(14 days)
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG and IgM anti-phosphatidyIserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit." It is primarily a regulatory approval document and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.
Specifically, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's clearance is based on its substantial equivalence to existing devices, rather than a de novo clinical trial demonstrating its performance against new, specific acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information would typically be detailed in a separate performance study report submitted as part of the 510(k), but it is not present in this clearance letter.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 device is an in-vitro diagnostic test kit (likely a lab test for antibodies), not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study in this context is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a test kit.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed performance study report. The information you're requesting regarding specific acceptance criteria, study sizes, expert involvement, and ground truth establishment is not available within this text.
§ 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).