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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The provided FDA 510(k) clearance letter and summary for the NOVEOS Specific IgE (sIgE) Assay outlines the device's performance, but it does NOT describe "acceptance criteria" in an explicit, quantifiable manner that is typically found in a clinical study report. Instead, the document presents study results and compares them to a predicate device (ImmunoCAP Specific IgE) to demonstrate substantial equivalence, and also to clinical diagnosis of allergic status. The closest approximations to acceptance criteria are implicit in the performance metrics presented (e.g., target ranges for sensitivity, specificity, agreement, precision, linearity).

This device is an in vitro diagnostic (IVD) assay, not an AI/ML-based diagnostic imaging or analysis system. Therefore, the concepts of "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts," "adjudication method," and "training set ground truth establishment" do not directly apply in the same way they would for AI-powered diagnostic imaging devices. The "ground truth" for this IVD device is established through reference methods (Skin Prick Test, Oral Food Challenge, ImmunoCAP predicate device) or established clinical diagnosis.

Here's a breakdown of the information that is provided and how it relates to the requested points, with interpretations where necessary for IVD context:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria are not stated. However, the performance data presented effectively serves as the "reported device performance" that presumably met the FDA's requirements for substantial equivalence. I will present the key performance metrics from the document.

Key Performance Metrics (Implicit Acceptance Criteria)

• G010 (Johnson Grass): 72.9% (95% CI 62.7% to 81.2%)
• T007 (Oak): 71.7% (95% CI 58.4% to 82.0%)
• G002 (Bermuda Grass): 76.1% (95% CI 66.3% to 83.8%)
• W001 (Common Ragweed): 62.0% (95% CI 50.3% to 72.4%)
• E005 (Dog Dander): 71.9% (95% CI 54.6% to 84.4%)
• T003 (Common Silver Birch): 55.1% (95% CI 41.3% to 68.1%)
• F001 (Egg White): 52.8% (95% CI 37.0% to 68.0%)
• F002 (Cow's Milk): 50.0% (95% CI 34.1% to 65.9%)
  Literature citation provided for lower sensitivity values to support observed performance. |
  | Clinical Specificity | High, to minimize false positives | Varies by Allergen:
• G010 (Johnson Grass): 99.2% (95% CI 95.9% to 99.9%)
• T007 (Oak): 97.8% (95% CI 92.5% to 99.4%)
• G002 (Bermuda Grass): 97.1% (95% CI 92.9% to 98.9%)
• W001 (Common Ragweed): 93.6% (95% CI 86.8% to 97.0%)
• E005 (Dog Dander): 100.0% (95% CI 95.2% to 100.0%)
• T003 (Common Silver Birch): 100.0% (95% CI 93.2% to 100.0%)
• F001 (Egg White): 100.0% (95% CI 97.4% to 100.0%)
• F002 (Cow's Milk): 100.0% (95% CI 97.2% to 100.0%) |
  | Positive Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 84.7%
• T007 (Oak): 83.8%
• G002 (Bermuda Grass): 89.4%
• W001 (Common Ragweed): 72.8%
• E005 (Dog Dander): 91.7%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 89.6%
• F002 (Cow's Milk): 64.5% |
  | Negative Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 99.3%
• T007 (Oak): 94.6%
• G002 (Bermuda Grass): 96.8%
• W001 (Common Ragweed): 95.0%
• E005 (Dog Dander): 96.7%
• T003 (Common Silver Birch): 96.1%
• F001 (Egg White): 96.2%
• F002 (Cow's Milk): 98.9% |
  | Total Agreement (vs. ImmunoCAP) | High, demonstrating overall comparability | Varies by Allergen:
• G010 (Johnson Grass): 92.5%
• T007 (Oak): 88.5%
• G002 (Bermuda Grass): 93.8%
• W001 (Common Ragweed): 82.2%
• E005 (Dog Dander): 94.1%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 94.3%
• F002 (Cow's Milk): 86.9% |
  | Precision (Total %CV) | Typically low %CV for quantitative assays (e.g.,

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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). 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 is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.

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 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.

