(112 days)
The KRONUS IA-2 Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to tyrosine phosphatase (1A-2) in human serum. The KRONUS IA-2 Autoantibody RIA Assay is useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. This type of document confirms that a device is substantially equivalent to a previously marketed device, without requiring a full premarket approval application. It does not typically include the detailed technical study information that would allow me to populate the table and answer the specific questions about acceptance criteria and device performance as if it were an AI diagnostic device study.
Therefore, many of the questions cannot be answered based on the provided text alone. The text focuses on the regulatory clearance process rather than a detailed technical performance study.
However, I can extract what limited information is available and explain why other information is not present.
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document is an FDA clearance letter, not a detailed study report. It mentions that the device is "substantially equivalent" to predicate devices, implying its performance is comparable, but does not provide specific acceptance criteria or reported performance metrics like sensitivity, specificity, or accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
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 present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
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
There is no indication that an MRMC study was performed, and this device (KRONUS IA-2 Autoantibody RIA Assay Kit) is an in vitro diagnostic assay kit, not an AI-assisted diagnostic tool. Therefore, questions about human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is an in vitro diagnostic assay kit, not an algorithm. The "standalone" performance would typically refer to the assay's performance itself, which is what would be evaluated. However, specific results from such an evaluation are not present in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document. For an assay kit, ground truth would typically be established through clinical diagnosis, often incorporating multiple factors beyond just the assay result.
8. The sample size for the training set
This information is not present in the provided document. For an in vitro diagnostic assay, there might not be a "training set" in the machine learning sense, but rather a set used for assay development and validation.
9. How the ground truth for the training set was established
This information is not present in the provided document.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).