(219 days)
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents Refer to your Product Manuals or On-Iıne Help System
COULTER LIN-X linearity controls are stabilized human blood components whose WBC, RBC, HGB, and PLT concentrations span the instrument's reportable range Results from repeated measurements for each concentration are compared to the established expected range to assess the instrument's calıbration and verify the reportable range
The provided text is a 510(k) summary for the COULTER® LIN-X Linearity Controls. It does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a study demonstrating device performance. The document generally states that studies were conducted but does not provide the quantitative results or methodologies in detail.
Here's an attempt to answer your questions based on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Stability, calibration assessment, value assignment and range determination studies were conducted and demonstrate acceptable performance per manufacturing specifications." However, specific acceptance criteria and the numerical results of the reported device performance are not provided in this summary. It only indicates that performance was "acceptable."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Demonstrated acceptable performance per manufacturing specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on:
- The sample size used for any test set.
- The data provenance (e.g., country of origin) or whether the studies were retrospective or prospective.
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)
The document relates to linearity controls for hematology analyzers, not a diagnostic device requiring expert interpretation for ground truth. Ground truth for linearity controls typically involves reference methods and established ranges. Therefore, this question is not applicable in the context of this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this is a linearity control product and not a device requiring human interpretation of results, an adjudication method for a "test set" in the traditional sense is not applicable. The performance is assessed against established ranges and manufacturing specifications.
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 is a linearity control product, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a control product used to assess the calibration of an analyzer. Its performance is inherent in its chemical and biological properties (stability, assigned values). It is not an algorithm, so a "standalone" algorithm-only performance study in that sense is not applicable. The performance studies likely focused on the control material itself within the context of the analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For linearity controls, the "ground truth" (or "expected results") is typically established through:
- Reference methods: Highly accurate and precise methods, often manual or semi-automated, used to determine the true concentration of analytes (WBC, RBC, HGB, PLT) in each control level.
- Value assignment: Through rigorous testing on multiple calibrated instruments and comparison to reference materials or methods, a consensus true value (or an expected range) is established for each control level over its shelf life.
The document refers to "established expected range" and "manufacturing specifications," implying use of such methods.
8. The sample size for the training set
The document does not provide information on the sample size for any "training set." Linearity controls are not machine learning models that require a training set in the typical sense. Performance is likely validated through extensive manufacturing runs, stability studies, and evaluation on target instruments.
9. How the ground truth for the training set was established
As the concept of a "training set" for a linearity control device is not applicable, the establishing of ground truth for such a set is also 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.