(262 days)
EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
EliA M2 Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 100 using the EliA IgG method.
EliA M2 Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of M2 antibodies with Phadia 250 using the EliA IgG method.
The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.
The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.
The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.
The provided text describes a submission for an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set size, expert adjudication, etc.) are not applicable and cannot be extracted from this document.
However, I can extract information regarding acceptance criteria and device performance from the provided text, focusing on the clinical study that supports its intended use.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the form of a table. However, it implies that the device's performance needs to be comparable to the predicate device and show appropriate results with clinically defined sera and normal populations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performance is substantially equivalent to predicate | "In summary, all available data support that the new devices are substantially equivalent to the predicate devices." (Based on comparison study, results with clinically defined sera, and results from apparently healthy subjects) |
| Appropriate results for clinically defined sera | "results obtained for clinically defined sera" (No specific numerical performance metric is given, but the data is stated to support substantial equivalence.) |
| Appropriate results for samples from apparently healthy subjects | "results obtained for samples from apparently healthy subjects (normal population)" (No specific numerical performance metric is given, but the data is stated to support substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the specific number of samples for the test set used in the comparison study, clinically defined sera, or normal population. It mentions "a data set including results obtained within a comparison study," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)."
- Data Provenance: Not specified in terms of country of origin. The study appears to be retrospective, using existing "clinically defined sera" and "samples from apparently healthy subjects."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an immunoassay, not an AI/ML device requiring expert interpretation of images or other complex data for ground truth establishment. The "ground truth" for this type of device would typically be the clinical diagnosis of primary biliary cirrhosis, likely established by standard clinical criteria, not by individual experts assessing the samples themselves for ground truth.
4. Adjudication method for the test set
Not applicable. This is an immunoassay. The concept of adjudication for a test set typically applies to areas where human interpretation or labeling is involved, such as image analysis.
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
Not applicable. This is an immunoassay, not an AI/ML device, and no human reader interpretation is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the immunoassay device itself. The study described focuses on the comparison of the new immunoassay device (EliA M2) to a predicate device (Quanta Lite M2 EP (MIT3), INOVA K052262), and its performance with clinically defined sera and healthy subjects. The entire system (reagents, instrument Phadia 100/250, and software for evaluation) constitutes the "standalone" performance of the diagnostic test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "clinically defined sera" and "samples from apparently healthy subjects" would be based on the established clinical diagnosis of Primary Biliary Cirrhosis (PBC) for positive cases and the absence of PBC for healthy subjects, determined through a combination of clinical findings and other laboratory tests. The document implies a clinical diagnosis.
8. The sample size for the training set
Not applicable. This is an immunoassay, not an AI/ML device that requires a training set in the conventional sense. The "training" of the device is inherent in its design and calibration, not through data learning.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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).