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The HbA 1c (Hemoglobin A 1c) Advanced assay on the Beckman Coulter DxC700 AU Clinical Chemistry Analyzer, is intended for the quantitative determination of mmol/mol HbA1c (DCCT/NGSP) concentration in human venous whole blood. The determination of HbA1c is used as an aid in the diagnosis of diabetes mellitus, for the monitoring of long-term glucose control in individuals with diabetes mellitus and identifying patients who may be at risk for developing diabetes mellitus. For in vitro diagnostic use only.

The HbA1c Advanced reagent kit is in a liquid format and is ready to use. It contains four reagents HbA1c R1 and HbA1c R2, Total Hemoglobin R1 and Hemolyzing reagent R1. The HbA1c calibrator is supplied with the reagent, in a liquid, ready to use format and contains 5 x 2mL calibrator levels. The sample hemolysis is automated on the DxC700 AU Clinical Chemistry analyzer. Sample handling is performed as follows: 200 uL of hemolyzing reagent is aspirated from the Hemolyzing Reagent R1and dispensed into a cuvette. Tetradecyltrimethylammonium bromide (TTAB) in the hemolyzing reagent eliminates interference from leukocytes. 2 µL of whole blood sample is then aspirated from the patient sample and added to the hemolyzing reagent in the cuvette. This hemolyzed whole blood is then added to the THb assay cuvette and HbA1c assay cuvette as per the assay parameters. The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP). Total Hemoglobin Reagent is used to measure total hemoglobin concentration by a colorimetric method. Change in absorbance is measured at 570/660 nm. HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm.

Here's an analysis of the acceptance criteria and study details for the HbA1c Advanced device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision (EP05-A3): Four levels of HbA1c K2 EDTA human venous whole blood patient samples (approx. 5.0%, 6.5%, 8.0%, 12%, and 14%) and two whole blood controls. Samples were analyzed in duplicate, twice daily, over 20 working days on 3 different instrument lots. (n=2 for each sample/control, 2x daily, 20 days: 80 measurements per sample/control per instrument, total for all samples/controls/instruments: 8073 = 1680 individual measurements for precision)
   • Linearity (EP06-A): High and low pools of human whole blood were used to create a linearity series to span the analytical range. The exact number of samples in the linearity series is implied to be at least 9 (N: ≥ 9 for regression parameters).
   • Method Comparison (EP09-A3): 138 venous human frozen whole blood specimens (K2 EDTA anticoagulant type). These were patient samples. The provenance is not explicitly stated as country of origin, but they are referred to as "venous human frozen whole blood specimens." The study design is prospective in the sense that the samples were collected and then tested for the study; it is not explicitly called out as retrospective/prospective.
   • Analytical Specificity (Interference - EP07): Two % HbA1c concentrations (approx. 6.5% and 8.0% HbA1c) using low and high pools prepared from human whole blood. Interfering substances were tested at a minimum of 5 levels each, with 10 replicates per level. The interference assessment was done on human venous whole blood K2 EDTA samples.
   • Hemoglobin Variants: A minimum of 20 samples were tested for each variant (HbC, HbD, HbE, HbF, HbS, HbA2), totaling at least 120 samples. These are patient samples with identified hemoglobin variants.

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

   • For the Method Comparison study, the ground truth was established by an "NGSP Secondary Reference Laboratory (SRL) using a test system (method X - HA8180V HPLC)." The specific number and qualifications of experts at the SRL are not detailed in this document.
   • For Hemoglobin Variants, the reference methods used to establish the ground truth were "Trinity Biotech Hb9210 and Ultra2, Menarini HA8181V and TOSOH G8," which are demonstrated to be free from hemoglobin interference. Again, the number and qualifications of the operators of these reference methods are not specified.

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

   • The document does not describe an adjudication method involving multiple human readers for establishing ground truth. The ground truth for method comparison and hemoglobin variant studies relies on reference methods/laboratories.

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

   • No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or described, as this device is an in-vitro diagnostic (IVD) test system (HbA1c assay) and not an imaging AI device that would typically involve human reader interpretation.

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

   • Yes, the performance characteristics described are for the "HbA1c Advanced reagent on the DxC 700 AU Clinical Chemistry Analyzer" as a standalone device (algorithm only performance, in a laboratory setting). The entire submission details the analytical performance of the device itself.

