expected Values/Reference Range: 124 healthy individuals (89 adults, rest children).

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

The ground truth for the clinical studies (systemic mastocytosis diagnosis) was established based on the WHO recommendations for mastocytosis, primarily the 4th edition of "WHO classification of tumors of hematopoietic and lymphoid tissues from 2008".

The studies mention the "Spanish Network on Mastocytosis" coordinated sample collection and patient classification. The WHO criteria themselves are based on a consensus proposal from "a large number of patients with established mastocytosis in different centers of Europe and North America" and involved a "consensus meeting 'Year 2000 Working Conference on Mastocvtosis'".

It is not specified how many individual experts established the ground truth for the specific 138 adult and 156 pediatric cases used in these studies, nor their individual qualifications (e.g., specific years of experience for radiologists). However, the ground truth is anchored in an internationally recognized consensus process and WHO classification, indicating a high level of expert involvement in developing the criteria.

4. Adjudication Method for the Test Set

The diagnostic classification for systemic mastocytosis was done "according to the WHO recommendations for mastocytosis, without consideration of the fourth minor criterion of tryptase levels persistently exceeding 20 ug/L" for the initial analysis. A reanalysis then included tryptase results to see the impact on classification.

This indicates an adjudication method based on an established medical guideline (WHO criteria), where the device's output (tryptase level) was initially excluded from the diagnosis to evaluate its standalone performance against the other criteria, and then included to reflect its intended use. There is no mention of a traditional reader adjudication method like 2+1 or 3+1 involving human readers explicitly reviewing cases to establish ground truth for each test case. Instead, the ground truth is derived from a set of clinical and laboratory findings interpreted by clinicians/pathologists following WHO guidelines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies evaluate the analytical performance of the automated ImmunoCAP Tryptase assay and its clinical effectiveness (sensitivity and specificity) in diagnosing systemic mastocytosis based on a WHO-defined cutoff, not the improvement of human readers with AI assistance. This device is an in vitro diagnostic test, not an AI-powered image analysis tool that assists human readers.

6. If a Standalone Study Was Done

Yes, standalone (algorithm only) performance was done. The precision, linearity, recovery, detection limit, hook effect, analytical specificity, and matrix/instrument comparison studies all assess the analytical performance of the ImmunoCAP Tryptase assay system itself, independent of human interpretation or assistance.

The clinical studies also present the device's performance (sensitivity and specificity) using a predefined cut-off (20 ug/L) against a clinical diagnosis established by other WHO criteria, which can be considered a standalone evaluation of its diagnostic utility.

7. The Type of Ground Truth Used

The ground truth used for the clinical studies was expert consensus / clinical diagnosis based on established guidelines. Specifically, the diagnosis of Systemic Mastocytosis was classified "according to the WHO recommendations for mastocytosis." These recommendations are themselves based on a consensus proposal developed from extensive clinical and laboratory data, and reviewed scientific literature. The criteria include major criteria (e.g., mast cell infiltrates in organs) and minor criteria (e.g., abnormal mast cell morphology, C-kit mutation, CD2/CD25 expression), excluding tryptase levels for the initial evaluation of the device.

8. The Sample Size for the Training Set

The document does not explicitly state a sample size for a training set. This is a diagnostic assay, and its performance characteristics (precision, linearity, etc.) are typically established through analytical studies using characterized samples rather than a "training set" in the machine learning sense. The clinical studies used patient samples for validation.

The "Traceability" section mentions that "The original reference standard was produced in-house and its concentration determined by the supplier. Each subsequent lot is standardized against reference standards." This implies an internal process for calibrating and standardizing the assay, which might involve a form of internal "training" or calibration, but not a distinct "training set" of patient data for algorithm development as seen in AI/ML products.

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

As there is no explicitly defined "training set" for an algorithm in the context of an FDA submission for a fluorescence immunoassay, the concept of establishing ground truth for a training set is not directly applicable here. The assay relies on a biochemical reaction and a predefined calibration curve. The reference standards mentioned in the traceability section are used to standardize the assay, and their concentrations are determined by the supplier, implying analytical validation rather than expert-labeled ground truth in a clinical context.

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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Phadia 100, Phadia 250 and Phadia 1000 instruments with built-in software process all steps of the assay and print results automatically after the assay is completed.

The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

The provided text describes the ImmunoCAP Allergen Components, an in vitro quantitative assay for the measurement of allergen-specific IgE antibodies. The submission (K111919) covers the addition of 12 new ImmunoCAP Allergen Components to the existing ImmunoCAP Specific IgE assay.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the "Performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the immunological specificity of the allergen components."

However, specific numerical acceptance criteria (e.g., "precision must be X%) | Stated that inhibition studies verified immunological specificity. |
| Comparison to Predicate Devices | Agreement/correlation with extract-based predicate devices (specific thresholds not given). | Stated that new components were compared with extract-based predicate devices using clinical samples and healthy donors. |

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document states that performance characteristics were established using "clinical samples, as well as samples from healthy, nonatopic donors." However, no specific numerical sample size for the test set is provided.
• Data Provenance: The country of origin is not specified. Given that the manufacturer is Phadia AB (Sweden) and the distributor is Phadia US Inc. (USA), it's plausible the samples could be from either or both regions, but this is an inference, not a stated fact. The studies involved "clinical samples" suggesting they were from patients, and "healthy, nonatopic donors." The document doesn't explicitly state if the studies were retrospective or prospective.

