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The provided document is a 510(k) notification for HemoCue HemoLin, a control solution used for HemoCue B-Hemoglobin analyzers. It primarily focuses on demonstrating substantial equivalence to a predicate device (HemoCue Whole Blood Control manufactured by Streck Laboratories) rather than presenting a study of a medical device's performance against specific acceptance criteria for a diagnostic claim. Therefore, much of the requested information about device performance, ground truth, expert involvement, and reader studies is not applicable or cannot be extracted from this document.
However, I can extract the information related to the control solution's performance where applicable.
Here's the information that can be extracted or deduced:
- A table of acceptance criteria and the reported device performance
This document focuses on demonstrating comparable precision and accuracy to a predicate control device rather than stating specific acceptance criteria for "device performance" in terms of diagnostic accuracy. The performance mentioned is for the control solution itself.
| Acceptance Criteria (Implied) | Reported Performance (for HemoCue HemoLin) |
|---|---|
| Comparable Precision (to predicate) | Precision study performed with 5 levels of HemoLin and 3 levels of predicate on 3 analyzers, in replicates of 10. (Details of actual precision values are not provided in this summary.) |
| Comparable Accuracy (to predicate) | Accuracy comparison done with predicate control. (Details of actual accuracy values are not provided in this summary.) |
| Product Shelf Life | Tested over 0 to 876 days at 2-8℃ and 25℃ using various production lots. (Specific passing criteria or results not detailed.) |
| Open Vial Stability | Tested at room temperature and 2-8℃. (Specific passing criteria or results not detailed.) |
| Compatibility & Non-interference with Analyzer | Tested for compatibility and non-interference. (Specific results not detailed.) |
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Sample size used for the test set and the data provenance
- Test Set Description: "A precision study of five (5) levels of HemoCue HemoLin as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on three (3) different HemoCue B-Hemoglobin analyzers, in replicates of 10."
- Sample Size (Test Set): For the precision study, 5 levels of HemoLin x 10 replicates each = 50 measurements. 3 levels of predicate control x 10 replicates each = 30 measurements. Total of 80 measurements for precision on each of the 3 analyzers. (The total number of individual vials used isn't specified, but it implies multiple readings from multiple vials across different levels).
- Data Provenance: Not explicitly stated, but clinical data for this type of control solution is typically generated in a laboratory setting. There is no mention of country of origin of data or whether it's retrospective or prospective. Given the nature of a 510(k) for a control, it would be prospective laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is for a control solution, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for control solutions usually refers to the manufacturer's assigned reference values, which are established through extensive analytical testing using reference methods. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable (see point 3). -
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 a control solution, not an AI-assisted diagnostic device or a study involving human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for a control solution. The HemoCue B-Hemoglobin analyzer is the "device," and the HemoLin is a control material for it. The performance evaluated here is the analytical performance of the control itself and its comparability to a predicate control using the analyzer. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For control solutions, the "ground truth" (or reference values) for the control levels would be established by the manufacturer (Direct Solutions/HemoCue) through established analytical methods and traceable standards. The document states that "assay values for HemoLin" are established and attached for comparison. -
The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set. -
How the ground truth for the training set was established
Not applicable.
§ 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.