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

   • Precision: Internal validation against the device's own specifications.
   • Linearity: Internal validation for demonstrating accurate measurement across specific concentration ranges.
   • Method Comparison: Comparison to an NGSP Secondary Reference Laboratory (SRL) standardized method (HA8180V HPLC).
   • Analytical Specificity (Interference): Comparison to baseline measurements of samples without interferents, assessed against a 7% recovery criteria.
   • Hemoglobin Variants: Comparison to reference methods demonstrated to be free from hemoglobin interference (Trinity Biotech Hb9210 and Ultra2, Menarini HA8181V and TOSOH G8).

7. The sample size for the training set:

   • This document describes the analytical validation of a biochemical assay on an automated analyzer. There is no "training set" in the context of machine learning, as the device is a reagent and instrument system, not an AI/ML algorithm that is trained on data. The device's performance is rigorously tested as described above.

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

   • Not applicable, as this is not an AI/ML device with a training set. The assay's analytical parameters are established through chemical and immunochemical principles and optimized during development.

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System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.

The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.

Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Ireland Inc. Ceruloplasmin reagent, based on the provided document:

Acceptance Criteria and Device Performance

Study Details:

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

   • Method Comparison: 120 samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
   • Precision Study: The report lists 6 "pools" with varying concentrations. The number of individual samples within each pool or the total number of samples used for the precision study is not explicitly stated beyond what is implied by the "Pool" structure. The data provenance is also not specified.

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

   • This is a chemistry test system (in vitro diagnostic reagent) for quantitative determination of ceruloplasmin. The ground truth (reference values) for the method comparison study was established using a predicate device, the Siemens N Antisera to Human Ceruloplasmin. For precision, the ground truth is based on the inherent variability measurements of the device itself.
   • Therefore, the concept of "experts establishing ground truth" in the way it might apply to image-based diagnostic AI is not directly applicable here. No human experts are explicitly mentioned as establishing the ground truth for these quantitative measurements.

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

   • Not applicable. This device provides quantitative measurements, which are directly compared to values obtained from a predicate device or assessed for statistical precision, rather than requiring subjective expert adjudication of qualitative interpretations.

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

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

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

   • Yes, essentially. The stated performance data (Method Comparison, Precision) reflects the standalone performance of the Ceruloplasmin reagent system on Beckman Coulter AU analyzers without direct human intervention in the result generation process, beyond operating the analyzer and performing necessary calibration/quality control.

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

   • For the Method Comparison study, the ground truth was established by another legally marketed predicate device: Siemens N Antisera to Human Ceruloplasmin. This is a form of comparative ground truth against an established method.
   • For the Precision study, the ground truth is statistical, derived from repeated measurements of samples to quantify variability relative to the mean of those measurements.

7. The sample size for the training set:

   • This document describes a 510(k) premarket notification for an in-vitro diagnostic reagent. It does not refer to a "training set" in the context of machine learning or AI. The development process for such a reagent would involve internal verification and validation studies during manufacturing, but these are not typically referred to as "training sets" in the same way as for AI. The document only reports performance data, not development data.

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

   • Not applicable, as there is no "training set" described in the context of AI. For the development and validation of an IVD reagent, ground truth would be established through a combination of using certified reference materials, comparison to existing gold standard methods, and defined analytical protocols to ensure accuracy and precision. However, these specific details are not provided in this 510(k) summary.

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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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Urine/CSF Albumin:

The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only.

Urine/CSF Albumin Calibrator:

The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.

The Urine/CSF Albumin reagent kit is in a liquid, ready to use format. There are two kit concepts available. Each kit concept contains an R1 and an R2 reagent vial with different fill volumes. The Urine/CSF Albumin calibrator kit is in a liquid, ready to use format and contains 5 x 2 mL calibrator levels. It is packaged and sold separately to the reagent kit. Urine/CSF Albumin reagent is used to measure albumin concentration by a turbidimetric method. In the reaction, anti-human serum albumin antibodies combine with albumin from the sample to form immune complexes that scatter light in proportion to their size, shape and concentration. The absorbance of these aggregates is proportional to the albumin concentration in the sample. Change in absorbance is measured at 380nm with subtraction of a reference wavelength at 800nm. The Urine/CSF Albumin reagent and calibrator is designed for optimal performance on Beckman Coulter AU clinical chemistry analyzers.