3. Number of Experts and Qualifications:

The document does not mention using experts to establish ground truth for the test set. For IVD devices like this, ground truth is typically established through a combination of clinical diagnosis and comparison to established reference methods using the biological samples themselves.

4. Adjudication Method:

The document does not mention any adjudication method as it does not rely on expert interpretation of images or complex data that would necessitate such a process.

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

This type of study is not applicable to this device. An MRMC study typically involves human readers interpreting data (e.g., medical images) with and without AI assistance to measure improvements in diagnostic accuracy or efficiency. The ImmunoCAP Allergen Components are an automated in vitro quantitative assay, not an AI-assisted diagnostic imaging tool.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The entire "Performance characteristics" section describes the evaluation of the device itself (ImmunoCAP Allergen Components) in isolation to establish its precision, linearity, limit of detection, reproducibility, and immunological specificity. The system processes all steps automatically and prints results, indicating a standalone device without human-in-the-loop performance being part of the primary evaluation of the assay's core functionality.

7. Type of Ground Truth Used:

The ground truth for evaluating the performance of the ImmunoCAP Allergen Components would be derived from:

• Clinical Diagnosis: For the "clinical samples," the ground truth likely involves correlating the IgE levels to the patient's diagnosed IgE-mediated allergic disorders or lack thereof.
• Reference Methods/Clinical Status: For "healthy, nonatopic donors," the ground truth is their confirmed non-allergic status.
• Predicate Device Comparison: The document states the new components were "compared with the extract based predicate devices." This implies that the results from the predicate devices served as a form of reference or comparative ground truth to assess the performance of the new components.
• Immunological Specificity: For inhibition studies, the ground truth relates to the expected specific immunological reaction.

8. Sample Size for Training Set:

The document does not provide any information regarding a "training set." This terminology is more common in machine learning contexts. For an in vitro diagnostic assay like this, the development process might involve internal validation, but it's not typically described using "training set" in regulatory submissions. The emphasis is on the performance evaluation of the final product.

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

As no training set is mentioned, this information is not provided.

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1. EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA; citrate ) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instruments Phadia 100 and Phadia 250.

2. EliA RF IgA is intended for the in vitro quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

3. EliA RF Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 100 using the EliA IgM or IgA method.

4. EliA RF Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA IgM or lgA method.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbellifery1-BD-Galactoside as substrate.

The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, respectively, derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The provided document describes the EliA™ RF IgM Immunoassay and EliA™ RF IgA Immunoassay, along with their respective positive controls, for aiding in the diagnosis of rheumatoid arthritis. The study provided focuses on establishing laboratory equivalence to a predicate device, rather than defining specific acceptance criteria for diagnostic performance metrics like sensitivity or specificity against a clinical ground truth.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined standard of truth. Instead, the study's goal was to demonstrate laboratory equivalence to existing predicate devices.

The "reported device performance" is summarized conceptually as:

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

• Sample Size: The document mentions "a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, the exact numerical sample sizes for these test sets are not provided.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be retrospective, as it involves comparing results from existing serum and plasma samples with the new devices against predicate devices.

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

The document does not describe the establishment of a "ground truth" for the test set in the traditional sense of expert consensus on patient diagnosis. Instead, the study aims to establish equivalence to predicate devices. The "clinically defined sera" used would have implicit ground truth based on their clinical diagnosis of rheumatoid arthritis, but the process of establishing this clinical diagnosis (e.g., how many experts, their qualifications) is not detailed. It's likely these were pre-diagnosed samples.

4. Adjudication Method for the Test Set

Since the study focuses on laboratory equivalence to predicate devices and not on establishing a new diagnostic ground truth by expert review, an adjudication method (like 2+1 or 3+1) for diagnosing patients within the test set is not applicable and not mentioned.

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

This section is not applicable to this device. The EliA™ RF immunoassays are in vitro diagnostic devices that measure specific antibodies in patient samples. They are not AI-powered devices that assist human readers (e.g., radiologists) in interpreting medical images or other complex data. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are outside the scope of this submission.

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

The EliA™ RF immunoassays are standalone devices in the sense that they provide quantitative measurements of RF IgM and IgA levels directly. The "algorithm" here is the biochemical assay and the instrument's software for calculating results from fluorescence measurements. Their performance is evaluated independently of human interpretation of the raw assay signal (though a clinician then interprets the final quantitative result). The study described focuses on this standalone performance in comparison to predicate devices.

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

The primary "ground truth" for the comparison study is the results obtained from the legally marketed predicate devices. For the "clinically defined sera," the ground truth would be the clinical diagnosis of Rheumatoid Arthritis established by treating physicians using a combination of clinical findings and other laboratory tests. For "samples from apparently healthy subjects," the ground truth is the absence of Rheumatoid Arthritis. The method by which these clinical diagnoses were originally established (e.g., based on ACR/EULAR criteria, pathology, long-term outcomes) is not specified in this document.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For immunoassay development, "training" typically refers to the development and optimization of the assay itself, selection of reagents, and establishment of calibration curves. The document mentions that the total IgM and IgA calibration is based on a set of six WHO-standardized IgM and IgA Calibrators, but this is for calibration, not a "training set" in the context of machine learning.

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

As no specific "training set" in the machine learning sense is described, the question of how its ground truth was established is not applicable. The "ground truth" for the instrument's calibration is based on WHO-standardized IgM and IgA Calibrators, which are reference materials with known concentrations.

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