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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:

1. 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

2. 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.

3. 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.

4. Adjudication method for the test set

   • Not applicable.

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

   • Not applicable. This device is a calibrator for an in-vitro diagnostic assay, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is a calibrator.

7. The type of ground truth used

   • Not applicable.

8. The sample size for the training set

   • Not applicable. No machine learning training process is described.

9. How the ground truth for the training set was established

   • Not applicable.

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The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.

The OpusTM System pipettes patient sample from a sample cup and dispenses it onto the glass fiber paper where it reacts with immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted from a sealed well within the test module, onto the reaction zone of the paper. During a second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibodyantigen-labeled antibody sandwich. A substrate wash solution is pipetted from a second sealed well on the test module, to the wash port. Unbound labeled antibody is eluted away from the optical read window of the Opus™ System through lateral capillary action. The substrate, 4-methylumbelliferyl phosphate is included within the wash solution allowing simultaneous substrate conversion with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by the instrument's optical system.

The provided document is a 510(k) premarket notification for an in vitro diagnostic device, the Opus™ Troponin I (cTn) Test Modules. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or threshold format. Instead, it uses a substantial equivalence approach, comparing the performance of the new device to a legally marketed predicate device. The primary performance metric reported is a correlation between the two devices.

Note: The acceptance criteria are "implied" because the document states the device is "substantially equivalent in principle and performance" based on the comparison metrics. A correlation coefficient of 0.9856, a slope of 1.01, and an intercept of 0.1516 ng/mL between the two methods are considered strong evidence for substantial equivalence in the context of clinical immunoassay comparisons.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 132 clinical patient samples.
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: Not explicitly stated, but the phrase "clinical patient samples ranging from 0.16 - 45.95 ng/mL" suggests real-world samples, the collection method (retrospective or prospective) is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not applicable to this submission. The study is a method comparison study (split sample comparison) comparing a new device (Opus™) to a predicate device (Dimension® RxL Troponin I). The "ground truth" for the test set is effectively the result provided by the predicate device, or a reference method if the predicate was also being validated against one. There is no mention of human experts interpreting results or establishing a "ground truth" classification for the samples in this context.

4. Adjudication Method for the Test Set

Not applicable. As this is a method comparison study between two analytical devices, rather than a diagnostic interpretation study involving human readers, there is no expert adjudication process described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC study was not done. This document describes the analytical performance of an in vitro diagnostic device, not the interpretive performance of human readers, with or without AI assistance. Therefore, there is no discussion of human reader improvement with AI.

6. Standalone Performance Study

Yes, a form of standalone performance was implicitly done. The "split sample comparison" tests the Opus™ device in its intended operational mode, providing quantitative results directly comparable to the predicate device. The results (correlation, slope, intercept) demonstrate the analytical standalone performance characteristics of the Opus™ device when analyzing patient samples.

7. Type of Ground Truth Used

The "ground truth" in this context is established by the predicate device, the Dimension® RxL Troponin I assay. The study implicitly assumes the predicate device provides accurate measurements of cardiac troponin I, and the goal of the Opus™ device is to provide quantitatively similar results.

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay system, not an AI/ML-based diagnostic algorithm that requires a "training set." The system's performance is based on its chemical and optical principles, not on learned patterns from a training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device.

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