(18 days)
ADVIA TESTpoint CSF Controls are hematology reference materials for monitoring the precision and accuracy of the ADVIA 120 Hematology System when analyzing CSF samples.
ADVIA TESTpoint CSF Controls is an assay control mixture used for quality control of the ADVIA 120 CSF (cerebral spinal fluid) method. The control materials are composed of red blood cells and white blood cells derived from human sources stored in a stabilizing medium. The control materials consist of two levels that simulate a low cell count (Level 1) and a higher abnormal count (Level 2).
Here's an analysis of the provided text regarding the ADVIA TESTpoint CSF Controls, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly states the acceptance criterion in the conclusion: "The control materials have demonstrated acceptable precision as observed by the minimal variability (SD and %CV) found in stability testing, and meets the manufacturer's intended specifications for both shelf life and open vial stability."
However, the specific numerical thresholds for "minimal variability" (SD and %CV) and the "manufacturer's intended specifications" for shelf life and open vial stability are not explicitly provided in the given text. Without these direct numerical targets, a table showing a comparison isn't fully possible.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Precision (Variability) | Minimal variability (SD and %CV) – Specific numerical thresholds not provided | "Acceptable precision as observed by the minimal variability (SD and %CV) found in stability testing." |
| Shelf Life Stability | Manufacturer's intended specifications – Specific duration and stability metrics not provided | "Meets the manufacturer's intended specifications for both shelf life..." |
| Open Vial Stability | Manufacturer's intended specifications – Specific duration and stability metrics not provided | "...and open vial stability." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the "test set." It mentions "stability testing" but does not quantify the number of runs, samples, or trials.
- Data Provenance: The data appears to be prospective as it involves "stability testing" which is typically conducted to generate performance data over time. No information is provided regarding the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided for this device. The ADVIA TESTpoint CSF Controls are hematology reference materials, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. Their "ground truth" is their precisely measured and stable composition, which is verified through laboratory testing.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided for this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation of diagnostic results to resolve discrepancies. As discussed above, this device does not involve such human interpretation for its performance evaluation.
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:
This information is not applicable and not provided. This device is a quality control material for an automated hematology system (ADVIA 120). It is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its purpose.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device itself is a control material, not an "algorithm." Its performance is evaluated through its stability and ability to provide consistent results when run on the ADVIA 120 system. The "study" here is essentially the stability testing of the control material itself, and its consistency when used with the automated analyzer.
7. The Type of Ground Truth Used:
The "ground truth" for the ADVIA TESTpoint CSF Controls is established by the inherent, precisely manufactured composition of the control materials (red blood cells and white blood cells in a stabilizing medium) and their intended target ranges. The validation study (stability testing) verifies that this manufactured "ground truth" remains stable over time and across different conditions (e.g., open vial). It is not pathology, outcomes data, or expert consensus in the typical sense for a diagnostic test.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm that requires a "training set." Its development involves formulation, manufacturing, and stability testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the same reasons as in point 8.
§ 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.