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The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum and plasma using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma when using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.

The ARCHITECT B12 Reagent Kit consists of 100 (1 x 100) or 500 (1 x 500) tests. Each kit contains 1 bottle each of the following reagents: ARCHITECT B12 Microparticles, ARCHITECT B12 Conjugate, ARCHITECT B12 Assay Diluent, ARCHITECT B12 Pre-Treatment Reagent 1, ARCHITECT B12 Pre-Treatment Reagent 2, ARCHITECT B12 Pre-Treatment Reagent 3.

Each ARCHITECT B12 Calibrator Kit contains 6 Bottles (4 mL each) of ARCHITECT B12 Calibrators (1 bottle each of Calibrators A – F).

Each ARCHITECT B12 Control Kit contains 3 bottles (8 mL each) of ARCHITECT B12 Controls (1 bottle of low control, 1 bottle of medium control, and 1 bottle of high control).

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Precision": {
      "Acceptance Criteria": "< 10% CV for total (within-laboratory) imprecision",
      "Reported Device Performance": "Low Panel (Lot 1, Inst 1): 6.7% CV; Low Panel (Lot 1, Inst 2): 6.3% CV; Medium Panel (Lot 1, Inst 1): 3.1% CV; Medium Panel (Lot 1, Inst 2): 3.1% CV; High Panel (Lot 1, Inst 1): 3.7% CV; High Panel (Lot 1, Inst 2): 3.1% CV; Low Panel (Lot 2, Inst 1): 6.0% CV; Low Panel (Lot 2, Inst 2): 6.9% CV; Medium Panel (Lot 2, Inst 1): 4.4% CV; Medium Panel (Lot 2, Inst 2): 3.1% CV; High Panel (Lot 2, Inst 1): 6.0% CV; High Panel (Lot 2, Inst 2): 3.3% CV. All values were ≤ 10% CV."
    },
    "Tube Type Equivalence (Lithium Heparin Plasma vs. Serum)": {
      "Acceptance Criteria": "Difference between tube types within +/-10.0% criteria (non-parametric two-sided 95% confidence limits around the median).",
      "Reported Device Performance": "Median % Difference: 3.3%; 95% CI: (2.2%, 4.7%). The limits fell entirely within the +/-10.0% criteria."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Precision Study": {
      "Sample Size": "Low, Medium, and High lithium heparin plasma panels (number of distinct panels not specified, but tested in replicates).",
      "Data Provenance": "Not specified, but internal study conducted by Abbott Laboratories suggests prospective, lab-based data."
    },
    "Tube Type Study": {
      "Sample Size": "63 unique donors (each providing both plasma and serum samples).",
      "Data Provenance": "Not specified, but internal study conducted by Abbott Laboratories suggests prospective, lab-based data."
    }
  },
  "3. 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. This is an in-vitro diagnostic device for quantitative measurement, and performance is assessed by analytical studies (precision, method comparison) rather than subjective expert interpretation."
  },
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. Ground truth for analytical studies is established through quantitative measurements against a reference method or predetermined statistical criteria, not through expert 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 in-vitro diagnostic device, not an AI-assisted diagnostic tool for human readers."
  },
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance described is standalone algorithm performance for the quantitative determination of vitamin B12."
  },
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": {
    "Precision Study": "The ground truth for precision is the analytical variability of the device itself, measured by calculating standard deviation and coefficient of variation from repeated measurements of known analyte concentrations in control samples/panels.",
    "Tube Type Study": "The ground truth for tube type equivalence is the measurement obtained from the control tube type (plastic serum tubes), which serves as the reference for comparison with the evaluation tube type (lithium heparin plasma separator tubes)."
  },
  "8. The sample size for the training set": "Not applicable. The provided document describes validation studies for an in-vitro diagnostic assay, not machine learning model training."
  },
  "9. How the ground truth for the training set was established": "Not applicable. The provided document describes validation studies for an in-vitro diagnostic assay, not machine learning model training."
  }
}

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The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum when using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.