This looks like a 510(k) premarket notification for a medical device: "Urine/CSF Albumin and Urine/CSF Albumin Calibrator." The document describes various analytical performance studies to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing a new clinical claim. Therefore, some of the requested information (like MRMC study effect size, number of experts for ground truth, adjudication method, and training set details) is not directly applicable to this type of submission.

However, I can extract and organize the available "acceptance criteria" (implicitly, the performance targets demonstrated) and "device performance" (the results of the studies).

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating equivalence through analytical performance, the "acceptance criteria" are implied by the precision, linearity, sensitivity, and interference limits typically expected for such devices, and demonstrated by the successful results presented. The "reported device performance" is the direct result from the validation studies.

• Low: 0.02 SD (0.9% CV)
• Mid: 0.02 SD (0.6% CV)
• High: 0.3 SD (1.4% CV)
  CSF:
• Low: 0.07 SD (1.0% CV)
• Mid: 0.4 SD (1.6% CV)
• High: 0.7 SD (1.9% CV) |
  | Precision (Within Laboratory/Total Imprecision) | Urine:
• Low: 0.07 SD (4.3% CV)
• Mid: 0.08 SD (2.5% CV)
• High: 0.4 SD (2.1% CV)
  CSF:
• Low: 0.11 SD (1.8% CV)
• Mid: 0.6 SD (2.4% CV)
• High: 0.9 SD (2.5% CV) |
  | Analytical Range (Linearity) | Urine: 0.7 - 45 mg/dL (acceptable linearity demonstrated)
  CSF: 1 - 45 mg/dL (acceptable linearity demonstrated) |
  | Reagent Shelf-Life Stability | 18 months at 2-8°C |
  | Calibrator Shelf-Life Stability | 18 months at 2-8°C |
  | Reagent On-Board Stability | 60 days |
  | Calibration Frequency | 60 days |
  | Calibrator Open Vial Stability | 30 days |
  | Sensitivity (LoB) | Urine: 0.00 mg/dL
  CSF: 0.00 mg/dL |
  | Sensitivity (LoD) | Urine: 0.07 mg/dL
  CSF: 0.13 mg/dL |
  | Sensitivity (LoQ) (≤ 0.7 mg/dL for urine, ≤ 1.0 mg/dL for CSF) | Urine: 0.70 mg/dL
  CSF: 0.70 mg/dL (met acceptance criteria) |
  | Interference (No Significant Interference: ≤ ± 10% or ± 0.2 mg/dL) | Urine:
• Calcium: NSI up to 78 mg/dL
• Creatinine: NSI up to 300 mg/dL
• Glucose: NSI up to 3000 mg/dL
• Urea: NSI up to 5000 mg/dL
• Ascorbic Acid: NSI up to 500 mg/dL
• Citrate: NSI up to 50 mg/dL
• Magnesium: NSI up to 400 mg/dL
• Oxalate: NSI up to 30 mg/dL
• Conjugated Bilirubin: NSI up to 40 mg/dL
• Hemoglobin: NSI up to 500 mg/dL
• Acetone: NSI up to 350 mg/dL
• Uric Acid: NSI up to 10 mg/dL
• Urobilinogen: NSI up to 2.25 mg/dL
• Acetaminophen: NSI up to 300 mg/dL
• Ibuprofen: NSI up to 400 mg/dL
• Metronidazole: NSI up to 600 mg/dL
• 5-aminosalicylic acid: NSI up to 150 mg/dL
  CSF:
• Hemoglobin: NSI up to 500 mg/dL
• Conjugated Bilirubin: NSI up to 40 mg/dL |
  | Prozone Tolerance | All samples from upper end of linear range up to claimed prozone tolerance generated a flagged result (indicating a result above the linear range), meaning no false low readings for high concentrations. Prozone high pool tested at ≥ 2000 mg/dL. |
  | Method Comparison (Urine) (vs. commercially available assay) | Slope = 1.09, Intercept = 0.03 mg/dL, r = 1.0; Sample range = 0.81 - 40.7 mg/dL (n=131) |
  | Method Comparison (CSF) (vs. commercially available assay) | Slope = 1.05, Intercept = -0.77 mg/dL, r = 0.99; Sample range = 1.72 - 41.2 mg/dL (n=131) |

