(35 days)
This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate
High Metabolite QUALICHECK is a single level quality control system consisting of: High Metabolite QUALICHECK (S7570). The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.
The provided documentation describes the High Metabolite QUALICHECK, a quality control system. As such, the concept of "acceptance criteria" and "device performance" is focused on its ability to serve as a reliable control for other diagnostic devices, rather than directly diagnosing a condition. The "study" described is a value assignment study to establish the accepted control ranges for the device.
Here's a breakdown of the information requested:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a quality control material are typically the established target ranges for its analytes, determined through a rigorous value assignment process. The "reported device performance" refers to the specific values found for the analytes within the control solution, which then form these target ranges.
| Analyte | Acceptance Criteria (Target Range) | Reported Device Performance (Established Range) |
|---|---|---|
| pO2 | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| ctHb | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| cGlucose | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| cLactate | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
Note: The document states "Target ranges are calculated based on the mean ±2SD" but does not explicitly list the numerical target ranges or the actual performance values. This information would typically be found in the device's insert.
Study Details
This section focuses on the value assignment study for the High Metabolite QUALICHECK.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 72 ampoules (12 ampoules sampled from each of 6 trays). Additionally, a "reference batch" was used, though its size is not explicitly stated in terms of ampoules. A total of 144 measurements were performed for each parameter.
- Data Provenance: Not explicitly stated, but assumed to be generated in a controlled laboratory environment by the manufacturer (Radiometer Medical ApS, Denmark) as part of the product development and validation for regulatory submission. This is a prospective study for establishing control values.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense for this type of device. The "ground truth" for a quality control material is established through precise and extensive instrumental measurements on a well-characterized batch.
- Qualifications of Experts: The measurements were performed on "a minimum of 3 validated ABL7xx series" instruments. The expertise lies in the calibration, validation, and operation of these high-precision instruments and the personnel trained to use them for quality control value assignment.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. The "ground truth" (target ranges) is established statistically from a large number of instrumental measurements (144 measurements per parameter) from established and validated analyzers, rather than through expert consensus or adjudication of subjective interpretations.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a quality control material for in vitro diagnostic instruments, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical quality control solution, not an algorithm. Its "performance" is its ability to provide stable and accurate reference values when measured by compatible analyzers. The value assignment study itself is a standalone evaluation of the control solution's inherent characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth is established through reference method measurements or highly precise, validated instrumental measurements on a large, representative sample of the quality control material. Specifically, it's based on the statistical analysis (mean ± 2SD) of 144 measurements from validated ABL7xx series analyzers.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the initial production of the control material according to specifications.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set for this type of device in the machine learning sense. The "ground truth" (i.e., the target values) for the product is established through the value assignment process described in point 6 above for the manufactured batches.
§ 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.