(167 days)
The Bayer ADVIA® IMS PSA assay is an in vitro diagnostic device intended to quantitatively measure prostate specific antigen (PSA) in human serum. This assay is indicated for the measurement of serum PSA as an aid in management (monitoring) of prostate cancer patients. PSA values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined.
Not Found
The provided text describes the acceptance criteria and the study for the Bayer ADVIA® IMS PSA assay.
Here's the information extracted and organized as requested:
Acceptance Criteria and Device Performance for Bayer ADVIA® IMS PSA Assay
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather reports performance characteristics. Based on the data presented and common analytical testing standards, the implicit acceptance criteria are inferred to be comparable or superior to the predicate device (Immuno 1 PSA Assay).
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than predicate device Immuno 1. Generally, lower CV% is better. | Level 2.6 ng/mL: 2.7% |
| Level 6.5 ng/mL: 1.8% | ||
| Level 24.1 ng/mL: 1.7% | ||
| Level 99.1 ng/mL: 2.0% | ||
| (Predicate Immuno 1: Level 3 ng/mL: 3.1%, Level 23 ng/mL: 3.4%, Level 96 ng/mL: 2.5%) | ||
| Correlation (R-value) | R-value close to 1 (indicating strong linear correlation with predicate). | Serum (N=54): R = 0.999 |
| Serum (N=44): R = 0.999 | ||
| Regression Slope | Close to 1.0 (indicating similar proportionality to predicate). | Serum (N=54): 0.97 |
| Serum (N=44): 0.97 | ||
| 95% Confidence Interval (Slope): 0.951 - 0.981 | ||
| Regression Intercept | Close to 0.0 (indicating similar bias to predicate). | Serum (N=54): -0.18 |
| Serum (N=44): -0.06 | ||
| 95% Confidence Interval (Intercept): -0.49 - 0.37 | ||
| Sy.x (Std Error of Est.) | Low value, indicating low variability around the regression line. | Serum (N=54): 0.93 ng/mL |
| Serum (N=44): 0.78 ng/mL | ||
| 95% Confidence Interval (Sy.x): 0.53 - 1.27 | ||
| Interfering Substances (Effect %) | Recovery bias found to be of no clinical significance. | Hemoglobin: 2.8% |
| Lipids (Triglycerides): 0.1% | ||
| Bilirubin: 0.7% | ||
| Immunoglobulin (IgG): -5.3% | ||
| Albumin: -1.3% | ||
| Cross-reactants (PAP, Kallikrein): 0.013%-0.018% | ||
| Various Drugs: -1.8% to +2.4% (All reported as "of no clinical significance") | ||
| Recovery (%) | Recovery within a specified acceptable range (e.g., 90-110%). | Overall Mean Recovery: Sample #1: 99%, Sample #2: 101%, Sample #3: 100%, Sample #4: 101% (Individual dilution recoveries ranged from 97% to 104%). |
| Analytical Range | Clearly defined and clinically appropriate range. | 0.01 – 100 ng/mL |
| Minimum Detectable Concentration (ng/mL) | Comparable to or better than predicate device. | ADVIA IMS: 0.01 ng/mL |
| (Predicate Immuno 1: 0.03 ng/mL) |
2. Sample sizes used for the test set and the data provenance
-
Correlation Studies (Test Set):
- N=54 serum samples (0.37-79.70 ng/mL)
- N=44 serum samples (0.07-62.93 ng/mL)
-
Imprecision Study: Six calibrator levels and commercial controls were tested. The exact number of individual samples (replicates for each level) is not specified but implied to be sufficient for robust CV calculation.
-
Interfering Substances Study: Serum pool with PSA concentration of 4.0 ng/mL was spiked. Specific number of samples beyond "serum pool" is not detailed.
-
Recovery Study: Four samples were used, each with several dilutions (5 dilution points per sample).
-
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The study type is retrospective as it involves analyzing existing serum samples and comparing the new assay results to those obtained from a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of in vitro diagnostic device (immunoassay) does not typically involve human expert interpretation for establishing ground truth in the same way as imaging or pathology studies. The "ground truth" for the test set is established by the measurements from the predicate device (Immuno 1 PSA Assay), which is itself a legally marketed and presumably validated diagnostic tool. Therefore:
- Number of experts: Not applicable in the context of interpretation.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
Not applicable. The ground truth for comparative studies of quantitative assays is typically the result from the established predicate method, not a consensus of human interpretations.
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 imaging or AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Recovery, Analytical Range, Minimum Detectable Concentration) are all standalone performance evaluations of the ADVIA IMS PSA assay system. There is no human intervention in the measurement process once the sample is loaded and the assay runs. The results are quantitative values generated directly by the device.
7. The type of ground truth used
The primary ground truth used for performance validation is:
- Predicate Device Measurements: For correlation studies, the results obtained from the Immuno 1 PSA Assay on the same samples serve as the comparison (reference) "ground truth" for the new ADVIA IMS assay.
- Known Concentrations/Spikes: For imprecision, recovery, and interfering substance studies, known concentrations of PSA or spiked substances are used as the "ground truth" against which the device's measurements are evaluated.
8. The sample size for the training set
This document does not describe a "training set" in the context of machine learning or AI models. For an immunoassay, the concept of a training set is not directly applicable. The assay is developed and optimized during its R&D phase, and the studies presented here are for validation.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI model in this document. The "ground truth" for developing an immunoassay would be established through a combination of chemical principles, antibody specificity, detection methods, and extensive optimization using known calibrators and 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.