(75 days)
R&D Retic-PG™ is a tri-level, assayed hematology control designed to document and monitor reticulocyte values obtained from the CELL-DYN® 3500 System.
R&D Retic-PG is an in vitro diagnostic reagent composed of human erythrocytes and a reticulocyte surrogate suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of CELL-DYN® 3500 reticulocyte results. R&D Retic-PG is available in three levels of reticulocytes and is stained and run in the same manner as patient specimens.
Here's an analysis based on the provided text, outlining the acceptance criteria and study information for the R&D Retic-PG™ HEMATOLOGY CONTROL device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Stability | Met acceptance criteria for recovery of values within the Expected Range through the life of the product. |
| Shelf Life | Established as 62 days from shipment if stored at 2 -8°C. |
| Open-Vial Stability | Established as 20 days. |
| Substantial Equivalence | Demonstrated to be substantially equivalent to R&D Retic-I™. |
Note: The document states that the stability studies "met acceptance criteria," but it does not explicitly define what those criteria were (e.g., a specific percentage of recovery, a defined range limit).
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the performance data. It only states "Results of studies met acceptance criteria."
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 in the document. The device is a hematology control, and the "ground truth" would likely refer to the established expected range of reticulocyte values, which would be determined through laboratory methods rather than expert consensus on individual cases.
4. Adjudication method for the test set
This information is not applicable and therefore not provided. The study focuses on the stability and performance of a control solution against an expected range, not on human interpretation or adjudication of diagnostic findings.
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
An MRMC comparative effectiveness study was not done. This device is a hematology control, not an AI diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The R&D Retic-PG™ is a control reagent used to verify the accuracy and precision of a hematology analyzer (CELL-DYN® 3500), not a standalone algorithm. Its performance is evaluated against an expected range by observing the output of the instrument.
7. The type of ground truth used
The ground truth used for evaluating the R&D Retic-PG™ would be the expected range of reticulocyte values for the control materials. This range is likely established through a rigorous internal characterization process using reference methods and statistical analysis.
8. The sample size for the training set
This information is not provided and is likely not applicable in the traditional sense of machine learning. As a control reagent, its "training" involves establishing its stable characteristics and expected ranges through manufacturing and quality control processes.
9. How the ground truth for the training set was established
This information is not explicitly detailed in the provided document. However, based on the nature of a hematology control, the "ground truth" (i.e., the expected range of values) for the manufacturing and characterization (analogous to training) would be established through:
- Extensive testing: Running numerous replicates of the control material on the target instrument (CELL-DYN® 3500) and possibly reference methods.
- Statistical analysis: Determining the mean and standard deviation of results to establish an acceptable range.
- Comparison to predicate device: The document mentions substantial equivalence to R&D Retic-I™, implying that its performance characteristics would be informed by established ranges for similar predicate controls.
- Quality control procedures: Adherence to established manufacturing and quality assurance protocols for in vitro diagnostics.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.