(20 days)
OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.
OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.
The provided document is a 510(k) Notification for the OPUS hLH Controls, a quality control material, not an AI/ML powered device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of medical device submission.
However, I can extract information related to the device performance characteristics, which serve as the acceptance criteria for this quality control material.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Device Performance |
|---|---|
| Intra-assay Precision (Overall %CV) | Ranged from 4.51% to 6.48% (for three levels of control material) |
| Inter-assay Precision (Overall %CV) | Ranged from 2.48% to 6.41% (for three levels of control material) |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Intra-assay precision: 20 replicates for each of the three levels of control material (total of 60 measurements).
- Inter-assay precision: Duplicate measurements over a five-day period, totaling 20 replicates for each of the three levels of control material (total of 60 measurements).
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is a submission for a quality control material, and such studies are typically performed in a controlled laboratory setting by the manufacturer (Dade-Behring Inc., located in Westwood, MA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material. Its "ground truth" (i.e., expected LH levels) is established during its manufacturing and assay process, not by expert review of patient data. The study focuses on the precision of the control material when run on an analyzer.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication for the performance of a quality control material. The performance is assessed purely based on statistical precision metrics.
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 device is a quality control material, not an AI/ML-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a quality control material for an immunoassay, not an algorithm.
7. The type of ground truth used
For quality control materials, the "ground truth" refers to the target or assigned values for the analytes within the control. These are established through:
- Manufacturer's internal assays: Batch testing during production to determine the concentration of hLH at each control level.
- Assigned values: The control material is "assayed," meaning it comes with lot-specific values, likely determined by the manufacturer against a reference method or standard.
The study then assesses how precisely the OPUS hLH assay measures these known levels within the control material.
8. The sample size for the training set
Not applicable. Quality control materials do not typically have a "training set" in the context of AI/ML or classification algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 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.