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Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys Troponin T Gen 5 STAT Immunoassay is a one-step sandwich immunoassay on the cobas e 601 and cobas e 801 analyzer. The assay uses streptavidin-coated microparticles, a biotinylated monoclonal anti-cardiac Troponin T-specific antibody, a monoclonal anti-cardiac Troponin T-specific antibody labeled with a ruthenium complex and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve (6-point calibration) provided with the reagent bar code.

Here's an analysis of the acceptance criteria and supporting study for the Elecsys Troponin T Gen 5 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating individual acceptance criteria for each analytical performance metric. However, for some metrics, "predetermined acceptance criterion" is mentioned. I will extract those with stated criteria and their outcomes.

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

• Analytical Performance Studies (Precision, LoB, LoD, LoQ, Linearity, Interference, Cross-Reactivity):

  • Sample Types: Human Li-Heparin plasma samples (native, pooled, or spiked with recombinant Troponin T).
  • Provenance: Not explicitly stated for specific samples, but implied to be from internal or external sites where the tests were conducted (e.g., "one internal site," "three different sites (one internal and two external sites)"). These are typically retrospective samples used for method validation.
  • Sample Sizes (examples):
    • Precision (Repeatability/Intermediate): Six human samples (sample pools) for 21 days with two replicates/day (4 replicates total per day for 21 days). Total 6 samples * 4 replicates/day * 21 days = 504 measurements per sample material.
    • Precision (Reproducibility): Five human Li-Heparin plasma samples and two controls, measured five-fold for 5 days on three analyzers at three sites. Total 7 materials * 5 replicates * 5 days * 3 sites = 525 measurements across all sites.
    • LoB: One analyte-free Li-Heparin plasma sample, measured in ten-fold determinations in each of six runs over at least three days. Total 60 measurements.
    • LoD: Five low-analyte Li-Heparin plasma samples, measured in two-fold determination, six runs over at least three days. Total 60 determinations per reagent lot (so 180 for 3 lots).
    • LoQ: Ten native Li-Heparin plasma pools and two controls, collected over 21 days with two runs per day. Total 12 materials * 2 runs/day * 21 days = 504 runs, with variance components calculated from these.
    • Linearity: Three high analyte Li-Heparin plasma samples diluted with three low analyte samples to generate at least sixteen concentrations (15 dilutions). Assayed in 3-fold determinations within a single run.
    • HAMA/Endogenous Interference: Two samples with low cTnT spiked with HAMA (in duplicate); Three native Li-Heparin plasma samples (low, medium, high cTnT) for endogenous interferents (3-fold determination).
    • Cross-Reactivity: Three concentrations of troponin samples spiked with four different cross-reactants, tested in three-fold determination.
    • Exogenous Interference (Drugs): Native Li-Heparin plasma samples spiked with 17 common pharmaceutical compounds and 22 cardiac drugs (3-fold determination).

• Clinical Performance Studies (APACE Trial and second multicenter study):

  • APACE Trial:
    • N: 1074 subjects enrolled, 3023 available samples. 188 adjudicated diagnoses of MI.
    • Provenance: International, multicenter prospective trial.
  • Second Multicenter Study:
    • N: 1679 subjects presenting emergently with chest pain were enrolled. 173 adjudicated MIs. 1675 subjects evaluated on the cobas e 601 analyzer.
    • Provenance: Multicenter study (locations not specified, but typically clinical sites).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• APACE Trial: "Independent adjudication committee which included cardiologists."
• Second Multicenter Study: "Independent adjudication committee which included cardiologists and emergency medicine physicians."
• Qualifications: "Cardiologists" and "emergency medicine physicians" are the stated qualifications. Specific years of experience are not provided.

4. Adjudication Method for the Test Set

• APACE Trial: "In the case of a disagreement, a third independent cardiologist was used as the tie breaker." This describes a 2+1 or 3-way consensus adjudication method.
• Second Multicenter Study: "Final diagnoses were determined by an independent adjudication committee... using the universal guidelines." The specific tie-breaking method is not explicitly stated, but implies a consensus process.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a method comparison study (comparing the candidate device to a predicate device) and clinical performance studies (diagnostic sensitivity/specificity of the device against a clinical ground truth).
• There is no mention of human readers' performance with and without AI assistance, nor is there an effect size for human improvement with AI. This is an in vitro diagnostic device, not a diagnostic imaging AI algorithm that would typically involve human reader studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, this is a standalone performance study. The Elecsys Troponin T Gen 5 immunoassay is an in vitro diagnostic device that provides quantitative measurements of cardiac troponin T (cTnT). Its performance (analytical and clinical) is evaluated against established methods and clinical endpoints, independent of real-time human interpretation or intervention in the measurement process itself. The "human-in-the-loop" would be the clinician interpreting the result, but the device's measurement itself is standalone.