Here's a breakdown of the acceptance criteria and study details for the ImmunoCAP Allergen Components, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a single summary table, but rather presents the results of studies supporting the device's performance. The implied acceptance criteria for most analytical studies would be that the results achieved demonstrate suitable performance for the intended use (e.g., low imprecision, good linearity, sufficient detection limits, absence of significant interference, and adequate stability).

For the purpose of this summary, I'll extract the key performance metrics and the reported results from the provided text.

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

• Precision/Reproducibility:
  • Within-laboratory: 5 or 6 positive samples tested in 4 replicates per day for 20 days (total 80 replicates per sample), except for one sample with 3 replicates for 11 runs over 20 days (33 replicates).
  • Lot-to-lot: 4 or 5 positive samples and 1 negative sample. Each lot (3 lots total) tested with 12 replicates per sample in one run.
  • Provenance: Not explicitly stated, but clinical and non-clinical samples are mentioned in other studies suggesting human samples.
• Linearity: 3 or 4 positive samples, each diluted to generate at least six 2-fold consecutive dilutions. Samples tested with a minimum of 4 replicates in one run.
  • Provenance: Not explicitly stated, but clinical/patient samples are implied.
• Detection Limit: 5 blank samples (for LoB) and 5 low positive samples (for LoD). Blank samples determined in 3 runs with 5 replicates per run. Low positive samples measured in 15 replicates.
  • Provenance: Not stated.
• Analytical Specificity (Inhibition Studies): One positive sample for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Interference (Endogenous Substance): Three samples (two positive and one negative) for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Stability: Three lots of each ImmunoCAP Allergen component. The accelerated stability study for rSes i 1 (f449) used two positive and one negative sample across three lots.
  • Provenance: Not stated.
• Method Comparison Study (vs. Predicate):
  • f433, rTri a 14: 33 positive clinical samples, 10 positive non-clinical samples, 100 negative samples. Total = 143.
  • f416, rTri a 19: 34 positive clinical samples, 14 positive non-clinical samples, 100 negative samples. Total = 148.
  • f449, rSes i 1: 32 positive clinical samples, 30 positive non-clinical samples, 100 negative samples. Total = 162.
  • Provenance: Samples from individuals with clinical history of allergy-like symptoms, sensitized individuals without documented clinical history, and healthy non-atopic donors. The location or retrospective/prospective nature is not specified, but it implies a mix of historical and presumably current clinical samples.
• Clinical Sensitivity and Specificity:
  • f433, rTri a 14: 133 atopic (clinical history of allergy-like symptoms upon exposure to wheat, physician-diagnosed) and 100 non-atopic (healthy, no reported clinical reaction to allergen) samples. Total = 233.
  • f416, rTri a 19: 129 atopic and 100 non-atopic samples. Total = 229.
  • f449, rSes i 1: 35 atopic and 100 non-atopic samples. Total = 135.
  • Provenance: "Selected samples from individuals with a clinical history of allergy-like symptoms upon exposure to wheat/sesame, as diagnosed by a physician" and "samples from healthy subjects with no reported clinical reaction." Location and retrospective/prospective nature not explicitly stated.

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

• For the Clinical Sensitivity and Specificity studies, the ground truth for "atopic" cases was established by "clinical diagnosis of allergy" by a "physician." The specific number or qualifications of these physicians are not detailed in the document. For "non-atopic" cases, it relied on "no reported clinical reaction to the allergen."

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for establishing the clinical diagnosis (ground truth) in the clinical studies. The mention of "diagnosed by a physician" suggests individual physician diagnoses were used.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that measures allergen-specific IgE levels, not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This device is a standalone diagnostic test in the sense that the assay itself provides quantitative results for specific IgE antibodies. The performance characteristics described (precision, linearity, detection limit, analytical specificity, interference, stability, method comparison, and clinical sensitivity/specificity) are all "algorithm only" or device-only performance measures. The "human-in-the-loop" aspect comes in the interpretation of these quantitative results by a clinician in conjunction with other clinical findings, as stated in the Indications for Use. The clinical studies evaluate how well the device's output correlates with a clinical diagnosis, not how well humans perform with or without the device.

