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The ADVIA Centaur® C-peptide (CpS) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur C-peptide assay.

The ADVIA Centaur® Insulin (IRI) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Insulin assay.

ADVIA Centaur® C-peptide Master Curve Material is an in vitro diagnostic product containing various levels of C-peptide spiked in citric acid buffer with casein and preservatives. Each set contains ten levels (MCM1–10); ready-to-use 1.0 mL per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values 0.0 0.14, 0.25, 0.55, 1.05, 2.05, 4.00, 8.00, 16.0, 32.5 ng/mL.

ADVIA Centaur® Insulin Master Curve Materials is an in vitro diagnostic product containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (<0.1%), and preservatives. Each set contains ten levels (MCM1-10); ready-to-use 1.0 mL per level. MCM1 contains no analyte. The IRI MCMs assigned values are lotspecific of target values: 0.0, 2.5, 4.5, 10.0, 20.0, 39.0, 79.0, 158, 225, and 300 mU/L.

The provided document describes the Siemens ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM) and ADVIA Centaur Insulin (IRI) Master Curve Material (MCM). These devices are described as in vitro diagnostic products for the verification of calibration and reportable range of their respective assays. The document focuses on establishing substantial equivalence to predicate devices and describes relevant performance characteristics, primarily stability and value assignment.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Device Type: In vitro diagnostic Master Curve Material (MCM) - these are control materials used to verify the calibration and reportable range of an assay, not a diagnostic device that produces patient-specific results. Therefore, the questions related to clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, PPV, NPV), multi-reader multi-case studies, human reader improvement with AI, and specific ground truth types like pathology or outcomes data are not applicable in the context of this device and the provided documentation. The "performance" here refers to the stability and accurate value assignment of the control material itself.

1. Acceptance Criteria and Reported Device Performance

For ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM):

For ADVIA Centaur Insulin (IRI) Master Curve Material (MCM):

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

The document does not explicitly define a "test set" in the context of clinical or diagnostic performance, as the device is a control material. Instead, testing involves stability studies and value assignment.

• Sample Size for Stability Studies:
  • C-peptide MCM: For each MCM level, 3 replicates were run at each time point (T=0, 3, 9, 12, 13 months for real-time; T=0, 2, 4, 5 hours for on-board).
  • Insulin MCM: For each MCM level, 3 replicates were run at each time point (T=0, 3, 7, 9, 12 months for real-time; T=0, 2, 4, 6, 8, 9 hours for on-board).
• Sample Size for Value Assignment:
  • C-peptide MCM: MCM1-10 are run in 3 replicates across two ADVIA Centaur instruments using two reagent kit lots, run twice on each instrument. This totals 24 replicates per MCM level (3 replicates * 2 instruments * 2 reagent lots * 2 runs). Additionally, MCM9 is run diluted 1:2 using MCM1. Three levels of commercially available controls and two levels of in-house controls are used.
  • Insulin MCM: MCM1-10 are run in replicates of three across two ADVIA Centaur instruments using two reagent kit lots, run twice on each instrument. This totals 24 replicates per MCM level. MCM10 is also run diluted 1:2 using MCM1. Two lots of commercially available controls (3 levels each) are used.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. Given the nature of stability and value assignment studies for an in-house manufactured control material, it is highly likely that these studies were conducted prospectively by the manufacturer (Siemens Healthcare Diagnostics Inc., based in Tarrytown, NY, USA).

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

This information is not applicable as the devices are control materials for assay calibration verification. The "ground truth" here is the assigned value of the control material, which is established through a standardized value assignment process rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the sense of a collection of cases requiring interpretation or adjudication. The studies involve objective measurements of analyte concentration in control materials.

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

This is not applicable. The device is a control material, not an AI-powered diagnostic system or an imaging device designed for human reader interpretation. No human-in-the-loop performance is being evaluated.

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

This is not applicable. The device is a physical control material used in conjunction with an immunoassay analyzer. It does not involve an algorithm working in "standalone" mode.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For both the C-peptide and Insulin MCMs, the "ground truth" (or reference value) is established through traceability to World Health Organization (WHO) international reference materials.

• C-peptide MCM: Traceable to WHO IS 84/510 reference material.
• Insulin MCM: Traceable to WHO 1st IRP 66/304 reference material.

The assigned values for master curve standards, calibrators, and MCMs are directly traceable to these international standards.

8. The Sample Size for the Training Set

This is not applicable. As a control material, there is no "training set" in the machine learning sense. The devices are manufactured according to specifications and their performance (stability and assigned values) is evaluated. The "value assignment" process could be considered analogous to establishing the expected values for the controls, but it's not a training phase for an algorithm.

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

This is not applicable for the reasons outlined in point 8. The ground truth for the value assignment of the MCMs themselves is established through traceability to WHO international reference materials, as described in point 7.

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