(51 days)
Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.
The provided text describes the Cal-Chex CD Plus device, an in-vitro diagnostic calibrator for hematology instruments. Let's break down the acceptance criteria and study details based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, the acceptance criteria are framed around performance characteristics observed in the studies, demonstrating the device's suitability as a calibrator.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Reproducibility | Consistently reproducible in run-to-run studies. |
| Equivalence to Whole Blood Calibration | Substantially equivalent to whole blood calibration methods. |
| Stability (Long Term) | Stable for the entire product dating. |
| Stability (Open Vial) | Stable (implied for entire product dating). |
| Safety and Effectiveness | Safe and effective alternative to Whole Blood Calibration. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of samples or runs. It mentions "Three studies of Cal-Chex CD Plus were conducted," but details on the number of units or measurements within these studies are not provided.
- Sample Size: Not specified quantitatively.
- Data Provenance: Not specified (e.g., country of origin). The studies were conducted by Streck Laboratories, Inc., the manufacturer. It is a retrospective analysis of internal studies.
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. For a calibrator, "ground truth" would typically refer to established reference values or methods for calibration. The document states the device was compared to "whole blood calibration methods," implying these methods served as a reference, but does not detail the process or expert involvement in establishing these reference values.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts might disagree on an interpretation, often in imaging or clinical diagnosis. For a quantitative calibrator, the assessment is based on measurements against a reference.
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
This information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improve with AI" are relevant for devices involving human interpretation of data, often in the context of AI-assisted diagnostics. Cal-Chex CD Plus is a calibrator for automated hematology instruments, not a device that assists human readers in interpreting data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This concept is not directly applicable in the same way it would be for an AI algorithm. Cal-Chex CD Plus is the device (a physical calibrator), and its performance is its "standalone" performance when used with the specified hematology instruments. The studies evaluate the performance of the calibrator itself.
7. The Type of Ground Truth Used
The ground truth used for comparison was "whole blood calibration methods." This implies using fresh patient samples calibrated through established and presumably validated laboratory procedures as the reference standard against which the performance of Cal-Chex CD Plus was assessed.
8. The Sample Size for the Training Set
This information is not provided. For a physical calibrator, the concept of a "training set" as understood in machine learning is not directly applicable. The formulation and initial testing of the product would involve extensive internal R&D, but this is not typically framed as a distinct "training set" in the context of device validation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable in the typical machine learning sense. The "ground truth" for developing the calibrator (its formulation, stability, etc.) would have been established through a combination of scientific principles, laboratory development, and comparison to existing validated calibration methods for hematology parameters.
§ 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.