7. The Type of Ground Truth Used

• Clinical Diagnosis (by a physician) / Reported Clinical Reaction: For the clinical sensitivity and specificity studies, the ground truth was based on a "clinical diagnosis of allergy" by a physician for atopic individuals and "no reported clinical reaction" for non-atopic individuals.
• Absence of IgE Antibodies / Healthy Non-atopic Donors: For the method comparison study, "healthy, non-atopic donors" and "undetectable levels of specific IgE antibodies" (

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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.

The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

Here's a breakdown of the acceptance criteria and the study information for the NOVEOS Specific IgE (sIgE) Assay, Capture Reagent M006, Alternaria alternata, based on the provided text:

Acceptance Criteria and Reported Device Performance

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The OPTIGEN® Allergen-Specific IgE Assay 12 Allergen Bundle A is an in vitro test for use in the semi-quantitative determination of circulating allergen specific IgE concentrations in human serum. OPTIGEN® Allergen-Specific IgE assays are meant to be included in panel tests to be used with the AP3600™ instrument. Each assay is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergenic disorders in conjunction with other clinical findings and are to be used in clinical laboratories.

The OPTIGEN® 12 Allergen Bundle A includes Almond (f20), Bermuda Grass (g2), Cashew (f207), Crab (f23), Hazelnut (Food) (f17), Oak, White (f7), Salmon (f41), Sesame Seed (f10), Shrimp (f24), Tuna (f40), and Walnut (Food) (f256).

Not Found

This document is a marketing authorization letter for a device, not a study report. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of a device based on its substantial equivalence to previously marketed devices, not on the presentation of performance data from a specific study against predefined acceptance criteria.

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The Aptiva Celiac Disease IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-tissue transglutaminase IgG autoantibodies and anti-deamidated gliadin peptide IgG autoantibodies in human serum. The presence of these antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis, particularly in patients with selective IgA deficiency.

The Aptiva Celiac Disease IgG Reagent is intended for use with the Inova Diagnostics Aptiva System.

The Aptiva Celiac Disease IgG reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]) in the Aptiva Celiac Disease IgG reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG capture antibody (IgG Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.

The Aptiva instrument is a fully automated, random access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.

The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that preserve the proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge.

A patient's serum is diluted 1:23 with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a small magnet that holds the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated one more time. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human lgG (known as PE Tracer IgG) is added to the microparticles in the cuvette, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37℃. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the of the instrument, where a charge coupled device (CCD) camera takes multiple images in order to identify and count the three unique microparticle regions, as well as determine the amount of conjugate on the microparticles. The control microparticle, a third particle, coated with goat anti-human IgG, is included in the reagent in as a control to flag low concentrations of IgG the patient serum sample as an assay verification step. The median fluorescent intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgG, which is proportional to the amount of IgG antibodies bound to the corresponding microparticle regions.

For quantitation, the DGP IgG and tTG IgG assays (together as part of the Aptiva Celiac Disease IgG Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge RFID tag. Every new lot of reagent cartridge must be calibrated before first use with the reagent specific calibrators. Based on the results obtained with the calibrators included in the Aptiva Celiac Disease IgG Calibrator kit (sold separately), an instrument specific Working Curve is created for each assay, which is used to calculate reported fluorescent light units (FLU) from the median fluorescent intensity (MFI) instrument signal obtained for each sample, on each of the two assays within the reagent.

Aptiva Celiac Disease IgG Calibrators and Aptiva Celiac Disease IgG Controls are sold separately.

The Aptiva Celiac Disease IgG Reagent kit contains the following materials:

One (1) Aptiva Celiac Disease IgG Reagent Cartridge, containing the following reagents for 200 determinations:

• a. Aptiva Celiac Disease IgG microparticle containing 3 unique microparticle regions coated with recombinant tissue transglutaminase, deamidated gliadin peptide, or goat antihuman IgG antibody.
• b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
• C. PE Tracer IgG - phycoerythrin (PE) labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
• ð. Rehydration Buffer - containing protein stabilizers and preservatives.

