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510(k) Data Aggregation
(25 days)
CARDIAC TROPONIN-I (TROP) CALIBRATOR
The Cardiac Troponin-I 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.
The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.
This document is a 510(k) premarket notification for a medical device called the "Cardiac Troponin-I (TROP) Calibrator." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics for an AI/device, nor does it report "device performance" in terms of accuracy, sensitivity, or specificity. Instead, the focus is on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" here are implicitly linked to the characteristics of the predicate device, the Stratus® Cardiac Troponin-I Calibrators, which the new device aims to match or be comparable to. The reported "device performance" is a comparison of features and intended use.
| Feature / Criterion | Dimension® RxL TROP Calibrator (New Device) | Stratus® Cardiac Troponin-I Calibrators (Predicate Device) | Statement of Equivalence |
|---|---|---|---|
| Intended Use | Calibrator | Calibrator | Substantially Equivalent |
| Analyte | cardiac troponin-l | cardiac troponin-l | Substantially Equivalent |
| Matrix | buffered bovine protein | buffered bovine protein | Substantially Equivalent |
| Form | frozen | frozen | Substantially Equivalent |
| Volume | 2.0 mL per vial | 2.0 mL per vial | Substantially Equivalent |
| Values | Assigned | Nominal | Substantially Equivalent (difference noted but deemed not to affect equivalence) |
| Levels | 5 levels | 6 levels | Substantially Equivalent (difference noted but deemed not to affect equivalence) |
2. Sample size used for the test set and the data provenance:
This type of information (sample size, data provenance from specific countries, retrospective/prospective studies) is not applicable to this document. This is a 510(k) submission for a calibrator, which is a reference material used to ensure the accuracy of a diagnostic test. It's not a diagnostic device itself that processes patient data or images. The "test set" in this context would refer to internal validation tests performed by the manufacturer, but details of such tests are not provided in this summary.
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. The device is a calibrator, not a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for a calibrator is its assigned value, which is determined through a rigorous manufacturing and quality control process using established analytical methods, not by expert medical consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic interpretations, which is not relevant for a calibrator.
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 information is not applicable. This document describes a calibrator, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of AI assistance to human readers would be performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This device is a biochemical calibrator, not an algorithm, so the concept of standalone algorithmic performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Cardiac Troponin-I (TROP) Calibrator is its assigned concentration value of cardiac troponin-I. This is established through the manufacturer's internal quality control processes, which would involve precise analytical measurements using reference methods and traceable standards. It is a chemical/analytical ground truth, not a medical or expert-based truth like pathology or outcomes data.
8. The sample size for the training set:
This information is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of data used to train an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as #8.
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