Sample and Pre-Treatment Reagent 1, Pre-Treatment Reagent 2, and Pre-Treatment Reagent 3 are combined. An aliquot of the pre-treated sample is aspirated and transferred into a new reactions vessel (RV). The pre-treated sample, assay diluent, and intrinsic factor coated paramagnetic microparticles are combined. B12 present in the sample binds to the intrinsic factor coated microparticles. After washing, B12 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of B12 in the sample and the RLUs' detected by the ARCHITECT i System optics.

Acceptance Criteria and Device Performance Study for ARCHITECT B12 Assay

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the ARCHITECT B12 assay to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., target accuracy, precision thresholds) that the ARCHITECT B12 assay needed to meet. Instead, the study aimed to demonstrate substantial equivalence to a predicate device. The performance was assessed through a comparison study.

Note: The 510(k) summary focuses on demonstrating equivalence rather than meeting specific numerical acceptance criteria for a new device type. The key acceptance was the FDA's determination of "substantial equivalence."

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 172 patient samples.
• Data Provenance: Not explicitly stated, but based on the context of a medical device submission, these would typically be human serum samples. The geographical origin (e.g., country) is not specified. The study is implicitly retrospective as it involves testing archived patient samples against an existing predicate device.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for this type of assay comparison is established by the results of the legally marketed predicate device, not by expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison is objective, based on quantitative measurements from two different assay systems, rather than subjective interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret images. The ARCHITECT B12 assay is a quantitative in-vitro diagnostic test.
• Effect Size of Human Reader Improvement with AI: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, the study described is a standalone performance study in the context of an in-vitro diagnostic device. The ARCHITECT B12 assay's performance was evaluated independently by comparing its results to a predicate device, without direct human-in-the-loop interpretation of the assay results themselves. The "algorithm" here refers to the entire assay system and its methodology.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by the results obtained from the legally marketed predicate device, the Roche Elecsys E170 Vitamin B12 assay (K060755). This is considered the "gold standard" for comparison in demonstrating substantial equivalence for an in-vitro diagnostic device.

8. Sample Size for the Training Set

• Sample Size: The 510(k) summary does not provide specific details about a "training set" for the ARCHITECT B12 assay in the context of machine learning or AI. In the development of an in-vitro diagnostic, calibration and validation samples are used during the development and manufacturing process, but these are distinct from a "training set" in an AI/ML context. The information provided focuses on the pivotal study for regulatory submission.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established (Training Set): As no specific training set in the AI/ML sense is described, the method for establishing its ground truth is not applicable in this document portion. For the overall assay, calibration materials are used, and their values are typically traceable to reference methods or primary standards, but this is a different concept than ground truth for a machine learning model.

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The Abbott ARCHITECT B12 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma.

The Abbott ARCHITECT B12 Calibrators are liquid, ready-for-use materials in a buffered aqueous solution. Concentrations of the calibrator components span the dynamic range of the assay.

The provided text describes the Abbott ARCHITECT® B12 Calibrators, which are for calibrating the ARCHITECT i System for quantitative determination of vitamin B12 in human serum and plasma. The study presented is a correlation analysis between the new 6-Point Calibrators and the predicate 2-Point Calibrators.

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

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

The acceptance criteria are not explicitly stated in the provided text. However, the study aims to demonstrate that the performance of the new 6-Point Calibrators is "comparable to the performance of the predicate device." The reported performance metrics are based on a correlation analysis.

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

• Sample size used for the test set: 495 specimens
• Data provenance: Not explicitly stated, but the specimens were "serum specimens tested." The country of origin and whether the data was retrospective or prospective are not mentioned.

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

This information is not provided in the text. The study is a comparison of two calibration methods, not a diagnostic test requiring expert ground truth in the traditional sense. The "ground truth" here is the measurement obtained by the predicate device's 2-Point Calibrators.

