(36 days)
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.
The IRON calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit consists of 6 ampules, two at each of three levels.
Here's an analysis of the provided text regarding the Dimension® Iron Calibrator and its performance:
1. Acceptance Criteria and Reported Device Performance
The document describes the stability and traceability of the Dimension® Iron Calibrator (IRON Cal - DC 85). However, the specific quantitative acceptance criteria for performance (e.g., recovery percentages, maximum allowable drift) are not explicitly stated in a table format within the provided text. The document focuses on the methods used to assess stability and traceability, rather than specific results against pre-defined thresholds.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or described) | Reported Device Performance |
|---|---|---|
| Stability | Target shelf life: 12 months. Requires 13 months of real-time testing on three lots. Calibrator drift must be dissociable from analytical system drift (by comparing 4°C vs. -20°C storage). | "Studies require 13 months of real time testing on three lots of product." (No explicit pass/fail result stated, but implies the study was conducted to support the 12-month shelf life). |
| Traceability | Assigned values are standardized to NIST SRM 937. | "The assigned values of the IRON calibrator are standardized to NIST SRM 937..." (This describes the method of traceability, not a performance metric like a correlation coefficient or recovery percentage against the standard). |
| Value Assignment | New calibrator lot must have acceptable recovery versus the Reference Lot (NIST SRM 937) and a Control Calibrator Lot. | "The new calibrator lot must have acceptable recovery verses the Reference Lot and a Control Calibrator Lot..." (This describes the process for value assignment, not specific recovery results that met a defined "acceptable" criterion). |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: For stability studies, "three lots of product" were used. For traceability and value assignment, it mentions "six working Iron Standard Solutions of NIST SRM 937" for assigning values, and the comparison of "new calibrator lot" against "Reference Lot" and "Control Calibrator Lot." The number of individual samples or measurements within these lots/solutions is not specified.
- Data Provenance: The data is generated internally by Dade Behring Inc. (the applicant). It is prospective data, as it describes studies conducted to support the device's claims (e.g., 13 months of real-time stability testing). The country of origin of the data is implicitly the United States, where Dade Behring Inc. is located.
3. Number of Experts and Qualifications for Ground Truth
The provided summary does not mention any human experts being used to establish ground truth for the performance studies of this calibrator device. The ground truth for a calibrator is typically established through a highly controlled and standardized reference material.
4. Adjudication Method for the Test Set
Since no human experts are mentioned for establishing ground truth, there is no adjudication method described or applicable in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this device. This is an in vitro diagnostic calibrator, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, no comparison of human readers with or without AI assistance was performed.
6. Standalone Performance Study
Yes, the studies described, particularly the stability studies and the traceability/value assignment studies, can be considered standalone performance studies for the calibrator device itself. These studies evaluate the calibrator's inherent properties (stability over time, accuracy of assigned values against a gold standard) independent of a human operator's interpretation. The calibrator's function is to provide a known reference point for the Dimension® clinical chemistry system, so its "performance" is evaluated on its ability to maintain that reference.
7. Type of Ground Truth Used
The primary ground truth used for this calibrator is NIST SRM 937 (National Institute of Standards and Technology - Standard Reference Material). This is a highly certified and recognized reference material, considered a "gold standard" for iron concentration.
8. Sample Size for the Training Set
This document describes a calibrator, not a machine learning model. Therefore, the concept of a "training set" in the context of AI or algorithms is not applicable. The calibrator itself does not learn from data; its values are assigned based on comparisons to a reference standard.
9. How Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the AI/machine learning sense for this device. The values of the calibrator are established through direct comparison and standardization against the NIST SRM 937, which is intrinsically the ground truth for iron concentration. The process involves:
- Preparing six working Iron Standard Solutions from NIST SRM 937.
- Assigning values to new lots of the calibrator by recovering these reference solutions.
- Ensuring acceptable recovery against the NIST SRM 937 (Reference Lot) and an approved Control Calibrator Lot.
§ 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.