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510(k) Data Aggregation
(452 days)
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the DxI Access Immunoassay Analyzers to aid in the diagnosis of myocardial infarction (MI).
The Access hsTnl assay is a sandwich immunoenzymatic assay. The Access hsTnl assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access hsTnl reagent pack, Access hsTnl calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
The provided text describes the Beckman Coulter Access hsTnI device, a chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) to aid in the diagnosis of myocardial infarction (MI). The information below summarizes the acceptance criteria and the study used to prove the device meets these criteria.
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance (Method Comparison) | Slope 1.00 ± 0.10 (compared to predicate) | Met, supporting equivalence of Access hsTnI on Dxl 9000 to Access hsTnI on Dxl 9000 Access Immunoassay Analyzer for plasma and serum samples. |
| Imprecision | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL; ≤ 1.15 pg/mL within-laboratory SD for concentrations < 11.5 pg/mL | Serum: 2.3% to 6.4% for concentrations ≥ 11.5 pg/mL; 0.17 to 0.33 SD for concentrations < 11.5 pg/mL. Plasma: 1.7% to 4.4% for concentrations ≥ 11.5 pg/mL; 0.17 to 0.40 SD for concentrations < 11.5 pg/mL. |
| Linearity (Non-linearity) | Within ± 10% for values ≥ 11.5 pg/mL; Within ± 1.15 pg/mL for values < 11.5 pg/mL | Met |
| Limit of Blank (LoB) | Not explicitly stated, but implies a low value acceptable | 0.5 pg/mL |
| Limit of Detection (LoD) | Not explicitly stated, but implies a low value acceptable | Serum: 0.9 pg/mL Plasma: 0.8 pg/mL |
| Limit of Quantitation (LoQ) at ≤20% within-lab CV | ≤ 20% within-lab CV | Serum: 1.0 pg/mL Plasma: 0.8 pg/mL |
| Carryover | Unspecified, but implies minimal effect on low samples | No clinically significant carryover for ≥95% of high samples tested (up to 270,000 pg/mL), based on a concentration shift of <3.5 pg/mL when testing a low sample (≤10 pg/mL). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the clinical performance (method comparison), imprecision, linearity, LoB/LoD, LoQ, or carryover studies.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an immunoassay for quantitative determination of a biomarker, not a diagnostic imaging or AI-assisted diagnostic tool that requires expert human interpretation for ground truth establishment in the traditional sense. The ground truth for this type of device is typically established through biochemical analysis and reference methods, not expert consensus on image interpretation or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of immunoassay device. Adjudication methods like 2+1 or 3+1 are typically used in studies where human experts interpret results (e.g., medical images) and their decisions need to be arbitrated.
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. The Access hsTnI device is a standalone in-vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study assessing human reader improvement with AI assistance would not be conducted for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described (clinical performance, imprecision, linearity, LoB/LoD, LoQ, carryover) represent standalone performance evaluations of the assay system without human-in-the-loop performance being a primary evaluation criterion. The device itself provides a quantitative result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an immunoassay like Access hsTnI, the ground truth is established by:
- Reference Methods: Comparison to established and accepted laboratory methods for measuring cTnI, typically the predicate device (Access hsTnI on Access 2 Immunoassay System) as indicated in the method comparison study.
- Analytical Standards: Use of precisely characterized control materials and calibrators with known concentrations of cTnI to assess accuracy, linearity, and limits of detection/quantification.
8. The sample size for the training set
Not applicable in the context of machine learning model training. This is an immunoassay, not an AI/ML device that requires a training set in that sense. The "training" for such a device involves iterative development and validation using various samples to define its analytical characteristics.
9. How the ground truth for the training set was established
Not applicable as it's not an AI/ML device with a distinct "training set" in the machine learning paradigm. The development and optimization of the immunoassay reagents and protocol would have relied on well-characterized samples with known cTnI concentrations, established through analytical methods and reference standards.
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