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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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IMMULITE® 2000 Beta-2 Microglobulin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Beta-2 Microglobulin assay on the IMMULITE 2000 systems
IMMULITE® 2000 High Sensitivity CRP Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE High Sensitivity CRP assay on the IMMULITE 2000 systems

The IMMULITE® 2000 Beta-2 Microglobulin Calibration Verification Material (CVM) contains one set of four vials each 3mL. CVM1 contains bovine protein buffer matrix with preservatives and CVM2, CVM3, and CVM4 contain various levels of human Beta-2 Microglobulin in a lyophilized bovine protein buffer matrix with preservatives.
The IMMULITE® 2000 High Sensitivity CRP Calibration Verification Material (CVM) contains one set of four vials, 2mL each. CVM1 contains a bovine protein/buffer with 0.098% sodium azide and preservative. CVM2, CVM3, and CVM4 contain various levels of human CRP in a bovine protein/buffer with 0.098% sodium azide and preservative.

This document describes two calibration verification materials (CVMs): IMMULITE® 2000 Beta-2 Microglobulin CVM and IMMULITE® 2000 High Sensitivity CRP CVM. Since they are distinct devices with separate studies and acceptance criteria, I will describe them separately.

IMMULITE® 2000 Beta-2 Microglobulin Calibration Verification Material

This device is a quality control material intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Beta-2 Microglobulin assay on the IMMULITE 2000 systems.

1. Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through stability studies. The acceptance criteria for stability are divided into two parts:

• Part 1: Guideline Acceptance Criteria:
  • CVM Level 2: Dose value to fall within ±15% of the assigned dose.
  • CVM Level 3 and 4: Dose value to fall within ±20% of the assigned dose.
• Part 2: Review Limits Criteria: If Part 1 criteria are not met, the dose value of the controls must be within 2 Standard Deviations (SD) of the control target value when generated from the stability calibrator curve.

The document states that the stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claims. It also reports:

• Real-time shelf life: Stable up to 9 years when stored at -20°C prior to opening. The study for lots 011 and 012 is ongoing until the 119-month time point.
• Open component (in-use) stability: 8 hours of stability at ambient or room temperature (15-25°C) after opening.

The document does not provide a direct table comparing the acceptance criteria to actual numerical results for each CVM level. Instead, it states that the testing demonstrated the device meets the performance specifications.

2. Sample Size and Data Provenance for Test Set

• Sample Size:
  • For stability testing, CVMs were run in duplicate (as a minimum) at specified time points. Three lots were used: Lot 010, Lot 011, and Lot 012. Each lot had 4 CVM levels.
  • For open component testing, CVM lot 012 was tested using IMMULITE 2000 Beta-2 Microglobulin (L2KBM) kit lot 247 at 2-hourly intervals for up to 9 hours.
  • For Expected Values/Target Values/Reference Range establishment: Each CVM level was tested for a total of 15 replicates (5 runs and 3 replicates per run) using 3 different reagent kit lots and 5 IMMULITE 2000 systems.
• Data Provenance: The information does not specify the country of origin of the data. The studies are described as "non-clinical performance testing," implying they are internal validation studies conducted by the manufacturer. The data is prospective as it involves stability testing over time.

3. Number of Experts and Qualifications for Ground Truth

• This device is a calibration verification material. The "ground truth" for CVMs is typically established through precise analytical methods and traceability to reference materials. The document doesn't mention the involvement of "experts" in establishing ground truth in the same way clinical diagnostic devices might have radiologists or pathologists.
• The CVMs are described as traceable to an internal material which has been gravimetrically prepared. Value assignment involves generating dose values using a curve generated by assigned reference calibrators, with values averaged across systems. Quality control is performed by calculating recovery of patient samples (40 samples: 20 spiked and diluted urine, 10 neat urine, 10 diluted serum) and controls.

4. Adjudication Method for Test Set

Not applicable for a calibration verification material's performance studies. The evaluation is based on quantitative measurements against established internal and traceable standards.

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

Not applicable. This is a calibration verification material, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies for the calibration verification material itself. Its performance is evaluated independently against its established criteria and traceability.

7. Type of Ground Truth Used

The ground truth or reference values for the CVMs are established through:

• Traceability: To an internal material gravimetrically prepared.
• Value Assignment: Using assigned reference calibrators and averaging recovered values across systems.
• Validation: Through recovery calculation of patient samples (spiked and diluted urine, neat urine, diluted serum) and controls.