7. Type of Ground Truth Used

• Clinical Performance Studies (APACE Trial & second multicenter study):

  • Adjudicated Clinical Diagnosis of Myocardial Infarction (MI). This ground truth was established by an independent adjudication committee (cardiologists, sometimes with emergency medicine physicians) using established diagnostic criteria (e.g., ACC/ESC/AHA guidelines, including ECG changes, symptoms, and elevation of cardiac troponin). For the APACE trial, 60-day follow-up information was also used.

• Analytical Performance Studies:

  • For most analytical studies like precision, LoB, LoD, LoQ, linearity, and interference, the ground truth is often defined by:
    • Reference materials/standards: For calibration and standardization.
    • Known concentrations: For spiked samples and dilution series.
    • Analyte-free samples: For LoB determination.
    • Predicate device results: For method comparison studies. This isn't strictly "ground truth" but a reference for comparative equivalence.

8. Sample Size for the Training Set

• The document describes a measurement device (immunoassay), not an AI/ML algorithm that is "trained" in the conventional sense on a dataset. Therefore, there isn't a "training set" in the context of an AI algorithm learning from data.
• The device's calibration and standardization, however, rely on specific procedures:
  • Calibration Curve: Generated specifically on each instrument by a 2-point calibration and a master curve (6-point calibration) provided with the reagent bar code. This essentially "calibrates" the device to provide accurate quantitative results.
  • Standardization: Against Elecsys Troponin T STAT assay (4th generation), which in turn was standardized against the Enzymun-Test Troponin T (CARDIAC T) method. This refers to the traceable method of establishing the quantitative scale.

9. How the Ground Truth for the Training Set Was Established
As noted in point 8, this device does not utilize a "training set" in the context of AI/ML. Its operational "ground truth" or reference for quantitative measurement is established through:

• Known Calibrator Values: The master curve calibration relies on calibrators with accurately assigned values, which are traceable back to a primary reference method (Enzymun-Test Troponin T, and further through the 4th generation assay).
• Analytical Validation Studies: The various analytical studies (precision, linearity, LoB, LoD, LoQ) are validation steps to ensure the device accurately measures cTnT across its intended range, rather than a "training" phase. These studies confirm the device's ability to consistently provide results that align with expected or known values.

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Immunoassay for the in vitro quantitative determination of cardiac troponin T (cTnT) in lithium heparin plasma. The immunoassay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas system analyzers. CalSet Troponin T Gen 5 STAT is used for calibrating the quantitative Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and cobas e immunoassay analyzers. PreciControl Troponin is also used for quality control of the Elecsys Troponin T Gen 5 STAT immunoassay on the cobas system analyzers. The Elecsys Troponin T Gen 5 CalCheck 5 is an assayed control for use in the calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T Gen 5 reagent on the cobas system analyzers.

(1) The Elecsys Troponin T Gen 5 STAT Immunoassay is a two-step sandwich immunoassay on the cobas e 411analyzer and a one-step process on the cobas e 601 analyzer. The assay uses streptavidin-coated.

This document describes the analytical and clinical performance of the Elecsys Troponin T Gen 5 STAT Assay and its associated calibrators and quality controls. It demonstrates the device's substantial equivalence to previously marketed devices.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Results" sections showing that the device's performance metrics either

• met specific numerical targets (e.g., CV% for precision, ng/L for LoQ), or
• were within a defined percentage recovery or range (e.g., ±10% for interferences, 90-110% for control recovery, 80-120% for CalCheck recovery).

Here’s a table summarizing the performance based on the provided text, where acceptance criteria are explicitly stated or clearly implied by the successful results.

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The Elecsys Troponin T CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a quality control material, the Elecsys Troponin T CalCheck 5. This type of device does not involve studies with "device performance," "sample sizes for test sets," "experts for ground truth," "adjudication methods," or "MRMC comparative effectiveness studies" in the way these terms are typically used for diagnostic or AI-driven medical devices.

Instead, the "performance" of a quality control material refers to its ability to accurately verify the calibration and assay range of an in vitro diagnostic (IVD) test (in this case, the Elecsys Troponin T reagent on specific immunoassay analyzers).

