(42 days)
IMMULITE® 2000 Anti-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of antithyroid peroxidase in serum and EDTA plasma, as an aid in the clinical diagnosis of thyroid diseases.
IMMULITE® 2000 Anti-TPO Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer
This document describes the IMMULITE® 2000 Anti-TPO Ab device, an in vitro diagnostic assay for the quantitative measurement of antithyroid peroxidase in serum and EDTA plasma, used as an aid in the clinical diagnosis of thyroid diseases. The provided text is a 510(k) summary for regulatory clearance and focuses on substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data in the format requested.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a specific table of acceptance criteria or quantified performance metrics from a study to prove the device meets those criteria. The clearance is based on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided document. The 510(k) summary focuses on the device itself and its intended use, not on specific clinical study data details like test sets or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available in the provided document.
4. Adjudication Method for the Test Set:
This information is not available in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. This type of study is more common for imaging devices or diagnostic tools where human interpretation is a key component. The IMMULITE® 2000 Anti-TPO Ab is an automated immunoassay.
6. If a Standalone Study Was Done:
The document states that the "data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE 2000 Anti-TPO Ab." This implies that data was presented to demonstrate the device's performance, likely in comparison to the predicate device, but the details of this "standalone" performance study (if it can be called that in the context of the requested information) are not detailed. It is highly probable that performance claims (e.g., precision, accuracy, linearity) would have been substantiated by internal studies, but these are not explicitly described nor are their results presented in this summary.
7. The Type of Ground Truth Used:
This information is not explicitly stated in the provided document. For an immunoassay, the "ground truth" would typically be established by comparison to a reference method, a well-characterized set of patient samples with known clinical diagnoses, or results from the predicate device that has established clinical utility.
8. The Sample Size for the Training Set:
This information is not available in the provided document. As this is an immunoassay (a laboratory test) rather than an AI/ML-based diagnostic device, the concept of a "training set" for an algorithm is generally not applicable in the same way as described in the prompt.
9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided document, as the concept of a "training set" for an algorithm is generally not directly applicable to this type of immunoassay.
§ 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).