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

• Precision (Repeatability and Total Imprecision): 3 sample levels (Low, Mid, High) for both Urine and CSF. Each level analyzed in duplicate, twice daily, over 20 working days (n=80 total measurements per level).
  • Data Provenance: Pooled human urine samples (spiked with purified human serum albumin) and pooled human CSF samples (diluted or spiked with purified human serum albumin). Origin country not specified but implied to be from samples handled in a clinical laboratory setting within the context of a US FDA submission. Prospective for the purpose of the study.
• Analytical Range (Linearity): 11 linearity concentration levels. Each dilution assayed in quadruplicate.
  • Data Provenance: Urine and CSF pools prepared by spiking with HSA or dilution. Origin country not specified. Prospective for the purpose of the study.
• Sensitivity (LoB, LoD, LoQ):
  • LoB/LoD: Replicate measurements on blank and low-level samples using three reagent lots. 60 blank replicates per reagent lot and 60 low-level sample replicates per reagent lot (total of 180 blanks and 180 low-level samples across 3 lots). Comprised of 4 blank samples and 4 low-level samples for urine and CSF, run 5-fold for 3 days. Four separate saline pools were used as blanks.
  • LoQ: Six pools (0.1, 0.2, 0.35, 0.5, 0.7, 1 mg/dL albumin in urine and CSF). Each pool measured in duplicate, twice daily, over 20 working days (n=80 total measurements per pool).
  • Data Provenance: Saline for blanks, quantified urine and CSF pools (diluted with saline) for low-level samples, and spiked urine and CSF pools for LoQ. Origin country not specified. Prospective for the purpose of the study.
• Interferences: Urine and CSF pools tested at two different albumin concentrations (1.5-3 mg/dL and 10-20 mg/dL for urine; 10-20 mg/dL and 25-35 mg/dL for CSF). Each interferent concentration tested in quadruplicate.
  • Data Provenance: Pooled human urine and CSF samples, spiked with purified human serum albumin and various interfering substances. Origin country not specified. Prospective for the purpose of the study.
• Prozone: Human urine and CSF spiked with human serum to create a prozone high pool (≥ 2000 mg/dL). Prozone panels run n=3.
  • Data Provenance: Human urine and CSF, spiked. Origin country not specified. Prospective for the purpose of the study.
• Method Comparison (Urine): n = 131 patient urine samples.
  • Data Provenance: Patient urine samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
• Method Comparison (CSF): n = 131 patient CSF samples.
  • Data Provenance: Patient CSF samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
• Reference Interval Validation (Urine): 20 urine samples.
  • Data Provenance: Urine samples. Origin country not specified. Prospective for the purpose of validation.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement. The "ground truth" for the analytical performance studies is established by the known concentrations of calibrators, spiked samples, or comparison to a cleared reference method, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, "ground truth" is analytical, not based on expert review and adjudication.

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

Not applicable. This is an IVD device, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers." The device quantifies albumin concentration directly.

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

Yes, the device (Urine/CSF Albumin reagent and calibrator on Beckman Coulter AU clinical chemistry systems) is a standalone algorithm/instrument-based system that quantifies albumin concentration. Its performance is evaluated analytically, without a human-in-the-loop component for the direct measurement itself. Human oversight and interpretation of the numerical results are part of clinical practice, but the device's measurement function is autonomous.

7. The Type of Ground Truth Used

The "ground truth" or reference for the analytical performance studies relies on:

• Known concentrations: For precision, linearity, and sensitivity studies, this is achieved by using prepared pools with known added amounts of human serum albumin (HSA) or specific dilutions.
• Traceability to a Certified Reference Material: The Urine/CSF Albumin calibrator values are traceable to the International Federation of Clinical Chemistry Certified Reference Material ERM® - DA470k.
• Comparison to a legally marketed predicate device/method: For method comparison studies, the results are compared against another commercially available and presumably FDA-cleared assay for Urine Albumin and CSF Albumin.
• Literature-based reference intervals: Expected values/reference ranges are drawn from established medical literature.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense for diagnostic image interpretation or similar tasks. It's an immunoassay for quantitative analysis. The development process would involve internal R&D tests and optimization, but a defined training set for an AI model is not relevant here.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.

The System calibrator kit is a lyophilized human serum based product intended to provide calibration for AU Enzyme reagents (ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH) for the quantitative determination of the relevant analyte on Beckman Coulter AU analyzers. The following is the kit configuration for the system calibrator: 66300 kit has 20 vials with 5 ml contents for Level 1. The System calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The System calibrator contains lyophilized human serum with chemical additives, preservatives, and enzymes of human, animal and plant origin.

