(34 days)
The Elecsys N-MID Osteocalcin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys N-MID Osteocalcin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys N-MID Osteocalcin CalCheck 5 is a lyophilized product consisting of synthetic osteocalcin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided document is a 510(k) summary for the Elecsys N-MID Osteocalcin CalCheck 5. This device is a quality control material, and the provided text does not contain specific acceptance criteria, a study proving performance, or detailed information about test sets, ground truth establishment, or training sets in the way that would typically be described for a diagnostic device that detects or measures a specific condition in patient samples.
Instead, the document details the device's intended use, its comparison to a predicate device (another control material), and its stability. The evaluation of performance characteristics mentioned is related to "value Performance Characteristics assignment and stability," which refers to how accurately the control material's known values are established and maintained over time.
Therefore, many of the requested fields cannot be filled from the provided text, as they pertain to clinical or diagnostic studies that are not relevant to a quality control material's 510(k) submission in this context.
Here's an attempt to answer the questions based only on the provided information, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format for the device's performance in the way a diagnostic device would. It mentions "evaluation for value Performance Characteristics assignment and stability." The stability aspect has a specific reported performance.
| Acceptance Criteria Category (Implied from differences with predicate) | Reported Device Performance (from "Differences" section) |
|---|---|
| Intended Use | Not applicable here, as it's a description of function, not a performance metric. |
| Stability (Reconstituted at 20-25°C) | 5 hours |
| Analyte | Osteocalcin |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for performance evaluation.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a control material with pre-determined concentrations (known values), not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This study type is for diagnostic devices, particularly those involving human interpretation, often with AI assistance. This device is a quality control material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a quality control material, not an algorithm.
7. The type of ground truth used
For a quality control material, the "ground truth" for its performance is its assigned value and its stability. The document states: "During manufacture, the analyte is spiked into the matrix at the desired concentration levels." This indicates the known concentrations are established during manufacturing.
8. The sample size for the training set
Not applicable. This device is a quality control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.