(84 days)
Mission Trinity B™ Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation. For In Vitro Diagnostic Use
Trinity B is a specially formulated, three-level, aqueous material intended for use to monitor all analytes measured by the Bayer line of blood gas, electrolyte, metabolite and CO-Oximetry analyzers. Trinity B controls provide a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC as a part of their quality assurance program. Trinity B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, chloride, ionized calcium, glucose, lactate and suitable concentrations of dyes to simulate clinically relevant values of hemoglobin, and hemoglobin derivatives: O2Hb, COHb, MetHb and HHB.
Here's the information regarding the acceptance criteria and study for the Mission Trinity B device, extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or detailed performance data in a table format. It mentions "Tests were conducted to verify specific performance requirements" and that "side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence" was performed.
| Criterion Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Stability | (Implied: Demonstrated stability over time under specified conditions) | "Accelerated (high temperature) stress test to support stability" was conducted. The specific results are not detailed, but the conclusion states "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." |
| Equivalence | (Implied: Performance comparable to the predicate device for all specified analytes on intended instruments) | "Side by side testing of Mission Trinity B vs. Predicate (OEM) product on intended instruments to o demonstrate equivalence" was conducted. The conclusion states the device is substantially equivalent, implying this testing confirmed comparable performance. Specific data on individual analytes' equivalence is not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Side by side testing," suggesting that samples of both the Mission Trinity B and the predicate device were analyzed multiple times on the intended instruments.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a prospective comparison study conducted by the manufacturer, Diamond Diagnostics Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a quality control material intended for instrument calibration/quality verification, not a diagnostic device that produces results requiring human expert interpretation for "ground truth." The "ground truth" for the performance of a quality control material such as this would be its known assayed values, and the performance is measured by how accurately and precisely the instruments measure these known values compared to the predicate control.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or other interpretation-based systems, not for quality control materials for automated analyzers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of "standalone performance" of an algorithm is not applicable in this context. Mission Trinity B is a chemical control solution, not an algorithm or a software-based device. Its "performance" is its stability and its ability to serve as a reliable reference material for analytical instruments. The testing involved instrument analysis of the control material, similar to a "standalone" chemical analysis.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" is its established assayed values for the analytes it contains. These values are determined through rigorous analytical methods (e.g., reference methods, highly precise laboratory techniques) by the manufacturer. The purpose of the study was to demonstrate that instruments measure these values comparably to how they measure the predicate control.
8. The Sample Size for the Training Set
This information is not applicable. Quality control materials like Mission Trinity B do not involve machine learning algorithms that require a "training set." The product is a chemical formulation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.