(94 days)
ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.
The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.
Here's a summary of the acceptance criteria and study information for the ARCHITECT® STAT MYO immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (K042924) is a 510(k) summary for a diagnostic device. In this type of submission, specific numerical acceptance criteria for performance metrics are often compared against the predicate device rather than against predefined, distinct "acceptance criteria" for the new device as would be seen in a clinical trial protocol. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device.
Therefore, the "acceptance criteria" are implied by the performance of the predicate device (Abbott AxSYM® MYO Assay, K983848), and the "reported device performance" demonstrates that the new device is substantially equivalent to that predicate. Explicit numerical acceptance criteria are not detailed in this summary, but rather the conclusion of substantial equivalence in key performance areas.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Precision | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Linearity | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Interferences | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Stability | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Method Comparison (Clinical Equivalence) | Agreement with Abbott AxSYM® MYO Assay demonstrating substantial equivalence | Demonstrated substantial equivalence with AxSYM® MYO assay |
| Sample Stability | No systematic gain or loss of MYO detectability under evaluated storage conditions | No systematic gain or loss of MYO detectability under evaluated storage conditions for Lithium Heparin and Serum Separator tubes |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size for the clinical method comparison study. It only states that a "method comparison using the CLSI EP-9A (EP-9A) was also conducted with the ARCHITECT® STAT MYO and AxSYM® MYO assays."
- Sample Size: Not explicitly stated. CLSI EP-9A provides guidance on method comparison studies, which typically involve a reasonable number of patient samples to demonstrate correlation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective or prospective laboratory comparison of samples on two different devices. Given the context of a 510(k) in the US, it's likely the data was generated in a US-based laboratory, but this is not confirmed. It's an analytical and clinical comparison study, not a population-based study in terms of provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. This is an immunoassay for a biomarker (myoglobin). The "ground truth" for the test set is established by the results from the predicate device (Abbott AxSYM® MYO Assay), which is already legally marketed and established. The study's purpose is to show agreement between the new device and the predicate device's measurements. There are no "experts" involved in determining the "truth" of the myoglobin levels other than the performance of the predicate method itself.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is primarily based on the predicate device's measurements. There is no independent panel or expert adjudication process described for the myoglobin values themselves. The adjudication, if any, would be in the statistical analysis and clinical interpretation of the comparison results by regulatory reviewers.
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 device is an in vitro diagnostic immunoassay for a biomarker. It is not an imaging AI device that involves human readers or their improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone algorithm (an immunoassay performed by an automated instrument). Its performance is evaluated analytically and in comparison to a predicate device, without a human "in-the-loop" influencing the immediate result generation for a single test. The "human-in-the-loop" aspect comes in the clinician's interpretation of the measured myoglobin level in conjunction with other clinical data. The summary describes the standalone analytical performance of the ARCHITECT® STAT MYO immunoassay.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" for this comparative study is the measurements obtained from the legally marketed predicate device (Abbott AxSYM® MYO Assay). The new device's performance is compared against these established measurements to demonstrate substantial equivalence, rather than against an independent physiological "ground truth" like pathology or clinical outcomes. The clinical utility is framed in terms of its ability to measure myoglobin, which is then used by clinicians for diagnosis, but the study itself focuses on equivalence to an existing method.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set." It is an immunoassay based on chemical and biological reactions. The development of such assays involves optimization and validation, but not in the sense of an "AI training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The development and calibration of the assay would involve various analytical methods to ensure accuracy and precision, but this is distinct from establishing "ground truth" for an AI model.
§ 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).