(14 days)
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.
The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.
The provided text describes the Bayer Healthcare SETpoint Chemistry Calibrator. It is a calibrator for multiple analytes intended for in vitro diagnostic use to calibrate various Technicon and ADVIA Chemistry systems.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., specific thresholds for performance metrics). Instead, it states that the device's performance is "similar to other products in commercial distribution intended for similar use" and validates stability according to Bayer procedures. The primary performance characteristic discussed is stability.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Bayer SETpoint Calibrator) |
|---|---|---|
| Intended Use | Calibrate specified chemistry systems (Technicon RA, opeRA, RA-100, DAX, ADVIA 1650/2400, ADVIA IMS Chemistry systems) | Intended for in vitro diagnostic use to calibrate the listed systems. (Matches intended use) |
| Stability (Unreconstituted) | Stable at 2-8°C until expiration date printed on label. | Stable at 2-8°C until last day of the month (expiration date) printed on label. (Meets implied criteria) |
| Stability (Reconstituted) | Stable for a specified period when refrigerated at 2-8°C and protected from light. | Stable 48 hours when reconstituted according to directions when refrigerated at 2-8°C and protected from light, with the exception of total and direct bilirubin, which are stable for eight hours. (Meets implied criteria, with specific exceptions noted) |
| Calibrator Format | Lyophilized solution with appropriate constituents | Lyophilized bovine serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations. (Consistent with calibrator format) |
| Levels | Single level calibrator | Single Level (Consistent with predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The stability of the SETpoint calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material."
- Sample Size for Test Set: Three separate lots of calibrator material.
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Bayer Healthcare Diagnostics Division. The data is prospective, as it involves the testing of the newly developed lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is typically not applicable to calibrator performance studies. The "ground truth" for a calibrator's performance lies in its ability to consistently produce accurate and stable values for the analytes it is designed to measure. This is assessed through analytical methods and comparisons to established reference standards, not through consensus of human experts.
4. Adjudication Method for the Test Set
Not applicable. Statistical or analytical methods are used to determine stability and performance, not human adjudication.
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 calibrator device, not an AI-powered diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not directly applicable in the terms of an "algorithm only" study, as this is a physical calibrator product. However, the stability validation of the calibrator itself can be considered a standalone performance assessment. The document states: "The stability of the SETpoint calibrator values has been validated according to Bayer procedures..." This indicates that the performance of the calibrator material itself was evaluated independently to ensure it met internal specifications for stability.
7. The Type of Ground Truth Used
The ground truth for the performance of a chemical calibrator is established by:
- Reference Standards: The manufacturer uses highly accurate reference methods and/or certified reference materials to assign target values to the analytes within the calibrator.
- Analytical Methods: The stability and accuracy of the calibrator's assigned values are verified through a series of analytical tests over time and under various conditions to ensure they remain within acceptable specifications.
In this document, the "ground truth" for stability is established by Bayer's internal procedures and validated against those procedures, which would involve comparison to expected values or reference standards for the analytes.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a calibrator happens during its manufacturing process to ensure proper formulation and assigned values, rather than through data input.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of an AI algorithm. The quality and "ground truth" of a calibrator are established through manufacturing, quality control, and testing against recognized analytical standards, as mentioned in point 7.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.