(59 days)
The VALIDATE Chem 6 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: uric acid.
VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analyte. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.
Here's an analysis of the provided text regarding the VALIDATE Chem 6 Calibration Verification Test Set, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by its demonstration of "functional equivalence" and "substantial equivalence" to the predicate device, specifically in terms of linearity and correlation. The study aims to show that the VALIDATE Chem 6 performs as well as the predicate for its intended use.
| Acceptance Criteria (Implied) | Reported Device Performance (VALIDATE Chem 6) | Predicate Device Performance (DOCUMENT Uric Acid CAL•VER) |
|---|---|---|
| Strong linear correlation (Correlation Coefficient (r)) for Uric Acid | 0.99995 | 0.99996 |
| Regression equation demonstrating similar linearity (Y=intercept + slope(X)) for Uric Acid | Y = 0.031 + 0.956(x) | Y = 0.155 + 0.91(x) |
| Functional equivalence for calibration verification and linearity assessment to the predicate device | Demonstrated functional equivalence using pre-production lots on a Beckman Synchron CX | Established as a legally marketed device; performance serves as the benchmark for equivalence |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the analyte (Uric Acid) was "tested in triplicate." This refers to the number of replicates for each level of the calibration verification test set, not the total number of patient samples. The test set itself consists of six levels (including zero).
- Data Provenance: The data was generated using "pre-production lots of VALIDATE Chem 6 Calibration Verification Test Sets." The instrument used was a "Beckman Synchron CX." The data provenance is internal to the manufacturer's testing and development process, likely conducted in the USA (manufacturer is in Maine, USA). It is a prospective study in the sense that it involves testing the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (calibration verification test set) does not involve human expert interpretation of results to establish ground truth in the same way an imaging or diagnostic AI device would. The "ground truth" for linearity and calibration verification is established through the inherent chemical properties and expected concentrations of the analytes within the test solutions, which are then measured by a laboratory instrument. The performance of the predicate device serves as the benchmark for comparison. Therefore, there were no external experts used to establish ground truth in the traditional sense. The expertise lies in the analytical chemistry and metrology of the reference materials and the careful execution of laboratory measurements.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this product does not involve human interpretation or subjective assessment that would require adjudication. The performance is determined by quantitative measurements against known reference values or comparisons to an established predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret images or other data, and the AI device either assists them or performs the interpretation independently. The VALIDATE Chem 6 is a laboratory quality control material, not a diagnostic interpretation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a sense, a standalone performance was done for the device itself. The device is a "Calibration Verification Test Set," meaning it is a material used by an instrument. The "performance" being evaluated is how the material interacts with the instrument (Beckman Synchron CX) and how the instrument recovers the expected values, demonstrating linearity. The reported correlation coefficients and regression equations are measures of the intrinsic performance of the test set as measured by an instrument. There is no "human-in-the-loop" component to the test set itself, only to the laboratory professional who uses it and interprets the instrument's output.
7. Type of Ground Truth Used
The ground truth is based on:
- Reference Values/Expected Concentrations: The "theoretical operation" of linearity and calibration verification is based on the known, manufactured concentrations of uric acid in each level of the VALIDATE Chem 6 set.
- Performance of the Predicate Device: The DOCUMENT Uric Acid CAL•VER serves as the established benchmark for "substantial equivalence," meaning its previously validated performance implicitly defines the acceptable range for the new device's ground truth.
8. Sample Size for the Training Set
Not explicitly stated or applicable in the traditional sense of an AI/ML device. This device is a chemical reagent set, not a software algorithm that learns from data. Its "performance" is based on its chemical formulation and interaction with an analyzer. There isn't a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The ground truth for the device's performance is established through the analytical chemistry principles by which the calibration verification materials are manufactured and assayed, and then demonstrated by direct comparison to a legally marketed predicate device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.