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The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.

The document provided describes the Access Myoglobin assay. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Method Comparison: 148 samples were used.
• Dilution Recovery (Linearity): An unspecified number of lithium heparin plasma samples were used.
• Analytical Specificity: "None of the RF samples or the HAMA samples," and "Two heterophile samples."
• Reference Intervals: No specific sample size is given for the population used to establish the reference intervals, but separate limits were computed for LHS and EDTA assays for males and females.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• This document describes an in vitro diagnostic (IVD) device for quantitative determination of Myoglobin levels. For such devices, "ground truth" is typically established through a reference measurement procedure or comparison to a legally marketed predicate device, rather than through expert human interpretation of images or clinical findings.
• The predicate device used for comparison was the "Access® Myoglobin Beckman Coulter Inc." (510(k) Number: K000196). The performance of this predicate device serves as a benchmark for comparison.
• No human experts were explicitly "establishing ground truth" in the sense of consensus reads for the analytical performance studies.

4. Adjudication Method for the Test Set:

• Not applicable as this is an IVD device for quantitative measurement, not a system requiring human interpretation adjudication. Measurements are taken and compared to established analytical performance criteria and a predicate device.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation systems where human readers are involved. This document describes an automated immunoassay system.

6. Standalone (Algorithm Only) Performance:

• Yes, the entire submission describes the standalone performance of the Access Myoglobin assay, which is an algorithm-driven automated immunoassay system. The reported performance metrics (precision, sensitivity, linearity, method comparison, etc.) are all for the algorithm (assay) itself, without human-in-the-loop performance being a variable.

7. Type of Ground Truth Used:

• For the analytical performance studies:
  • Method Comparison: The "ground truth" for the new device was established by comparing its measurements against those obtained from the predicate device (Access® Myoglobin Beckman Coulter Inc., K000196). This is a common approach for demonstrating substantial equivalence for IVDs.
  • Other analytical studies (e.g., precision, linearity, sensitivity): Ground truth is inherent in the experimental design, using known concentrations, samples with established values, or statistical methods to define performance characteristics. For instance, for sensitivity, the detection limit is determined against a zero calibrator.

8. Sample Size for the Training Set:

• The document does not specify a training set size. For an immunoassay, the "training" analogous to machine learning models often refers to the development and optimization of the assay reagents and protocols. The studies described are typically considered verification and validation studies (test sets) for the finalized assay.

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

• As above, explicit "training set ground truth establishment" in the context of machine learning is not directly applicable here. The development of an immunoassay involves extensive laboratory work to optimize reagent concentrations, reaction conditions, and calibration curves. This optimization process, drawing on many samples and experiments, is analogous to training. The performance of these optimized parameters is then validated through the analytical studies described.

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The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm.

The RAMP™ Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

The RAMP Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

Diluted EDTA whole blood is applied into the sample well of the Test Cartridge. The red blood cells are retained in the sample pad, and the separated plasma migrates along a strip, through a contact zone where it interacts with fluorescent latex particles. Latex (test) particles, coated with mouse monoclonal anti-myoglobin antibodies bind to myoglobin in the sample.

The sample moves by capillary action towards the end of the strip. As the sample migrates to the detection zone, myoglobin anti-myoglobin particles are immobilized at the detection zone. and additional particles are immobilized at the internal control zone.

The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

This document describes the regulatory submission for the RAMP™ Myoglobin Assay and RAMP Reader.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of pass/fail thresholds for clinical performance but are implied by demonstrating substantial equivalence to predicate devices through correlation. The reported device performance is presented as correlation coefficients (r), slopes, and intercepts from method comparison studies, and precision data.

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

• Method Comparison Study (vs. Beckman ACCESS Myoglobin Assay):
  • Test Set Size: 415 subjects (196 normal individuals, 219 patients suspected of AMI).
  • Data Provenance: Not explicitly stated but inferred to be from a clinical setting where samples for patients suspected of AMI were collected and compared with the predicate device. The samples were "EDTA whole blood samples obtained for each of these subjects." The study was likely prospective to obtain samples for direct comparison.
• Precision Study (duplicate testing):
  • Test Set Size: 179 subjects (77 normal individuals, 102 patients suspected of AMI).
  • Data Provenance: Samples were "selected randomly from those obtained during the Method Comparison Study." These samples were stored refrigerated for up to five days between analyses. This suggests retrospective analysis of samples collected during the method comparison, or a subset of freshly collected samples used specifically for this precision arm.
• Expected Values (Normal Range Study):
  • Test Set Size: 196 healthy individuals.
  • Data Provenance: Not explicitly stated, but "Whole blood samples from 196 healthy individuals" implies prospective collection from a healthy population.

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

There were no experts used to establish ground truth in the traditional sense. The device's performance was evaluated by comparing its quantitative myoglobin measurements to those obtained from an already marketed, legally predicate device (Beckman ACCESS Myoglobin Assay). The "ground truth" here is the measurement provided by the predicate device at the time of the study rather than a consensus of human experts interpreting diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set

No adjudication method was used, as this was a quantitative measurement comparison study against a predicate device. The comparison involved direct numerical measurements, not subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. It does not involve human readers interpreting cases with or without AI assistance.

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

Yes, the studies presented are standalone performance studies. The RAMP Myoglobin Assay, when used with the RAMP Reader, directly generates a quantitative myoglobin result. The performance data (precision, linearity, analytical sensitivity, and method comparison) evaluate the device's ability to produce accurate and reproducible measurements independently. Human input is limited to sample collection, loading, and reading the final numerical result from the RAMP Reader.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the method comparison studies was the quantitative myoglobin concentration determined by the predicate device, the Beckman ACCESS Myoglobin Assay. For analytical performance, the "ground truth" was established by known concentrations of myoglobin antigen (e.g., for linearity and analytical sensitivity).

8. The Sample Size for the Training Set

The document does not provide details about a specific "training set" for the RAMP™ Myoglobin Assay in the context of machine learning or AI models. This device is an immunochromatographic assay; its "training" or calibration would typically involve laboratory procedures to establish standard curves and internal controls during manufacturing and quality control, rather than a data-driven training set in the AI sense.

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

As noted in point 8, the concept of a "training set" and its "ground truth" in the AI sense does not apply directly to this particular device. Calibration and quality control for an immunoassay involve:

• Known Calibrators: Using substances with precisely known concentrations of myoglobin to establish a standard curve for the RAMP Reader to accurately convert fluorescence signals into myoglobin concentrations.
• Controls: Running samples with known myoglobin concentrations (quality controls) to ensure the assay is performing within established limits over time.

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