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For the in vitro quantitative determination of N-terminal proBrain natriuretic peptide in human serum and plasma. Elecsys proBNP is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome or congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

A device for the measurement of human proBNP in serum or plasma.

Here's an analysis of the provided text regarding the Elecsys® proBNP Immunoassay's acceptance criteria and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily compares the expanded intended use device with a predicate device (K032646) which has the same core technology. The performance characteristics presented are more about consistency with the predicate rather than specific acceptance criteria against defined thresholds for new indications. However, implicit acceptance criteria can be inferred from the data provided demonstrating equivalent or better performance in the listed categories.

The "study that proves the device meets the acceptance criteria" for the expanded indications primarily relies on three literature articles that support the clinical utility of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in the new indications (risk stratification in stable and unstable CAD, and assessment of increased risk of cardiovascular events/mortality in patients at risk for heart failure with stable CAD). The provided text confirms that the analytical performance characteristics (precision, hook effect, analytical sensitivity, limitations, measuring range, result interpretation) of the current device are the same as an existing predicate device (K032646), which presumably already met its own set of acceptance criteria. The submission is for an expanded intended use, implying the analytical performance itself is not a new challenge, but rather the clinical validation of the biomarker for additional conditions.

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

• Clinical Studies (Expanded Indications): The document does not explicitly state the sample size, provenance (country, retrospective/prospective), or specific details of the patient populations for the three literature articles cited. These are external peer-reviewed publications.
  • 1. Schnabel R, et al. (2005) - AtheroGene Study cohort.
  • 2. Kragelund C, et al. (2005) - Copenhagen.
  • 3. Ndrepepa G, et al. (2005) - Unknown.
• Analytical Performance Studies (Precision, Hook Effect, etc.): The sample sizes for the internal analytical performance studies are not provided. The text states "Elecsys proBNP (add'l indication)" and refers to the predicate device's performance, implying either that new studies for these parameters were performed and yielded identical results, or that the existing data for the predicate device is considered applicable due to the identical assay protocol, traceability, calibrator, controls, and instrument.

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

• Clinical Studies (Expanded Indications): This information would be within the cited literature articles, not directly in this 510(k) summary. These studies involve clinical endpoints and patient outcomes, which are not typically "expert-established ground truth" in the same way an image interpretation might be. The "ground truth" would be the observed clinical events (e.g., cardiovascular events, mortality) and patient diagnoses.
• Analytical Performance Studies: Not applicable. Ground truth for these studies relates to spiked samples or reference materials, not expert consensus.

4. Adjudication Method for the Test Set:

• Clinical Studies (Expanded Indications): This information would be within the cited literature articles. Clinical trials often have adjudication committees for endpoints, but the specific methods are not detailed here.
• Analytical Performance Studies: 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:

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic imaging or interpretation device. Therefore, the concept of "human readers improving with AI assistance" is not applicable. The device provides a quantitative measurement of a biomarker.

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

• Yes, in a sense, a "standalone" performance was done for the analytical characteristics. The device itself provides a quantitative measurement (pg/mL) directly. The analytical performance metrics (precision, sensitivity, interference, hook effect, measuring range) are intrinsic to the device's function and were demonstrated without human intervention in the measurement process. The interpretation of these results for clinical decision-making is then done by a healthcare professional, but the measurement itself is automated.

7. The type of ground truth used:

• Clinical Studies (Expanded Indications):
  • For the diagnosis of congestive heart failure and risk stratification of acute coronary syndrome/congestive heart failure: Presumed clinical diagnosis and patient outcomes/events (e.g., mortality, cardiovascular events) as defined and adjudicated within the cited clinical studies.
  • For assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure with stable coronary artery disease: Presumed observed cardiovascular events and mortality over follow-up periods, as defined in the cited literature.
• Analytical Performance Studies: Presumed reference methods, defined concentrations in spiked samples, or reference materials for accuracy, precision, sensitivity, and interference studies.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. For an immunoassay like this, there isn't typically a "training set" in the machine learning sense. The assay is built and validated based on biochemical principles, antibody specifications, and instrument calibration. The clinical utility is established in clinical trials, but these aren't "training sets" for an algorithm. If referring to assay development, that data is not provided.

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

• Not Applicable / Not Provided. As mentioned above, "training set" is not a direct concept for this type of IVD. The development and validation of the immunoassay itself relies on established analytical chemistry and immunoassay principles, using characterized reagents and reference standards to establish the analytical performance.

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For the in vitro quantitative determination of N-terminal proBrain natriuretic peptide in human serum and plasma.

Elecsys proBNP is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers

A device for the measurement of human proBNP in serum or plasma.

Here's a breakdown of the acceptance criteria and study information for the Elecsys® proBNP Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the document presents a comparative analysis against a predicate device (Elecsys proBNP (K022516)) and another predicate for conceptual use (Triage BNP (K021317)). The "acceptance" is implied by demonstrating substantial equivalence to these legally marketed devices.

The table below summarizes the performance characteristics of the Elecsys proBNP (add'l indication) and compares them to the predicate devices. The "acceptance criteria" column reflects the performance of the primary predicate for the device.

