(55 days)
The QUANTA Plex™ ANCA Profile is a fluorescent immunoassay for the semi-quantitative detection of anti-MPO and anti-PR3 antibodies in human serum. The presence of these antibodies is used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of the autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis.
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This is a 510(k) premarket notification for a medical device (QUANTA Plex™ ANCA Profile) and does not contain the specific details of a study that proves the device meets acceptance criteria in the format requested. The document is an FDA clearance letter and an "Indications For Use" statement.
Therefore, most of the information requested in your prompt cannot be extracted from this document, as it would typically be found in the actual clinical study report submitted to the FDA, not in the clearance letter itself.
However, I can provide a limited response based on the information available:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy. These would be detailed in the study report that accompanied the 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
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 document does not provide information on the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This document does not describe any adjudication method.
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:
This device is an "immunological test system" (QUANTA Plex™ ANCA Profile), which is an in-vitro diagnostic device for semi-quantitative detection of antibodies (anti-MPO and anti-PR3). It is not an AI-assisted imaging or diagnostic tool where a "human reader" would "improve with AI assistance." Therefore, an MRMC comparative effectiveness study in the context of human reader improvement with AI 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 document does not specify if a standalone performance study was done. For an immunological test system, "standalone performance" refers to the accuracy of the assay itself, which would have been part of the validation studies conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states the device aids in the diagnosis of "autoimmune vasculitides microscopic polyarteritis, Crescentic glomerulonephritis and Wegener's granulomatosis." For immunological tests designed to detect antibodies for diagnosis, the ground truth for validating the diagnostic accuracy would typically involve clinical diagnosis based on a combination of patient symptoms, other laboratory tests, biopsy (pathology), and specialist clinical assessment. However, the specific method for establishing ground truth is not detailed in this document.
8. The sample size for the training set:
This document does not provide information on the sample size for a training set. This information would be found in the detailed study report.
9. How the ground truth for the training set was established:
This document does not provide information on how the ground truth for a training set was established.
In summary, the provided document is a regulatory clearance letter and an indication for use, not a detailed clinical study report. Therefore, it lacks the specific information required to answer most of your detailed questions about acceptance criteria and study particulars.
§ 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).