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The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha DX Analyzer. The Alpha DX Cardiac Panel Test Kits are fluorescence Immunoassay Analyzer for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

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I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the "Alpha DX System," and it primarily concerns the regulatory approval process rather than detailed performance data or study results.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It mentions the "Alpha Dx Cardiac Panel Test Kit" for the rapid measurement of myoglobin, CK, CK-MB, and Tnl with the Alpha DX Analyzer, but it does not include the following crucial information for your request:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm-only performance study.
• Type of ground truth used (e.g., pathology, outcomes).
• Sample size for the training set.
• How ground truth for the training set was established.

To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the detailed study protocols, results, and justification for the substantial equivalence claim. The provided FDA letter is merely the official notification of market clearance.

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The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer. The analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

The Alpha Dx Analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Alpha Dx System" from 2001, indicating substantial equivalence to predicate devices but does not include:

• Specific acceptance criteria values (e.g., sensitivity, specificity, accuracy thresholds).
• Reported device performance data (e.g., actual sensitivity, specificity, accuracy values).
• Details about the study design, sample sizes (test or training set), data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
• Information on standalone performance or the type of ground truth used in studies.

The document primarily focuses on regulatory clearance based on substantial equivalence, not a detailed performance study report.

Therefore, I cannot provide the requested table and detailed answers based solely on the input text.

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Ask a specific question about this device

The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.

The Alpha Dx Cardiac Panel Test Kits, when used with the Alpha Dx Analyzer, are fluorescence immunoassays for the rapid measurement of myoglobin, CK, CK-MB and TnI in human whole blood or serum. The Alpha Dx Cardiac Panel Test Kits are two-site fluorescence immunoassays. Monoclonal and polyclonal antibodies are used in the Alpha Dx Cardiac Panel Test Kits.

Acceptance Criteria and Device Performance for Alpha Dx System

The Alpha Dx System is intended for rapid, quantitative, and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB), and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The acceptance criteria and device performance are primarily demonstrated through correlation studies with predicate devices and an assessment of clinical sensitivity and specificity for cardiac troponin I (TnI) and CK-MB.

1. Table of Acceptance Criteria and Reported Device Performance

Implicit Acceptance Criteria: The primary acceptance criterion for the Alpha Dx system is substantial equivalence to legally marketed predicate devices. This is demonstrated by showing comparable analytical and clinical performance. For correlation studies, slopes near 1 and high correlation coefficients (r values near 1) indicate good agreement. For clinical sensitivity and specificity, the acceptance is that the Alpha Dx performance is within the confidence intervals of the predicate devices, indicating no statistically significant difference in diagnostic performance.

2. Sample Sizes and Data Provenance for Test Set

• Correlation between Whole Blood and Serum Samples (Table 45):

  • Sample Size: Paired whole blood and serum samples from 72 chest pain patients and 24 healthy individuals.
  • Data Provenance: Not explicitly stated, but implied to be from patient populations where AMI diagnosis is relevant. Retrospective or prospective is not specified, but the "serial draws" suggest a prospective collection with follow-up.

• Correlation between Alpha Dx System and Predicate Methods (Table 46):

  • Sample Size: Serial samples from 410 chest pain patients and 134 healthy individuals.
  • Data Provenance: Not explicitly stated, but implied to be from patient populations where AMI diagnosis is relevant. Retrospective or prospective is not specified, but "serial samples" hint at a prospective component.

• Clinical Sensitivity and Specificity (Table 47) and Concordance:

  • Sample Size: 362 subjects were tested for concordance between Alpha Dx TnI and Stratus CK-MB. The specific number of patients used to calculate the sensitivity and specificity values for each method (Alpha Dx TnI, Stratus TnI, Access TnI, Stratus CK-MB) is not explicitly stated but is derived from the overall clinical study population involving chest pain patients and healthy individuals.
  • Data Provenance: Not explicitly stated, but implied to be from patient populations relevant to AMI diagnosis.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., radiologists interpreting images). The "ground truth" for this in-vitro diagnostic device appears to be the clinical diagnosis of AMI, established through standard clinical practice for chest pain patients. This likely involves a combination of clinical assessment, EKG findings, and results from other diagnostic tests, as would be performed by medical professionals (e.g., emergency physicians, cardiologists). The specific number or qualifications of these clinical experts are not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the context of expert consensus or disagreement. The "ground truth" (clinical diagnosis of AMI) would have been established through a standard clinical diagnostic process, which inherently involves medical professionals making a diagnosis. There is no mention of a separate adjudication panel for discordant cases beyond the typical clinical decision-making process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study pertains to an in-vitro diagnostic device (a blood test kit and analyzer), not an imaging device or AI-assisted diagnostic tool that would typically involve human readers interpreting output. Therefore, the concept of human readers improving with or without AI assistance does not apply here.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies presented are essentially standalone performance studies for the Alpha Dx System (the "algorithm/device only" in this context). The correlation studies (comparing Alpha Dx to predicate devices) and the clinical sensitivity/specificity calculations demonstrate the performance of the Alpha Dx System itself in measuring biomarkers and its diagnostic utility relative to established methods. There is no human element interacting with the "algorithm" output that would require a human-in-the-loop study in the way it's typically understood for AI systems.

7. Type of Ground Truth Used

The primary type of ground truth used for assessing clinical performance (sensitivity and specificity) is the clinical diagnosis of Acute Myocardial Infarction (AMI). This diagnosis in clinical practice is typically based on a combination of:

• Patient symptoms (chest pain)
• Electrocardiogram (ECG) changes
• Biomarker levels (including those measured by predicate devices, and presumably, overall clinical assessment and follow-up from medical professionals).

For the analytical performance (correlation studies, precision, analytical sensitivity), the "ground truth" is established by the measurements from the predicate devices (e.g., Dade Stratus, Johnson & Johnson Vitros, Beckman Access systems) and by the known concentrations in samples used for analytical sensitivity and precision testing.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. For an in-vitro diagnostic device like the Alpha Dx System, the "training" (calibration and optimization of the assays) would be performed during the development phase using various controlled samples with known concentrations and patient samples. The information provided focuses on the validation studies, which serve as the "test set." Therefore, a specific sample size for a "training set" as understood in AI is not applicable or provided.

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

Given that this is an in-vitro diagnostic device and not an AI algorithm in the common sense, the concept of "ground truth for a training set" as it applies to AI is not directly relevant. For the development and calibration of the Alpha Dx assays, the "ground truth" would have been established through:

• Known concentrations of purified analytes: Used to create calibration curves and set analytical sensitivity.
• Reference materials and spiked samples: Used to optimize assay performance and ensure linearity and recovery.
• Carefully characterized patient samples: Used during assay development to ensure performance across a range of physiological concentrations and patient conditions, likely confirmed by predicate methods and clinical diagnosis.

The process involves standard laboratory practices for assay development and validation, rather than the "ground truth establishment" methods used for AI training data.

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