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510(k) Data Aggregation
(258 days)
VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.
A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
The provided document describes the VIDAS® CEA (S) Assay, a medical device for measuring Carcinoembryonic antigen (CEA) in human serum, and compares its performance to a predicate device, the TOSOH ST AIA-PACK CEA. This is an In Vitro Diagnostic (IVD) device, not an AI or imaging device, so many of the requested fields (like number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set information) are not applicable or typically reported for this type of device.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices like the VIDAS® CEA (S) Assay, acceptance criteria are typically demonstrated through analytical and clinical performance studies that show equivalence to a legally marketed predicate device. The document uses the TOSOH ST AIA-PACK CEA as its predicate. The key performance metrics are analytical precision (intra-assay and inter-run) and method comparison (correlation with the predicate device).
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Equivalence) | Reported VIDAS® CEA (S) Assay Performance |
|---|---|---|
| Intra-Assay Precision (CV) | Predicate: < 4.3% (Sample 1), < 3.6% (Sample 2), < 4.0% (Sample 3), < 3.1% (Sample 4) | Pool C: 2.7 - 4.4%Pool B: 3.5 - 4.4%Pool A: 3.7 - 5.3% |
| Inter-Run Precision (CV) | Predicate: < 3.9% (Sample 1), < 3.3% (Sample 2), < 3.6% (Sample 3), < 3.2% (Sample 4) | Pool C: 0 - 1.3%Pool B: 0 - 1.6%Pool A: 0 - 1.0% |
| Limits of Detection | Predicate: 0.5 ng/mL | < 0.5 ng/mL |
| Method Comparison (Slope) | Implied acceptance range for substantial equivalence typically includes a slope close to 1.0. The 95% CI of the slope for the predicate device is not explicitly given, but clinical equivalence would expect the CI for the new device to include 1.0 or be very close to it. The predicate device's performance is not described in terms of a method comparison study in this document, but rather it serves as the benchmark against which the new device is compared. The acceptance criteria would be that the new device shows strong correlation with the predicate. | Slope = 0.9410 (95% confidence interval = 0.8238 to 1.0582) |
| Method Comparison (Intercept) | Implied acceptance range for substantial equivalence typically includes an intercept close to 0.0. The 95% CI of the intercept for the predicate device is not explicitly given. Clinical equivalence would expect the CI for the new device to include 0.0 or be very close to it. | Intercept = -1.2905 (95% confidence interval = -1.6812 to -0.8998) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison (Clinical Comparison): 1,307 samples
- Sample Size for Precision (Non-clinical):
- Intra-Assay/Inter-Run: 40 runs (across sites and lots) for the VIDAS device. The exact number of individual samples within these runs for precision is not specified, but typically involves replicate measurements of control pools.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective method comparison using collected patient samples, as it references "Number of patients = 1,307 samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic assay that measures a biomarker concentration. "Ground truth" for such devices is established by reference methods or comparison to a predicate device, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. This is an in vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation (e.g., radiology reads), not for laboratory measurements of biomarker concentrations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic assay and does not involve human readers interpreting cases or AI assistance in that context. Therefore, there is no effect size reported for human readers improving with or without AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence, the performance data presented (precision, limits of detection, and method comparison) represents the standalone performance of the VIDAS® CEA (S) assay system. The device is automated, and its output (CEA concentration) is directly generated by the instrument based on the ELFA technique. There is no human interpretation or intervention in the generation of the quantitative result itself.
7. Type of Ground Truth Used
The "ground truth" for the VIDAS® CEA (S) assay's performance is established by:
- Analytical Standards: Traceability to reference standards (bioMérieux, Inc. standards and the CarcinoEmbryonic Antigen 1st International Reference Preparation, NIBSC code 73/601).
- Predicate Device Comparison: The clinical comparison section uses the TOSOH ST AIA-PACK CEA as the reference method ("X = TOSOH ST AIA-Pack CEA; y = VIDAS® CEA (S)"). Therefore, the performance of the predicate device serves as the operational ground truth for validating the new device's accuracy and correlation.
8. Sample Size for the Training Set
No specific "training set" of patient samples is mentioned in the context of machine learning or AI. For IVD assays, "training" typically refers to the internal development and optimization of the assay's reagents and calibration curve, which is often done using characterized materials, calibrators, and internal validation samples rather than a distinct "training set" of patient data as understood in AI/ML. The document mentions "Master curve for each kit lot and each calibrator lot are traceable to reference standards..." which describes how the assay is calibrated.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a traditional "training set" with ground truth in the AI/ML sense. For the calibration and development of the assay, the "ground truth" would be established through:
- Reference Standards: The use of internationally recognized reference preparations (e.g., NIBSC code 73/601) and internal bioMérieux reference standards. These standards have assigned CEA values, providing the "truth" against which calibrations are performed and validated.
- Internal Validation: Through rigorous analytical studies to establish assay linearity, recovery, interference, and other performance characteristics during product development.
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