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This assay is designed for the in vitro measurement of human IgA in serum using the MININEPH analyzer.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Minineph IgA antiserum." This document indicates that the device is a reclassified in vitro diagnostic device and does not contain information about the acceptance criteria, study details, or performance metrics in the context of an AI/ML powered device. The letter is a clearance notification and not a study report. Therefore, I cannot extract the requested information from this document.

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The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.

The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a

IgA from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 um. The increase in turbidity is proportional to the concentration of IgA and it is calculated from a five point calibration curve.

PEG IgA + Antibody ------------------------> IgA-Antibody Complex

a The antibody is manufactured by Dade Behring, Marburg, Germany

The provided text describes a 510(k) submission for the IGA Flex™ Reagent Cartridge, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

Note: The document implies these criteria by presenting the results of the comparison study as evidence of substantial equivalence. Explicit acceptance criteria values (e.g., "correlation coefficient must be greater than 0.95") are not directly stated but are inferred from the conclusion of substantial equivalence based on these high values.

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

• Sample Size (Test Set): 100 clinical patient samples
• Data Provenance: The samples are referred to as "clinical patient samples," suggesting they were collected from patients, but the country of origin is not specified. The study is retrospective, as it involves a "split sample comparison" where existing samples would have been analyzed by both devices. It is also prospective relative to the device submission date of 1999.

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

This information is not provided in the document. The "ground truth" for this type of device (quantitative measurement of a biomarker) is typically established by the predicate device's measurement, which is considered a reference standard rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth or evaluate different interpretations, such as in image analysis or diagnostic assessments. For a quantitative immunoassay comparing a new device to a predicate, the comparison of numerical outputs doesn't involve adjudication in this sense.

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 an automated in vitro diagnostic system, not an AI-assisted diagnostic tool that requires human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

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

Yes, a standalone performance study was done. The "split sample comparison" between the IGA Flex™ reagent cartridge and the Beckman Immunoglobulin A assay represents a direct comparison of the performance of the new device (algorithm/system) against an established method, without human intervention in the measurement process itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation was the measurements obtained from the predicate device, the Beckman Array® Immunoglobulin A Method. In this context, the predicate device acts as the reference standard against which the new device's measurements are compared.

8. The sample size for the training set

This information is not provided in the document. For a traditional immunoassay device like this, there isn't typically a "training set" in the machine learning sense. Any initial assay development or calibration would rely on characterized samples or standards, but those details are not part of this summary.

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

This information is not provided and is largely not applicable in the typical sense for this type of device. If developmental samples were used, their "ground truth" would likely be based on established laboratory methods or certified reference materials, but these details are beyond the scope of this 510(k) summary.

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The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure immunoglobulin G (IgG) in serum and plasma.

The IGG Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgG by its polyclonal antibodies.a IgG from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgG and it is calculated from a five point calibration curve.

Here's a breakdown of the acceptance criteria and the study information for the IGG Flex™ Reagent Cartridge, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 111 clinical patient samples.
• Data Provenance: The text does not explicitly state the country of origin. It indicates "clinical patient samples," suggesting real-world patient data. The study is retrospective in nature, as it involves comparing the new device's measurements on existing "clinical patient samples" to a legally marketed predicate device.

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

This information is not provided in the document. For in vitro diagnostic (IVD) devices like this, the "ground truth" is typically established by measurements from a well-characterized, legally marketed predicate device, rather than direct expert interpretation of raw data. The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study design is a direct comparison to a predicate device, not an interpretation-based task requiring expert adjudication. The comparison method involved running the same samples on both devices and analyzing the statistical correlation of the quantitative results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for imaging devices where human readers interpret diagnostic images. The IGG Flex™ is an in vitro diagnostic reagent and system, and its performance is assessed through quantitative agreement (correlation) with a predicate device, not by human reader interpretation. Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance.

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

Yes, in effect, a standalone performance study was done. The IGG Flex™ Reagent Cartridge, as an in vitro diagnostic assay on the Dimension® clinical chemistry system, operates as a standalone automated system. The reported performance (correlation, slope, intercept) reflects the direct output of this system compared to the predicate device, without direct human intervention in the result generation or interpretation for the comparison study itself. While humans operate the instruments, the "performance" here refers to the analytical capabilities of the assay and instrument combination.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was established by the measurements obtained from the legally marketed predicate device: the Beckman Array® Immunoglobulin G Method. The comparison was directly between the quantitative results of the IGG Flex™ system and the Beckman Array® system for the same patient samples.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or "training set sample size" for the IGG Flex™ reagent. This is typical for IVD assays. The development of such assays involves analytical validation, calibration, and optimization, which would use various samples, but these are not usually referred to as a "training set" in the same way machine learning algorithms are. The reported study focuses on clinical validation/comparison.

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

Since no specific "training set" is mentioned in the context of algorithm development (as it's not an AI/ML device), the concept of establishing ground truth for a training set in that sense is not applicable here. The ground truth for the reported study (comparison to predicate) was the Beckman Array® Immunoglobulin G Method results, as explained in point 7. For the initial development and calibration of the IGG Flex™ assay itself, ground truth would have been established through a combination of analytical methods, reference materials, and established laboratory practices to ensure accurate IgG quantification.

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The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies. IgM from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgM and it is calculated from a five point calibration curve.

Here's an analysis of the provided text, focusing on acceptance criteria and the study conducted for the IGM Flex™ Reagent Cartridge:

This submission is a 510(k) premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device rather than setting and proving specific acceptance criteria in the same way a novel device might establish clinical utility. For 510(k)s, the "acceptance criteria" are often implicitly tied to demonstrating comparable performance to the predicate.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device, the Beckman Array® Immunoglobulin M Method. This is primarily assessed through correlation between the new device and the predicate device.

Interpretation: The reported performance metrics (correlation coefficient, slope, and intercept) are presented as evidence that the IGM Flex™ Reagent Cartridge is "substantially equivalent in principle and performance" to the predicate, thus meeting the implicit acceptance criteria for a 510(k) clearance.

Study Details

The study described is a split sample comparison between the IGM Flex™ Reagent Cartridge and the predicate Beckman Immunoglobulin M Assay.

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

   • Sample Size: 94 clinical patient samples.
   • Data Provenance: Not explicitly stated, but it refers to "clinical patient samples," suggesting human samples. The country of origin for the data is not specified, and neither is whether it was retrospective or prospective.

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

   • Not applicable / Not explicitly stated. For this type of in vitro diagnostic device (IVD) comparison, the "ground truth" for the test set is established by the predicate device's measurement. The study aims to correlate the new device's readings with the predicate's readings, rather than establishing a gold standard through expert consensus.

3. Adjudication method for the test set:

   • Not applicable. There was no human adjudication process involved in this direct comparison of quantitative measurements from two IVDs. The measurements from each device were compared statistically.

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 was a comparison of two in vitro diagnostic assays, not an AI-assisted human reader study.

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

   • Yes, in essence. Both devices (the IGM Flex™ cartridge on the Dimension® system and the Beckman Array® IgM method) operate as standalone automated analytical systems. The study compared the direct output of these two systems. There is no "human-in-the-loop" component for interpretation described.

6. The type of ground truth used:

   • The "ground truth" in this comparative performance study is the measurements obtained from the legally marketed predicate device (Beckman Array® Immunoglobulin M Method). The new device's performance is gauged against this established method.

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This device is an IVD reagent cartridge, not a machine learning algorithm that requires a "training set" in the computational sense. The data presented is for performance validation, not for algorithm training.

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

   • Not applicable. As explained above, there isn't a "training set" for this type of device in the context of the provided information.

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