8. Sample Size for the Training Set

Not applicable. This is a calibration verification material; it does not involve machine learning or a "training set" in the conventional sense. The "training" of the assay itself (which these materials verify) would involve its own calibration process, which is distinct from the CVM performance study.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

IMMULITE® 2000 High Sensitivity CRP Calibration Verification Material

This device is a quality control material intended for in vitro diagnostic use in the verification of calibration of the IMMULITE High Sensitivity CRP assay on the IMMULITE 2000 systems.

1. Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through stability studies. The acceptance criteria for stability are divided into two parts:

• Part 1: Guideline Acceptance Criteria:
  • CVM Level 2: Dose value to fall within ±20% of the assigned dose.
  • CVM Level 3: Dose value to fall within ±6% of the assigned dose.
  • CVM Level 4: Dose value to fall within ±10% of the assigned dose.
• Part 2: Review Limits Criteria: If Part 1 criteria are not met, the dose value of the controls must be within 2 Standard Deviations (SD) of the control target value when generated from the stability calibrator curve.

The document states that the stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claims. It also reports:

• Real-time shelf life: Stable up to 11 months when stored at 2-8°C prior to opening. The study for lots 025, 026, and 090 is ongoing (up to 23, 12, and 11 months respectively).
• Open component (in-use) stability: 8 hours of stability at ambient or room temperature (15-25°C) after opening.

The document does not provide a direct table comparing the acceptance criteria to actual numerical results for each CVM level. Instead, it states that the testing demonstrated the device meets the performance specifications.

2. Sample Size and Data Provenance for Test Set

• Sample Size:
  • For stability testing, CVMs were run in duplicate (as a minimum) at specified time points. Three lots were used: Lot 025, Lot 026, and Lot 090. Each lot had 4 CVM levels.
  • For Expected Values/Target Values/Reference Range establishment: CVMs were tested on 15 replicates in total (comprised of 5 runs and 3 replicates per run) on 4 IMMULITE 2000 systems and 3 different reagent kit lots.
• Data Provenance: The information does not specify the country of origin of the data. The studies are described as "non-clinical performance testing," implying they are internal validation studies conducted by the manufacturer. The data is prospective as it involves stability testing over time.

3. Number of Experts and Qualifications for Ground Truth

• Similar to the Beta-2 Microglobulin CVM, this device is a calibration verification material. The "ground truth" for CVMs is typically established through precise analytical methods and traceability to reference materials. The document doesn't mention the involvement of "experts" in establishing ground truth in the same way clinical diagnostic devices might have radiologists or pathologists.
• The CVMs are described as traceable to WHO 1st IS 85/506 and CRM 470. Value assignment involves generating dose values using a curve generated by assigned reference calibrators, with values averaged across systems. Quality control is performed by calculating recovery of patient samples (28 samples: 21 normal, 7 spiked) and controls.

4. Adjudication Method for Test Set

Not applicable for a calibration verification material's performance studies. The evaluation is based on quantitative measurements against established internal and traceable standards.

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

Not applicable. This is a calibration verification material, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies for the calibration verification material itself. Its performance is evaluated independently against its established criteria and traceability.

7. Type of Ground Truth Used

The ground truth or reference values for the CVMs are established through:

• Traceability: To WHO 1st IS 85/506 and CRM 470.
• Value Assignment: Using assigned reference calibrators and averaging recovered values across systems.
• Validation: Through recovery calculation of patient samples (normal and spiked) and controls.

8. Sample Size for the Training Set

Not applicable. This is a calibration verification material; it does not involve machine learning or a "training set" in the conventional sense. The "training" of the assay itself (which these materials verify) would involve its own calibration process, which is distinct from the CVM performance study.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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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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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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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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The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.

The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.

Here's a breakdown of the acceptance criteria and the study information for the Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data for a method comparison study and an imprecision study to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the device performs comparably to the predicate device and exhibits acceptable imprecision for its intended use.

Here's a table summarizing the reported device performance, with the understanding that these are the results that presumably met the underlying (unspecified) acceptance criteria for substantial equivalence:

Study Details

The provided document describes two main studies: a method comparison study and an imprecision study.

