(123 days)
IMMULITE Anti-TPO Ab is a solid-phase, enzyme chemiluminescent immunoassay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of antibodies against thyroid peroxidase (TPO) in serum and EDTA plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.
IMMULITE Anti-TPO Ab is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer.
Here's the breakdown of the acceptance criteria and study information for the IMMULITE Anti-TPO Ab, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for agreement, sensitivity, or specificity. Instead, it presents the results of a method comparison study as the performance data that supports substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (vs. ORGenTec anti-TPO PIN Immuno Assay) |
|---|---|
| Agreement: 97.8% | |
| Relative Sensitivity: 100% | |
| Relative Specificity: 95.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 94 patient samples
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the samples were retrospective or prospective, though "patient samples" often implies retrospective samples collected for analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study compares the IMMULITE Anti-TPO Ab to a predicate device (ORGenTec anti-TPO PIN Immuno Assay), implying the results from the predicate device likely served as the comparative "truth" or reference, rather than an independent expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Since the comparison is between two quantitative immunoassays, a specific adjudication method for a test set (like 2+1 or 3+1 for qualitative assessments) might not be applicable in the same way. The comparison is based on the agreement, sensitivity, and specificity of the results against the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison between two automated immunoassay devices, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The IMMULITE Anti-TPO Ab is an automated immunoassay system, and its performance was evaluated by directly comparing its output to that of another automated immunoassay (the ORGenTec anti-TPO PIN Immuno Assay). There is no "human-in-the-loop" component to the device's operation or the comparison described.
7. The Type of Ground Truth Used
The "ground truth" for this method comparison study was the results obtained from the predicate device, the ORGenTec anti-TPO PIN Immuno Assay. The study aimed to show substantial equivalence, meaning the new device's results were comparable to an already legally marketed device.
8. The Sample Size for the Training Set
This information is not provided in the document. As this is a 510(k) summary for an immunoassay, the concept of a "training set" in the context of machine learning algorithms (where this term is most commonly used) is not directly applicable. The device's robust performance relies on its biochemical design and calibration, not a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable in the context of this type of immunoassay device described. Immunoassays are designed based on established biochemical principles and validated through empirical testing and calibration, rather than being "trained" on a dataset with an established ground truth in the way a machine learning model would be.
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).