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510(k) Data Aggregation
(254 days)
For in vitro diagnostic use as a control for calibration verification of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE 1000, 2000 systems.
The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.16, 2.70 and 11.2 ng/ml, and 0.00, 0.19, 2.90 and 12.00 for IMULITE 2000 systems. The matrix is estriol in processed horse serum.
One set of four vials, 2 mL each, containing low, intermediate and high levels of unconjugated estriol in processed horse serum, with preservative, and an unconjugated estriol free sample. The calibration verification material (CVM) is supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. CVM's are for single use only, immediately after opening, and discard after use.
Here's a breakdown of the acceptance criteria and the study details for the IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material, based on the provided 510(K) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device revolve around the precision and accuracy of the assigned values for the Calibration Verification Materials (CVMs) across different platforms.
| Parameter | Acceptance Criteria (IMMULITE/IMMULITE® 1000) | Reported Device Performance (IMMULITE/IMMULITE® 1000) | Acceptance Criteria (IMMULITE® 2000) | Reported Device Performance (IMMULITE® 2000) |
|---|---|---|---|---|
| CVM 1 (0 ng uE3/mL) | Range: 0 - 0.07 ng uE3/mL | CVM 1 = 0.0 ng/mL (Target) | Range: 0 - 0.07 ng uE3/mL | CVM 1 = 0.0 ng/mL (Target) |
| Precision: NA | Consistent with 0 target | Precision: NA | Consistent with 0 target | |
| CVM 2 (Target u: 0.16 ng uE3/mL) | Range: 0.07 - 0.25 ng uE3/mL | Within range (based on value assignment) | Range: 0.09 - 0.29 ng uE3/mL | Within range (based on value assignment) |
| Precision: <15% CV | Met (<15% CV) | Precision: <15% CV | Met (<15% CV) | |
| CVM 3 (Target u: 2.7 ng uE3/mL) | Range: 1.91 - 3.49 ng uE3/mL | Within range (based on value assignment) | Range: 2.03 - 3.77 ng uE3/mL | Within range (based on value assignment) |
| Precision: <10% CV | Met (<10% CV) | Precision: <10% CV | Met (<10% CV) | |
| CVM 4 (Target u: 11.2 ng uE3/mL) | Range: 8.73 - 13.7 ng uE3/mL | Within range (based on value assignment) | Range: 8.86 - 15.14 ng uE3/mL | Within range (based on value assignment) |
| Precision: <10% CV | Met (<10% CV) | Precision: <10% CV | Met (<10% CV) | |
| Overall Acceptance | CVM ranges fall within established ranges for all levels. | Achieved | CVM ranges fall within established ranges for all levels. | Achieved |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed under the "Performance" section, specifically regarding "The traceability, value assignment, and stability of the Calibration Verification Materials."
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document states that "Production lots of calibration verification materials are value assigned against the reference calibrators using multiple reagent lots which are run on at least three different instruments." While a specific number for "multiple reagent lots" and the number of individual CVM units tested from each lot isn't provided, it implies a systematic testing approach across different manufacturing batches and analytical systems.
- Data Provenance: The data is generated internally by Siemens Healthcare Diagnostics. The specific country of origin for the data generation is not explicitly stated, but the applicant's address is Tarrytown, NY, USA, suggesting the studies were conducted within the US or under the purview of their US operations. The study is prospective in the sense that new production lots of CVMs are being analyzed for value assignment and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not directly applicable in the context of this device. This is a calibration verification material, not a diagnostic device that interprets medical images or generates a diagnosis requiring expert review for ground truth.
Instead, the "ground truth" for the uE3 values in the reference calibrators is established by GC-MS (Gas Chromatography-Mass Spectrometry). This is a highly accurate and precise analytical method considered a gold standard for quantifying specific analytes. The document mentions that these reference calibrators are assigned values using a panel of real serum samples from pregnancy patients, which were value-assigned by GC-MS.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The value assignment involves running the CVMs on multiple instruments and averaging the observed values.
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 chemical/analytical device (calibration verification material), not a diagnostic imaging or AI-assisted diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a chemical/analytical device. The performance refers to the accuracy and precision of the CVMs when analyzed on the IMMULITE systems, not an algorithm's performance.
7. The Type of Ground Truth Used:
The ground truth for the uE3 values in the reference calibrators (which are then used to assign values to the CVMs) is established by GC-MS (Gas Chromatography-Mass Spectrometry). This is considered an analytical gold standard.
8. The Sample Size for the Training Set:
This information is not explicitly provided as a classical "training set" for an algorithm. However, the development of the "uE3 reference calibrator values" involved using a "panel of real serum samples from pregnancy patients" that were value-assigned by GC-MS. The size of this panel (i.e., the number of patient samples) is not specified.
9. How the Ground Truth for the Training Set was Established:
The ground truth for the uE3 reference calibrator values was established by analyzing a panel of real serum samples from pregnancy patients using GC-MS (Gas Chromatography-Mass Spectrometry). These GC-MS derived values then served as the basis for assigning values to the internal reference calibrators, which in turn are used to value assign the CVMs.
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