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System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. For In Vitro Diagnostic use only.

The Beta-2-Microglobulin reagent kit is a System Reagent for the Quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. The ßeta-2-Microglobulin kit is a liquid, ready to use and consists of 4 x 10mL R1 reagent vials and 4 x 8mL R2 reagent vials. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay. The ßeta-2-Microglobulin reagent is designed for optimal performance on Beckman Coulter AU analyzers.

The provided text describes the Beckman Coulter Beta-2-Microglobulin reagent, but it does not contain information about a study proving that a device meets acceptance criteria in the context of AI/ML or medical imaging analysis.

The document is a 510(k) summary for an in vitro diagnostic reagent used to measure Beta-2-Microglobulin in human serum. This type of product is different from a "device" in the context of AI/ML, which typically refers to software or hardware that assists in diagnosis or treatment based on complex data analysis (like image interpretation).

Therefore, I cannot provide an answer based on the detailed requirements you outlined, such as multireader multidevice studies, expert adjudication for ground truth, or training set details, as these are not relevant to the type of product described in the input.

However, I can extract the acceptance criteria and performance data that are present for this specific reagent:

Acceptance Criteria and Reported Reagent Performance (for Beta-2-Microglobulin Reagent)

• Ascorbate 20 mg/dL
• Bilirubin 40 mg/dL
• Hemolysis 500 mg/dL
• Lipemia 500 mg/dL |
  | | Dynamic Range / Linearity | 0.05 - 1.6 mg/dL |
  | | Precision Within Run | ≤ 5% CV |
  | | Precision Total | ≤ 10% CV |

Further details from the document (as far as applicable):

• Sample size used for the test set and data provenance: Not explicitly stated as "test set" in the context of an AI device. For stability testing, "one reagent lot" was used. The document refers to "human serum" generally for the intended use and does not specify geographical origin or if it was retrospective or prospective.
• 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): Not applicable for a reagent. The "ground truth" for a reagent's performance is typically established through analytical methods and comparison to existing validated methods or reference materials.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a reagent.
• 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 for an in vitro diagnostic reagent, not an AI medical device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For analytical performance (e.g., linearity, precision), analytical validation is the ground truth (e.g., comparing results to known concentrations, reference methods, or statistical limits). The document mentions "controls" and "calibration" as part of the stability testing.
• The sample size for the training set: Not applicable. This is not an AI device.
• How the ground truth for the training set was established: Not applicable.

Study Proving Device Meets Acceptance Criteria:

The document describes a non-clinical study to demonstrate that the Beta-2-Microglobulin system reagent is as safe, effective, and performs as well as the predicate device.

• Study type: Analytical performance study, focusing on stability (on-board and calibration frequency).
• Methodology for Stability: "Testing was performed using one reagent lot. Calibration was performed on the first day. Controls were run to check calibration and the reagent. Linearity was run on the last number of shots of reagent. The maximum time point exceeded the claim. Calibration was performed again at day 90."
• Conclusion: The tests established a 90-day reagent on-board claim and a 90-day calibration frequency claim, indicating the proposed device meets the stability performance of the predicate.
• Other performance characteristics (Specificity (Interferences), Dynamic Range / Linearity, Precision Within Run, Precision Total): The table states "Similar" for the proposed device compared to the predicate, implying that these characteristics were either demonstrated to be equivalent through testing or are inherent to the described technology and formulation which are similar to the predicate. Specific details of how these were proven beyond "similar" are not provided in this summary but would be in the full submission.

In summary, the provided document details the analytical performance and stability of a laboratory reagent, not an AI or imaging device, thus many of your specific questions are not applicable.

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The kit is intended for the quantitative in vitro determination of beta-2 microglobulin (β2M) in human unne using the SPAPLUS analyser, to aid the diagnosis of active rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings

Not Found

The provided document is a 510(k) premarket notification letter for the "Human Beta-2 Microglobulin Kit for use on SPAplus™". It discusses the regulatory approval of the device but does not contain information about the acceptance criteria or the study that proves the device meets those criteria.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Information on any multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Details about standalone (algorithm only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot answer the specific questions based on the provided text. The document is primarily a regulatory approval letter, not a performance study report.