This document describes the Beckman Coulter System Calibrator (66300), a lyophilized human serum-based product intended for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT, and LDH enzymes on Beckman Coulter AU480, AU680, and AU5800 analyzers.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Open Vial Stability: 3 individual calibrator lots.
• Shelf Life Stability: 3 individual lots of calibrator.
• Value Assignment: Multiple reagent lots and calibrator vials were used. 10 replicates from 8 runs were performed, resulting in a total of 80 data points per individual enzyme. Distinct runs with minimum gaps of 2 hours were performed, and 8 calibration events were used.

The data provenance is not explicitly stated in terms of country of origin. The studies appear to be internal validation studies conducted by Beckman Coulter Ireland, Inc. and may be considered prospective as they were specifically designed for this submission.

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

Not applicable for this type of device. The ground truth for this calibrator is based on analytical performance specifications and traceability to theoretical extinction coefficients, not expert consensus interpretation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This device is a calibrator for in vitro diagnostic assays, and its performance is evaluated through quantitative analytical methods and stability testing, not through expert adjudication of qualitative outcomes.

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

No. An MRMC comparative effectiveness study is not relevant for this device. This product is a calibrator, not an imaging or diagnostic algorithm requiring human interpretation.

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

Yes, in the sense that the performance characteristics (stability, value assignment) are determined directly from the calibrator's analytical behavior on Beckman Coulter AU analyzers without human intervention in the result determination process. The "device" (calibrator) performs its function (calibrating assays) independently of human judgment on the results, although human operators perform the testing.

7. The Type of Ground Truth Used

The ground truth for the System Calibrator's values and performance is established through:

• Analytical Performance Specifications: The device's stability (open vial and shelf life) is evaluated against a maximum allowable drift of ±5%.
• Traceability to Theoretical Extinction Coefficients: The assigned values for each enzyme are traceable to specific theoretical extinction coefficients (e.g., Amylase OSR6x06: 11320, ALP OSR6x04: 17900), which are fundamental physicochemical properties.
• Internal Test Procedures and Protocols: Value assignment was determined utilizing internal procedures and protocols that involved multiple reagent lots and calibrator vials.

8. The Sample Size for the Training Set

Not applicable. This document describes a calibrator, not a machine learning or AI model that requires a training set. The "training" in this context refers to the calibration of an analyzer using the calibrator, not the development of an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. For the calibrator's value assignment, the ground truth was established by calculating the overall mean from 80 data points (10 replicates from 8 runs) for each individual enzyme, ensuring incorporation of variation from calibration and environmental sources, and tracing these values to theoretical extinction coefficients.

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The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyzers. For in vitro diagnostic use only.

The Bicarbonate Calibrator kit is a two level aqueous preparation of sodium carbonate intended to provide calibration for the Bicarbonate reagent for the calibration of bicarbonate on Beckman AU Coulter analyzers. This is available in the following configurations Cat # OSR6137, OSR6237 and OSR6537. For convenience this is often referred to internally and externally as OSR6x37. The following is the kit configuration for the Bicarbonate Calibrator: ODC0019 has 3 vials with 25ml contents for Level 1 and 3 vials with 25ml for Level 2. The Bicarbonate Calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The calibrator contains sodium o-phenylphenate tetrahydrate which acts as a preservative.

The provided text describes the acceptance criteria and the study for the Beckman Coulter Bicarbonate Calibrator.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Stability Studies: Open vial and shelf life stability used "3 individual calibrator lots" for testing. "Multiple time points" were used during the claim period and beyond. For each time point, controls were run in "replicates of 5" and test vials were compared with "freshly opened calibrator vial."
  • Value Assignment and Traceability: "A sample from test calibrator and NIST SRM 351 standard was run (n=10)." and "NIST351 standard and test calibrator recovered (n=10)."
• Data Provenance: The studies were conducted by Beckman Coulter Ireland, Inc. and Beckman Coulter in the USA. The data appears to be prospective as it involves real-time stability testing and direct experimental runs for value assignment and traceability. No specific mention of country of origin for patients or samples, as this is a calibrator, not a diagnostic device using patient samples directly.

3. Number of Experts and Qualifications

Not applicable. This device is a calibrator, not a medical imaging device or algorithm requiring expert interpretation of results. The performance is assessed against analytical standards and established methods, not human expert consensus on clinical data.

4. Adjudication Method

Not applicable. This is an analytical device for calibration, not a diagnostic device requiring adjudication of clinical interpretations. Performance is determined by quantitative analytical results meeting predefined specifications.

