(28 days)
The Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.
The Elecsys TSH CalSet consists of equine serum matrix (Cal 1) and a human serum matrix with human TSH (Cal 2) in two concentration ranges. The Elecsys TSH CalSet is supplied in ready for use liquid format.
This 510(k) summary (K060754) for the Elecsys TSH CalSet provides limited information regarding specific performance studies and acceptance criteria typically found for diagnostic devices. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys TSH CalSet K961491) rather than presenting detailed performance data from a new clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria or report specific device performance metrics in the format of a table with numerical values for sensitivity, specificity, accuracy, etc. This type of information is generally expected for diagnostic devices that analyze patient samples.
The comparison table in the 510(k) summary focuses on device features of the modified Elecsys TSH CalSet versus the predicate, such as intended use, traceability, levels, storage form, matrix, stability, and target concentrations. These are design and manufacturing specifications, not performance metrics against clinical outcomes or a ground truth.
For example, it states "Stability: Unopened... at 2-8°C up to the stated expiration date," and "Opened... after opening in aliquots at 2-8°C for 12 weeks." While these are important characteristics, they are not performance metrics like accuracy or precision.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective or prospective data). The submission is for a calibrator, which is used to standardize an assay, not to directly diagnose patients from a test set of patient samples. Therefore, a "test set" in the traditional sense of patient samples for diagnostic performance evaluation is not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. A calibrator's "ground truth" relates to its traceable concentration values, not to interpretations by medical experts. The document states "Assay standardized against the 2nd IRP WHO reference standard 80/558," which indicates traceability to an international reference standard, not ground truth established by medical experts for diagnostic outcomes.
4. Adjudication Method
This information is not applicable or provided. Adjudication methods are used to resolve discrepancies among experts when establishing ground truth for diagnostic studies using patient data. Since this submission is for a calibrator and does not involve patient diagnoses or expert interpretation, adjudication is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices) to assess the impact of AI assistance on human reader performance. As the Elecsys TSH CalSet is a chemical calibrator for an automated immunoassay, human readers are not directly involved in its function or interpretation in a way that would necessitate an MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study, as typically understood for diagnostic algorithms, was not conducted and is not mentioned. The Elecsys TSH CalSet itself is a physical calibrator used within an automated immunoassay system. Its performance relates to its ability to correctly set the assay's measurement scale, which is typically evaluated through analytical studies (e.g., precision, accuracy, linearity) of the overall assay system when calibrated. The document implies that the performance of the assay itself (when calibrated with the device) is acceptable, but does not detail studies specifically for the calibrator's standalone performance in isolation.
7. Type of Ground Truth Used
The ground truth used for the Elecsys TSH CalSet is based on international reference standards and defined concentrations. The document explicitly states: "Assay standardized against the 2nd IRP WHO reference standard 80/558." This refers to a recognized international reference for TSH measurements, which provides the basis for establishing the "true" concentration values of the calibrator.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is because the Elecsys TSH CalSet is a chemical reagent (calibrator), not an AI algorithm or a diagnostic model that requires a training set in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI algorithm or diagnostic model, the method for establishing its ground truth is not applicable or provided. The "ground truth" for the calibrator's stated concentrations is established through reference to the 2nd IRP WHO reference standard 80/558, as mentioned above.
In summary:
This 510(k) submission for the Elecsys TSH CalSet focuses on demonstrating substantial equivalence to a predicate calibrator by comparing manufacturing specifications and intended use. It does not contain detailed performance studies or acceptance criteria typical for diagnostic devices that interpret patient data. The "studies" implied are likely internal analytical validations of the calibrator's characteristics (e.g., stability, concentration accuracy) and its impact on the overall TSH assay, rather than clinical trials with patient cohorts.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.