(350 days)
The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.
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Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text is a 510(k) clearance letter from the FDA. It does not contain a table of specific acceptance criteria or detailed reported device performance. The letter states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device met the performance standards demonstrated by the predicate device(s) in the 510(k) submission, but those specific criteria and performance values are not present in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The FDA letter is a conclusion of the review, not the detailed submission itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The device is a "Rheumatoid factor immunological test system," implying its output is a direct measurement, and ground truth would likely be established through clinical diagnosis of Rheumatoid Arthritis, but the specifics are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
The device described is an "ELISA" (enzyme-linked immunosorbent assay) for detecting autoantibodies. This is a laboratory test, not an AI-based imaging or diagnostic tool that would typically involve "human readers" or MRMC studies in the context of improving human performance. Therefore, an MRMC study with human readers and AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the device's performance as a standalone test. The "TheraTest EL-anti-CCP/2TM" is an in vitro diagnostic test, meaning its performance is inherently standalone in the sense that it provides a result (detection and measurement of autoantibodies) without direct human intervention in the assay itself. The indication for use states it is "intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests," acknowledging that a physician still interprets the result within a broader clinical picture. The specific performance metrics (e.g., sensitivity, specificity, accuracy) of this standalone test are not provided in the letter, but would have been part of the 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device would likely be the clinical diagnosis of Rheumatoid Arthritis (RA), established by rheumatologists based on a combination of patient symptoms, physical examination, imaging, and other laboratory tests (e.g., ACR/EULAR classification criteria for RA). The device itself measures specific autoantibodies, and its performance would be assessed against this clinical diagnosis. However, the exact methodology for establishing this ground truth is not detailed in the provided text.
8. The sample size for the training set
Given that this is an ELISA diagnostic kit, there isn't typically a "training set" in the machine learning sense. The device's performance is established through validation studies on clinical samples. The sample size used for these validation studies is not available in the provided text.
9. How the ground truth for the training set was established
As noted in point 8, the concept of a "training set" in the machine learning context does not directly apply to this type of in vitro diagnostic device. For the clinical validation samples (which would be analogous to a test set in ML), the ground truth would be established by clinical diagnosis of Rheumatoid Arthritis, likely by rheumatologists using established diagnostic criteria. The specifics are not available in the provided text.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).