This document describes the analytical and clinical performance of the Aptiva Celiac Disease IgG Reagent, an immunoassay for the semi-quantitative determination of anti-tissue transglutaminase IgG autoantibodies (tTG IgG) and anti-deamidated gliadin peptide IgG autoantibodies (DGP IgG) in human serum. This device is intended as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The document presents several analytical performance characteristics and their corresponding acceptance criteria, along with the reported performance values. The primary clinical acceptance criteria are related to sensitivity and specificity, and the agreement with a predicate device.

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The Aptiva Celiac Disease IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-tissue transglutaminase IgA autoantibodies and anti-deamidated gliadin peptide IgA autoantibodies in human serum. The presence of these autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of celiac disease and dermatitis herpetiformis. The Aptiva Celiac Disease IgA Reagent is intended for use with the Inova Diagnostics Aptiva System.

The Aptiva Celiac Disease IgA reagent utilizes particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (tissue transglutaminase [tTG] and deamidated gliadin peptide [DGP]) in the Aptiva Celiac Disease IgA reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgA capture antibody (IgA Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.

The Aptiva instrument is a fully automated, random access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.

The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that preserve the proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using buffer located within the cartridge.

A patient's serum is diluted 1:46 with Aptiva system rinse by the instrument in a disposable cuvette. A small amount of the diluted sample is combined with assay buffer and the microparticle suspension in a second cuvette, and mixed (final serum dilution: 1:230). This reaction cuvette is incubated for 9 ½ minutes at 37°C. The cuvette is then exposed to a small magnet that holds the microparticles in place. The liquid is aspirated, and the microparticles are resuspended as system rinse is added to the cuvette and the magnet is removed. This wash cycle is repeated one more time. During the third wash, no system rinse is added after the aspiration step. After the third wash, phycoerythrin conjugated polyclonal anti-human IgA (known as PE Tracer IgA) is added to the microparticles in the cuvette, and mixed. Again, the cuvette is incubated for 9 ½ minutes at 37℃. Three wash steps, as described above, are performed on the microparticles. Following the wash steps, the microparticles are transferred to the of the instrument, where a charge coupled device (CCD) camera takes multiple images in order to identify and count the three unique microparticle regions, as well as determine the amount of conjugate on the microparticles. A third particle, coated with goat antibodies, is present in the reagent as a control to flag low concentrations of IgA in the sample as an assay verification step. The median fluorescent intensity (MFI) is proportional to the amount of PE Tracer that is bound to the human IgA, which is proportional to the amount of IgA antibodies bound to the corresponding microparticle regions.

For quantitation, the DGP IgA and tTG IgA assays (together as part of the Aptiva Celiac Disease IgA Reagent) each utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge RFID tag. Every new lot of reagent cartridge must be calibrated before first use with the reagent specific calibrators. Based on the results obtained with the calibrators included in the Aptiva Celiac Disease IgA Calibrator kit (sold separately), an instrument specific Working Curve is created for each assay, which is used to calculate reported fluorescent light units (FLU) from the median fluorescent intensity (MFI) instrument signal obtained for each sample, on each of the two assays within the reagent.

Aptiva Celiac Disease IgA Calibrators and Aptiva Celiac Disease IgA Controls are sold separately.

The Aptiva Celiac Disease IgA Reagent kit contains the following materials:

One (1) Aptiva Celiac Disease IgA Reagent Cartridge, containing the following reagents for 250 determinations:

• a. Aptiva Celiac IgA microparticle containing 3 unique microparticle regions coated with recombinant tissue transglutaminase, deamidated gliadin peptide, or goat anti-human IgA antibody.
• b. Assay buffer - colored pink, containing protein stabilizers and preservatives.
• PE Tracer IgA phycoerythrin (PE) labeled anti-human IgA antibody, containing buffer, C. protein stabilizers and preservative.
• d. Rehydration Buffer - containing protein stabilizers and preservatives.

The provided text is a 510(k) Summary for the Aptiva Celiac Disease IgA Reagent, an in vitro diagnostic device. It describes the analytical and clinical performance of the device to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or the establishment of ground truth by expert consensus. Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device studies.

However, I can extract the acceptance criteria and reported performance for analytical aspects of this specific in vitro diagnostic device, as well as details regarding sample size, data provenance, and the type of ground truth used for performance evaluation.

