(54 days)
CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.
CVA is a suspension of stabilized human red blood cells, human white cells, and simulated platelets (from mammalian red blood cells) packaged as separate components. CVA is supplied in glass vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
The provided 510(k) summary does not describe an AI/ML device or a device that performs a diagnostic or predictive function based on an algorithm. Instead, it describes a hematology quality control mixture (CVA) intended for calibrating and verifying the linearity of automated hematology analyzers.
Therefore, many of the requested categories in the prompt (e.g., acceptance criteria for device performance in a diagnostic sense, sample size for test sets/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of device.
However, I can extract information relevant to the "acceptance criteria" in the context of a quality control product and the "study that proves the device meets the acceptance criteria" as described in the 510(k) summary.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For a quality control product like CVA, "acceptance criteria" relate to its analytical performance characteristics (reproducibility, stability, and equivalence to predicate) rather than diagnostic accuracy.
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Lot-to-lot reproducibility | "CVA to be consistently reproducible" |
| Within-lot reproducibility | "CVA to be consistently reproducible" |
| Equivalence to predicate product (CBC-LINE) | "substantially equivalent to the predicate product" |
| Stability (long-term and open vial) | "stable for the entire product dating" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the summary. The summary mentions "three studies" but does not provide details on the number of samples, runs, or instruments used in these studies.
- Data Provenance: Not specified. It's safe to assume the studies were conducted within Streck Laboratories, Inc. in Omaha, Nebraska, USA, given the submitter information, but this is not explicitly stated.
- Retrospective/Prospective: Not specified. Standard practice for QC product validation would involve prospective studies but this is not confirmed.
3. 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 device is a control material, not a diagnostic device requiring expert interpretation for ground truth. Its "truth" is established by its manufacturing specifications and analytical measurements on reference instruments or predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No human adjudication is involved for this type of product.
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
Not applicable. This is not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for its performance would typically be:
- Its manufactured values for cell counts and hemoglobin based on reference methods.
- Performance consistency compared to its own established specifications.
- Performance comparison against an established predicate device (CBC-LINE in this case) using standard analytical comparisons (e.g., correlation, bias studies).
- Whole blood samples (as mentioned in Study II) would serve as a "real-world" comparator.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study and Conclusions (as presented in the 510(k)):
- Studies Conducted:
- Lot to lot reproducibility
- Within lot reproducibility and comparison with predicate product & whole blood
- Long term and open vial stability
- Study Results:
- CVA was found to be consistently reproducible.
- CVA was found to be substantially equivalent to the predicate product (CBC-LINE).
- CVA was found to be stable for its entire product dating period (both long-term and open vial).
- Conclusions: Based on these studies, the sponsor concluded that CVA is a safe and effective hematology control when used as instructed.
§ 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.