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The IMMULITE® Ferritin Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Ferritin assay on the IMMULITE 2000 systems.

The IMMULITE® IGFBP-3 Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGFBP-3 assay on the IMMULITE 2000 systems

The Ferritin Calibration Verification Material (CVM) contains one set of four vials. CVM1 contains 5.0mL of human serum albumin with preservatives. CVM2, CVM3, and CVM4 contain 2.0mL/vial of various levels of human ferritin in a human serum albumin matrix with preservatives. The CVMs are supplied in liquid form.

IMMULITE® 2000 IGFBP-3 Calibration Verification Material (CVM) contains one set of four vials each 2.0mL/vial. CVM1 contains bovine protein buffer matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of processed human serum (source of IGFBP-3) in bovine protein buffer matrix with preservatives. The CVMs are supplied in liquid form.

The document describes the acceptance criteria and stability studies for two calibration verification materials: the IMMULITE® 2000 Ferritin Calibration Verification Material (CVM) and the IMMULITE® 2000 IGFBP-3 Calibration Verification Material (CVM).

Here's a breakdown of the requested information for each device:

IMMULITE® 2000 Ferritin Calibration Verification Material (CVM)

1. Table of acceptance criteria and reported device performance

Acceptance Criteria for Stability of IMMULITE 2000 Ferritin CVM (from Table 3):

Reported Device Performance (Stability Summary - Section 7.1 and 7.1.1):
The document states that the IMMULITE® 2000 Ferritin Calibration Verification Materials are stable for up to 18 months when stored at 2-8°C prior to opening, and for 8 hours at ambient or room temperature (15-25°C) after reconstitution. The stability study involved testing CVM levels at time points 0, 6, 12, and 18 months, with "dose value determined from the reference calibrator curve." For open component testing, results were determined at 2-hourly intervals for up to 9 hours and compared to time zero. The document implies that the device met these criteria, as it concludes: "Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use." and "The substantial equivalence of the device is supported by the non-clinical testing...". However, specific numerical results of the stability study demonstrating adherence to each range are not explicitly provided in the excerpt.

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

• Test Set Sample Size: For stability testing, CVMs and reference CVMs were run in duplicate (as a minimum) at specified time points (0, 6, 12, 18 months). For open component testing, Ferritin CVM lot 016A was tested at 2-hourly intervals for up to 9 hours. For value assignment and expected values, each CVM level was tested on 4 different days, on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 5 IMMULITE 2000 systems and 3 different reagent kit lots. Additionally, five levels of commercially available controls and 30 samples (15 spiked and 15 normal samples) were used to validate calibrator/CVM value assignments.

• Data Provenance: Not explicitly stated. The manufacturer is Siemens Healthcare Diagnostics Inc. in Tarrytown, NY, USA, suggesting a US-based or international company, but specific country of origin for the data is not mentioned, nor is it specified if the data is retrospective or prospective. Given it's a stability study, it would be prospective data collection.

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)

• Number of experts: Not applicable. This is a calibration verification material for an in vitro diagnostic assay, where "ground truth" (or assigned value) is established through a metrological traceability chain rather than expert consensus on medical images or clinical outcomes.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. The process involves direct measurement against reference calibrators and statistical analysis, not human adjudication of observations. The CVM values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.

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

• MRMC study: Not applicable. This device is a quality control material for an automated assay, not an AI-assisted diagnostic tool involving human readers.

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

• Standalone study: The performance evaluated here is inherently "standalone" in the sense that it's the performance of the calibration material itself when run on the IMMULITE 2000 systems. There isn't an "algorithm only" device for this type of product separate from its use with the instrument.

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

• Type of Ground Truth: The ground truth for the Ferritin CVMs is based on traceability to WHO 2nd IS 80/578 and internal value assignment using assigned reference calibrators. These reference calibrators are prepared using Ferritin antigen stock. This represents a form of metrological traceability to an international standard.

8. The sample size for the training set

• Training Set Sample Size: Not explicitly applicable in the conventional sense of machine learning algorithms. The concept of a "training set" doesn't directly apply here. However, the value assignment process, which determines the "target values" for the CVMs, involves extensive testing with multiple replicates, instruments, and reagent lots. It's the equivalent of establishing the expected performance characteristics based on a large internal dataset.

