(85 days)
For calibration of the Opus™ Troponin I assay used for the quantitative measurement of cardiac troponin I in human serum and heparinized plasma.
The Opus™ Troponin I Calibrator is an in vitro diagnostic product intended to be used to calibrate Opus™ Troponin I Test Modules.
Opus™ Troponin I Calibrator is a six level frozen product with target concentrations of 0, 2, 8, 18, 25, 30, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of six vials packaged as one set.
The provided document does not contain specific acceptance criteria or a detailed study demonstrating that the Opus™ Troponin Calibrator meets such criteria.
This document is a 510(k) premarket notification for a medical device (Opus™ Troponin I Calibrator), which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study against predefined acceptance criteria.
The core of the submission is a comparison between the proposed device and a predicate device (Dimension® RxL Troponin I Calibrator) based on intended use, analyte, matrix, form, volume, values, and levels. The conclusion is that the Opus™ Troponin I Calibrator is substantially equivalent to the predicate device because they are manufactured using the same matrix, contain the same analyte source, and are intended for the same purpose.
Therefore, many of the requested details about acceptance criteria, performance tables, sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission.
However, based on the information provided, here's what can be inferred or stated:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., accuracy, precision). The "acceptance criteria" here is implicitly "demonstration of substantial equivalence" to the predicate device (Dimension® RxL Troponin I Calibrator) based on its characteristics and intended use.
- Reported Device Performance: No quantitative performance data (e.g., accuracy, precision, linearity) is provided for the Opus™ Troponin I Calibrator. The performance information is limited to a comparison of its design characteristics to the predicate device.
Characteristic Acceptance Criterion (vs. Predicate) Opus™ Troponin I Calibrator Intended Use Same as predicate Calibrator Analyte Same as predicate (native human troponin complex) Native human troponin complex Matrix Same as predicate (buffered bovine protein) Buffered bovine protein Form Same as predicate (frozen) Frozen Volume Comparable to predicate 1.0 mL per vial Values Assigned (similar to predicate) Assigned Levels Comparable to predicate 6 levels -
Sample size used for the test set and the data provenance
- Not applicable in this document. No specific "test set" or clinical study data is presented to evaluate performance against acceptance criteria. The submission relies on design and functional similarity to a legally marketed predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "ground truth" establishment for performance evaluation is described.
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Adjudication method for the test set
- Not applicable.
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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 device is a calibrator for an in-vitro diagnostic assay, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a calibrator.
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The type of ground truth used
- Not applicable.
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The sample size for the training set
- Not applicable. No machine learning training process is described.
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How the ground truth for the training set was established
- Not applicable.
§ 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.