(16 days)
The Access® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.
The Access AFP QC are tri-level controls consisting of human AFP in human serum with preservatives. They are targeted to cover the assay range of approximately 7.0 ng/ml to 1725 ng/ml. with the controls targeted at 7, 80 and 1725 na/ml.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance Study for Access AFP QC
This 510(k) summary describes the Access AFP QC, a quality control product for Alpha-fetoprotein (AFP) immunoassays. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, the Lyphochek® Immunoassay Control Serum, rather than establishing a de novo set of performance criteria for a new measurement device. Therefore, the "acceptance criteria" here are framed around demonstrating comparable performance and stability to existing standards or expectations for quality control materials.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a quality control product, the acceptance criteria are focused on its stability and precision rather than diagnostic accuracy.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Imprecision (Precision) | Within-run, between-run, and total imprecision | Less than 5% CV for all three levels of Access AFP QC |
| Stability | Stable for a specified duration under storage conditions | Stable for up to 13 months when stored at 2-8° C |
| Target Assay Range | Targeted to cover the assay range of approximately | Targeted to cover 7.0 ng/ml to 1725 ng/ml (controls at 7, 80, and 1725 ng/ml) |
| Material Equivalence | Human AFP in human serum with preservatives | Human AFP in human serum with preservatives |
| Readiness of Use | Ready to use | Provided ready to use |
Note: The core "acceptance criterion" for this 510(k) is substantial equivalence to the predicate device, K891475. The study's purpose is to demonstrate that the Access AFP QC performs comparably to or within acceptable parameters for such a control.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the imprecision (test set) studies. It only mentions "all three levels of the Access AFP QC," implying that the study was conducted across the low, medium, and high control levels.
The data provenance is not specified (e.g., country of origin). Since it's a submission from Beckman Coulter, Inc. located in Chaska, MN, USA, it's highly probable the study was conducted in the USA. The type of study is prospective in nature, as it involves testing the performance of the newly developed Access AFP QC materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a quality control material like Access AFP QC, the concept of "ground truth" as established by experts (e.g., radiologists, pathologists) is not applicable in the same way it would be for a diagnostic device.
The "ground truth" for a control material is its expected value or designated target range, which is typically established through a robust formulation and value assignment process by the manufacturer, followed by internal validation. The summary mentions the controls are "targeted at 7, 80 and 1725 ng/ml," which are the assigned target values. The experts involved would likely be biochemists, analytical chemists, and quality control specialists internal to Beckman Coulter, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Since the "ground truth" (target values and expected performance parameters like precision) is established by the manufacturer and the study focuses on quantitative measurements of imprecision and stability, an external "adjudication method" involving independent experts (like 2+1, 3+1 consensus) is not relevant or described in this context. The study data (imprecision, stability) would be analyzed against predefined statistical acceptance limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or needed.
MRMC studies are typically performed for diagnostic imaging or interpretation devices where human readers (e.g., radiologists) are involved in interpreting results and their performance is compared with and without AI assistance. The Access AFP QC is a quality control material for an automated immunoassay system, and human interpretation of control results is standard process, not a "reading" that would be assisted by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, a standalone (algorithm only) performance assessment was done.
The studies described ("Within-run, between-run and total imprecision" and "stability") directly assess the inherent performance characteristics of the control material itself when processed by the Access Immunoassay System. There is no human "in the loop" performing an interpretive step that would alter the control's fundamental performance; the human interaction is typically limited to loading the controls and reviewing the quantitative results generated by the instrument. The "algorithm" here would be the immunoassay system's method for measuring AFP.
7. The Type of Ground Truth Used
The "ground truth" for the Access AFP QC is based on:
- Manufacturer's assigned target values: The controls are "targeted at 7, 80 and 1725 ng/ml."
- Established analytical performance parameters: The expected precision (%CV) and stability are based on industry standards for quality control materials and internal validation by the manufacturer.
It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
A "training set" is not applicable or described for this device.
The Access AFP QC is a physical control material, not an AI/ML algorithm that requires training data. The immunoassay system itself would have been developed and validated using training/development data, but this submission is about the control material.
9. How the Ground Truth for the Training Set was Established
As noted above, there is no "training set" for this quality control material itself. The ground truth for the control's target values and expected performance is established through rigorous internal manufacturing, formulation, and validation processes by Beckman Coulter.
§ 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.