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The IMMULITE® 2000 PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen.

The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each. LPTSCVM1 contains processed chicken serum matrix with preservative. LPTSCVM2, LPTSCVM3 and LPTSCVM4 contain low, intermediate and high levels of PSA respectively, in processed chicken serum/buffer matrix with preservative.

This document describes a 510(k) premarket notification for the SIEMENS IMMULITE® 2000 PSA Calibration Verification Material (CVM). It is a quality control material used to monitor the performance of the IMMULITE Immunoassay System for the quantitative measurement of PSA antigen.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies, while noting the absence of AI-specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance criterion mentioned relates to the investigation of potential matrix effects.

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

• Matrix Effects Study: Three concentrations of purified PSA antigen were spiked into human serum and an evaluation lot of chicken serum. The specific number of samples or replicates for each concentration is not explicitly stated beyond "three concentrations" and "each of the samples met the acceptance criteria."
• Expected Values/Reference Range Study: Each CVM level was tested on 27 replicates in total, comprised of nine runs, six instruments, and five different reagent kit lots.
• Data Provenance: The studies appear to be internal laboratory studies conducted by Siemens (the manufacturer) and are therefore prospective from the manufacturer's perspective, without external country of origin specified.

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

Not applicable. This device is a calibration verification material, not an AI diagnostic tool that requires expert human interpretation for ground truth. The "ground truth" for the performance characteristics is derived from analytical measurements and traceability to international standards.

4. Adjudication Method for the Test Set

Not applicable. As described above, expert adjudication is not relevant for establishing the performance characteristics of this type of device.

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 submission is for an in-vitro diagnostic (IVD) calibration verification material, not an AI software or system that assists human readers.

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

Not applicable. This is an IVD material, not an algorithm.

7. The Type of Ground Truth Used

• Traceability: The IMMULITE PSA Calibration Verification Materials are traceable to WHO 1st International Standard 96/670. This international standard serves as the primary ground truth for the PSA values.
• Value Assignment: The CVMs are value assigned using assigned reference calibrators, which in turn are traceable to the WHO international standard. Internal "Gold Standards" also play a role, anchored to the same WHO standard. Production lots are value assigned against the Gold Standard.

8. The Sample Size for the Training Set

• Training for Value Assignment (Internal Calibrators/Gold Standards): The document mentions "8-level Calibrators are for internal use only" and "Gold Standards are anchored to WHO international standard NIBSC 96/670." It doesn't specify a "training set" in the context of an algorithm.
• CVM Value Assignment: The CVMs were tested on 27 replicates in total comprised of nine runs, six instruments, and five different reagent kit lots. This data was used to generate target mean values and guideline ranges for the CVM levels.
• When validating CVM value assignments for production lots, 30 patient samples (10 normal male, 10 spiked human serum, and 10 PSA samples) and three levels of commercially available controls were used.

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

• Ground Truth for PSA Values: The ultimate ground truth is established through traceability to the WHO 1st International Standard 96/670.
• Ground Truth for CVM Value Assignment: The CVM values are calculated based on recovered values from internal runs using assigned reference calibrators (traceable to WHO standard). Quality control is performed by calculating the recovery of patient samples and controls using the assigned values, with controls needing to fall within their target ranges. This indicates an internal verification process against established analytical targets and the WHO standard.

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The DPC IMMULITE 2000 PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.

Not Found

This is a clearance letter from the FDA, not a study or regulatory submission containing performance criteria. Therefore, the requested information about acceptance criteria, study data, sample sizes, expert qualifications, and ground truth cannot be extracted from this document.

The document states that the "Immulite 2000 PSA Kit" is substantially equivalent to legally marketed predicate devices and is intended for the quantitative measurement of prostate-specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients. However, it does not provide details on how this substantial equivalence was determined, nor does it contain the study data or acceptance criteria used for that determination.

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