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

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

The IMMULITE® 2000 Calcitonin Calibration Verification Material (CVM) contains one set of four vials each 3mL after reconstitution. CVM1 contains bovine protein buffer matrix with preservatives and CVM2, CVM3, and CVM4 contain calcitonin in bovine protein buffer matrix with preservative.

The IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (CVM) contains one set of four vials, 2mL each after reconstitution. CVM1 contains a bovine protein/buffer with 0.27% sodium azide and preservative. CVM2, CVM3, and CVM4 contain human prostatic acid phosphatase in a bovine protein/buffer matrix with 0.27% sodium azide and preservative.

This document describes two distinct calibration verification materials: IMMULITE® 2000 Calcitonin Calibration Verification Material and IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material. I will address each product separately as the acceptance criteria and supporting studies differ.

IMMULITE® 2000 Calcitonin Calibration Verification Material

This section describes the acceptance criteria and study for the IMMULITE® 2000 Calcitonin Calibration Verification Material (CVM).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the stability study supports the stated claims, which implies the acceptance criteria were met, but does not provide specific performance data points for a direct, side-by-side comparison in the summary.

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

• Test Set Sample Size for Stability:
  • Shelf-life stability: "The CVM study protocols are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) at the time points shown in Table 2."
    • Time points: Day 0, 48 months, 54 months, 60 months for all 4 CVM levels.
    • Therefore, at least 2 replicates x 4 levels x 4 time points = 32 measurements.
  • Open Component (in-use) stability: "CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions." No specific number of replicates or runs for this part is explicitly stated beyond "results were determined from a 2-point adjustment."
• Test Set Sample Size for Expected Values/Target Values/Reference Range: "Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run, 3 different reagent kit lots and 8 IMMULITE 2000 systems."
• Data Provenance: The document does not explicitly state the country of origin. It is a submission to the FDA (USA). The study is prospective in nature as it is a stability study tracking performance over time.

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

• Not applicable. This device is a calibration verification material for an in vitro diagnostic assay, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The "ground truth" (assigned dose values) for the CVMs is established through a scientific process involving reference calibrators and measurement procedures.

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

• Not applicable. This is not a study requiring human adjudication. The results are quantitative measurements against predefined criteria.

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

• Not applicable. This is not an AI/imaging device.

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

• This is an in vitro diagnostic calibration verification material. Its performance is evaluated intrinsically through laboratory testing, essentially a "standalone" evaluation of the material's stability and value assignment, but not in the context of an AI algorithm.

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

• The ground truth for the CVM is its "assigned dose" values. These values are established through:
  • Traceability to WHO 2nd IRP 89/620.
  • Manufacture using qualified materials and measurement procedures.
  • Value assignment using assigned reference calibrators, with dose values generated using curves from these reference calibrators.
  • Values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.
  • Quality control is performed by calculating the recovery of patient samples, spiked patient samples, and controls using the assigned CVM values.

8. The sample size for the training set

• Not applicable for a calibration verification material. There is no "training set" in the context of machine learning or AI for this product. The manufacturing and value assignment processes inherently involve generating data to establish the CVM's characteristics, but this isn't structured as a training set for an algorithm.

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

• Not applicable. See #8.

IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material

This section describes the acceptance criteria and study for the IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (CVM).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the stability study supports the stated claims, which implies the acceptance criteria were met, but does not provide specific performance data points for a direct, side-by-side comparison in the summary.

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

• Test Set Sample Size for Stability:
  • Shelf-life stability: "The CVM study protocols are run as part of the calibrator stability testing. The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 2."
    • Time points: Day 0, 96 months, 108 months, 120 months for all 4 CVM levels.
    • Therefore, at least 2 replicates x 4 levels x 4 time points = 32 measurements.
  • Open Component (in-use) stability: Stable for 8 hours at ambient or room temperature (15-25°C) after opening. The specific testing methodology and sample size for this claim are not detailed beyond the claim itself.
• Test Set Sample Size for Expected Values/Target Values/Reference Range: "The PAP 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 document does not explicitly state the country of origin. It is a submission to the FDA (USA). The study is prospective in nature as it is a stability study tracking performance over time.

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

• Not applicable. This device is a calibration verification material for an in vitro diagnostic assay, not an imaging or diagnostic AI requiring expert human interpretation for ground truth. The "ground truth" (assigned dose values) for the CVMs is established through a scientific process involving internal standards and measurement procedures.

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

• Not applicable. This is not a study requiring human adjudication. The results are quantitative measurements against predefined criteria.

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

• Not applicable. This is not an AI/imaging device.

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

• This is an in vitro diagnostic calibration verification material. Its performance is evaluated intrinsically through laboratory testing, essentially a "standalone" evaluation of the material's stability and value assignment, but not in the context of an AI algorithm.

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

• The ground truth for the CVM is its "assigned dose" values. These values are established through:
  • Traceability to an internal standard.
  • Manufacture using qualified materials and measurement procedures.
  • Value assignment using assigned reference calibrators, with dose values generated using curves from these reference calibrators.
  • Values are calculated based on recovered values for each run on each instrument independently and then averaged across all systems.
  • Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values, and controls must fall within their target ranges.
  • Six levels of commercially available controls and 27 samples (22 spiked serum samples and 5 normal female serum samples) were used to validate calibrator/CVM value assignments.

8. The sample size for the training set

• Not applicable for a calibration verification material. There is no "training set" in the context of machine learning or AI for this product.

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

• Not applicable. See #8.

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