(52 days)
R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits. The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
Here's an analysis of the provided text regarding the R&D Sickle QC Hematology Control, presented according to your requested format:
Acceptance Criteria and Device Performance Study for R&D Sickle QC Hematology Control
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remain within assay range over the life of the product | "R&D Sickle QC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Demonstrate precision | "R&D Sickle QC Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing." |
| Established expiration dating | 6 months (closed vial) and 100 days (open vial) when stored at 2 - 8° C and handled according to instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "3 validation lots" were used for testing. The specific number of individual samples within these lots is not provided.
- Data Provenance: The data appears to be prospective as it describes "laboratory testing" that was conducted to validate the product. The country of origin is implicitly the United States, as the submission is to the U.S. FDA by R&D Systems, Inc., based in Minneapolis, MN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text. The "ground truth" for the performance metrics (assay range, precision) would likely be established by the product specifications and analytical methods of the lab conducting the validation, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of diagnostic cases where there might be disagreement (e.g., in medical image analysis). This is a laboratory control product, and its performance is evaluated against predefined analytical metrics.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that impact human interpretation of cases. The R&D Sickle QC Hematology Control is a laboratory control material, not a diagnostic device that humans interpret in conjunction with AI.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Yes, a form of standalone performance evaluation was done. The "laboratory testing of 3 validation lots" directly assessed the performance characteristics (precision, stability within range) of the Sickle QC product itself, independent of human interpretation or assistance. It's important to note this isn't an "algorithm" in the typical AI sense, but rather the performance of the control material in a laboratory setting.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is established by analytical specifications and established laboratory methods/standards. For example, the "assay range" would be a pre-defined range within which the control is expected to perform, and "precision" would be measured against statistical benchmarks for variability. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This information is not applicable and therefore not provided. The R&D Sickle QC Hematology Control is a physical control material, not an AI/machine learning algorithm that requires a training set.
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.
§ 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.