Therefore, a direct answer to your request in the context of a diagnostic or AI device is not applicable for this document.

However, I can extract the relevant information about the acceptance criteria and how a device like this would meet them, based on the principles of regulatory clearance for IVD quality control products.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study for Acceptance Criteria:

The "study" for a quality control material like Elecsys Troponin T CalCheck 5 is typically a verification and validation (V&V) program conducted by the manufacturer. This program encompasses various tests and analyses rather than a single clinical trial with patient data or expert reads.

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

• Test Set Sample Size: Not applicable in the sense of patient samples. For a QC material, the "test set" would be the number of vials/lots of the QC material tested and the number of measurements taken to establish its characteristics (e.g., homogeneity, stability, value assignment). This is typically determined by statistical sampling plans to ensure representativeness and sufficient power for the specific tests. The provenance would be the manufacturer's internal laboratories.
• Data Provenance: The data would originate from prospective internal laboratory studies conducted by Roche Diagnostics during the product development and manufacturing process. This would typically be conducted at their facilities in a controlled environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. For a quality control material, "ground truth" for its characteristics (assigned values, stability) is established through rigorous analytical testing and metrological traceability using established reference methods and calibrated instruments, not by expert interpretation of clinical data. The experts involved would be analytical chemists, biochemists, and statisticians with expertise in IVD manufacturing and assay development, rather than clinical experts like radiologists.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used to resolve discrepancies in expert interpretation of clinical data. For a QC material, objective analytical measurements are the primary data source. Statistical methods are used to analyze the results and determine if they meet pre-defined specifications.

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

• No. An MRMC study is relevant for evaluating the impact of a diagnostic device (especially imaging or AI-driven) on human reader performance. Elecsys Troponin T CalCheck 5 is a quality control material, not a diagnostic device that humans interpret.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This concept is specific to AI or algorithmic diagnostic devices. A quality control material like CalCheck 5 does not involve an algorithm with "standalone performance" in this context. Its function is to verify the performance of an analyzer/reagent system.

7. Type of Ground Truth Used:

• The "ground truth" for a quality control material is its analytically determined and metrologically traceable assigned value for each analyte (Troponin T in this case) at each control level. This value is established through a comprehensive process involving:
  • Reference Methods: Often comparing results to a higher-order reference measurement procedure (e.g., isotope dilution mass spectrometry, if available and appropriate).
  • Consensus Studies: Using multiple instruments and laboratories to generate a robust mean value.
  • Certified Reference Materials (CRMs): Ensuring traceability to international or national standards.

8. Sample Size for the Training Set:

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model.

In summary, the provided document pertains to regulatory clearance for a quality control material. The acceptance criteria and "studies" for such a device are fundamentally different from those for diagnostic or AI-powered medical devices. The focus is on analytical performance, stability, homogeneity, and traceability of the control material itself, rather than clinical performance based on patient data or expert interpretation.

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

Here's an analysis of the acceptance criteria and the study details for the Elecsys® Troponin T STAT Assay, based on the provided document:

Acceptance Criteria and Device Performance for Elecsys® Troponin T STAT Assay

The document describes a modified device (4th Generation) and compares its performance to a predicate device (3rd Generation). The acceptance criteria are implicitly established by demonstrating comparable or improved performance to the predicate device, particularly for key analytical parameters.

1. Table of Acceptance Criteria (Implicitly based on Predicate Performance) and Reported Device Performance

Summary of Acceptance: The modified device demonstrates comparable performance across most parameters and shows improvements in sample types accepted (K2-EDTA and Li-heparin plasma) and potentially tighter precision at some concentrations compared to its predicate. The calibration frequency has a slight difference for Elecsys 1010 at higher temperatures, and the specific controls used are now narrower. The modifications in precision values suggest that new studies were done to establish these figures, and they are presented as the device's performance. The "acceptance criteria" for these would have been to meet or demonstrate improved analytical performance metrics compared to the predicate, which appears to be the case (e.g., lower CVs at comparable or different concentration points).

