(100 days)
This Hematocrit and 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: cGlucose, cLactate, Hct
Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of:
- Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039
- Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040
The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.
The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.
The provided text describes the Hematocrit and Metabolite QUALICHECK, a quality control system, and its substantial equivalence to a predicate device. However, the document does not contain the specific acceptance criteria, study details proving meeting these criteria, or most of the requested information about test and training sets, expert involvement, or comparative effectiveness studies.
This device is a quality control material, not a diagnostic or prognostic medical device that would typically involve AI, human-in-the-loop performance, or extensive clinical trials with patient data and expert ground truth establishment in the manner usually associated with the questions asked. The performance is assessed by comparing its measured values to established reference values and demonstrating stability.
Therefore, many of your requested points cannot be answered from the provided text. I will answer what is available and indicate when information is not present.
Acceptance Criteria and Device Performance (Limited Information Available)
The document states: "All study results met the acceptance criteria," but it does not explicitly list the acceptance criteria in a table or otherwise. It also does not report device performance data in a quantitative manner against specific criteria. The closest information available is in the "Stability" section, which mentions:
- Stability Claim: Control solutions are stable for 2 years at 2 °C to 25 °C.
- Performance against "Acceptance Criteria" (unspecified): "All study results met the acceptance criteria."
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific criteria not provided in document | Specific performance data against criteria not provided. |
| Stability for 2 years at 2 °C to 25 °C | Met the (unspecified) acceptance criteria for stability. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Hct: For value assignment, 30 ampoules were sampled from the batch (5 from each of 6 trays) and 30 ampoules were sampled from a reference batch. Measurements were repeated 5 times per ABL555 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
- Glucose and Lactate: Similar sampling: 30 ampoules from the batch and 30 from a reference batch. Measurements were repeated 5 times per EML105 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
- Data Provenance: Not explicitly stated, but the company (Radiometer Medical ApS) is based in Denmark. The study is part of the regulatory submission process for a medical device quality control, suggesting it is a controlled, prospective study for regulatory purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable or not specified. Ground truth for quality control materials for analytes like glucose, lactate, and hematocrit is established through highly calibrated reference methods and analyzers, not typically by human expert consensus or interpretation in the same way as imaging or diagnostic assessments.
- Qualifications of Experts: Not applicable/not specified. The "ground truth" (referred to as "true value" in the document) is determined by "validated ABL555" and "validated EML105" analyzers and "validated algorithms" in an Excel spreadsheet.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The ground truth is established by instrumental measurements and calculations, not human adjudication.
5. 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 analytical instruments, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, in a sense. The "performance" of this device is its inherent accuracy and stability as a quality control material, which is assessed instrumentally without human in-the-loop performance altering its "reading." The device itself doesn't have an "algorithm" in the AI sense; its function is to provide known analyte concentrations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: "True value" established through measurements on validated reference analyzers (ABL555 for Hct, EML105 for Glucose and Lactate) and validated algorithms for calculation. This is an analytical ground truth based on reference methods.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a quality control material, not an AI algorithm that requires a "training set." The materials are manufactured, and then their "true values" and stability are verified.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set." The "true values" for the device itself (which are the reference for other instruments using it for quality control) are established as described in point 7.
§ 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.