(98 days)
ARCHITECT STAT Troponin-I is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of cardiac troponin-l (cTnl) in human serum and plasma on the ARCHITECT i System with STAT capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT Troponin-I Calibrators are for calibration of the ARCHITECT i 2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum or plasma.
The ARCHITECT STAT Troponin-I assay is a two-step assay to determine the presence of cardiac troponin-I in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
In the first step, sample, assay diluent and anti-troponin-l antibody-coated paramagnetic microparticles are combined. After incubation and washing, anti-troponin-l 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 chemilyminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of troponin-I in the sample and the RLUs detected by the ARCHITECT i system optics. The concentration of troponin-I is read relative to a standard curve established with calibrators of known troponin-l concentration.
Here's a breakdown of the acceptance criteria and study information for the ARCHITECT® STAT Troponin-I Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance thresholds for sensitivity, specificity, or other metrics. Instead, it frames the acceptance criteria implicitly as demonstrating "substantial equivalence" to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Substantially equivalent to the ACCESS® AccuTnl assay | Demonstrated substantial equivalence |
| Linearity | Substantially equivalent to the ACCESS® AccuTnl assay | Demonstrated substantial equivalence |
| Interferences | Substantially equivalent to the ACCESS® AccuTnl assay | Demonstrated substantial equivalence |
| Stability | Substantially equivalent to the ACCESS® AccuTnl assay | Demonstrated substantial equivalence; "no systematic gain or loss of the detectability of troponin-I in serum or plasma samples under any of the storage conditions evaluated" |
| Sensitivity | Substantially equivalent to the ACCESS® AccuTnl assay at the optimal AMI "cut-off" of 0.30 ng/mL | Demonstrated substantial equivalence |
| Specificity | Substantially equivalent to the ACCESS® AccuTnl assay at the optimal AMI "cut-off" of 0.30 ng/mL | Demonstrated substantial equivalence |
| Method Comparison | Two systems (ARCHITECT STAT Troponin-I and ACCESS AccuTnl) demonstrate substantial equivalence. | Demonstrated substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical data in this 510(k) submission" and a "sample stability study." However, specific numbers for patients or samples are not provided.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. It refers to "clinical data" which typically implies human samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. The comparison is made against a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an in-vitro diagnostic assay, not an imaging or interpretation system that would typically involve multiple human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is an in-vitro diagnostic (IVD) assay, which by nature operates as a standalone algorithm (the ARCHITECT i System) to determine troponin-I concentration. The performance described (precision, linearity, sensitivity, specificity) is inherent to the assay and the instrument, without a human-in-the-loop performance component in the traditional sense of AI system evaluation. The output is a quantitative value used by clinicians for diagnosis.
7. Type of Ground Truth Used
The ground truth for evaluating the ARCHITECT® STAT Troponin-I assay's performance (specifically sensitivity and specificity for MI diagnosis) is implicitly established by comparison to the ACCESS® AccuTnl Assay as a predicate device, using an "optimal AMI 'cut-off' of 0.30 ng/mL." This suggests that the ground truth for MI diagnosis with respect to troponin-I levels was derived from established clinical criteria and comparison to a legally marketed equivalent device, rather than pathology or long-term outcomes data explicitly.
8. Sample Size for the Training Set
The document does not provide information on the sample size for any training set. This is typical for an IVD assay where development often involves calibration and validation with characterized samples rather than a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Since no "training set" is explicitly mentioned in the context of machine learning, the establishment of its ground truth is not applicable or described in this document. The assay's "ground truth" implicitly refers to the accuracy and reliability of its quantitative measurements of cTnl compared to established methods and its ability to assist in MI diagnosis per clinical standards.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.