• 0.9%CV @ 474 pg/mL
• 1.1%CV @ 8005 pg/mL
• 0.9%CV @ 13682 pg/mL
  Total:
• 5.8%CV @ 494 pg/mL
• 4.1%CV @ 7827 pg/mL
• 3.7%CV @ 13143 pg/mL
  E1010/2010 Within run:
• 2.7%CV @ 175 pg/mL
• 2.4%CV @ 355 pg/mL
• 1.9%CV @ 1068 pg/mL
• 1.8%CV @ 4962 pg/mL
  E1010/2010 Total:
• 3.2%CV @ 175 pg/mL
• 2.9%CV @ 355 pg/mL
• 2.6%CV @ 1068 pg/mL
• 2.3%CV @ 4962 pg/mL | Same as Elecsys proBNP (K022516) |
  | Hook Effect | No effect up to 300,000 pg/ml | No effect up to 300,000 pg/ml |
  | Analytical Sensitivity | 5 pg/mL | 5 pg/mL |
  | Limitations (Interference) | Bilirubin: No interference up to 35 mg/dL
  Hemoglobin: No interference up to 1.4 g/dL
  Triglycerides: No interference up to 4000 mg/dL
  Biotin: No interference up to 30 ng/mL
  Rheumatoid Factor: No interference up to 1500 IU/mL | Same as Elecsys proBNP (K022516) |
  | Measuring Range | 5-35,000 pg/mL | 5-35,000 pg/mL |

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

The provided 510(k) summary does not contain specific details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mainly focuses on the performance characteristics and comparison to predicate devices, but the underlying study details are not present.

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

This information is not provided in the 510(k) summary. For an in vitro diagnostic device, "ground truth" for performance studies typically comes from reference methods, clinical diagnosis, or patient outcomes, rather than expert consensus on images or similar data.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods are more commonly described in studies where human interpretation of data is a variable (e.g., medical imaging studies).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, especially AI-assisted diagnostic tools. The Elecsys proBNP Immunoassay is a laboratory-based immunoassay, not an AI-powered image analysis or interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance characteristics presented (precision, hook effect, analytical sensitivity, measuring range, limitations) represent the standalone performance of the immunoassay itself, without human-in-the-loop performance impacting the measurement results. The device quantifies a biomarker directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance characteristics described:

• Precision and Analytical Sensitivity: Ground truth is established by well-defined analytical methods using control materials or spiked samples with known concentrations.
• Hook Effect: Established by testing samples with extremely high concentrations to determine if the assay accurately reports or produces a falsely low result.
• Limitations (Interference): Established by testing samples spiked with known interferents at various concentrations.

For the clinical indications for use (aid in diagnosis of CHF, risk stratification for ACS and CHF), the underlying ground truth would be established through clinical diagnosis, patient outcomes, and potentially other diagnostic tests in clinical trials (which are not detailed in this 510(k) summary).

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The Elecsys proBNP Immunoassay is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The assay is developed and validated through biochemical and analytical testing.

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

As noted above, this is not applicable for this type of device.

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Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

A device for the measurement of human proBNP in serum or plasma.

The provided text describes the Elecsys proBNP Immunoassay and its substantial equivalence to a predicate device, the Biosite Triage BNP Test. However, it does not contain a detailed study report that would typically outline acceptance criteria and prove the device meets them with specific performance metrics and study designs. Instead, it provides a comparison of features and general performance characteristics between the new device and the predicate.

Therefore, I cannot fully answer all points of your request based solely on the provided input. I will highlight what information is available and what is missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical performance. Instead, it compares the Elecsys proBNP Immunoassay against a predicate device based on various features and analytical performance metrics. The implicit "acceptance" is based on demonstrating substantial equivalence to the legally marketed predicate device (Biosite Triage BNP Test, cleared under K003475).

Here's a table based on the provided comparison, highlighting analytical performance characteristics. It's crucial to note these are reported characteristics, not explicit acceptance criteria with pass/fail thresholds against which a study directly demonstrated compliance.

Study Details

The provided text does not contain a detailed study report that would include information on sample sizes, data provenance, expert ground truth, adjudication methods, or specific comparative effectiveness studies.

Based on the information available:

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "performance characteristics" and "limitations," implying studies were conducted to determine these, but it does not specify the number of samples or their origin.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an immunoassay measuring a biomarker concentration, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for analytical performance would be against known concentrations of the analyte or comparison to a reference method.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of immunoassay.
4. 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 (IVD) immunoassay, not an AI-powered diagnostic imaging device involving human readers or AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay measuring ProBNP levels. Its performance is inherent to the assay itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, ground truth for analytical performance would typically be established by:
   • Known concentrations: For precision, linearity, analytical sensitivity/detection limit.
   • Spiking studies: For interference.
   • Comparison to a gold standard or reference method: For accuracy and correlation.
   • Clinical correlation: Showing the measured biomarker levels correlate with the presence or absence of congestive heart failure. The document indicates its use "as an aid in the diagnosis," suggesting clinical correlation studies formed part of its validation.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses training sets in the computational sense. Instead, the "training" for such a device involves developing and optimizing the assay reagents and protocols.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence of an immunoassay to an existing device. It highlights comparative features and analytical performance specifications rather than a detailed study report with specific acceptance criteria and clinical validation study designs.

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