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The MyAllergyTest® is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest® is intended for use with the MyAllergyTest® system. The MyAllergyTest® is intended for home use.

MyAllergyTest ® is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The device modification is to revise the limitations statement to allow testing of the whole blood sample for up to 30 days following collection. Currently the limitations states 10 days. No changes to the kit components.

The provided document describes a 510(k) premarket notification for a modification to the MyAllergyTest® device. The modification is to extend the allowable time for a whole blood sample to be tested from 10 days to 30 days after collection.

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

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

Note: The document does not explicitly state numerical acceptance criteria (e.g., specific percentage agreement or correlation thresholds). The acceptance criterion is implied by the need to ensure an "accurate assessment" of IgE levels after 30 days.

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

The document does not specify the sample size used for the stability studies (test set). It also doesn't indicate the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The study appears to be about sample stability for laboratory testing, not interpretation by human experts. The "ground truth" would likely be established by lab-based assay results, not expert consensus in the traditional sense.

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

This is not applicable as the study involves laboratory measurements for sample stability, not expert interpretation requiring adjudication.

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

This is not applicable. The device is a sample collection kit, and the study focuses on the stability of the collected sample, not on human reader performance or AI assistance.

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

This is not applicable. The device is a physical sample collection kit, and the study evaluates the bio-chemical stability of the collected sample, not an algorithm's standalone performance.

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

The ground truth for the stability studies would be the allergen specific IgE profile testing results obtained from the clinical laboratory at different time points (including 30 days) and compared against a baseline (e.g., immediate testing). The "accuracy" would be determined by comparing these results, likely through quantitative measures of IgE levels.

8. The sample size for the training set

This is not applicable. The study is a validation of sample stability, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device modification study.

Summary of the Study:

The study described is a "Blood Sample Stability Study." Its purpose was to "obtain assurance that the whole blood sample would still provide an accurate assessment of allergen specific IgE for the entire transport time indicated in the labeling (30 days)." The study involved "Initial testing and validation results," which "confirmed that the sample would be stable during the indicated transport time." This implies a comparison of IgE levels from samples tested at baseline and after 30 days to ensure they remain consistent or within an acceptable variation range, thereby maintaining the accuracy of the overall allergen-specific IgE assessment. The specific methodologies and statistical analysis are not detailed in this document but are referred to in "Attachment (s) B and C."

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The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex 100TM Integrated System.

The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system used as an aid in the clinical diagnosis of IgE mediated allergic disorders.

ImmuneTech™ Total IgE System is a test for the measurement of total IgE in human serum. The ImmuneTech™ Total IgE System consists of two components.

• 1. Flow Cytometer instrument with software for ImmuneTech™ Total IgE System
• 2. ImmuneTech™ Total IgE System Reagents

A serum sample is mixed with anti-IgE coupled microspheres. If present, IgE in the sample will bind with the microspheres and form an anti-human IgE / IgE complex. This complex is then sequentially incubated with biotin-labeled-anti-human IgE antibody and fluorescent-labeled-streptavidin. If IgE is present in the sample, the final sandwich complex of anti-human IgE / IgE / biotin-anti IgE / fluorescent-streptavidin will form. Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of total IgE in the sample. The flow cytometer with ImmuneTech ™ Total IgE System specific software will measure total IgE concentrations.

This summarizes the acceptance criteria and study details for the ImmuneTech™ Total IgE System, based on the provided 510(k) summary.

I. Acceptance Criteria and Reported Device Performance

II. Study Details

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

   • The document does not explicitly state the specific sample size for the test set.
   • The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

   • Not applicable. The ground truth for this in vitro diagnostic device is based on analytical performance metrics (e.g., comparison to a predicate device, known concentrations for sensitivity, specificity, and recovery).

3. Adjudication method for the test set:

   • Not applicable. This is an in vitro diagnostic device assessing analytical performance, not a diagnostic imaging or clinical judgment study requiring expert adjudication.

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

   • No. This is an in vitro diagnostic system, not a device that involves human readers or AI assistance in interpretation in the context of an MRMC study.

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

   • Yes, at least in part. The studies evaluating "Method Comparison, Sensitivity, Specificity, Accuracy (recovery) and Precision" describe the analytical performance of the ImmuneTech™ Total IgE System itself, independent of human interpretation. While the system operates on a flow cytometer, the reported performance metrics focus on the device's ability to measure IgE concentrations directly.

6. The type of ground truth used:

   • The ground truth appears to be established through:
     • Comparison to a legally marketed predicate device: "MyAllergyTest™ System" and "Pharmacia CAP System IgE FEIA" were used as comparators for method comparison.
     • Known concentrations/samples: For sensitivity, specificity, recovery, and precision studies, it is implied that samples with known IgE concentrations or characteristics (e.g., non-atopic vs. atopic individuals, samples without cross-reacting substances) were used.

7. The sample size for the training set:

   • Not specified. The document does not mention details about a training set, as this typically applies more to machine learning algorithms, which are not explicitly detailed here beyond the software component. The performance data focuses on analytical validation.

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

   • Not applicable, as a training set and its ground truth establishment are not discussed in the provided summary.

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The MyAllergyTest™ is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest™ is intended for use with the MyAllergyTest™ System. The MyAllergyTest™ is intended for home use by the lay consumer (Over-the-Counter).

