(155 days)
The MESACUP-2 TEST Mitochondria M2 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Mitochondrial antibodies in human serum as an aid in the diagnosis of primary biliary cirrhosis.
The MESACUP-2 Test Mitochondria M2 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with mitochondria M2 antigens. Incubation allows the antimitochondria M2 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the mitochondria M2 bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H3O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-mitochondria M2 antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-mitochondria M2 antibodies in patient samples.
Here's a breakdown of the acceptance criteria and study information for the MESACUP-2 Test Mitochondria M2 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format, but rather compares the performance of the MESACUP-2 Test to a legally marketed predicate device (Quanta Lite Mitochondria M2 ELISA) and implies that comparable performance is the measure of acceptance. The key performance metrics are clinical specificity and sensitivity.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (MESACUP-2 Test) |
|---|---|---|
| Clinical Specificity (Healthy Donors) | 100% (based on Quanta Lite) | 100% |
| Clinical Sensitivity (Primary Biliary Cirrhosis Population) | 95% (based on Quanta Lite) | 91% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical value for each group. The text mentions "a healthy donor serum population" and "a primary biliary cirrhosis population."
- Data Provenance: The studies were "In-house studies," suggesting they were conducted by RhiGene, Inc. The country of origin of the data is not specified but implied to be the US given the submission to the FDA. The studies were likely retrospective as they involve patient populations already categorized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The text does not elaborate on how the classification of "healthy donor serum population" or "primary biliary cirrhosis population" was established.
4. Adjudication Method for the Test Set:
This information is not provided in the 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:
This is not applicable. The device is an ELISA assay for detecting antibodies, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone in vitro diagnostic (IVD) test. It's an "algorithm only" in the sense that it provides a semi-quantitative result based on a chemical reaction and optical density reading, without direct human interpretation of complex patterns in the way an imaging AI would. The performance metrics (specificity and sensitivity) are derived from the device's output.
7. The Type of Ground Truth Used:
The ground truth used was clinical diagnosis/status. The populations were defined as "healthy donor serum population" and "primary biliary cirrhosis population." It's assumed that this classification was based on established clinical diagnostic criteria (e.g., patient history, physical examination, other laboratory tests, biopsies if applicable for PBC).
8. The Sample Size for the Training Set:
This information is not provided. The document describes a comparison study, implying that the MESACUP-2 Test has already been developed. There is no mention of a separate "training set" for the device itself, as it's a biochemical assay rather than a machine learning algorithm that requires explicit training data in the modern sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is largely not applicable in the context of a traditional ELISA assay development, which focuses on chemical and biological validation rather than algorithmic training with ground truth labels in the same way an AI model would be.
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).