(54 days)
The Elecsys® CalCheck IgE is intended for use in periodic verification of the calibration of the Elecsys IgE assay.
The Elecsys CalCheck IgE is manufactured using a human serum matrix, human IgE, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
The provided text is a 510(k) summary for the "Elecsys CalCheck IgE" device, which is a calibration verification material. This type of device does not typically involve the complex clinical studies or AI performance metrics requested in the prompt. Therefore, several of the requested categories are not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based on the provided text, while noting limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Elecsys® CalCheck IgE was evaluated for value assignment and stability." However, specific quantitative acceptance criteria or detailed performance data for "value assignment" and "stability" are not provided in this 510(k) summary. These would typically be found in a more detailed study report or in the submission itself, not necessarily summarized in the public 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided 510(k) summary. For a calibration verification material, the "test set" would refer to the samples used during the validation of the material's properties (value assignment, stability). The document does not specify the number of samples or their origin (country, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This is not applicable for a calibration verification material. Ground truth in this context would likely refer to the assigned values of the IgE concentrations, which are determined through a manufacturing and assay process, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable for a calibration verification material. Adjudication typically refers to resolving discrepancies in expert interpretations, which isn't relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This is not applicable. An MRMC study assesses the performance of human readers, with or without AI assistance, on diagnostic tasks. The "Elecsys CalCheck IgE" is a calibration material, not a diagnostic imaging or interpretive device that human readers would use in this way.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical calibration material, not an algorithm.
7. The Type of Ground Truth Used
For a calibration verification material, the "ground truth" would be the assigned target values for the IgE concentrations within the CalCheck IgE material. These values are established through the manufacturing process and metrology, not typically through expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device as it is not an AI/ML algorithm.
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.