2. Sample Size and Data Provenance

• Test Set Sample Size (Method Comparison): 111 samples (for serum analytes)
• Data Provenance: Not explicitly stated, but clinical laboratory device studies for FDA submission typically use samples from a clinical population. The document does not specify country of origin or whether samples were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. For this type of in vitro diagnostic device (IVD) studying an analyte's quantitative determination, ground truth is established by a reference method (the predicate device in this case) and traceable calibrators, not by expert interpretation.

4. Adjudication Method

• Not Applicable. No human interpretation or adjudication process is mentioned, as the study is a quantitative comparison of analytical methods.

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

• No. An MRMC study is not relevant for this type of IVD, which quantifies a biomarker. MRMC studies are typically used for imaging diagnostics or other modalities requiring human interpretation.

6. Standalone Performance (Algorithm Only)

• Yes. The studies present the analytical performance of the IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent as a standalone system. The results (slope, intercept, correlation, imprecision) directly reflect the algorithm's (reagent and instrument's) ability to measure the analyte without human interpretation in the results generation process.

7. Type of Ground Truth Used (Test Set)

• Reference Method / Predicate Device Output. The "ground truth" for the method comparison study was the results obtained from the predicate device, the Beckman Array® Beta-2-Microglobulin (B2M) on the Array 360 system.

8. Sample Size for Training Set

• Not explicitly stated/Not applicable in the same way as AI/ML. For IVD assay development, there isn't a "training set" in the machine learning sense. Instead, development involves experiments to optimize reagent formulation, calibration curves, and instrument parameters, which effectively "train" the assay to measure accurately. The document does not provide details on the number of samples used during this development/optimization phase.

9. How Ground Truth for Training Set Was Established

• Not applicable in the same way as AI/ML. For IVD assays, the "ground truth" during development is established through the use of characterized reference materials, calibrators with known concentrations, and comparison to established reference methods or primary standards, ensuring traceability and accuracy. The document does not detail this process but it is standard for IVD development.

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The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.

The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

The Beckman IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent is intended for the quantitative determination of human beta-2-microglobulin in serum by rate nephelometry. The study provided focuses on demonstrating substantial equivalence to a predicate device through method comparison, stability, and imprecision experiments, rather than establishing acceptance criteria against a specific clinical performance threshold.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each performance metric. Instead, it presents the results of studies and implies that these results demonstrate substantial equivalence to the predicate device.

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

• Method Comparison Study: The snippet of the table for method comparison is largely unreadable. It's impossible to determine the sample size from the provided text.
• Imprecision Study (Within-Run): A sample size of N=80 was used for each of the three levels tested.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Typically, such studies for device submission are prospective and conducted in clinical laboratory settings.

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

This information is not applicable to this type of device and study. The IMMAGE Immunochemistry System B2M Reagent is an in-vitro diagnostic (IVD) device that quantitatively measures a biomarker (Beta-2-Microglobulin). The "ground truth" for such devices is typically established by reference methods or validated comparative methods, not by expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as it pertains to subjective interpretations or classifications, which is not the nature of this quantitative IVD device.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, often with and without AI assistance. The Beckman IMMAGE system is a laboratory instrument for quantitative biomarker measurement.

6. Standalone (Algorithm Only) Performance Study

The provided document describes the performance of the entire device system (reagent with the IMMAGE Immunochemistry System), not just an isolated algorithm. The "algorithm" in this context is the rate nephelometry methodology, which is an integral part of the measurement system. Therefore, a standalone algorithm-only performance study as understood in the context of AI tools is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by quantitative measurements derived from comparison to a predicate device (Array System Beta-2-Microglobulin (B2M) reagent) and through internal analytical performance studies (stability, imprecision). For quantitative assays, "ground truth" often refers to the true concentration of the analyte, frequently determined by validated reference methods or the performance of a legally marketed predicate device.

8. Sample Size for the Training Set

This information is not explicitly stated and is likely not applicable in the context of traditional IVD device development for chemical reagents and equipment. The IMMAGE Immunochemistry System B2M Reagent uses a nephelometric methodology. This is a physics-based measurement technique, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves calibrating the instrument with known standards to establish a calibration curve. Sample preparation and testing involves real patient samples (test set), but not algorithm training.

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

As explained above, there isn't a "training set" with established ground truth in the machine learning sense for this traditional IVD device. The calibration of the system would involve using known calibrator materials (e.g., Beckman Calibrator 2, mentioned in the Intended Use) with assigned values, which act as the "ground truth" for the instrument's calibration curve.

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