(372 days)
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.
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This document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on the "Indications for Use" and the substantial equivalence determination rather than a comprehensive description of acceptance criteria and a deep dive into the study details. However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics in a structured table format. The EliA™ SmDP Immunoassay is an "Antinuclear Antibody Immunological Test System" (21 CFR §866.5100), and its performance would typically be evaluated based on its ability to detect IgG antibodies directed to Sm with acceptable sensitivity and specificity for aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
Without a dedicated section on performance data, it's impossible to create the requested table from the provided text.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for any test set. For immunological assays like this, the "ground truth" often involves clinical diagnosis of SLE based on established ACR or SLICC criteria, which might involve expert physicians, but this isn't detailed here.
4. Adjudication method for the test set
The document does not mention any adjudication method used for a test set.
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, the EliA™ SmDP Immunoassay, is an in vitro diagnostic (IVD) assay designed to semi-quantitatively measure antibodies. It is not an AI-based device that would typically involve "human readers" or "AI assistance" in the way a medical imaging AI device would. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable to this type of device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an IVD immunoassay, essentially a laboratory test system. Its "performance" is inherently standalone in the sense that the assay results are generated by the instrument (Phadia 100 or Phadia 250) based on the sample, without real-time human interpretation affecting the raw measurement. The human-in-the-loop comes in when a clinician interprets the results in conjunction with other clinical findings. The document doesn't provide a specific study abstract, but the nature of an immunoassay implies standalone analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the "Indications for Use" state "as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings," the ground truth for evaluating the device's performance would most likely be established based on clinical diagnosis of SLE, potentially using established classification criteria (e.g., American College of Rheumatology (ACR) criteria or Systemic Lupus International Collaborating Clinics (SLICC) criteria), which implicitly involves a form of expert consensus and possibly other laboratory and pathology findings. The document itself doesn't explicitly state the methodology for establishing this ground truth for the studies conducted.
8. The sample size for the training set
The document does not provide details about a training set or its sample size. For an immunoassay, the concept of a "training set" in the context of machine learning (where this question typically applies) is not directly relevant. Instead, the assay's parameters would be established during development and analytical validation, which involves calibration and analytical studies, not a "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its ground truth establishment, as typically applied to AI/ML, isn't directly applicable for this type of immunoassay. The clinical "ground truth" for evaluating its diagnostic utility would be established through clinical studies, as described in point 7.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).