(237 days)
CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (109/L), RBC (1012/L), HGB (g/dL), MCV (fL), PLT (109/L)
CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all of the following: stabilized human or mammalian 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. The vials will be packaged in a four (4) welled vacuum formed clamshell container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
Here's an analysis of the provided text regarding the CELL-DYN 22 Plus Calibrator, structured to answer your questions about acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the CELL-DYN 22 Plus Calibrator. Instead, it describes general performance characteristics and equivalence to the predicate device. The "Acceptance Criteria" are implied by the conclusions drawn from the tests, focusing on reproducibility, substantial equivalence, and stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility | Consistently reproducible |
| Substantial Equivalence | Substantially equivalent to the predicate product (Cal-Chex) |
| Open-Vial Stability | Stable for 5 days |
| Closed-Vial Stability | Stable for 45 days |
| Fulfillment of Intended Use | Fulfills its intended use when used as instructed in the product information sheet |
| Safety and Effectiveness | Safe and effective product |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the studies (Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Verification, Calibration Equivalency).
The data provenance (country of origin, retrospective/prospective) is not explicitly stated. Given that Streck is a US-based company (Omaha, NE), it is highly probable the studies were conducted in the US. The studies appear to be prospective, laboratory-based verification and validation tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the involvement of experts for establishing ground truth in the context we typically associate with human interpretation of medical images or diagnostic tests. For a calibrator device, the "ground truth" would be established by reference methods or highly accurate analytical techniques within a laboratory setting, rather than expert consensus on diagnostic interpretations. Therefore, the number and qualifications of experts in this sense are not applicable or reported here.
4. Adjudication Method for the Test Set
As mentioned above, the nature of a calibrator device's validation does not typically involve adjudication methods like "2+1" or "3+1" that are used for subjective interpretations. The "truth" for a calibrator's performance is determined by quantitative measurements against established standards or predicate devices. Therefore, an adjudication method is not applicable or reported here.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and their performance (with or without AI assistance) is evaluated. For a hematology calibrator, this type of study is not appropriate.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device itself is a calibrator, not a diagnostic algorithm. The studies conducted (Run-to-Run Reproducibility, Closed-Vial Stability, Open-Vial Stability, Calibrator Performance Verification, and Calibration Equivalency) are essentially "standalone" performance evaluations of the calibrator's inherent characteristics. The device's "performance" is its ability to consistently provide a known value for calibration, not to make a diagnosis or interpretation. Therefore, in a sense, all listed studies are standalone performance studies of the calibrator material itself.
7. Type of Ground Truth Used
The ground truth for the performance of a calibrator is established by:
- Reference materials/standards: For parameters like WBC, RBC, HGB, MCV, PLT, there are established reference methods and materials to determine the true values.
- Predicate device comparison: The study explicitly mentions "Calibration Equivalency" to the predicate device, Cal-Chex. This implies the predicate device, with its established performance, serves as a de facto "ground truth" for comparison.
- Internal laboratory validation using metrological traceability: Ensuring the calibrator's values are traceable to higher-level reference standards.
The document refers to "Calibrator Performance Verification," which would involve verifying that the calibrator produces expected values when analyzed on the target system (CELL-DYN Emerald 22).
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning algorithms. The CELL-DYN 22 Plus Calibrator is a physical reference material, not an AI or algorithm. Therefore, there is no training set in the conventional sense for this device. Its values are assigned through manufacturing and analytical testing, not an algorithmic learning process.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this calibrator device, this question is not applicable. The values assigned to the calibrator batches are determined through analytical testing and metrological principles, not through an iterative learning process with a "ground truth" dataset.
§ 864.8150 Calibrator for cell indices.
(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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.