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The IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen.

Device Description

The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. L3PSCVM1 contains processed chicken serum matrix with preservative. L3PSCVM2, L3PSCVM3 and L3PSCVM4 contain low, intermediate and high levels of PSA respectively, in processed chicken serum matrix with preservative.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the IMMULITE®/IMMULITE 1000 Third Generation PSA Calibration Verification Material, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Traceability	The Calibration Verification Materials (CVMs) must be traceable.	The IMMULITE Third Generation PSA CVMs are traceable to Gold Standards prepared using purified PSA antigen stock solution whose concentration was defined by optical density. CVMs are manufactured using qualified materials and measurement procedures.
Stability (Unopened)	Stable until the expiration date when stored frozen at -20°C.	The IMMULITE®/IMMULITE 1000 Third Generation Calibration Verification Materials are stable up to 12 months when stored frozen at -20°C prior to opening. Unopened stability is indicated by expiration date on the label when stored at -20°C.
Value Assignment	CVMs are value assigned using a previous reference lot, tested on a minimum of nine runs comprised of a minimum of three systems and two different reagent kit lots. CVM values are derived by data reduction for each run on each instrument and then averaged across all systems. Production lots are value assigned against the previous reference lot using two reagent kit lots and on a minimum of three instruments.	The CVMs are value assigned using a previous reference lot of materials. Standards are prepared using purified PSA antigen stock solution. The CVMs are manufactured using qualified materials and measurement procedures. The CVMs are tested on a minimum of nine runs comprised of a minimum of three systems and two different reagent kit lots. CVM values are derived by data reduction for each run on each instrument. CVM values are then averaged across all systems. Production lots of CVMs are value assigned against the previous reference lot using two reagent kit lots and on a minimum of three different instruments.
Matrix Effects (Spiking Recovery)	Spiking recovery of purified PSA antigen into chicken serum should demonstrate no matrix effects compared to human serum. The acceptance criteria were 100% ±15% with an overall average of ±10%.	Siemens spiked three concentrations of purified PSA antigen into human serum and an evaluation lot comprised of chicken serum. The PSA values of the evaluation lot were compared to the human serum lots. Each of the samples met the acceptance criteria (100% ±15% with an overall average of ±10%). Siemens concluded that there were no matrix effects.
Guideline Range Establishment	Each CVM level was tested for a total of 27 replicates (9 runs, 3 replicates per run). 2 different reagent kit lots and 9 different instruments were used. Guideline Range (95% confidence interval) was established based on the Target Mean and ± 2 Standard Deviation (SD).	Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run. 2 different reagent kit lots and 9 different instruments were used to gain the 27 replicates. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). Reported Values:

Level 1: Target Mean 0.000 ng/mL, Guideline Range ≤ 0.005 ng/mL
Level 2: Target Mean 0.085 ng/mL, Guideline Range 0.072 - 0.098 ng/mL
Level 3: Target Mean 4.45 ng/mL, Guideline Range 4.01 - 4.90 ng/mL
Level 4: Target Mean 18.6 ng/mL, Guideline Range 15.8 - 21.4 ng/mL |

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

The provided document describes a validation study for the Calibration Verification Material (CVM) itself, not a test set for an algorithm assessing patient data. The "samples" referred to are the CVM materials and the substances used to validate them.

For demonstrating matrix effects: Three concentrations of purified PSA antigen were spiked into human serum and an evaluation lot of chicken serum. The specific number of individual samples (e.g., number of human serum samples, chicken serum samples) is not explicitly stated beyond "three concentrations."
For establishing Guideline Ranges: Each CVM level (4 levels) was tested for a total of 27 replicates. This means 4 levels * 27 replicates = 108 individual test measurements were performed to establish the guideline ranges across different runs, systems, and reagent lots.
For validating CVM value assignments: Three levels of commercially available controls, twenty-five spiked human serum samples, and five male patient samples were used.
Data Provenance: The studies were conducted by Siemens Healthcare Diagnostics Inc. and involve laboratory testing of the CVMs. The human serum samples likely originated from a clinical setting, but the specific country of origin or whether they were retrospective/prospective is not specified. The chicken serum is a matrix component.

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

This information is not applicable to this submission. The device is a Calibration Verification Material, a quality control product, not an AI/diagnostic device that interprets patient data requiring expert ground truth for a test set. Its performance is evaluated through analytical methods like traceability, stability, and value assignment, not clinical interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. There was no "test set" in the sense of a set of cases requiring adjudication by experts. Analytical measurements and statistical methods (like determining 95% confidence intervals and comparing values to acceptance criteria) were used for validation.

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 information is not applicable. This is not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device relates to the accuracy and known concentration of the PSA antigen within the Calibration Verification Materials.

For traceability and value assignment: The ground truth is established by purified PSA antigen stock solutions whose concentrations were defined by optical density, serving as "Gold Standards." This is a highly controlled and metrologically sound reference.
For matrix effects: The ground truth is the expected recovery of known spiked amounts of purified PSA antigen.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. As mentioned above, there is no training set for this type of device.

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