Acceptance Criteria and Reported Device Performance

The device under review is an in vitro diagnostic (IVD) test, not an AI/ML-based medical imaging device. As such, the acceptance criteria and performance evaluation are based on typical analytical validation parameters for immunological assays, such as precision, limit of detection, linearity, interference, and clinical sensitivity/specificity against established reference methods or patient diagnoses.

Table of Acceptance Criteria and Reported Device Performance:

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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemilyminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IqE) 11/234.

This document describes the validation of the NOVEOS Specific IgE (sIgE) assays for Cat Dander (E001, Felis domesticus) and Timothy Grass (G006, Phleum pratense). This is a quantitative in vitro diagnostic device, not an AI/ML powered device. Therefore, many of the typical acceptance criteria for AI models, such as MRMC studies, ground truth establishment by experts, and training set details, are not applicable.

The acceptance criteria for this device are based on its analytical and clinical performance when compared to a legally marketed predicate device (ImmunoCAP Specific IgE Assay) and clinical diagnosis.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance metrics reported and the statistical analysis acceptable for FDA clearance of an in vitro diagnostic device of this type. The key performance indicators for a quantitative assay would typically include linearity, precision (imprecision/reproducibility), agreement with a predicate device, and clinical concordance (sensitivity and specificity).

Performance Table for NOVEOS Specific IgE (sIgE) Assays

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ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is intended for in vitro diagnostic use, in human serum or EDTA plasma, as an aid in the diagnosis of IgE mediated mammalian (red) meat hypersensitivity, due to alpha-Gal sensitization, and to be used in conjunction with other clinical findings. This test is not to be the sole criterion for diagnosing allergy to alpha-Gal. It is a quantitative test to be used in clinical laboratories. ImmunoCAP Allergen 0215, alpha-Gal is to be used with the ImmunoCAP Specific IgE assay on the instrument Phadia™ 250.

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is a component of, and is designed to be used with, the ImmunoCAP Specific IgE assay, previously cleared under K051218. The test has the same overall design as all other ImmunoCAP Allergen components and uses identical assay and system specific reagents, instruments and software.

This document describes the performance characteristics and acceptance criteria for the ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine test, which is intended to aid in the diagnosis of IgE mediated mammalian (red) meat hypersensitivity.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes both analytical and clinical performance studies, but directly states acceptance criteria only for analytical performance implicitly through the successful completion of the studies. For clinical performance, it discusses the study design and patient numbers, from which performance can be inferred.

Analytical Performance Characteristics:
The document states that analytical performance characteristics were established by studies of:

• Precision
• Lot-to-Lot Reproducibility
• Linearity
• Limit of Quantitation
• Sample Matrix Equivalency
• Interference
• Inhibition
• Stability

While specific numerical acceptance criteria for each of these analytical characteristics are not explicitly listed in the provided text, the overall conclusion is that the device's analytical performance was verified and supports its substantial equivalence. The document concludes: "Analytical performance characteristics for the new ImmunoCAP Allergen Components were established by studies of Precision, Lot-to-Lot Reproducibility, Linearity, Limit of Quantitation, Sample Matrix equivalency, Interference, Inhibition and Stability." This implies that the device met the pre-defined acceptance criteria for these analytical aspects.

Clinical Performance Characteristics:
For clinical performance, a retrospective study was conducted. The document does not explicitly present a table of acceptance criteria (e.g., minimum sensitivity, specificity) against which the device's performance was measured for clinical use. Instead, it describes the study design, and the implied acceptance is that the device demonstrated sufficient performance to be considered an "aid in the diagnosis."

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

• Test Set Sample Size: The clinical performance was evaluated using samples from 200 subjects with a case history of mammalian meat hypersensitivity (cases) and 110 control subjects.
• Data Provenance: The study was a retrospective study. The country of origin of the data is not specified in the provided text.

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

The document does not specify the number of experts used to establish the ground truth for the test set, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that the 200 subjects had a "case history of mammalian meat hypersensitivity," implying that their status was established through clinical diagnosis, likely by medical professionals.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the test set.

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

No MRMC comparative effectiveness study was reported in which human readers' improvement with AI vs. without AI assistance was assessed. This device is an in-vitro diagnostic assay, not an AI-assisted imaging device, so such a study would not be applicable.

