(49 days)
Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na " CI K+ BUN, Hab, Hct, and Glucose.
Chem-Chex STAT is a suspension of stabilized human red blood cells in an aqueous buffered medium. Manufactured in two clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene iars.
Here's the analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria for the device's performance. It discusses "reproducibility," "substantial equivalence," and "stability," but without numerical targets or thresholds. The reported device performance is qualitative, stating that the device was "consistently reproducible," "substantially equivalent to the predicate product," and "stable for the entire product dating."
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified | Not specified |
| Qualitatively Reproducible | Consistently reproducible |
| Qualitatively Substantially Equivalent | Substantially equivalent to the predicate product |
| Qualitatively Stable | Stable for the entire product dating |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for any of the three studies conducted (lot-to-lot reproducibility, within-lot reproducibility, and stability). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the device described. Chem-Chex STAT is a chemistry control used to verify the accuracy of a measuring instrument. Its "ground truth" would be established by reference methods or validated assay values, not by expert interpretation. Experts are not mentioned in this context.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or diagnoses to resolve discrepancies in expert opinions. This device is a chemistry control, and its performance is assessed against established values or methods.
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
This is not applicable. The device is a chemistry control, not an AI-powered diagnostic tool, and involves no human "readers" in its primary function. Therefore, no MRMC study or assessment of human improvement with AI assistance would have been conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical chemistry control, not an algorithm. Its performance is inherent to its chemical and physical properties.
7. The type of ground truth used
The informal "ground truth" for a chemistry control involves its assigned assay values for the analytes it contains (Na+, Cl-, K+, BUN, Hb, Hct, Glucose). These values are established through rigorous analytical methods using reference materials or highly calibrated instruments. The document states "Chem-Chex STAT is an assayed control," implying that specific values for the analytes are determined and provided. However, the exact methodology for establishing these "ground truth" assay values is not detailed.
8. The sample size for the training set
This is not applicable. Chem-Chex STAT is a physical chemistry control, not a machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
§ 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.