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Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.

The Elecsys Troponin T STAT is a two step sandwich immunoassay with streptavidin micro particles and electrochemiluminescence detection, for the measurement of human TnT in serum or plasma.

The provided document is a 510(k) summary for the Elecsys Troponin T STAT test, comparing it to an older version of the same device (K984105). The purpose of this submission is to demonstrate substantial equivalence, primarily due to expanding the intended use of the device.

Therefore, the document does not contain a new study that establishes acceptance criteria and proves the device meets them from scratch. Instead, it asserts that the new version of the device is substantially equivalent to the predicate device (an older, already cleared version) and thus meets the established performance characteristics of the predicate. The "acceptance criteria" for the new device are essentially that its performance characteristics are "Same" as the predicate.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison between the "Elecsys® Troponin T STAT (modified intended use)" and the "Predicate device Elecsys® Troponin T STAT (K984105)". For most performance characteristics, the new device's performance is simply stated as "Same" as the predicate. This implies that the predicate device's performance characteristics serve as the de facto acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily focuses on demonstrating substantial equivalence by stating that the new device's analytical performance characteristics are "Same" as the predicate device (K984105).

• Test Set (for performance characteristics listed as "Same"): The document does not provide details of a new test set or clinical study conducted specifically for this 510(k) submission to validate these "Same" characteristics. It relies on the previously established performance of the predicate device.
• For the expanded Indications for Use related to acute coronary syndrome, risk stratification, and renal failure: The document mentions "Comparative studies on 770 patients confirm the prognostic utility of cTnT." This suggests that the clinical utility for these expanded indications has been demonstrated, likely through existing literature or previous studies supporting the general use of cTnT, rather than a new study specific to this submission's device to prove new performance characteristics.
  • Data Provenance: Not specified (country, retrospective/prospective for the 770 patients).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is an in-vitro diagnostic device measuring a biomarker (Troponin T). The "ground truth" for the test set comes from the known analytical characteristics of the specified samples and controls (e.g., concentration levels in control materials, samples with known interferents). The clinical utility for the expanded indications would be based on clinical outcomes relevant to myocardial damage, risk stratification, etc., not expert consensus on image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for subjective assessments, like medical imaging interpretation, where multiple experts might disagree on findings. This device measures a quantitative biomarker, so "adjudication" in that sense is not relevant. The accuracy of the measurement is assessed against reference methods or known concentrations.

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 is an in-vitro diagnostic device for biomarker measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

This refers to the performance of the immunoassay device itself. The characteristics listed (precision, sensitivity, measuring range, hook effect, interference) are all measures of the device's standalone performance. The document asserts this performance is "Same" as the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the analytical performance characteristics (precision, sensitivity, measuring range, etc.), the ground truth would be based on:

• Reference materials with known concentrations: Calibrators and controls (e.g., Elecsys Troponin T STAT CalSet, Elecsys PreciControl Troponin T or Elecsys PreciControl Cardiac).
• Method comparison against established reference methods (implied for original predicate clearance).
• Defined levels of interferents (e.g., specific concentrations of bilirubin, hemoglobin, intralipid) to test interference.

For the expanded clinical indications (aid in differential diagnosis of acute coronary syndrome, risk stratification, cardiac risk in chronic renal failure, selection of therapy), the ground truth for clinical utility would be based on:

• Patient outcomes data: Diagnosis of AMI, major adverse cardiac events, mortality, response to specific treatments, etc. This is supported by the statement "Comparative studies on 770 patients confirm the prognostic utility of cTnT."

8. The sample size for the training set

The document does not describe a training set for the new device, as it is claiming substantial equivalence to an existing predicate device based on its inherent analytical characteristics being the "Same." Immunoassays typically do not have a "training set" in the machine learning sense. The development of an immunoassay involves optimizing reagents, antibodies, and protocols, which is an iterative process often using many samples, but not typically referred to as a "training set" in this context.

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

Not applicable for the reasons stated above (no "training set" in the ML sense). The ground truth for developing and validating an immunoassay would be established via highly characterized reference materials and patient samples with clinically confirmed diagnoses or outcomes.

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