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

The document does not explicitly state a single dedicated "test set" sample size or its provenance in the way one would for a clinical validation or a standalone AI study. Instead, it describes analytical performance characteristics that would have been derived from various studies using different samples:

• Precision (Within-run and Total): The precision data is reported for "human serum" and "PreciControl" (a control material). It lists specific CVs at different concentration points. While the exact number of samples or runs to generate these CVs is not provided, this would typically involve multiple replicates of samples at different concentrations across multiple runs and days.
• Interference Studies: These require testing samples spiked with various interferents (icterus, hemolysis, lipemia, biotin, rheumatoid factor) and comparing them to unspiked samples.
• Sample Type Evaluation: Plasma samples (K3-EDTA, Na-citrate, K2-EDTA, Li-heparin) are compared to serum samples, implying a set of patient samples collected in different tube types.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's an in-vitro diagnostic device submission, the analytical studies are typically conducted by the manufacturer, likely in a controlled laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is an analytical device (immunoassay) for quantitative measurement of a biomarker. Therefore, traditional "ground truth" as established by expert consensus (e.g., radiologists interpreting images) or pathology is not applicable in the same way as for diagnostic imaging or pathology devices.

• Ground Truth (Analytical): For an immunoassay, the "ground truth" or reference values are established through highly controlled laboratory methods, calibrated against international standards if available, and verified through other reference methods or highly accurate assays. The device itself is designed to measure the concentration of Troponin T, and its accuracy is assessed against the expected concentration in reference materials or patient samples already characterized.
• Experts: The development and validation of such an assay would involve analytical chemists, biochemists, clinical chemists, and other scientific experts who design, perform, and interpret these analytical studies, rather than clinical experts establishing a "diagnosis" as ground truth.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., images, clinical symptoms) is being evaluated and discrepancies resolved. This is not directly applicable to the analytical performance studies of an immunoassay device. The performance metrics (precision, sensitivity, specificity, interference) are determined by quantitative laboratory measurements and statistical analysis.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices where human readers interpret output (e.g., medical images) and the AI's impact on their performance is being evaluated. This document is for an automated immunoassay where the device provides a quantitative result directly. The device's "effectiveness" is in its analytical accuracy and precision in measuring Troponin T.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented indirectly represent a standalone performance evaluation. The Elecsys® Troponin T STAT Assay is an automated immunoassay designed to provide a quantitative measurement. The precision, measuring range, analytical sensitivity, hook effect, and interference studies describe the performance of the algorithm/device itself (the immunoassay system) independent of human interpretation of the primary data (other than loading samples and reading the final numerical result). This is inherently a "standalone" evaluation for such a device.

7. Type of Ground Truth Used

For this immunoassay, the "ground truth" is established through:

• Reference Materials/Standards: Calibrators and control materials with known or assigned Troponin T concentrations are used to calibrate the device and verify its accuracy. The document states its traceability to the 2nd and 3rd generation Troponin T tests.
• Spiked Samples: For interference studies, samples are "spiked" with known concentrations of interferents, and the ground truth is the expected Troponin T concentration in the absence of interference.
• Comparative Methods: Although not explicitly detailed in this summary, often new assays are compared to established reference methods or highly accurate laboratory methods to establish accuracy.

8. Sample Size for the Training Set

The document describes a 510(k) for a device modification, focusing on analytical performance rather than a machine learning algorithm that requires a "training set" in the computational sense. Therefore, there is no explicit mention of a "training set" as it would apply to AI/ML models.

The device is an immunoassay, meaning its "learning" or optimization during development would involve:

• Reagent Formulation and Optimization: Iterative testing and adjustment of antibodies, buffers, and detection systems.
• Calibration Curve Development: Generating data points to establish the relationship between signal and concentration.

These development activities would involve numerous experiments and a large number of samples, but not usually referred to as a "training set" in this context.

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

As noted above, a "training set" in the computational sense is not directly applicable here. The "ground truth" during device development (analogous to training) would be established by:

• Careful preparation of standard solutions with known concentrations of Troponin T.
• Characterization of patient samples or quality control materials using established reference methods or highly accurate laboratory assays to determine their true Troponin T levels.
• These known concentrations are then used to develop and validate the device's ability to accurately measure Troponin T, forming the basis for its calibration and performance specifications.

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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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For the in vitro quantitative determination of troponin T in human serum and plasma.

The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage.

The determination of cTnT in serum is an important component in the diagnosis of myocardial ischemia, e.g. AMI and myocarditis, as well as in monitoring the course of unstable angina pectoris and assessing the associated risk.

The Boehringer Mannheim Elecsys ® Troponin T STAT test is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined via a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.

This document describes the Boehringer Mannheim Elecsys® Troponin T STAT Test, an immunoassay for the quantitative determination of troponin T in human serum and plasma, used in the diagnosis of myocardial ischemia.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state specific acceptance criteria or provide a table summarizing device performance metrics against such criteria. It mentions "Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5," but this attachment is not included in the provided excerpts.

