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510(k) Data Aggregation
(270 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 Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
The Access hsTnI is a two-site immunoenzymatic ("sandwich") assay. Monoclonal anti-cTnl antibody coniugated to alkaline phosphatase is added to a reaction vessel along with a surfactant-containing buffer and sample. After a short incubation, paramagnetic particles coated with monoclonal anti-cTnl antibody are added. The human cTnl binds to the anti-cTnl antibody on the solid phase, while the anti-cTnl antibody-alkaline phosphatase conjugate reacts with different antigenic sites on the cTnl molecules. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a breakdown of the acceptance criteria and study details for the Access hsTnI device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Candidate) |
|---|---|---|
| Precision | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL ≤ 1.15 pg/mL within laboratory SD for concentrations < 11.5 pg/mL | Method comparison: Slope 1.00 ± 0.10 (met). Within-lab precision: 3% to 4% CV for concentrations ≥ 11.5 pg/mL; SD of 0.52 pg/mL for concentrations < 11.5 pg/mL. |
| Analytical Measuring Range | 2.0 pg/mL to 27,027 pg/mL | Implicitly met as the Analytical Measuring Range from predicate is stated as "Same". |
| Linearity | Not explicitly stated as a numerical criterion in the "Predicate" column. | Higher order (2nd or 3rd) term of polynomial fit is non-significant (p > 0.05), or if significant, bias ≤ 10% across the analytical measuring range. |
| LoB (Limit of Blank) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 0.6 pg/mL |
| LoD (Limit of Detection) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 1.0 pg/mL (serum) and 0.6 pg/mL (plasma) |
| LoQ (Limit of Quantitation) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 0.8 pg/mL (serum) and 0.7 pg/mL (plasma) at ≤20% within-lab CV |
| Carryover | Not explicitly stated as a numerical criterion in the "Predicate" column. | ≥ 95% of maximum individual replicate carryover events < 3.5 pg/mL when testing a low sample (≤ 10 pg/mL) following a high sample (~150,000 pg/mL). |
| Method Comparison (Slope) | Slope 1.00 ± 0.10 | 1.00 ± 0.10 (met) |
| Bias | Implicitly met for reference intervals | Bias data support the reference intervals defined on the instruments have not changed appreciably from the commercialized product. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size:
- Method Comparison: 92 samples (41 Lithium Heparin Plasma and 51 Serum).
- Precision (within-laboratory): Not explicitly stated, but results are given for concentrations ≥ 11.5 pg/mL and < 11.5 pg/mL.
- Linearity: Not explicitly stated how many samples were used, but it mentions "each sample concentration range."
- LoB/LoD/LoQ: Not explicitly stated.
- Carryover: Not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The samples were "human serum and plasma," suggesting patient samples were collected, but the specific details are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic (IVD) immunoassay for the quantitative determination of cardiac troponin I (cTnl). The "ground truth" for such devices is established by the analytical measurement of the analyte itself, not typically by expert consensus of images or clinical assessments in the same way as, for example, an AI diagnostic tool for radiology.
Therefore, the concept of "experts establishing ground truth for the test set" (e.g., radiologists) is not directly applicable here. The "truth" is based on the highly controlled and validated measurements of cTnl concentrations using established laboratory methods.
4. Adjudication Method for the Test Set
Since the ground truth for this type of device is established by analytical measurement rather than subjective interpretation, an adjudication method like 2+1 or 3+1 (common in image-based diagnostic studies) is not applicable. The measurements are taken directly and compared to a reference method or validated analytical ranges.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of an AI system on human reader performance, especially in image-based diagnostics. The Access hsTnI is a standalone immunoassay directly measuring a biomarker, not an AI-assisted diagnostic tool that aids human interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Yes, the studies conducted (precision, linearity, LoB/LoD/LoQ, carryover, method comparison) evaluate the standalone performance of the Access hsTnI device (the immunoassay system itself) without human-in-the-loop interaction for interpretation, other than standard laboratory procedures for running the assay. The device provides a quantitative measurement directly.
7. Type of Ground Truth Used
The ground truth used is analytical measurement of cardiac troponin I (cTnl) concentrations. This is established through highly precise and accurate laboratory methods, often using reference standards and validated instrumentation. For the method comparison, the "IVD Access hsTnl (Current Assay Protocol File (APF))" likely served as the reference or comparative method against the "proposed Access hsTnl (Proposed APF)".
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, which typically relies on chemical reactions and signal detection, not a machine learning model that requires a training set. The term "training set" is not applicable in this context. The "calibration" mentioned ("Analyte concentration is automatically determined from a stored calibration") implies a process by which the instrument is set up to accurately measure concentrations, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the AI sense is not applicable. For instrument calibration, the ground truth (e.g., known concentrations of cTnl) is established using certified reference materials or highly characterized standards with defined concentrations. These known concentrations are then used to generate a calibration curve that allows the instrument to quantify cTnl in unknown samples.
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