Search Results
Found 1 results
510(k) Data Aggregation
(67 days)
ELECSYS PSA, MODEL 2010
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 cancer patients.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), 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-generated by 2-point calibration and a master curve provided via the reagent bar code.
Here's an analysis of the provided text regarding the Elecsys® PSA assay, structured to address your specific questions.
It's important to note that this document is a 510(k) summary for a diagnostic assay (a lab test), not a medical imaging device or an AI-powered system in the modern sense. Therefore, some of your questions, particularly those related to imaging, AI performance, human readers, and ground truth establishment for AI, are not directly applicable or addressable by this type of submission. This summary focuses on the analytical performance of the assay itself compared to a predicate assay.
Acceptance Criteria and Study Details for Elecsys® PSA Assay
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" for each performance characteristic in a formalized table. Instead, it presents performance data for the new device (Elecsys PSA, 2nd Gen) and the predicate device (Elecsys PSA, 1st Gen) side-by-side, implying that the new device's performance should be comparable or improved relative to the predicate to establish substantial equivalence.
Based on the "Performance Characteristics" section, here's a table summarizing the reported device performance and implicitly accepted levels (by showing equivalence to the predicate):
| Feature | Elecsys PSA, 2nd Gen. Performance | Implicit Acceptance Criteria (based on Predicate) |
|---|---|---|
| Precision | (Comparable to Elecsys PSA, 1st Gen.) | |
| HS1 | Within-Run %CV: 1.8 | Within-Run %CV: 1.5 |
| Total %CV: 2.4 | Total %CV: 2.9 | |
| HS2 | Within-Run %CV: 2.5 | Within-Run %CV: 1.8 |
| Total %CV: 2.9 | Total %CV: 2.3 | |
| HS3 | Within-Run %CV: 2.2 | Within-Run %CV: 1.6 |
| Total %CV: 3.8 | Total %CV: 2.3 | |
| PC-TM1 | Within-Run %CV: 2.5 | Within-Run %CV: 1.1 |
| Total %CV: 2.7 | Total %CV: 2.1 | |
| PC-TM2 | Within-Run %CV: 2.3 | Within-Run %CV: 1.2 |
| Total %CV: 2.9 | Total %CV: 2.2 | |
| Sensitivity | (Comparable to Elecsys PSA, 1st Gen.) | |
| Analytical | 0.002 ng/mL | 0.002 ng/mL |
| Functional | 0.03 ng/mL | 0.03 ng/mL |
| Linearity | 0.002 - 100 ng/mL (±10% deviation) | 0.002 - 100 ng/mL (±10% deviation) |
| Method Comparison | y=1.0098x + 0.734 (r=0.998, N=108) (Least Squares) | (Implicitly, strong correlation with predicate) |
| y=1.0335x + 0.219 (r=0.998, N=108) (Passing Bablok) | (Implicitly, strong correlation with predicate) | |
| Hook Effect | No Hook Effect up to 17,000 ng/ml PSA | No Hook Effect up to 15,000 ng/ml PSA |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: For each level (HS1, HS2, HS3, PC-TM1, PC-TM2), the sample size (N) was 60. The submission does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a lab assay performance study, these are typically prospective laboratory testing results.
- Method Comparison: The sample size (N) for the method comparison study was 108. No information on data provenance (country, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. For an in vitro diagnostic (IVD) assay like Elecsys® PSA, "ground truth" for the test set is established by the reference measurement procedure (i.e., the predicate device or a recognized reference method) or by the known concentrations of calibrators/controls used for analytical performance studies like precision and linearity. There are no "experts" in the sense of human readers/adjudicators for interpreting results in this context; performance is based on analytical measurements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting images or clinical data, which is not relevant for an analytical assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 medical imaging or decision support system that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable in the usual sense of an "algorithm" as an AI. This is an automated immunoassay system. The "standalone" performance is what is presented in the Precision, Sensitivity, Linearity, and Hook Effect sections, as it describes the analytical performance of the instrument/reagent system without human interpretation beyond pipetting and loading. The "algorithm" here refers to the instrument's calibration and calculation of results from the chemiluminescent signal.
7. The Type of Ground Truth Used
For the Elecsys® PSA assay, the "ground truth" for the performance studies would be:
- For Precision: The known target concentrations of the quality control samples (HS1, HS2, HS3, PC-TM1, PC-TM2).
- For Sensitivity/Linearity: The gravimetrically or otherwise accurately prepared concentrations of PSA in dilution series.
- For Method Comparison: The results obtained from the predicate device (Elecsys PSA, 1st Gen) on the same samples.
- For Hook Effect: Samples with extremely high, known concentrations of PSA.
8. The Sample Size for the Training Set
Not applicable in the context of machine learning. This is an IVD assay, not an AI algorithm that undergoes a "training phase" on a dataset. The assay involves chemical reactions and signal detection, with a calibration curve set up using internal calibrators.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there isn't a "training set" in the AI sense. Calibration curves, which are analogous to a "trained model" for converting signal to concentration, are established using known concentrations of PSA calibrators provided with the reagent kit.
Ask a specific question about this device
Page 1 of 1