(81 days)
IMMULITE AFP is for in vitro diagnostic use with the IMMULITE Analyzer – for the quantitative measurement of alpha-fetoprotein (AFP) in human serum, as an aid in the management of patients with nonseminomatous testicular cancer. IMMULITE 2000 AFP is for in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of alpha-fetoprotein (AFP) in human serum, as an aid in the management of patients with nonseminomatous testicular cancer.
IMMULITE® AFP is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer. IMMULITE® 2000 AFP is a clinical device for use with the IMMULITE 2000 Automated Immunoassay Analyzer.
IMMULITE AFP is a solid-phase, two-site sequential chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE Test Unit, is coated with a monoclonal antibody specific for AFP.
IMMULITE 2000 AFP is a solid-phase, two-site chemiluminescent immunometric assay. The solid phase is a polystyrene bead coated with a monoclonal antibody specific for AFP.
The provided document describes a 510(k) premarket notification for the IMMULITE® and IMMULITE® 2000 AFP Reagent systems, which are devices for the quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with nonseminomatous testicular cancer.
Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets for sensitivity, specificity, or agreement. Instead, it presents performance data from comparative studies with a predicate device and a related device, implying that a certain level of agreement and statistical confidence was considered acceptable for substantial equivalence.
Based on the performance equivalence section, we can infer the following:
| Performance Metric | Acceptance Criteria (Implied) | IMMULITE AFP Performance (vs. IMx AFP) - Site 1 | IMMULITE AFP Performance (vs. IMx AFP) - Site 2 | IMMULITE 2000 AFP Performance (vs. IMMULITE AFP) |
|---|---|---|---|---|
| Relative Sensitivity (95% CI) | High (e.g., >85%) | 94.9% (87.4% - 98.6%) | 95.4% (87.1% - 99.0%) | Not applicable (this comparison is linearity) |
| Relative Specificity (95% CI) | High (e.g., >90%) | 97.3% (93.8% - 99.1%) | 97.3% (93.2% - 99.3%) | Not applicable |
| Overall Agreement | High (e.g., >90%) | 96.6% | 96.7% | Not applicable |
| Linear Regression Correlation (r) | High (e.g., >0.95) | 0.99 | 0.99 | 0.998 |
| Linear Regression Slope (vs. IMx AFP) | Close to 1 (e.g., 0.8-1.2) | 0.83 | 0.83 | Not applicable |
| Linear Regression Intercept (vs. IMx AFP) | Close to 0 (e.g., -0.5 to 0.5) | -0.17 | -0.17 | Not applicable |
| Linear Regression Slope (vs. IML AFP) | Close to 1 | Not applicable | Not applicable | 1.04 |
| Linear Regression Intercept (vs. IML AFP) | Close to 0 | Not applicable | Not applicable | 0.34 IU/mL |
2. Sample Size Used for the Test Set and Data Provenance
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IMMULITE AFP (vs. Abbott IMx AFP):
- Site 1: 264 specimens. Provenance: "a clinical site in the northwestern United States." Retrospective or prospective is not explicitly stated.
- Site 2: 213 specimens. Provenance: "a second study in the southern United States." Retrospective or prospective is not explicitly stated.
- Combined for Linear Regression: 424 specimens; these were specimens from the two clinical sites with AFP measurements within the calibration ranges of both IMMULITE AFP and IMx AFP.
- Patient Population: Male patients with nonseminomatous testicular cancer, malignant and nonmalignant conditions, and a "few female patients."
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IMMULITE 2000 AFP (vs. DPC's IMMULITE AFP):
- Sample Size: 205 samples.
- Provenance: Male patients in different clinical stages (pre and post surgery) of their nonseminomatous testicular cancer. Location or retrospective/prospective nature is not specified beyond "patients."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document describes in vitro diagnostic devices for quantitative measurement of AFP and comparison with other similar devices. The "ground truth" here refers to the actual AFP levels in the patient samples, as measured by the comparative methods (Abbott IMx AFP or IMMULITE AFP). No human experts or radiologists were involved in establishing the ground truth for these quantitative measurements. The "ground truth" is essentially defined by the results of the predicate and reference assays.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of images or clinical data that would require an adjudication method. The outcome is a quantitative measurement compared to another quantitative measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging device or a device where human readers are interpreting results. It's a quantitative immunoassay. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies conducted are standalone performance evaluations of the IMMULITE® and IMMULITE® 2000 AFP systems. The systems quantify AFP levels in serum samples, and their performance is compared directly to other automated immunoassay systems. There is no human intervention in the measurement process itself, nor is there a human-in-the-loop component for result generation, only for result interpretation, which is typical for diagnostic tests.
7. Type of Ground Truth Used
The "ground truth" for the performance equivalence studies was the quantitative AFP measurement reported by the predicate device (Abbott IMx AFP) or their own previously cleared device (IMMULITE AFP).
8. Sample Size for the Training Set
The document does not specify a separate "training set" for the IMMULITE® and IMMULITE® 2000 AFP systems in the context of machine learning or AI. These are immunoassay reagent systems. Calibration of the assays would involve a set of known standards, but this is distinct from "training data" for an AI algorithm. The document focuses on validation studies against predicate devices.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" in the AI sense is mentioned for these immunoassay devices, this question is not directly applicable. For immunoassay systems, "ground truth" for calibration curves would be established using precisely known concentrations of purified AFP standards, likely traceable to international reference materials.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.