(132 days)
For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).
One set of four vials, 2 mL each, containing low, intermediate and high levels of progesterone in processed human serum, with preservative, and a progesterone-free sample. The Calibration Verifiers are supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. Stable at 2-8°C for 30 days after opening.
The provided text describes the Siemens IMMULITE®/IMMULITE® 1000 Progesterone Calibration Verification Material (CVM) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a detailed study proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies as these are typically applicable to diagnostic imaging or AI-driven diagnostic devices.
The document primarily focuses on establishing "substantial equivalence" for a calibration verification material. This type of device's performance validation usually involves demonstrating traceability to a standard, value assignment accuracy, and stability, rather than diagnostic accuracy metrics like sensitivity or specificity.
Here's a breakdown of the available information based on your requested points:
Description of Acceptance Criteria and Device Performance
The core "acceptance criteria" for this device, as described, revolve around traceability, value assignment, and stability. The study proving the device meets these criteria is the "validation following procedures of Siemens Healthcare Diagnostics."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Traceability | The IMMULITE/IMMULITE 1000 Progesterone assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. The CVM is traceable to this standard. |
| Value Assignment | Validated following procedures of Siemens Healthcare Diagnostics. |
| Stability | Unopened: Stable until the expiration date on the vial label. |
| Opened: Stable at 2-8°C for 30 days. (This is compared to the predicate's 14 days, indicating improved stability for the opened device). | |
| Substantial Equivalence | The device is deemed "substantially equivalent" to currently marketed devices with similar intended uses, specifically the ADVIA Centaur eE2 Master Curve Material, based on intended use and matrix. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, beyond being "internal standard manufactured using qualified materials and measurement procedures" and human serum used in the CVM. The CVM itself is made with processed human serum.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a calibration verification material, "ground truth" is typically established through reference methods and certified reference materials, not expert consensus on diagnostic images or clinical cases.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods are typically relevant for subjective assessments, such as expert interpretation of medical images or clinical findings, which is not the primary performance metric for a calibration verification material.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers, which is not the nature of this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a diagnostic reagent (calibration verification material), not an algorithm or AI system.
7. The type of ground truth used:
- Traceability to an internal standard: The CVM's values are linked to an internal standard developed using qualified materials and measurement procedures. This internal standard serves as the "ground truth" for the assigned values of the CVM.
8. The sample size for the training set:
- Not applicable/Not specified. As a calibration verification material, it does not involve a "training set" in the context of machine learning or AI. Its development relies on analytical method validation and manufacturing controls.
9. How the ground truth for the training set was established:
- Not applicable. (See #8). The ground truth for the CVM's assigned values is established through its traceability to the internal standard and validated value assignment procedures by Siemens Healthcare Diagnostics.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.