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510(k) Data Aggregation
(21 days)
ELECSYS PRECICONTROL TSH
Control for Thyroid Stimulating Hormone assays.
Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays.
Here's an analysis of the provided text, focusing on the requested acceptance criteria and study information:
This submission (K962573 for the Elecsys® PreciControl TSH Assay) is a 510(k) Pre-market Notification for a quality control material, not a diagnostic device that performs measurements. Therefore, the "acceptance criteria" and "device performance" are related to its suitability as a control, such as its stability and ability to be assigned a value, rather than diagnostic accuracy metrics like sensitivity or specificity.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a quality control material, the "acceptance criteria" relate to its manufacturing, stability, and value assignment, which are implicitly demonstrated through comparison to the predicate device and standardized methods. The document doesn't explicitly list "acceptance criteria" in the traditional sense of performance targets (e.g., minimum sensitivity). Instead, it describes the characteristics of the control material and confirms they are adequate for its intended use.
| Acceptance Criteria Category | Reported Device Performance (Elecsys® PreciControl TSH) |
|---|---|
| Intended Use | To be a control for Thyroid Stimulating Hormone assays. |
| Formulation | Horse serum albumin control with recombinant Thyroid Stimulating Hormone. (Same as predicate: Horse serum matrix, recombinant TSH) |
| Target Concentration | 0.18 μU/mL (Different from predicate, which had 0 and 1.4 μU/mL, but appropriate for a control material) |
| Standardization | Standardized against WHO-reference material (#80/558). (Same as predicate) |
| Storage Conditions | 2 - 8°C. (Same as predicate) |
| Reconstitution | None required, liquid. (Same as predicate) |
| Open Vial Stability | 4 weeks at 2 - 8°C. (Same as predicate) |
| Application Test System | Elecsys® 2010. (Same as predicate) |
| Manufacturer | Boehringer Mannheim Germany. (Same as predicate) |
| Substantial Equivalence | Substantially equivalent to Elecsys® TSH CalSet (K961491). Intended use changed to quality control material. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic performance. For a quality control material, testing would involve verifying its properties and stability. The specific sample sizes for these internal manufacturing and validation tests are not provided in the 510(k) summary. Given the date (1996), such detailed information for a control material was less frequently included in the public 510(k) summary than it might be today. There is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As this is a quality control material, there is no "ground truth" established by experts in the diagnostic sense (e.g., radiologists interpreting images). The "ground truth" for its value assignment comes from standardization against the WHO-reference material.
4. Adjudication Method for the Test Set
Not applicable. There is no diagnostic "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not a diagnostic device, and therefore, no MRMC study involving human readers' performance with or without AI assistance would be relevant or conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm or a diagnostic device, so standalone performance in that context is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys® PreciControl TSH is its assigned value, which is established by standardization against the World Health Organization (WHO) reference material #80/558. This is a recognized international standard for TSH assays.
8. The Sample Size for the Training Set
Not applicable. As a quality control material, there is no "training set" in the context of an algorithm or diagnostic model. Development would involve manufacturing and validation processes, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a quality control material.
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