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

This device is an in-vitro diagnostic test kit that provides quantitative measurements of IgE antibodies. Its performance, as described, is inherently "standalone" in the sense that the test itself generates a result without direct human interpretation influencing the measurement, though human interpretation is required for the final diagnostic aid. The "performance characteristics" detailed refer to the analytical and clinical performance of the assay itself, which is analogous to a standalone performance evaluation in the context of an IVD.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on a "case history of mammalian meat hypersensitivity" for the 200 subjects and "control subjects" for the 110 individuals. This suggests that the ground truth was established by clinical diagnosis and patient history, rather than a specific expert consensus on images, pathology, or outcomes data from a prospective study directly.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. This is typical for an IVD assay, where performance is established through validation studies rather than machine learning model training. The development process for such an assay would involve internal development and optimization, but not typically in the sense of a machine learning training set with a distinct ground truth establishment process as described for AI models.

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

Since no distinct "training set" is mentioned in the context of this device's validation, the method for establishing its ground truth is not applicable. The development of an IVD assay involves extensive R&D, but the concept of "ground truth for a training set" usually applies to machine learning algorithms.

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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS™ Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.

The provided document describes the analytical and clinical performance of the NOVEOS Specific IgE (sIgE) Assay for Dermatophagoides farinae (D002), an in vitro diagnostic device. It does not describe a study involving human readers assisting with AI, but rather a laboratory-based immunoassay. Therefore, information related to "Number of experts used to establish the ground truth for the test set," "Adjudication method," and "MRMC comparative effectiveness study" is not applicable for this type of device and study.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in vitro diagnostic assay, typical acceptance criteria would involve analytical performance metrics like accuracy (compared to a predicate or clinical diagnosis), precision (reproducibility), linearity, detection limits, and interference. The document presents these results rather than explicit "acceptance criteria" tables. However, we can infer the implicit criteria from the reported data.

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ImmunoCAP Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). 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 is to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

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 instrument systems, associated software, processes all steps of the assay and calculates results and a 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 a 510(k) submission for new ImmunoCAP Allergen Components (rCan f 4 Dog, rCan f 6 Dog, rFel d 7 Cat) to an existing ImmunoCAP Specific IgE assay system. While it mentions performance characteristics studies, it does not provide a specific table of acceptance criteria or reported device performance for these new components. It primarily focuses on the regulatory submission and overall claims of performance.

However, based on the provided text, I can infer and summarize what information is available and what is missing regarding acceptance criteria and the study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample size for the "clinical positive samples" and "samples from healthy, nonatopic donors" is not provided.
• Data Provenance: The country of origin is not provided. The studies appear to be retrospective in nature, as they involve testing existing samples.

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

This type of information is not provided in the document. For immunoassays, ground truth is typically established by the clinical status of the patient (e.g., diagnosed allergy, physician assessment, other valid allergy tests) rather than expert review of images.

4. Adjudication method for the test set

This information is not applicable as it pertains to expert review of diagnostic results, which is not described for this type of immunoassay. The ground truth would be based on the clinical diagnosis or reference methods.

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

• MRMC Study: This is not applicable. The device is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

• Standalone Performance: The described studies (Precision, Reproducibility, Linearity, LOD, Stability, Clinical Comparison) all represent the standalone performance of the immunoassay system (device and instrument). There is no "human-in-the-loop" component for interpretation described beyond the overall clinical context for diagnosis.

7. The type of ground truth used

The ground truth for the clinical studies appears to be based on:

• Clinical Status: "clinical positive samples" imply patients with a diagnosed IgE-mediated allergic disorder related to the specific allergens.
• Absence of Allergy: "healthy, nonatopic donors" implies individuals without (or assumed to be without) IgE-mediated allergic disorders.
• Predicate Device Comparison: The new components were compared against an "extract based predicate device," which itself serves as a reference standard, implying its results are also part of the ground truth or a comparator for performance.

8. The sample size for the training set

This information is not applicable as the device is an immunoassay kit, not a machine learning or AI algorithm that requires a separate training set.

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

This information is not applicable for the same reason as above.

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