(18 days)
Estradiol III CalSet is used for calibrating the quantitative Elecsys Estradiol III assay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Estradiol III CalSet is a lyophilized product consisting of synthetic Estradiol in a human serum matrix. It has been standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry).
Here's an analysis of the acceptance criteria and study information provided for the Elecsys Estradiol III CalSet, extracted from the given 510(k) summary:
Elecsys Estradiol III CalSet: Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| CalSet Value Assignment | Pre-defined acceptance criteria for PreciControl Universal (Level 1 & 2) must be met. | "Value assignment testing was conducted and passed pre-defined acceptance criteria." |
| Stability (Study 1): | ||
| - 2-8°C, -20°C (reconstituted) | 95 to 105 % signal recovery of the reference material value. | Not explicitly stated as passed/failed, but implied by "The on-test materials were reconstituted and stored...prior to testing." and "The on-test and reference materials were tested..." which generally indicates positive results if no failures are mentioned. |
| - Open vial (20-25°C) | 95 to 105 % signal recovery of the reference material value. | Not explicitly stated as passed/failed, but implied. |
| - Freeze/thaw cycles | 95 to 105 % signal recovery of the reference material value. | Not explicitly stated as passed/failed, but implied. |
| Accelerated Stability (Study 2): | 95 to 105 % recovery of the reference material value. | Not explicitly stated as passed/failed, but implied by the description of the study and the overall conclusion of substantial equivalence. |
| Real-Time Stability (Study 3): | 95-105 % recovery of the reference value for Estradiol III Calibrator 1 and 2 (stressed vs. unstressed). | "The testing will continue with this stability protocol until data to support a claim of 18 months are achieved." The study is ongoing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- CalSet Value Assignment: Not explicitly stated as a "test set" in terms of number of calibrator vials. However, for each lot, calibrators are run in duplicate on at least three (3) Elecsys 2010/cobas e 411 analyzers and at least three (3) cobas e 601/MODULAR ANALYTICS E170 analyzers. The assigned value is the mean over at least six (6) runs on at least three (3) analyzers. This implies a significant number of measurements for value assignment.
- Stability Studies (Study 1 & 2): "On-test and reference materials were tested in duplicate."
- Real-Time Stability (Study 3): "CalSets are tested in duplicate at specified intervals." One Estradiol III CalSet lot was evaluated in duplicate for accelerated stability.
- Data Provenance: Not explicitly stated (e.g., country of origin). The manufacturing establishments are Roche Diagnostics GmbH in Mannheim, Germany, and Penzberg, Germany. The US registration is for Roche Diagnostics United States. The testing locations are not specified, but typically studies for these types of devices are conducted in-house or by contract labs associated with the manufacturer. The studies are prospective in nature as they describe planned (real-time stability) or recently completed (value assignment, other stability) tests of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is a calibrator for an in vitro diagnostic assay. "Ground truth" in this context refers to metrologically traceable reference values rather than expert interpretation of clinical data.
- Ground Truth Establishment: The Elecsys Estradiol III CalSet was standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry). This is a highly accurate reference method.
4. Adjudication Method for the Test Set
This section is not applicable as it refers to a clinical data adjudication process. For this calibrator, "adjudication" is inherent in the analytical methods and statistical analysis of duplicates and runs on multiple systems. The acceptance criteria for recovery within a specific range serve as the "adjudication" of performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Elecsys Estradiol III CalSet is a laboratory calibrator, and its performance is assessed through analytical studies demonstrating its accuracy and stability against reference methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable in the traditional sense for an AI/algorithm. However, the performance studies described (CalSet Value Assignment, Stability Studies) are intrinsically "standalone" in that they evaluate the analytical performance of the calibrator itself, independent of operator interpretation in a clinical diagnostic sense. The device's "performance" is its ability to consistently produce accurate reference signals within defined parameters.
7. The Type of Ground Truth Used
The ground truth used for the Elecsys Estradiol III CalSet is analytical traceability to ID-GC/MS (isotope dilution gas chromatography mass spectrometry). This is a highly accurate and precise analytical method considered a "gold standard" for quantifying specific analytes.
8. The Sample Size for the Training Set
This question is not applicable as this device is not an AI/ML algorithm that requires a "training set." It is a physical calibrator for an immunoassay.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as this device is not an AI/ML algorithm that requires a "training set."
§ 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.