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510(k) Data Aggregation
(266 days)
Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of prostate cancer.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37°C).
· 1st incubation (9 minutes): Sample (40 µL), a biotinylated monoclonal PSA-specific antibody (60 uL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex.
· 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
•The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Elecsys® PSA Assay, structured according to your request:
Device: Elecsys® PSA Assay
1. Table of Acceptance Criteria and Reported Device Performance
The document provided (a 510(k) summary) doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance but instead compares the performance of the applicant device (Elecsys® PSA) to a legally marketed predicate device (TOSOH AIA-PACK PA). The comparison highlights key performance characteristics. I will interpret the predicate device's performance as a de facto benchmark for "acceptance criteria" in this context, and the Elecsys® PSA's performance as the "reported device performance."
| Feature | Acceptance Criteria (Predicate: TOSOH AIA-PACK PA) | Reported Device Performance (Elecsys® PSA) |
|---|---|---|
| Precision | Modified NCCLS (ng/mL): | |
| Level A (Predicate Equiv.) | Within-Run: 6.61, %CV: 2.9, Total: 6.52, %CV: 2.1 | Control 1: Within-Run: 1.88, %CV: 1.1, Total: 1.88, %CV: 2.1 |
| Level B (Predicate Equiv.) | Within-Run: 51.68, %CV: 3.9, Total: 52.26, %CV: 3.9 | Control 2: Within-Run: 14.00, %CV: 1.2, Total: 14.00, %CV: 2.2 |
| Level C (Predicate Equiv.) | Within-Run: 95.10, %CV: 3.0, Total: 98.33, %CV: 2.8 | Pool 1: Within-Run: 0.29, %CV: 1.5, Total: 0.29, %CV: 2.9 (Note: Predicate values are higher and in different units; direct comparison is difficult without context) |
| Pool 2: Within-Run: 3.95, %CV: 1.8, Total: 3.95, %CV: 2.3 | ||
| Pool 3: Within-Run: 48.48, %CV: 1.6, Total: 48.48, %CV: 2.3 | ||
| Lower Detection Limit | 0.1 ng/mL | 0.01 ng/mL (Functional: 0.07 ng/mL) |
| Linearity | 0.1 - 100 ng/mL | 0.01 - 100 ng/mL (with a deviation from a linear line of ±10%) |
| Method Comparison | Not shown (TOSOH AIA-PACK PA) | Vs TOSOH AIA-PACK PA: Least Squares: y = 0.86x + 0.01, r = 0.995, SEE = 0.251, N = 365 |
| Passing/Bablok: y = 0.90x - 0.28, r = 0.995, SEE = 0.892, N = 365 | ||
| Interfering substances | ||
| Bilirubin | No interference at 17 mg/dL | No interference at 25 mg/dL |
| Hemoglobin | No interference at 0.47 g/dL | No interference at 1.0 g/dL |
| Lipemia | No interference at 1600 mg/dL | No interference at 1000 mg/dL |
| Biotin | Not specified | No interference at 30 ng/mL |
| Specificity | ||
| PAP | 0.0% cross-reactivity | None |
| ACT | Not available | None |
| PSA | Not available | 100% |
| PSA-ACT | Not available | 100% |
| Hook Effect | Not available | No Hook Effect up to 13,900 ng/ml PSA |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Precision:
- Elecsys® PSA: 60 measurements per control/pool (Control 1, Control 2, Pool 1, Pool 2, Pool 3), implying a total of 300 measurements across 5 levels.
- TOSOH AIA-PACK PA: 20 measurements per precision level (A, B, C), implying a total of 60 measurements across 3 levels.
- Method Comparison: N = 365 (for comparison with TOSOH AIA-PACK PA).
- Precision:
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is a 510(k) submission, typically involving studies conducted by the manufacturer, but clinical trial details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the Elecsys® PSA Assay. For IVDs, "ground truth" is established through reference methods, calibrated materials, or comparison to an accepted predicate device, rather than expert consensus on individual cases. The document does not mention any expert review process for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring an analyte (PSA), there is no "adjudication method" in the sense of multiple experts reviewing and reaching consensus on an outcome. The performance is assessed by comparing quantitative results to a reference method or predicate device.
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 is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic assist device that involves "human readers" or "AI assistance" in the clinical interpretation of images or complex datasets.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented (precision, linearity, lower detection limit, method comparison, interference, specificity, hook effect) represents the standalone performance of the Elecsys® PSA assay. It is an automated electrochemiluminescence immunoassay, meaning its results are generated by the instrument and reagents without direct human interpretative intervention in the final measurement.
7. The Type of Ground Truth Used
The ground truth for performance characteristics of an IVD like this is generally established by:
- Reference Materials/Calibrators: For accuracy and calibration stability, the device's measurements are calibrated against known standard materials (e.g., Stanford Reference Standard is mentioned as "Assay Standardization" for the Elecsys® PSA).
- Comparison to a Legally Marketed Predicate Device: For substantial equivalence, the new device's performance is compared against an existing, accepted device (TOSOH AIA-PACK PA in this case) using patient samples. The predicate's results serve as a form of "ground truth" for the comparison study.
- Specific Analytical Methods: Linearity is assessed against expected values for diluted samples, detection limits against statistical variations at low concentrations, and interference against known concentrations of interfering substances.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For IVD devices, a "training set" in the machine learning sense is not typically used. Instead, methods are developed and optimized by the manufacturer using internal data, reagents, and instrument prototypes. The data presented in the 510(k) is akin to verification and validation data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned, the concept of a "training set" with established ground truth as in machine learning does not directly translate to the development and validation of traditional IVD assays like the Elecsys® PSA. Assay parameters are optimized based on biochemical principles, empirical testing, and calibration with reference materials.
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