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Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA® 1650 Chemistry systems. The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Calibrators: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method.

The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay sample is diluted and reacted with a buffer that contains latex particles coated with antibody specific for ß2microglobulin. The formation of the antibody-antigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 545 nm. The ß2-Microglobulin concentration in a sample is determined by constructing a standard curve from the absorbance of a reagent blank and a single-level calibrator.

The ADVIA Chemistry B2-Microglobulin Calibrator is a single analyte, lyophilized, buffer based product containing bovine serum albumin and human ß2-Microglobulin. The kit consists of 3 vials of a single level calibrator. The calibrator requires reconstitution with 1 mL of distilled water prior to use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA Chemistry β2-Microglobulin reagent:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in a dedicated section. However, the "Performance" section (Section 5, 6, 7, 8) outlines the studies conducted and their results, implying that these results met the criteria for substantial equivalence to the predicate device.

Based on the studies described, the implied acceptance criteria and reported device performance are summarized below:

Study Details

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

   • Analytical Sensitivity (LoD/LoB): 60 replicates of a blank sample, 60 replicates of a low serum sample.
   • Imprecision: 4 serum-based samples, tested 2 times per run, 2 runs per day, for at least 20 days (resulting in n=80 per level).
   • Interfering Substances: Multiple concentrations of β2-microglobulin (approx. 1, 3, and 11 mg/L) tested with various concentrations of interferents.
   • Method Comparison: 88 serum samples.
   • Serum/Plasma Equivalency: 57 matched specimens (serum, potassium EDTA plasma, lithium heparin plasma).

   Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It implies the studies were conducted by Siemens Healthcare Diagnostics. Given the context of a 510(k) submission, these would typically be controlled prospective studies conducted in a laboratory setting to demonstrate analytical performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is a laboratory assay for quantitative determination of β2-microglobulin. The "ground truth" for such assays is established through analytical methods and verification against reference materials or established predicate devices, not via expert consensus or clinical adjudication as would be for diagnostic imaging or clinical decision support systems. Therefore, the concept of "experts" to establish ground truth in the traditional sense doesn't apply here. The accuracy of the analytical measurements and the comparison to a legally marketed predicate device (Siemens N Latex β2-Microglobulin) serve as the basis for performance evaluation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable to a laboratory diagnostic assay of this type. Adjudication is typically used in clinical studies or for subjective interpretations (e.g., radiology reads) where multiple human readers are involved. This study evaluates the quantitative performance of an automated assay.

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:
   Not applicable. This is a study for an in vitro diagnostic assay, not an AI-assisted diagnostic tool involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the studies described are for the standalone analytical performance of the ADVIA 1650 Chemistry β2-Microglobulin assay. It's an automated process performed on an instrument, and the results presented represent the algorithm's (assay's) performance. There is no human-in-the-loop described in these performance evaluations.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this in vitro diagnostic assay is primarily:

   • Reference materials/standards: For analytical sensitivity (LoD/LoB) and potentially for calibrator values (traceability to WHO 1st International Standard is mentioned for the calibrator).
   • Measurements from a legally marketed predicate device: For method comparison (correlation study).
   • Known concentrations in spiked samples: For interfering substances studies.

7. The sample size for the training set:
   Not applicable. This is an in vitro diagnostic assay, not a machine learning model that requires a separate training set. The assay's parameters would have been developed and validated internally by the manufacturer through R&D, but there isn't a "training set" in the context of typical AI/ML studies.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set mentioned or implied in the context of an AI/ML model for this type of IVD device. The assay development involves chemical and biological principles, calibration, and optimization based on known analytical standards and performance targets.

