(16 days)
IMMULITE® Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of myoglobin in serum. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).
IMMULITE® Myoglobin is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. IMMULITE® Myoglobin is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for myoglobin. While the patient serum sample and alkaline phosphatase-conjugated polyclonal antibody are incubated for approximately 30 minutes at 37 "C in the Test Unit with intermittent agitation, myoglobin in the sample is bound to form an antibody sandwich complex. Unbound conjugate is then removed by a centrifygal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of myoglobin in the sample.
Here's a summary of the acceptance criteria and study information for the IMMULITE® Myoglobin device, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for this device appears to be demonstrating substantial equivalence to a legally marketed predicate device. The primary performance metric reported is a method comparison using linear regression analysis.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ACS:180 Myoglobin) in measuring myoglobin in serum for AMI diagnosis. | Linear Regression (IMMULITE® vs. ACS:180): |
| (IMMULITE®) = 0.87 (ACS: 180) + 5.7 ng/mL | |
| Correlation Coefficient (r) = 0.981 | |
| Mean Concentration Comparison: | |
| IMMULITE® Mean = 61 ng/mL | |
| ACS:180 Mean = 76 ng/mL |
Study Details
The provided document describes a method comparison study.
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Sample size used for the test set and the data provenance:
- Sample Size: 172 patient samples.
- Data Provenance: Not explicitly stated, but based on the date of preparation (November 5, 1998) and the context of a 510(k) submission, this would be considered retrospective clinical data used for device validation. The country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of device and study. The "ground truth" for a quantitative diagnostic assay is typically established by comparison to a reference method or a predicate device, rather than expert consensus on individual cases.
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Adjudication method for the test set:
- Not applicable. This was a direct method comparison, not a study involving human adjudication of results.
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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. This is a study comparing an automated immunoassay device to another automated immunoassay device, not an AI-powered diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation of the IMMULITE® Myoglobin device. It measures myoglobin quantitatively from serum samples without direct human intervention in the result generation process beyond operating the analyzer. Its performance was compared against another standalone device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard for this study was the results obtained from the predicate device (ACS:180 Myoglobin), a commercially available solid-phase immunoassay.
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The sample size for the training set:
- Not applicable. This document describes a validation study for a device, not the development or training of an algorithm in the sense of machine learning. The device itself (IMMULITE® Myoglobin) is a specific immunoassay technology, not an AI/ML model that requires a distinct training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI/ML model for this device. The development of the immunoassay itself would involve standard laboratory development and validation procedures to establish its analytical characteristics (e.g., sensitivity, specificity, linearity, precision), but these are distinct from the concept of a "ground truth" for a training set in an AI study.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).