(31 days)
The products encompassed by this request are intended for in-vitro diagnostics use and are intended r no products on only as and flushing the sample flow path of the equivalent AVL 98X series Analyzers. AVL Scientific Corp is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents. Mission reagents are intended to serve as direct replacements to like named products manufactured by AVL.
The Calibrators for the AVL Electrolyte Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path.
Acceptance Criteria and Study for Mission Diagnostic Reagents
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Mission Diagnostic Reagents" are implicitly established by demonstrating performance equivalence to the predicate AVL calibrators. This equivalence is primarily shown through precision data and method comparison (correlation) studies.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Mission Reagents) |
|---|---|---|
| Precision (within-run, between-day) | Low %CV values, indicating consistent and reproducible measurements across different analyte levels. (Specific thresholds are not explicitly stated but are assumed to be comparable to or better than predicate performance). | Na: 0.33% - 1.15% %CV |
| K: 0.58% - 3.65% %CV | ||
| Cl: 0.66% - 2.48% %CV | ||
| Ca: 1.72% - 2.21% %CV | ||
| Li: 1.63% - 3.23% %CV | ||
| Method Comparison/Correlation (with AVL reagents) | Slope (m) close to 1, Intercept (b) close to 0, and R² close to 1, indicating strong linear correlation and agreement with predicate measurements. | Na: Slope (0.9859-1.024), Intercept (-3.42 to 2.13), R² (0.9985-0.999) |
| K: Slope (0.9777-1.0094), Intercept (-0.02 to 0.12), R² (0.9984-0.9989) | ||
| Cl: Slope (0.9669), Intercept (3.97), R² (0.9984) | ||
| Ca: Slope (0.9004), Intercept (0.07), R² (0.9859) | ||
| Li: Slope (1.0144), Intercept (-0.02), R² (0.9940) |
The study aims to demonstrate that Mission reagents perform comparably to equivalent AVL reagents on AVL electrolyte instruments.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set Sample Size (N):
- For Na, K, Cl (AVL 983, Table 1): N values range from 44 to 48 for each analyte at each of three QC levels.
- For Na, K, Ca (AVL 984, Table 2): N values range from 49 to 51 for each analyte at each of three QC levels.
- For Na, K, Li (AVL 985, Table 3): N values range from 47 to 48 for each analyte at each of three QC levels.
- Total N for precision is difficult to calculate exactly without knowing if some measurements overlap, but it is in the hundreds.
- Correlation Test Set Sample Size (N):
- Na: 153 for 983, 135 for 984, 161 for 985.
- K: 153 for 983, 135 for 984, 162 for 985.
- Cl: 151 for 983.
- Ca: 134 for 984.
- Li: 132 for 985.
- Total N for correlation is in the hundreds for each specific analyte/instrument combination.
- Data Provenance: The document does not specify the country of origin. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission for in-vitro diagnostic (IVD) calibrators does not typically involve human experts establishing ground truth in the way a medical imaging AI study would. The "ground truth" here is the performance of the predicate, commercially available AVL calibrators, and the accuracy of the AVL electrolyte analyzers themselves. The study compares the new device's performance to this established gold standard.
4. Adjudication Method for the Test Set
Not applicable for this type of IVD calibrator study. Adjudication by human experts is not typically a component of performance evaluation for analytical precision and method comparison studies for calibrators. The results are quantitative and compared statistically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios involving human interpretation of results, not for the performance of IVD calibrators.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is a standalone performance study. The "device" in question (Mission Diagnostic Reagents) is an in-vitro diagnostic reagent, and its performance is evaluated directly on an instrument (AVL 98X Electrolyte Analyzers) without human interpretation affecting the raw analytical results. The outcome is quantitative data (e.g., %CV, slope, intercept).
7. The Type of Ground Truth Used
The ground truth for this device is the performance of the legally marketed predicate AVL calibrators. The study design directly compares the Mission reagents against these predicate reagents, with the assumption that the predicate reagents represent the accepted standard for accurate calibration on the AVL 98X analyzers. The "correlation with AVL Reagents" section explicitly states "Y = AVL results, X = Mission results," confirming the predicate AVL results are the reference.
8. The Sample Size for the Training Set
No explicit "training set" is mentioned in the context of this 510(k) summary. The study describes performance verification. IVD calibrators do not typically involve machine learning requiring a separate training set. The "samples" referenced are those used for the precision and correlation studies described above, which are test sets for performance evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no described "training set" in the machine learning sense is used for this device. The "ground truth" for the performance evaluation set (comparison with predicate AVL reagents) is established by the accepted analytical performance characteristics of those predicate reagents.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.