(32 days)
Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.
Retic-Chex Linearity for BC is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, containing 3.0 mL volumes. The device consists of five levels of reticulocyte percentage range from 0 to 29.5%. Closures are injection molded polypropylene screw top caps. The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assay sheet.
Acceptance Criteria and Device Performance Study for Retic-Chex Linearity for BC
This document describes the acceptance criteria and the study that demonstrates the Retic-Chex Linearity for BC device meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary implies that the acceptance criteria are based on achieving comparable stability and performance to the predicate device, Retic-Chex Linearity. The "reported device performance" refers to the conclusions drawn from the conducted studies, indicating that the device met these implicit criteria.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device) | Reported Device Performance |
|---|---|---|
| Closed Vial Stability | 105 days | 105 days |
| Open Vial Stability | 5 days | 5 days |
| Intended Use | Assess instrument accuracy and verify patient reportable ranges of automated/semi-automated hematology instrumentation capable of enumerating reticulocytes, similar to the predicate. | Fulfills intended use when used as instructed. |
| Formulation | Similar to predicate, with a difference in retic processing. | Same formula as Retic-Chex Linearity, with the only difference being the way retics are processed. |
| Storage Conditions | 2 - 10°C | 2 - 10°C |
| Reticulocyte Level 1 Range | 0.4% - 1.1% | 0.4% - 1.1% |
| Reticulocyte Level 2 Range | 4.4% - 5.6% | 4.7% - 6.8% |
| Reticulocyte Level 3 Range | 8.6% - 10.0% | 9.5% - 12.0% |
| Reticulocyte Level 4 Range | 12.7% - 14.4% | 14.2% - 17.2% |
| Reticulocyte Level 5 Range | 23% - 25% | 26.5% - 29.5% |
| Reproducibility | Consistently reproducible performance | Consistently reproducible |
| Equivalence | Substantially equivalent to the predicate product | Substantially equivalent |
| Overall Stability | Stable for the entire product dating | Stable for the entire product dating |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample sizes used for the test sets in the "Run to Run Reproducibility and Comparison to Whole Blood," "Long Term Stability," and "Open Vial Stability" studies.
Similarly, the data provenance (e.g., country of origin of the data, retrospective or prospective) is not mentioned in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this device's validation. Retic-Chex Linearity for BC is a linearity control material for automated hematology instruments. Its validation involves instrument performance, stability testing, and comparison to existing controls, rather than human expert interpretation of clinical images or data. Therefore, there are no "experts" in the context of establishing ground truth for a test set as described for imaging or diagnostic devices.
4. Adjudication Method
This information is not applicable as the validation does not involve human interpretation or subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted as this device is a linearity control material for automated instruments, not a diagnostic or AI-assisted interpretation tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, as understood for AI algorithms, was not conducted. The device itself is a material that is run on automated hematology instruments. The "performance" of the device is its ability to produce consistent and accurate values for reticulocyte percentages across its different levels when run on these instruments, and its stability over time. The studies conducted (reproducibility, long-term stability, open-vial stability) assess the intrinsic properties of the control material, which is analogous to a standalone performance, but not in the context of an "algorithm only" as typically discussed for AI.
7. Type of Ground Truth Used
For the purpose of evaluating Retic-Chex Linearity for BC, the "ground truth" for the reticulocyte percentages at each level would have been established by:
- Reference Method Assays: Likely using established, highly accurate laboratory methods for reticulocyte enumeration or by comparison to the established values of the predicate device.
- Predicate Device Values: The comparison table clearly shows the expected ranges for each level of the predicate device. The new device's levels are presented with corresponding ranges, implying these ranges serve as the target for the "ground truth" or acceptable performance.
- Internal Streck Standards: Internal laboratory standards and established manufacturing specifications would define the target values and acceptable ranges for each level.
Therefore, the ground truth is based on reference method assays and comparison to an established predicate device (Retic-Chex Linearity) with pre-defined analytical ranges.
8. Sample Size for the Training Set
This information is not applicable. As a linearity control material, there is no "training set" in the context of machine learning or AI algorithms for this device. The development and manufacturing process of the control material are based on chemical and biological stabilization techniques, not on data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device. The formulation and processing of the control material are based on established scientific principles for stabilizing blood components and manufacturing processes, rather than on data-driven ground truth establishment for a training set.
§ 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.