4. Adjudication method for the test set

This information is not applicable as it's a direct comparison of calibration methods and not a study requiring adjudication of diagnostic interpretations by experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a calibrator for an automated assay, not an AI-assisted diagnostic tool that would involve human readers.

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

This concept is not entirely applicable in the context of a calibrator for an automated immunoassay. The device is a component that enables standalone (algorithm-only, or in this case, instrument-only) performance of the ARCHITECT i System for B12 measurement. The study directly assesses the performance of this calibrator in conjunction with the instrument.

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

The "ground truth" for this study is essentially the results obtained using the predicate device's 2-point calibration assay. The new 6-point calibrators are being evaluated against the established performance of the existing calibrators.

8. The sample size for the training set

This information is not provided and is likely not relevant for this type of calibrator evaluation. Calibrators are developed based on specific chemical and manufacturing processes, not typically "trained" on large datasets in the way an AI algorithm would be.

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

This information is not provided and is likely not applicable for the reasons stated in point 8.

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Architect B12 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the B12 assay on the Abbott Architect i System.

Architect B12 MasterCheck Level 0 contains borate buffer with protein (bovine) stabilizers.

Architect B12 MasterCheck Levels 1, 2, 3 and 4 contain cyanocobalamin prepared in borate buffer with protein (bovine) stabilizers.

Preservative: Antimicrobial Agent.

The provided text is a 510(k) Summary for the Bio-Rad Architect B12 MasterCheck device. This type of submission is for in vitro diagnostic devices (IVDs), specifically controls used to verify the performance of an assay. The information requested (acceptance criteria, study details, sample sizes, ground truth, etc.) is typically found in performance studies for diagnostic assays or prognostic devices that classify or predict outcomes in patients.

For the Bio-Rad Architect B12 MasterCheck, which is a calibration verification and linearity control, the "acceptance criteria" and "device performance" are established in a different context. These devices are designed to have known concentrations of analytes, and their performance is typically evaluated by demonstrating that they produce expected results within a specified range when tested on the target analytical system (in this case, the Abbott Architect i System for B12 assay).

Therefore, many of the requested points are not directly applicable to this specific type of device or cannot be extracted from the provided 510(k) summary. I will answer the applicable questions based on the information available:

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

The 510(k) summary does not explicitly state specific numerical acceptance criteria or performance data for the Architect B12 MasterCheck. For a control device, performance is typically demonstrated by showing that the manufactured lots consistently yield the expected B12 concentrations when run on the Abbott Architect i System, verifying the system's sensitivity, calibration linearity, and reportable range.

The "performance" of such a device is inherently tied to its ability to control the assay it's designed for, rather than producing diagnostic results itself. The summary implies that "performance" is a comparison of its technological characteristics to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The summary does not describe a "test set" in the context of patient samples or a diagnostic study. This device is a control product. Performance verification would involve running multiple replicates of the control material on the Abbott Architect i System. The specific number of replicates or runs for a performance verification study is not provided. Data provenance is not available.

3. 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)

This is not applicable. The "ground truth" for a control material like Architect B12 MasterCheck is its manufactured, assigned concentration of B12. This concentration is established by the manufacturer (Bio-Rad Laboratories) through rigorous analytical methods and reference to recognized standards. It does not involve expert consensus in the diagnostic sense.

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

Not applicable, as there is no "test set" requiring adjudication in the context of diagnostic interpretation.

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

Not applicable. This device is a laboratory control, not an AI-assisted diagnostic tool, and involves no human readers or diagnostic interpretation.

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

Not applicable. This device is an IVD control, not an algorithm or AI system.

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

The "ground truth" for the Architect B12 MasterCheck is the assigned B12 concentration within each level of the control material. This is established through the manufacturer's gravimetric preparation and analytical value assignment processes, traceable to reference standards.

8. The sample size for the training set

Not applicable. This device is a control, not a machine learning algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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