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

Device Description

The CEA Calibration Verification Material (CVM) contains one set of four vials each 1.0mL after reconstitution. CVM1 contains lyophilized processed human serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of human CEA in a lyophilized processed human serum matrix with preservatives.

AI/ML Overview

This document describes the IMMULITE® 2000 CEA Calibration Verification Material (CVM), an in vitro diagnostic device used to verify the calibration of the IMMULITE CEA assay on IMMULITE 2000 systems. The provided text, however, does not align with the standard format for reporting AI/ML device studies as it describes a calibration verification material, not an AI-based device. Therefore, many of the requested fields are not applicable.

Here's the information extracted and adapted where possible:

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

Acceptance Criteria (Stability)	Reported Device Performance (Stability)
Real-time Shelf-Life: Sample dose falls within ±10% difference for CVM levels 2 and 3, and ±15% for CVM level 4, compared to dose at time point zero. (If criteria fail, stability assessed by analyte drift analysis as described in protocol summary)	Real-time Shelf-Life: Stable up to 6 years when stored at -20°C prior to opening. The study protocols for three lots (006, 007, 090) included time points up to 108 months, 84 months, and 6 months respectively for different CVM levels. The conclusion states the materials are stable up to 6 years at -20°C. Specific performance data with results against acceptance criteria are not presented in a table.
Open Component (in-use) Stability: Sample dose falls within ±10% difference for CVM levels 2 and 3, and ±15% for CVM level 4, compared to dose at time point zero. (If criteria fail, stability assessed by analyte drift analysis as described in protocol summary)	Open Component Stability: Stable for 8 hours at ambient or room temperature (15-25°C) after reconstitution. CVM lot 090 was tested at 2-hourly intervals for up to 9 hours to compare against time zero. Specific performance data with results against acceptance criteria are not presented in a table.

Acceptance Criteria (Stability)

Reported Device Performance (Stability)

Real-time Shelf-Life: Sample dose falls within ±10% difference for CVM levels 2 and 3, and ±15% for CVM level 4, compared to dose at time point zero. (If criteria fail, stability assessed by analyte drift analysis as described in protocol summary)

Real-time Shelf-Life: Stable up to 6 years when stored at -20°C prior to opening. The study protocols for three lots (006, 007, 090) included time points up to 108 months, 84 months, and 6 months respectively for different CVM levels. The conclusion states the materials are stable up to 6 years at -20°C. Specific performance data with results against acceptance criteria are not presented in a table.

Open Component (in-use) Stability: Sample dose falls within ±10% difference for CVM levels 2 and 3, and ±15% for CVM level 4, compared to dose at time point zero. (If criteria fail, stability assessed by analyte drift analysis as described in protocol summary)

Open Component Stability: Stable for 8 hours at ambient or room temperature (15-25°C) after reconstitution. CVM lot 090 was tested at 2-hourly intervals for up to 9 hours to compare against time zero. Specific performance data with results against acceptance criteria are not presented in a table.

2. Sample sized 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, three lots of CVMs (Lot 006, 007, and 090) were used. For value assignment and expected values, each CVM level was tested on 27 replicates in total, comprised of 9 runs, 3 replicates per run, using 9 IMMULITE 2000 systems and 5 different reagent kit lots.
Data Provenance: Not specified, but generally, such studies are conducted at the manufacturer's facilities. The document does not indicate country of origin or whether the data was retrospective or prospective, though stability studies are inherently prospective.

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 device is a calibration verification material for an in vitro diagnostic assay, not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" for CVMs is based on internal reference standards and gravimetric preparations.

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

Not applicable. This is not an AI/ML device requiring human adjudication of results.

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 a calibration verification material, 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

Not applicable. This is a physical control material.

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

Ground Truth for CVMs: The IMMULITE CEA CVMs are traceable to an internal standard. The assigned reference calibrators are prepared using CEA antigen stock and are traceable to an internal standard which has been gravimetrically prepared.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set. The "IMMULITE CEA kit lot 290" and "CEA CVM lot 090" mentioned in the stability protocol are parts of the experimental setup for assessing the CVM's performance, not a training set for an algorithm.

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

Not applicable. This is not an AI/ML device with a training set.

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