(67 days)
R&D Systems' Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.
The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. R&D Systems' Whole Blood Flow Control is composed of human leukocytes and erythrocytes in a stabilizing medium.
The provided text describes a medical device called "R&D Systems' Whole Blood Flow Control." However, it does not contain the specific information requested in the prompt regarding a study that proves the device meets acceptance criteria in the context of an AI-powered diagnostic device. The text describes a traditional laboratory control, not an AI device.
Therefore, I cannot fulfill the request for the following reasons based on the provided text:
- No AI-powered device: The product described is an "assay control mixture for flow cytometric determinations of leukocyte subsets," which is a laboratory reagent, not an AI diagnostic device.
- No acceptance criteria related to AI performance: The acceptance criteria mentioned ("remaining within the assay range over the life of the product" and "precision") are standard for laboratory controls and do not relate to metrics like sensitivity, specificity, AUC, or other performance indicators typical for AI diagnosis.
- No mention of experts, ground truth adjudication, or MRMC studies: These elements are specific to the evaluation of diagnostic algorithms involving human interpretation or AI interpretation, which are not applicable to the described device.
- No training or test set information: Since it's a lab control, there are no AI training or test sets.
Therefore, here is a summary of what can be extracted from the text regarding acceptance criteria and performance, as well as an explanation of why the other requested information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over life | WBFC passed this criterion. |
| Precision (small standard deviations, low CVs) | WBFC demonstrated precision as indicated by "small standard deviations and low CVs obtained during the testing." It also "exhibited similar reproducibility of performance" when compared to freshly drawn whole blood. The expiration dating was established as 28 days closed vial and 7 days open vial. |
Missing Information (and why it's missing from the provided text):
- Sample size used for the test set and the data provenance: Not applicable. The device is a control mixture, not an AI algorithm evaluated on a diagnostic test set. The "testing" referred to is performance lot-release testing, not a diagnostic trial.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic interpretations is not relevant to a laboratory control product.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a laboratory control. The "truth" for a control is its known concentration/composition within the specified range.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”