(36 days)
Eurotrol GAS-ISE Metabolites
Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics.
epoc Calibration Verification Fluids
epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System.
epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics.
Eurotrol GAS-ISE Metabolites and epoc Calibration Fluids are assayed blood gas, electrolyte and metabolite reference materials, to venify the precision and accuracy of the epoc@ Blood Analysis System. Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids are filled in 3 mL clear glass ampules.
Eurotrol GAS-ISE Metabolites provides three different physiologically relevant levels. epoc Calibration Verification Fluids provides five different physiologically relevant levels.
10 ampules of the same level of Eurotrol GAS-ISE Metabolites are packed in a carton box. 5 ampules, 1 ampule per level, of epoc Calibration Fluids are packed in a carton box. A product insert with Intended Use is inserted in each product box of GAS-ISE Metabolites and epoc Calibration Verification Fluids.
The provided 510(k) summary for Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for diagnostic algorithms. Instead, it focuses on substantial equivalence to a predicate device and the traceability of its reference materials.
Here's an breakdown of the information that is available and a note on what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or device performance in quantifiable metrics (e.g., sensitivity, specificity, accuracy, precision ranges for device vs. ground truth). Instead, it describes the intended use of the devices as "to verify the precision and accuracy of the epoc® Blood Analysis System" by providing assayed blood gas, electrolyte, and metabolite material.
The performance described is primarily related to the traceability of the analytes to recognized reference materials, which serves as an indirect form of performance validation for calibration verification fluids.
| Analyte | Reference Material |
|---|---|
| pH | NIST SRM: 186 I/II, 185, 187, 191 and 192 |
| pCO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| pO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| Na+ | NIST SRM 956b |
| K+ | NIST SRM 956b |
| Ca++ | NIST SRM 956b |
| Cl- | NIST SRM 956b |
| Glucose | NIST SRM 965c |
| Lactate | Biomed DuoCal Multi 10260 |
| Urea | Precipath U plus 159955 + Precinorm U plus 157249 |
| Creatinine | NIST SRM 967a |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on patient data. These devices are calibration verification fluids. For value assignment, the document states: "Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values." It also mentions "randomly selected samples from each lot."
- Sample Size: Not explicitly stated as a number of "samples" or "replicates" for verification, but implies multiple measurements for "value assignment."
- Data Provenance: Not applicable in the context of patient data. The provenance for the reference materials is stated as NIST (National Institute of Standards and Technology) and specific commercial products (Biomed DuoCal, Precipath U plus, Precinorm U plus). The study involves manufacturing and testing of the control fluids themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for these calibration fluids is established through traceability to certified reference materials (NIST SRMs), not by human expert consensus on clinical data. The value assignment process involves analytical measurements.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic algorithm evaluated on clinical cases requiring expert adjudication. The "value assignment" is based on instrumental measurements and takes the "mean of multiple determinations."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. These are calibration materials, not an AI or diagnostic device that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a control material, not an algorithm. Its performance is intrinsic to its chemical composition and its ability to provide stable, accurate values when measured by an analytical system.
7. The Type of Ground Truth Used
The ground truth for the analytes in the Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids is established through traceability to internationally recognized and certified reference materials (e.g., NIST Standard Reference Materials) and other commercial reference materials. This ensures the accuracy of the assigned values.
8. The Sample Size for the Training Set
Not applicable. These are calibration materials, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" in the context of this device. The ground truth for the product's assigned values is established through metrological traceability to reference standards (as listed under point 1).
§ 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.