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The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ß₂microglobulin in human serum, heparinized plasma, EDTA plasma and urine using the B2MIC Flex® reagent cartridge on the Dimension Vista® Systems. Measurement of ß 2 -microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: αγ-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), IS2-Microglobulin (B2MIC, B2MU**), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT),Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*, ICC-U**), Immunoglobulin G subclass 1(IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)
*For cerebrospinal fluid
** For urine

PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: α-Acid Glycoprotein (A1AG), α-- Antitrypsin (A1AT), a2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC-U *), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunodlobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
*For serum and plasma
** For Urine

PROT1 CON M is an assayed, mid-level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: : α -- Acid Glycoprotein (A1AG), α -- Antitrypsin (A1AT), α 2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC*,B2MIC-U**), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin G subclass 1 (IGG1), lmmunoqlobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR), and Transferrin (TRF),
*For serum and plasma
** For urine

Dimension Vista® B2MIC Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a+acid glycoprotein, a1 -antitrypsin, a1-macroglobulin, 132 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunodlobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin.

Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : q-acid glycoprotein, α-- antitrypsin, α 2-macroglobulin, ß-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoqlobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealburnin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin

Dimension Vista® Protein 1 Control M: Protein 1 Control M is a multi-analyte, mid level, liquid human serum based product containing: Q -- acid glycoprotein, a -- antitrypsin, as -macroglobulin, 13-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3. immunodobulin G subclass 4. immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® B2MIC Flex® reagent cartridge:

The document describes a 510(k) submission for an in vitro diagnostic device, primarily focusing on showing substantial equivalence to a legally marketed predicate device. This type of submission usually doesn't involve the same kind of acceptance criteria as AI/ML-based medical devices for image interpretation or diagnosis. Instead, the "acceptance criteria" here are typically performance characteristics that demonstrate the new device is comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a reagent cartridge for quantitative measurement), the key performance characteristic evaluated is method comparison against a predicate device. The performance is assessed using regression analysis.

Note: The acceptance criteria are "implied" because in a 510(k) for a quantitative assay, the goal is to show acceptable agreement with a predicate. While explicit numerical acceptance thresholds aren't stated here (e.g., "slope must be between 0.9 and 1.1"), the high correlation coefficient (0.988) and a slope close to 1 with an intercept close to 0 demonstrate substantial equivalence and acceptable performance.

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

• Sample Size for Test Set: 82 urine samples
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it's a "Method Comparison Study" where samples are analyzed by both the new device and a predicate device. The samples are collected and then tested on both systems.

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

For this type of in vitro diagnostic device measuring a biomarker concentration, the "ground truth" isn't established by human experts in the same way it would be for an imaging AI. Instead, the "ground truth" is typically the result obtained from the legally marketed predicate device, which is considered the reference method for comparison.

• Number of "Experts": Not applicable in the traditional sense. The predicate device (Siemens N Latex to Human ß₂-microglobulin on the BN ProSpec® System) served as the reference.
• Qualifications of "Experts": Not applicable. The predicate device itself is the standard against which the new device is compared.

4. Adjudication Method for the Test Set

Not applicable. As described above, the comparison is against the predicate device's results; there is no human adjudication process involved for establishing ground truth for individual samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement, not an AI/ML device for image interpretation or human assistance. Therefore, MRMC studies and "human reader improvement with/without AI" are not relevant to this submission.

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

Yes, in a sense. The described "Method Comparison Study" is a standalone evaluation of the device's analytical performance (i.e., its ability to accurately measure ß₂-microglobulin concentrations) against a reference method. It assesses the device's output numerically without direct human interpretation within the measurement process.

7. The Type of Ground Truth Used

The ground truth used for the method comparison study was the quantified measurement of ß₂-microglobulin obtained from the legally marketed predicate device (Siemens N Latex to Human ß₂-microglobulin on the BN ProSpec® System). This is a form of "reference method" ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a traditional IVD device, not an AI/ML algorithm that undergoes a training phase with a specific training set. The device's performance is based on its chemical reactions and optical detection, not on learning from a dataset.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth establishment for such a set.

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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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Dimension Vista™ B2MIC Flex® reagent cartridge: The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of ß2-microglobulin aid in the diagnosis of renal dysfunction.

Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the ßmicroglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control M and H: PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of ß2microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Dimension Vista™ B2MIC Flex® reagent cartridge: Polystyrene particles coated with specific antibodies to human β2-microglobulin are aggregated when mixed with samples containing human ß2-microglobulin. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing β2microalobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).

Dimension Vista" Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, liquid, human serum based products containing ß2-microglobulin C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin / transthyretin (PREALB).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista™ B2MIC Flex® reagent cartridge:

This document describes a 510(k) submission for an in vitro diagnostic device, specifically a reagent cartridge for measuring β2-microglobulin. The acceptance criteria and supporting study are focused on demonstrating substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document directly states the performance results from a method comparison study, but it does not explicitly list pre-defined "acceptance criteria" in numerical terms (e.g., "correlation coefficient must be ≥ 0.95"). However, the strong correlation (0.998) and slope/intercept values close to the ideal (1 and 0, respectively) implicitly demonstrate that the device met the unstated performance expectations for substantial equivalence in a method comparison study.

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

• Sample Size: 143 samples
• Data Provenance: The samples consisted of "serum and plasma samples with β2-Microglobulin assay values from 0.81 to 21.94 mg/L." The country of origin is not specified, but the manufacturer is based in Germany and the submitting office is in the US. The study appears to be retrospective, as it uses existing samples to compare the new device against the predicate.

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

This type of study (method comparison for an in vitro diagnostic assay) does not typically use "experts" to establish ground truth in the same way, for example, an imaging AI study would.

• Ground Truth Establishment: The "ground truth" or reference values for comparison were established by running the same samples on the predicate device, the "Dade Behring N Latex β₂-Microglobulin assay on the BN ProSpec® System." The predicate device’s results are considered the reference against which the new device's performance is measured.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a quantitative method comparison study using a predicate device as the reference, not a study requiring human expert adjudication of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a study for an in vitro diagnostic reagent and system, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

Yes, a standalone performance study was done. The "Method Comparison Study" evaluates the Dimension Vista™ B2MIC assay "standalone" performance against the predicate device. The results (slope, intercept, correlation coefficient) reflect the performance of the device's analytical algorithm and reagents without human-in-the-loop adjustments to the measurement itself.

7. The Type of Ground Truth Used

The "ground truth" for this method comparison study was established by the results obtained from the legally marketed predicate device (Dade Behring N Latex β₂-Microglobulin assay on the BN ProSpec® System). The predicate device's measured β2-microglobulin concentrations served as the reference values.

8. The Sample Size for the Training Set

The document does not provide information on a training set size. This is typical for a traditional in vitro diagnostic device validation, particularly a reagent, where the emphasis is on analytical performance and comparison to a predicate, rather than a machine learning model that requires a distinct training dataset. The device's calibration and controls are described, but not a "training set" in the context of an algorithm.

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

Not applicable, as a distinct "training set" for an algorithm is not described in this submission. The "ground truth" (or reference values) for the calibrator and controls would be established by the manufacturer through rigorous analytical methods and traceability to reference materials where appropriate.

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The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for The Quantitative determination of beta-2-microglubulin concentration in human serum or plasma the ?? Viro quarklative accension in the diagnosis of active rheumatoid arthritis and kidney disease.

Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with A1-AT) For in vitro diagnostic use

Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.

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 or plasma (EDTA) on the AEROSET® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510 (k) FDA submitted for use with Quantia A1-AT) For in vitro diagnostic use.

Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.

Here's a breakdown of the acceptance criteria and the study details for the Quantia Beta-2 Microglobulin device based on the provided text:

Quantia Beta-2 Microglobulin Acceptance Criteria and Performance Study

This document describes the performance characteristics of the Quantia Beta-2 Microglobulin, a latex particle enhanced immunoturbidimetric assay for the quantitative determination of beta-2-microglobulin in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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For in vitro diagnostic use.

DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

DakoCytomation Beta-2-Microglobulin Kit is an in vitro diagnostic assay device for the quantitative determination of human beta-2-microglobulin. Beta-2-microglobulin (B2M), a low molecular weight polypeptide of 11,800 daltons, is the light chain component of the major histocompatibility antigen (HLA). B2M is present on the membrane surface of all cells that express major histocompatibility antigens and it is normally present in the circulation as a result of cell membrane turnover.

