(131 days)
Mission Trinity R TM Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation. It is for in vitro diagnostics use and for the quantitative determination of the analytes listed on the Expected Values Chart.
Trinity R matrix consists of a buffered solution of electrolytes, glucose, lactate, dyes and preservative. It is equilibrated with specific levels of CO2, O2, and N2. It contains no human or biological materials. Trinity R is provided in three (3) distinct levels of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, % HbO2Sat, %COHb, %MetHb, %O2Ct & %HHb covering the significant range of the instrument performance. It is packaged in sealed glass ampules, each containing 1.8 ml of solution. Ampules are packaged in single level boxes (30 ampules of same level) or tri-level boxes (10 ampules of each level).
The provided text is a 510(k) Summary for the Mission Trinity R blood gas control device. It primarily focuses on demonstrating substantial equivalence to a predicate device (RNA Medical RA 525 Blood Gas, Electrolyte, Metabolite, CO-Oximeter Control) rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly available in the provided text.
The document states that Diamond Diagnostics, Inc. claims substantial equivalence for "Composition, Intended use, Packaging, Storage, and Shelf life" based on comparisons of these characteristics and analytes. It does not include a specific study design to prove performance against quantitative acceptance criteria for the device itself.
Here's a breakdown of what can be inferred or directly stated from the text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing. The document does not provide a table with quantitative acceptance criteria for device performance (e.g., accuracy, precision) for the analytes. It only lists the analytes and their intended use as quality control material.
- Implied Performance: The entire submission's purpose is to demonstrate that the Mission Trinity R control performs substantially equivalently to the predicate device. This implies that if the predicate device met performance standards, the Mission Trinity R is expected to meet similar, but not explicitly stated or quantified here, performance expectations.
2. Sample Size Used for the Test Set and Data Provenance:
- Missing. The document does not describe a "test set" in the context of device performance evaluation. It describes the product itself (30 ampules per box) but not the sample size used in a performance study.
- Data Provenance: Not applicable as no specific performance study data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Missing. Not applicable as no specific performance study with a test set requiring ground truth establishment is described. The "ground truth" for a quality control material would typically be its assigned target values, which are established by the manufacturer through rigorous characterization, but the details of this process are not in the document.
4. Adjudication Method for the Test Set:
- Missing. Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is more common for diagnostic imaging AI algorithms. The Mission Trinity R is a quality control material, not a diagnostic device requiring human reader interpretation, so an MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. The device is a quality control material, not an algorithm. Its "performance" is about its stability, accuracy of its assigned values, and its ability to monitor other instruments.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Implied (for Quality Control Materials): For quality control materials, the "ground truth" for the assigned values is typically established through a robust process of multiple measurements on reference instruments, often traceably linked to international standards or reference materials. This process ensures the target values assigned to the control material are accurate. However, the details of how the expected values for Mission Trinity R were established are not provided in this summary.
8. The Sample Size for the Training Set:
- Missing/Not Applicable. As the Mission Trinity R is a physical quality control material and not an AI algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Missing/Not Applicable. No training set for an AI algorithm.
Summary of available information related to equivalence, which is the focus of this 510(k):
The document details the characteristics of the Mission Trinity R control and directly compares it to the predicate device, RNA Medical RA 525 Controls.
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Similarities:
- Product Type: Assayed Blood Gas Control
- Intended Use: For in vitro diagnostics use for quality control of pH/Blood Gas analyzers, ISE analyzers, Metabolite analyzers, and CO-Oximeter Instrumentation.
- Matrix: Buffered Aqueous Solution
- Storage: 2-8°C
- Color: Red/purple solution
- Levels: Three (Levels 1, 2, 3)
- Analytes: pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb, %O2Ct, %O2Sat, and %HHb.
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Differences:
- Preservative: Mission Trinity R has a preservative; Predicate does not.
- Package Size: Mission Trinity R is 30 x 1.8mL; Predicate is 30 x 2.5mL.
- Shelf Life: Mission Trinity R has 24 months; Predicate has 36 months.
The 510(k) process primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It does not always require new clinical studies with defined acceptance criteria for quantitative performance if substantial equivalence can be shown through other means (e.g., similar materials, design, intended use, and performance claims derived from the predicate).
§ 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.