(11 days)
The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma, using the Access Immunoassay Systems. This device is intended to aid in the monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
The Access® Thyroglobulin reagents consist of reagent packs, calibrators, substrate and wash buffer.
The provided text describes a 510(k) summary for the Access® Thyroglobulin Reagents on the Access® Immunoassay Systems. The submission is for a modification to add a new instrument platform (Beckman Coulter UniCel™ DxI 800 Access® Immunoassay System) to the existing system. The core of the study is to demonstrate substantial equivalence between the new instrument platform and the previously cleared Access 2 system.
Here's an analysis of the acceptance criteria and study as requested:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Device Performance Report |
|---|---|
| Method Comparison | The Access Thyroglobulin assay met the established acceptance criteria for method comparison when tested on the DxI system compared to the Access 2 system. |
| Precision | The Access Thyroglobulin assay met the established acceptance criteria for precision when tested on the DxI system. |
| Analytical Sensitivity | The Access Thyroglobulin assay met the established acceptance criteria for analytical sensitivity when tested on the DxI system. |
Note: The specific numerical values or ranges for "established acceptance criteria" are not provided in the summary. The document only states that the criteria were met.
2. Sample size used for the test set and the data provenance
The document states that "method comparison, precision and analytical sensitivity studies were conducted." However, it does not provide any details on the sample sizes used for these studies or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The device is an immunoassay for quantitative determination of a biomarker, not an imaging or diagnostic device requiring expert interpretation for ground truth. The ground truth for such assays would typically be defined by reference methods or established laboratory standards.
4. Adjudication method for the test set
This information is not applicable as the study design does not involve human readers or interpretations that would require adjudication.
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
This information is not applicable. This is a laboratory immunoassay device, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Supporting Data" section indicates that "method comparison, precision and analytical sensitivity studies were conducted" for the Access Thyroglobulin assay on the DxI system to demonstrate substantial equivalence to the Access 2 system. This refers to the analytical performance of the instrument and reagents as a standalone system.
7. The type of ground truth used
The document does not explicitly state the "type of ground truth" in terms of clinical outcomes or pathology. For an immunoassay seeking substantial equivalence for a new instrument platform, the "ground truth" or reference for comparison would typically be the performance of the legally marketed predicate device (Access® Thyroglobulin Reagents on the Access® Immunoassay Systems on the Access 2 system). The studies would aim to show that the new platform produces equivalent analytical results (method comparison, precision, analytical sensitivity) to the predicate.
8. The sample size for the training set
This information is not applicable. The device is an immunoassay system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration using specific calibrator materials mentioned in the device description.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8. The "ground truth" for calibration would be established by the manufacturer based on certified reference materials or established laboratory standards for the calibrators.
§ 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.