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

• Ground Truth for Training Set: The "ground truth" (i.e., assigned values) for the calibrators and CVMs are established by Siemens Healthcare Diagnostics Inc. using a process outlined in Section 7.3 "Value Assignment". It involves:
  • Traceability to WHO 2nd IS 80/578.
  • Using assigned reference calibrators prepared with Ferritin antigen stock.
  • Testing CVMs on 4 different days, 15 replicates in total (5 runs, 3 replicates per run), 5 IMMULITE 2000 systems, and 3 different reagent kit lots.
  • Generating CVM dose values from curves generated by assigned reference calibrators, with values calculated for each run/instrument independently and then averaged across all systems.
  • Quality control through recovery of patient samples and commercial controls using the assigned CVM values, which must fall within their target ranges.

IMMULITE® 2000 IGFBP-3 Calibration Verification Material (CVM)

1. Table of acceptance criteria and reported device performance

Acceptance Criteria for Stability of IMMULITE 2000 IGFBP-3 CVM (from Table 3):

Reported Device Performance (Stability Summary - Section 7.1 and 7.1.1):
The document states that the IMMULITE® 2000 IGFBP-3 Calibration Verification Materials are stable for up to 4 years when stored at -20°C. The stability study involved testing CVM levels at time points 0, 30, 36, and 48 months, with "dose value determined from the reference calibrator curve." Similar to the Ferritin CVM, the document implies that the device met these criteria, concluding: "Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use." and "The substantial equivalence of the device is supported by the non-clinical testing...". Specific numerical results of the stability study demonstrating adherence to each range are not explicitly provided.

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

• Test Set Sample Size: For stability testing, CVMs and reference CVMs were run in duplicate (as a minimum) at specified time points (0, 30, 36, 48 months). For value assignment and expected values, each CVM level was tested on 3 different days, on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 3 IMMULITE 2000 systems and 3 different reagent kit lots. Additionally, two levels of commercially available controls and 30 diluted normal samples were used to validate calibrator/CVM value assignments.

• Data Provenance: Not explicitly stated. The manufacturer is Siemens Healthcare Diagnostics Inc. in Tarrytown, NY, USA, suggesting a US-based or international company, but specific country of origin for the data is not mentioned, nor is it specified if the data is retrospective or prospective. Given it's a stability study, it would be prospective data collection.

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)

• Number of experts: Not applicable. This is a calibration verification material for an in vitro diagnostic assay, where "ground truth" (or assigned value) is established through a metrological traceability chain.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. The process involves direct measurement against reference calibrators and statistical analysis, not human adjudication of observations. The CVM values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.

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

• MRMC study: Not applicable. This device is a quality control material for an automated assay, not an AI-assisted diagnostic tool involving human readers.

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

• Standalone study: The performance evaluated here is inherently "standalone" in the sense that it's the performance of the calibration material itself when run on the IMMULITE 2000 systems. There isn't an "algorithm only" device for this type of product separate from its use with the instrument.

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

• Type of Ground Truth: The ground truth for the IGFBP-3 CVMs is based on traceability to WHO NIBSC Reagent 93/560 and internal value assignment using assigned reference calibrators. These reference calibrators are prepared using IGFBP-3 antigen stock. This represents a form of metrological traceability to an international standard.

8. The sample size for the training set

• Training Set Sample Size: Not explicitly applicable in the conventional sense of machine learning algorithms. However, the value assignment process, which determines the "target values" for the CVMs, involves extensive testing with multiple replicates, instruments, and reagent lots. It's the equivalent of establishing the expected performance characteristics based on a large internal dataset.

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

• Ground Truth for Training Set: The "ground truth" (i.e., assigned values) for the calibrators and CVMs are established by Siemens Healthcare Diagnostics Inc. using a process outlined in Section 7.3 "Value Assignment". It involves:
  • Traceability to WHO NIBSC Reagent 93/560.
  • Using assigned reference calibrators prepared with IGFBP-3 antigen stock.
  • Testing CVMs on 3 different days, 15 replicates in total (5 runs, 3 replicates per run), 3 IMMULITE 2000 systems, and 3 different reagent kit lots.
  • Generating CVM dose values from curves generated by assigned reference calibrators, with values calculated for each run/instrument independently and then averaged across all systems.
  • Quality control through recovery of patient samples, spiked patient samples, and commercial controls using the assigned CVM values, which must fall within their target ranges.

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