(119 days)
The ADVIA® Centaur (DHEAS) Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Systems Dehydroepiandrosterone sulfate (DHEAS) assay.
The ADVIA® Centaur DHEAS Master Curve Material are 5 levels of varying concentrations of DHEAS in delipidated, steroid stripped, human defribrinated plasma with preservative. The MCM Master Curve Materials have expected values (lot specific) of 0, 60, 300, 900 and 1500 ug/dL.
The MCM Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.
The provided text is a 510(k) summary for the ADVIA® Centaur DHEAS Master Curve Material. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information about device performance and study design (especially for AI/standalone studies, expert involvement, and ground truth establishment) cannot be extracted from this summary.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria for the ADVIA® Centaur DHEAS Master Curve Material. Instead, it asserts that the product's performance has been validated and is "substantially equivalent to currently marketed devices with similar intended uses."
| Characteristic | Acceptance Criteria (Not Explicitly Stated as Quantitative Criteria) | Reported Device Performance |
|---|---|---|
| Traceability | Implied: Must be traceable to established standards. | Validated following Siemens Healthcare Diagnostics procedures. |
| Value Assignment | Implied: Values must be accurately assigned. | Validated following Siemens Healthcare Diagnostics procedures. |
| Stability | Implied: Must maintain performance over specified storage and open-vial duration. | Unopened: stable until expiration date. |
| Opened: stable for 60 days. | ||
| Intended Use | Must verify calibration and reportable range for DHEAS assay on ADVIA® Centaur Systems. | "for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems DHEAS assay." (Statement of Intended Use) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or laboratory testing that would have a sample size for performance evaluation. The "Master Curve Material" itself is the product being evaluated, and its performance (traceability, value assignment, stability) was internally validated. The "5 levels of varying concentrations of DHEAS" are part of the product and its stated characteristics, not a test set for performance evaluation in the typical sense of a diagnostic device.
There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The DHEAS Master Curve Material is a quality control product, and its "ground truth" would be established through a process of value assignment against reference materials or methods, not typically by expert consensus in a clinical image or diagnostic context.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in this technical summary.
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 510(k) for an in vitro diagnostic quality control material, not an AI-powered diagnostic device, so MRMC studies or AI involvement are outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For the DHEAS Master Curve Material, the "ground truth" (i.e., the assigned values and verification of performance) is established through:
- Reference Methods/Materials: The document states "The traceability, value assignment, and stability of the ADVIA® Centaur DHEAS Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics." This implies that the assigned values for DHEAS concentration are derived from reference materials or methods within their internal validation processes.
- Stated Concentrations: The MCM Master Curve Materials have expected values (lot-specific) of 0, 60, 300, 900, and 1500 ug/dL. These are the target "true" values for the material.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned.
§ 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.