MyAllergyTest™ is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing.

The provided text describes the MyAllergyTest™ and its 510(k) submission, primarily focusing on its intended use as a blood sample collection kit for home use. The studies performed are to demonstrate the kit's functionality and consumer usability, not the diagnostic performance of an AI algorithm. Therefore, many of the requested fields related to AI performance metrics, ground truth, and expert evaluation are not applicable to this device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not specify the sample sizes used for any of the studies (Stability, Mailing, Consumer, Consumer Comprehension, Readability). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the device is a sample collection kit, not an AI diagnostic tool. The "ground truth" for the studies listed is related to the physical stability of blood samples, the ability of lay users to follow instructions, and the readability of documentation, not expert interpretation of medical images or data.

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

Not applicable. This concept is relevant for reconciling discrepancies in expert ground truth assessment, which is not part of the described studies for this device.

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. The MyAllergyTest™ is a sample collection kit, not an AI system or software with a human-in-the-loop component.

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

Not applicable. The MyAllergyTest™ is a physical medical device (sample collection kit), not an algorithm or AI.

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

The "ground truth" for these studies would be defined by objective measurements based on the study type:

• Stability Studies & Mailing Studies: The "ground truth" would be the actual concentration or integrity of allergen-specific IgE markers in the blood samples after various transport conditions and durations, as measured by a clinical laboratory.
• Consumer Studies: The "ground truth" would be the successful collection of a blood sample by the lay consumer, verified objectively (e.g., by the presence of a viable sample).
• Consumer Comprehension Studies: The "ground truth" would be the ability of lay consumers to correctly answer questions or demonstrate understanding of the package insert.
• Readability Studies: The "ground truth" would be the calculated reading level of the package insert using the SMOG Readability Formula.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The MyAllergyTest System is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum samples. The MyAllergyTest System may only be run on the Luminex 100TM Integrated System Version 2.0. The MyAllergyTest™ System is used as an aid in the clinical diagnosis of IgE mediated allergenic disorders. Measurement of allergen specific IgE antibodies may aid diagnosis of asthma, allergies, and other pulmonary disorders.

MyAllergyTest™ System is a test for the measurement of allergen specific IgE in human serum. The MyAllergyTest™ System consist of two components: 1. MyAllergyTest™ System Reagents. 2. MyAllergyTest™ System support software for the Luminex 100m I S Version 2.0 A serum sample is mixed with allergen specific coupled microspheres. If present, specific IgE in the sample will bind with the microspheres and form an allergen/sIgE complex is then sequentially incubated with biotical ati-human IgE antibody and fluorescent-labeled-streptavidin. sequentially is present in the sample, the final sandwich complex of allergen/slgE/biotin-anti-It specific is the summers, Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of allergen specific IgE in the sample. The MyAllergyTest System may only be run on the Luminex 100m Intergented System Version 2.0. The MyAllergyTest™ System specific software for the Luminer 100m Integrated System Version 2.0 will simultaneously measure and identify allergen specific IgE concentrations.

The provided text describes the MyAllergyTest™ System, an in vitro diagnostic test for measuring allergen-specific IgE antibodies. The document presents a summary of safety and effectiveness, including performance data from studies conducted.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate set of predefined thresholds. Instead, it presents "Brief Description of Performance Data" with study results. We will assume these reported results represent the device's performance against implicitly accepted standards for substantial equivalence.

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

The document does not provide information regarding:

• The specific sample size used for the test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

The document does not provide information regarding:

• The number of experts used to establish the ground truth.
• The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not provide information regarding the adjudication method used for the test set.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The study focuses on the device's performance characteristics (sensitivity, specificity, etc.) rather than on human reader improvement with or without AI assistance.

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

The MyAllergyTest™ System is an "in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum." It is described as having "MyAllergyTest™ System support software for the Luminex 100m I S Version 2.0" that will "simultaneously measure and identify allergen specific IgE concentrations." This indicates that the device operates as a standalone system (algorithm/instrument only) to provide quantitative measurements, without directly involving human interpretation of images or complex data outputs that would require a human-in-the-loop performance study in the context of AI. The performance metrics (sensitivity, specificity, accuracy, precision) are characteristic of a standalone analytical device.

7. The Type of Ground Truth Used

The document explicitly states: "RAST inhibition verified the immunological specificity of the IgE binding for each allergen." This indicates that RAST inhibition was used as a method to verify the immunological specificity, which can be considered a form of ground truth or verification for the specific IgE binding. However, for the overall sensitivity, specificity, and accuracy, the specific "ground truth" (e.g., a reference standard test, clinical diagnosis, etc.) is not detailed beyond this verification step. Given it's an IgE test, a common ground truth would be a combination of clinical symptoms and established reference methods or assays. The document states it was compared to "Pharmacia CAP System™ Specific IgE FEIA" for substantial equivalence, implying the CAP system might have served as a reference or predicate to establish the "ground truth" for comparison for the performance metrics.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. It is an IVD device, not explicitly an AI/ML device where 'training set' is a standard term, though the underlying software would have been developed and validated.

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

The document does not provide any information regarding how the ground truth for the training set was established, nor does it explicitly mention a "training set" in the context of machine learning model development.

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