The document primarily focuses on establishing substantial equivalence to a predicate device, the Boehringer Mannheim Elecsys® Troponin T test (cleared by FDA in K961500), rather than detailing performance specifications and meeting predefined acceptance thresholds for this particular iteration of the device.

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 mentions "Comparative studies on 770 patients confirm the prognostic utility of cTnT." This appears to be the sample size for a clinical study related to the prognostic utility of cTnT, which supports the "Indications for Use." However, it's not explicitly stated if this 'test set' was for the modified device's performance validation against specific acceptance criteria, or if it refers to general clinical evidence for Troponin T as a biomarker.

• Sample Size (for prognostic utility): 770 patients.
• Data Provenance: Not specified regarding country of origin.
• Retrospective or Prospective: Not specified.

It's important to note that this is for the prognostic utility of cTnT, not necessarily the performance characteristics (e.g., accuracy, precision) of the device itself. The actual performance data for the device is referenced as being in "Attachment 5," which is not provided.

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)

This information is not provided in the given text.

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

This information is not provided in the given text.

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 device is an in vitro diagnostic (IVD) immunoassay; it is not an AI-assisted diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

This device is an in vitro diagnostic immunoassay. Its performance is inherently standalone in the sense that the test produces quantitative results directly. There is no "human-in-the-loop" component in the interpretation of the raw quantitative troponin T value produced by the instrument and reagent, although a clinician interprets the clinical significance of that value.

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

For the "Comparison to the Predicate Device," the ground truth implicitly is the performance of the predicate device. For the "Indications for Use" and the prognostic utility cited ("Comparative studies on 770 patients confirm the prognostic utility of cTnT"), the ground truth would likely be clinical outcomes data related to cardiac events and patient prognosis. However, the exact methodology for establishing specific ground truth for the device's analytical performance (e.g., accuracy, precision) is not described in the provided text, other than through comparison to the predicate.

8. The sample size for the training set

The concept of a "training set" as understood in machine learning (ML) or AI is not applicable to this traditional immunoassay device. Immunoassays do not have training sets in this sense. They are developed based on chemical and biological principles, and their performance is validated through analytical and clinical studies.

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

As noted above, the concept of a "training set" is not applicable to this type of device.

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For the in vitro quantitative determination of troponin T in human serum and plasma.
Diagnosis of acute myocardial infarction (AMI) is generally based on the presence of at least two of three classic findings: clinical symptoms, diagnostic ECG, and serological findings of abnormal levels of total CK, LD or their isoenzymes. Often, due to the presence of clinical symptoms and changes in the ECG, the CK, CK-MB, LD and LD1 serve primarily to confirm and monitor the course of the infarction. At other times, when chest pain is atypical, or ECG changes are non-diagnostic or absent, these markers provide important diagnostic information. Limitations to these serum markers include a relatively narrow diagnostic window, difficulty in interpreting small increases and a lack of cardiac specificity. Troponin T can be an effective serum marker whose cardiac specificity and wide diagnostic window makes it a valuable tool in the diagnosis of AMI.2,4

Troponin T has been shown to be elevated in all patients with AMI who are diagnosed by World Health Organization (WHO) criteria.1 Troponin T frequently appears in serum as early as one to three hours after the onset of pain.2,5 The sensitivity of troponin T reaches 100% within hours and remains at a high sensitivity level until day five. After 48 hours the CK-MB assay is frequently of little diagnostic value.1 Troponin T also remains elevated longer than total LD.3 Its levels can be measured for up to 14 days.5 Thus, the diagnostic window is broader due to the length of time troponin T is elevated in serum. The time interval of elevation in serum ranges from three hours to > 14 days.1,5
The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. 6 Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage. In cases of AMI with minimal cardiac damage, low elevations of CK and CK-MB are difficult to interpret due to the presence of normal levels of these enzymes in the blood, and their lack of cardiac specificity. The specificity of troponin T to cardiac tissue is of value in these difficult patients. 4,6

The Elecsys ® Troponin T test principle is based on a two step sandwich with streptavidin microparticles and electrochemiluminescence detection.

Total duration of assay: 9 minutes.
1st incubation: 15 ul of sample, a biotinylated monoclonal troponin T-specific antibody and a monoclonal troponin T-specific antibody labeled with a ruthenium complex react to form a sandwich complex
2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier
Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and then proving the device meets them. Instead, it directly compares the performance characteristics of the new device (Elecsys Troponin T) with the predicate device (Cardiac T Troponin T Enzymun Test). Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate comparable or superior performance.

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