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The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (K050613).

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared K050596.

Here's an analysis of the provided text regarding the Quantia Beta-2 Microglobulin device, presented according to your requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Quantia Beta-2 Microglobulin doesn't explicitly state "acceptance criteria" in a typical numerical pass/fail format. Instead, it demonstrates substantial equivalence to a predicate device through various performance characteristics. The table below outlines these performance metrics and the reported results. The implication is that these results were considered acceptable for demonstrating substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 110 urine samples were used for the method comparison study.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• This information is not provided in the document. The study involves a method comparison against a predicate device, which itself is an already cleared diagnostic for measuring a biochemical marker, Beta-2 Microglobulin. The "ground truth" here is the measurement by the predicate device, not typically established by human experts in this context.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Adjudication is typically associated with studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies, such as in image analysis or clinical diagnosis studies. For a quantitative assay comparing against a predicate, discrepancies are resolved through analytical comparison statistics.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists the human, and the effect size would relate to the improvement in human performance with AI assistance. The Quantia Beta-2 Microglobulin is an in-vitro diagnostic assay for quantitative biochemical measurement, not an AI-assisted interpretation tool for human readers.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence, the described performance studies are for the standalone performance of the Quantia Beta-2 Microglobulin assay. It measures the Beta-2 Microglobulin concentration without human intervention influencing the measurement result itself (though a human performs the test). The results for method comparison, precision, linear range, and interference are all measures of the device's standalone analytical performance.

7. Type of Ground Truth Used

• The "ground truth" used for the method comparison study was the measurement result obtained from the predicate device, the IL Test Beta-2-Microglobulin, on the same samples. For precision, linear range, and interference studies, the ground truth is derived from established analytical methods and reference values.

8. Sample Size for the Training Set

• This information is not provided or applicable in the traditional sense of a "training set" for machine learning algorithms. The Quantia Beta-2 Microglobulin is a reagent-based immunoturbidimetric assay, not a machine learning model that requires a labeled training set in the same way. Its development would involve analytical characterization and optimization using various samples, but not a distinct "training set" as understood in AI/ML contexts.

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

• As noted above, a "training set" in the context of machine learning is not directly applicable here. The development and optimization of such a diagnostic assay would typically involve using samples with known analyte concentrations (established through reference methods or other validated assays) to calibrate the assay, determine reaction kinetics, and establish performance characteristics. This is part of the assay's analytical development process rather than establishing a "ground truth" for a training set in an AI/ML context.

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As a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays.

The KAMIYA RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of RF immunoturbidimetric assays. Two levels of the KAMIYA RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).

This document is a 510(k) summary for the KAMIYA RF Control Set, an in vitro diagnostic device used to monitor the performance of RF immunoturbidimetric assays. The submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, de novo clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, a direct mapping to all requested fields for AI/ML device studies is not possible.

Here's an analysis based on the provided text, addressing the relevant points and noting where direct information is unavailable due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in the context of a traditional clinical study with patient samples. The evaluation is based on the performance of the control material itself in laboratory settings.

• Sample Size: Not explicitly stated for testing precision or reaction characteristics.
• Data Provenance: Not explicitly stated, however, the product is from KAMIYA BIOMEDICAL COMPANY in Seattle, WA, USA. The testing would have been conducted internally as part of the validation for the 510(k) submission. This is a retrospective evaluation against an existing predicate device rather than a prospective study on patient data.

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

Not applicable in this context. The "ground truth" for a control material is its assigned value and its performance characteristics (precision, linearity, etc.) when tested against a reference method or predicate device. This isn't a diagnostic device requiring expert interpretation of results on patient samples to establish ground truth.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation is based on laboratory measurements against a predicate 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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the KAMIYA RF Control is its assigned RF values, traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum, and its demonstrated precision and reaction characteristics in comparison to the predicate device.

8. The sample size for the training set

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

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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As a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays.

The KAMIYA ASO/CRP/RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays. Two levels of the KAMIYA ASO/CRP/RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned CRP values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. The assigned ASO values are traceable to the Japanese National Standard for ASO. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).

The provided text describes the Kamiya ASO/CRP/RF Control, a lyophilized human serum-based control product used to monitor the performance of ASO, CRP, and RF immunoturbidimetric assays. The document is a 510(k) summary, which indicates that the device has been cleared by the FDA based on its substantial equivalence to a legally marketed predicate device.

1. Table of acceptance criteria and the reported device performance:

The document states that the safety and effectiveness of the KAMIYA ASO/CRP/RF Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202).

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. It mentions "within run and between day precision," implying that multiple measurements were taken over different runs and days, but the number of samples or runs is not quantified. The data provenance is not specified (e.g., country of origin). The study appears to be a prospective validation conducted by the manufacturer to demonstrate equivalence.

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

This information is not applicable to this type of device. The ground truth for this control product is its assigned values, which are traceable to specific international or national reference materials (CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum for CRP, WHO International Reference Preparation of Rheumatoid Arthritis Serum for RF, and Japanese National Standard for ASO for ASO). These are not established by human experts in the context of image or signal interpretation.

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

Not applicable. This is not a study involving human interpretation or 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:

Not applicable. This device is a quality control product for laboratory assays, not an AI-powered diagnostic or assistive tool for human readers.

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

The device itself is a control material, not an algorithm. The study implicitly evaluates the standalone performance of the control material in terms of its precision and reaction characteristics when used with immunoturbidimetric assays, by comparing it to a predicate device.

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

The "ground truth" for the assigned values of the control product is established through traceability to international and national reference standards:

• CRP: CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum
• RF: WHO International Reference Preparation of Rheumatoid Arthritis Serum
• ASO: Japanese National Standard for ASO

8. The sample size for the training set:

Not applicable. This device is a control product, not an algorithm that requires a training set. The values are assigned based on reference materials, not derived from a machine learning model.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the control's values is established by its traceability to recognized international and national reference preparations/standards as described in point 7.

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