(20 days)
The LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXL™ integrated chemistry system with LOCI® module.
The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based product containing native human troponin complex with other components designed to stabilize the product.
The provided text describes the 510(k) summary for the LOCI® Cardiac Troponin I Calibrator, focusing on its substantial equivalence to a predicate device. This document is a regulatory submission for a calibrator, which is a reference material used to standardize a diagnostic test. Therefore, the "device" in this context is the calibrator itself, not an AI-powered diagnostic system.
As such, many of the requested elements for describing AI device performance (like multi-reader multi-case studies, AI assistance effect size, standalone algorithm performance, number of experts for ground truth, or sample size for AI training sets) are not applicable to this type of device and are not found in the provided text.
However, I can extract the relevant information available for this calibrator:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria or detailed performance data in a table format for the LOCI® Cardiac Troponin I Calibrator. Instead, it focuses on the "stability" as a key performance characteristic established through real-time data. The primary "performance" reported is that it has been determined to be "substantially equivalent" to the predicate device.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability | Established through real-time data on 3 lots of product; must pass pre-defined acceptance criteria. | "The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria." (Specific data not provided) |
| Technological Characteristics | Substantial equivalence to predicate device (Dimension Vista® Cardiac Troponin I Calibrator) | "Based on a review of the devices technological features, the LOCI® Cardiac Troponin I Calibrator is substantially equivalent to the legally marketed device, the Dimension Vista® Cardiac Troponin I Calibrator." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For stability testing, "3 lots of product" were used. The document does not specify the number of individual calibrator vials or measurements within each lot.
- Data Provenance: The data is generated internally by Siemens Healthcare Diagnostics Inc. and is described as "real-time data." It is prospective in the sense that stability studies are conducted over time as the product ages. The country of origin of the data is not explicitly stated but would be consistent with the submitter's location (Newark, DE, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a calibrator, not a diagnostic device requiring expert interpretation of results for ground truth establishment. The "ground truth" for a calibrator would refer to the true assigned values of the troponin I concentrations, which are determined through a manufacturing and standardization process, traceable to an internal master pool.
4. Adjudication Method for the Test Set
Not applicable. This is a calibrator, and its performance (e.g., stability, effectiveness in calibration) is assessed through analytical testing against predefined specifications, not through expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. MRMC studies are for diagnostic devices involving human interpretation, often with AI assistance, and are not relevant for a calibrator.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No. This concept is not applicable to a calibrator. The "performance" of the calibrator is its ability to accurately and consistently calibrate the associated assay, which is evaluated through laboratory methods.
7. The Type of Ground Truth Used
The ground truth for the calibrator's nominal values is established by traceability to an "internal master pool containing human cardiac troponin complex." This means the assigned values are based on a reference standard maintained by the manufacturer.
8. The Sample Size for the Training Set
Not applicable. Calibrators are not "trained" in the machine learning sense. Their nominal values and performance characteristics are determined through manufacturing processes and analytical validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The "ground truth" for its assigned values ("nominal values") is established through traceability to an internal master pool.
§ 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.