The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.

The provided document is a 510(k) summary for the DakoCytomation Beta-2-Microglobulin Kit. It describes the device's intended use and demonstrates its substantial equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Here's an breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "significant interference is defined as recovery within ± 10% at β2M > 6 mg/L or within ± 0.6 mg/L at β2M ≤ 6 mg/L" for interfering substances. This can be considered an acceptance criterion for interference.

Note: The document states that the new device meets these criteria but does not provide raw data or specific study results beyond stating that "do not significantly interfere." It primarily focuses on comparing features with the predicate device.

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

• Not explicitly stated. The document describes the device and its intended use, and compares it to a predicate. It mentions interference studies but does not provide sample sizes or the origin (country) of the data, nor whether it was retrospective or prospective.

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

• Not applicable / Not stated. This device is an in vitro diagnostic kit, not an AI-powered diagnostic tool requiring expert interpretation of images or other subjective data for "ground truth" establishment in a traditional sense. The "ground truth" for this type of device would typically be established through analytical validation studies against reference methods or clinical samples with known analyte concentrations, not through expert consensus on interpretations.

4. Adjudication method for the test set:

• Not applicable / Not stated. See explanation for #3. Adjudication methods are relevant for subjective interpretations, which is not the primary output for this type of quantitative assay.

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

• No. This is an in vitro diagnostic kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.

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

• Yes, in essence. The DakoCytomation Beta-2-Microglobulin Kit is a standalone diagnostic assay (an algorithm in this context refers to the chemical reactions and measurement principles), and its performance is evaluated independently. The device's output (quantitative beta-2-microglobulin levels) is directly used for diagnosis, not as an aid for human interpretation in the way AI imaging tools are used.

7. The type of ground truth used:

• For an in vitro diagnostic assay like this, the "ground truth" is typically established through:
  • Reference methods: Comparing results to a gold standard method for measuring beta-2-microglobulin.
  • Known concentration samples: Testing samples with precisely determined concentrations of beta-2-microglobulin.
  • Clinical samples with established clinical diagnoses: While the assay aids in diagnosis, its accuracy is validated by its ability to correctly quantify the analyte in samples from patients with and without the conditions of interest (rheumatoid arthritis, kidney disease) where the true B2M levels are well-characterized.
• The document implies that the device accurately measures beta-2-microglobulin, which is the underlying "ground truth" it's designed to detect.

8. The sample size for the training set:

• Not applicable / Not stated. This device is a chemical assay kit, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is based on its chemical and immunological principles, not on being trained on a dataset.

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

• Not applicable / Not stated. (See explanation for #8).

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This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format. The document is an FDA 510(k) clearance letter for the "MININEPH® Human Beta-2 Microglobulin Kit," which primarily outlines the regulatory approval based on substantial equivalence to a predicate device.

It does not include details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document only states the device's indications for use: "to aid in the diagnosis of active rheumatoid arthritis and kidney disease" by measuring human B2-Microglobulin in serum and urine.

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The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.

While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.

The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.

Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.

Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:

  • Accuracy: Agreement with a reference method.
  • Precision (Reproducibility & Repeatability): Consistency of results.
  • Linearity: Accuracy across the analytical measurement range.
  • Detection Limits: Lowest concentration that can be reliably measured.
  • Interference: Lack of significant impact from common interfering substances.
  • Carry-over: Minimal contamination between samples.
  • Stability: Reagent and calibration stability.
  • Correlation: Strong correlation with predicate device or reference method.

• Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.

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

• Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
• Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.

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

• Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
  • Reference interval studies: Involving a statistically significant number of healthy individuals.
  • Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
  • Control materials and calibrators: With known, certified values.
  • Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.

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

• MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.

7. The Type of Ground Truth Used

• Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
  • Reference methods: Highly accurate and validated analytical methods.
  • Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
  • Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
  • Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.

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