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

Not applicable. This is a calibrator, not a diagnostic device that humans would interpret with or without AI assistance.

6. Standalone Performance Study

Yes, the studies described above are standalone performance studies of the calibrator itself. The calibrator's performance (stability, value assignment, traceability) is assessed independently of a human operator making clinical decisions. The calibrator's function is to ensure the accuracy of the Beckman Coulter AU analyzers when running the Bicarbonate reagent.

7. Type of Ground Truth Used

• Stability Studies: The ground truth is the performance of the calibrator itself over time, compared to its initial established values and against the performance of freshly opened calibrator vials or within predefined control ranges and precision claims. The "appropriate control material" with "target ranges and precision claims" serves as a reference.
• Value Assignment and Traceability: The ground truth is established by the NIST (National Institute of Standards and Technology) SRM351 standard. This is a highly accurate, internationally recognized reference material for bicarbonate. The calibrator's values are directly traced to this gold standard.

8. Sample Size for the Training Set

Not applicable. This is a chemical calibrator for in vitro diagnostics, not a machine learning or AI algorithm that requires a training set. Its formulation is based on chemical principles and manufacturing processes, not data training.

9. How Ground Truth for the Training Set Was Established

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

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AU Bicarbonate reagent is intended for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Bicarbonate measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

For In Vitro Diagnostic Use

The AU Bicarbonate reagent kit is a liquid, ready to use and consists of four R1 reagent vials in vanous fill volumes. The calibrator is a Beckman Coulter lyophilized chemistry calibrator packaged as catalog number DR0070 and sold separately. The AU Bicarbonate reagent is an enzymatic method utilizing Bicarbonate (HCO3) and phosphoenolpyruvate (PEP), which are converted to oxaloacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). This oxidation of NADH results in a decrease in absorbance of the reaction mixture measured bichromatically at 380/410nm proportional to the Bicarbonate content of the sample.

The AU Bicarbonate reagent is designed for optimal performance on Beckman Coulter AU analyzers.

Here's a breakdown of the acceptance criteria and study information for the AU Bicarbonate Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

All reported device performances met their respective acceptance criteria as indicated by "Pass" in the Method Comparison and Precision tables.

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

• Method Comparison Test Set: N = 133 samples.
• Precision Test Set: The document refers to "Low pool," "Med pool," and "High pool" samples. It doesn't specify an overall sample size for the precision study, but implies multiple measurements were taken for each pool (e.g., within-run and total precision across multiple runs/days).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is clinical laboratory data, likely gathered prospectively during validation studies.

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

• This document describes an in vitro diagnostic reagent for quantitative determination of bicarbonate, not an imaging or diagnostic device requiring expert interpretation for ground truth.
• The "ground truth" for method comparison is a reference method (Thermo Scientific, TR28321) and for precision is based on statistical measures of reproducibility. No human expert "ground truth" establishment is described for these types of studies.

4. Adjudication Method for the Test Set:

• Not applicable. This is a quantitative chemical assay, not an interpretative diagnostic task requiring adjudication. The performance is assessed against predefined statistical and analytical criteria.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for an in vitro diagnostic reagent.

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

• Yes, this entire study represents the standalone performance of the AU Bicarbonate Reagent on Beckman Coulter AU analyzers. There is no human-in-the-loop component in the measurement and quantification of bicarbonate by this automated system.

7. The Type of Ground Truth Used:

• Quantitative Reference Measurement: For the method comparison, the "ground truth" is a comparison against a commercially available and presumably validated reference method (Thermo Scientific TR28321).
• Statistical Definitions: For precision, the "ground truth" is based on statistical definitions of within-run and total precision, where the target values are the mean concentrations of the control pools.
• Defined Standards/Limits: For sensitivity, linearity, and interfering substances, the ground truth is established against predefined analytical limits and standards (e.g., NIST standard for calibrator traceability).

8. The Sample Size for the Training Set:

• The document does not explicitly refer to a "training set" in the context of machine learning. This is a chemical reagent and instrument system, not an AI/ML algorithm that undergoes a distinct training phase with a labeled dataset. The development and optimization of the reagent itself would involve internal R&D studies, but these are not referred to as a "training set" in this context.

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

• Not applicable, as this device does not involve a machine learning "training set." The performance characteristics are established through analytical validation studies rather than machine learning model training.

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