(237 days)
CELL-DYN 22 Plus Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system.
Assayed parameters include:
WBC (108/L), RBC (1013L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), RDW (%), PLT (10°/L), MPV (iL), NEU (%), NEU (10°/L), LYM (%), LYM (10°/L), MON (10°/L), EOS (%),
EOS (10°/L), BAS (%), BAS (10°/L)
CELL-DYN 22 Plus Control is an in-vitro diagnostic product that contains stabilized human red blood cells, human, mammalian or simulated white blood cells and a platelet component in a preservative medium. The product is packaged in polypropylene plastic vials containing 2.5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
Here's a breakdown of the acceptance criteria and study information for the CELL-DYN 22 Plus Control, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document implicitly defines "acceptance criteria" through the types of studies conducted and the conclusions reached. It doesn't present a table with specific numerical thresholds for acceptance for each parameter (e.g., "WBC reproducibility must be within X% CV"). Instead, it states the overall goals and then concludes that the device met these goals.
Here's an interpretation of the implied acceptance criteria and the reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistently reproducible performance | "consistently reproducible" |
| Substantially equivalent to predicate device (Para 12 Plus) | "substantially equivalent to the predicate product" |
| Stable for the claimed shelf life (closed vial) | "stable for the entire product dating" |
| Stable for the claimed shelf life (open vial) | "stable for the entire product dating" |
| Fulfills intended use for accuracy and precision on CELL-DYN Emerald 22 system | "fulfills its intended use when used as instructed" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of samples or runs for each specific test (e.g., how many vials for closed-vial stability, how many individual tests for reproducibility).
- 10-Run Reproducibility: This indicates that at least 10 runs were performed for this specific test.
- External Site Recovery: No specific sample size is provided for this.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a medical device submission, it's highly likely the studies were prospective, conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of device (hematology control). Hematology controls are assayed products, meaning their expected values are pre-determined through precise laboratory measurements and statistical analysis, not through expert consensus like image interpretation. There were no "experts" establishing a ground truth in the sense of clinical interpretation.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like '2+1' or '3+1' are used when there's subjective interpretation involved, typically in clinical studies or image analysis where multiple readers evaluate cases and discrepancies need to be resolved. For a hematology control, performance is measured against pre-established assayed values or against the performance of a predicate device, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing how AI assistance impacts their performance. The CELL-DYN 22 Plus Control is a quality control material for an automated hematology analyzer, not a diagnostic tool requiring human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable in the context of this device. The CELL-DYN 22 Plus Control is a control material that is run on an automated analyzer. Its "performance" is how reliably it produces expected results on that analyzer. The device itself does not have an "algorithm" in the sense of an AI or diagnostic tool. The performance of the control is evaluated by measuring its values (e.g., WBC, RBC) on the CELL-DYN Emerald 22 system, which is an automated process. The "standalone" performance here would refer to the consistency and accuracy of the control material in isolation, which is what the stability and reproducibility studies aimed to demonstrate.
7. The Type of Ground Truth Used
The "ground truth" for the CELL-DYN 22 Plus Control is established by its assayed values. These values are determined through rigorous laboratory testing on reference instruments or using validated methods, and then likely subjected to statistical analysis to establish expected ranges for each parameter (e.g., WBC, HGB, PLT) for the low, normal, and high control levels. The performance of the control is then assessed by comparing the results obtained on the target instrument (CELL-DYN Emerald 22) to these predetermined assayed values and predicate product performance.
8. The Sample Size for the Training Set
This product does not have a "training set" in the context of machine learning or AI algorithms. It is a physical control material. Its "development" phase would involve formulating the material and then performing extensive testing (as described in the studies) to validate its stability, reproducibility, and assayed values.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this product, this question is not applicable. The ground truth (assayed values) for the control material itself is established through internal laboratory characterization and validation studies, often involving multiple runs on reference instruments and statistical analysis to determine the target ranges for each parameter.
§ 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.