(53 days)
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semi- quantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
MeDiCa Indirect Immunofluorescence (IIF) Anti- Endomysial Antibody Test Kit is used for the qualitative and semiquantitative detection of IgA class endomysial autoantibodies (AEmA) in human serum as an aid in the diagnosis of Celiac Disease and other related disorders such as Dermatitis Herpetiformis.
In general, MeDiCa and Scimedx Anti- Endomysial Antibody Test Kits have the following similarities:
- a) intended use
- b) methodology- indirect immunofluorescence method
- c) test kit composition
- d) type of substrate
MeDiCa and Scimedx test kits differ in the following features:
a) volume of conjugate and controls provided by MeDiCa is . about 50-65% less than Scimedx test kit.
b) presentation of substrate on slide wells. Both MeDiCa and Scimedx provide the same type of substrate. The only difference is that MeDiCa monkey esophaqus distal substrate sections are cut sequentially from one and the same block. They are deposited individually one after another and oriented the same way in all wells of each slide. The sections for Scimedx are cut from four different blocks at the same time, resulting in different orientation of sections from well to well.
The provided text describes a 510(k) pre-market notification for a medical device called the "MeDiCa Indirect Immunofluorescence (IIF) Anti-Endomysial Antibody (AEmA) Test Kit." The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the "Scimedx Anti-Endomysial IgA (EMA) Test System."
Here's an analysis of the acceptance criteria and the study as described in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance criteria are implicitly defined by demonstrating the MeDiCa device "matches" or is "substantially equivalent" to the predicate Scimedx test kit in terms of key performance characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance (MeDiCa IIF AEmA Test Kit) |
|---|---|
| Specificity | Matches Scimedx test kit. |
| Sensitivity | Matches Scimedx test kit. |
| Reproducibility | Matches Scimedx test kit. The sequential sectioning from a single block of substrate also "contributes to better reproducibility and comparability of test results." |
| Reactivity | Matches Scimedx test kit. |
| Intended Use | Similar to Scimedx test kit. (Qualitative and semiquantitative detection of IgA class endomysial autoantibodies in human serum as an aid in diagnosis of Celiac Disease and related disorders). |
| Methodology | Similar to Scimedx test kit (indirect immunofluorescence method). |
| Test Kit Composition | Similar to Scimedx test kit. |
| Type of Substrate | Similar to Scimedx test kit (monkey esophagus distal substrate sections). |
| Volume of Conjugate/Controls | Demonstrated to be sufficient, despite being 50-65% less than Scimedx. No issues with cross-contamination reported. |
| Presentation of Substrate | Different from Scimedx (sequential cutting from one block vs. four different blocks). This difference is presented as an advantage for MeDiCa, leading to "ease in interpretation of fluorescent patterns." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific details on the sample size used for the performance evaluation, nor does it mention the data provenance (country of origin, retrospective/prospective). It only states that "Results of performance evaluation show that MeDiCa IIF Anti-Endomysial Antibody Test Kit matches Scimedx test kit."
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)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of the device (an in vitro diagnostic test kit), ground truth would likely be established through clinical diagnosis, possibly confirmed by other diagnostic methods or pathology, rather than expert interpretation of images. However, the details of this process are not included.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the 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 section is not applicable as the device is an in vitro diagnostic test kit for the detection of antibodies, not an AI-powered image analysis tool requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not fully applicable to this device in the same way it would be for an AI algorithm. The device itself is a laboratory test kit that produces a result (qualitative or semi-quantitative detection of antibodies) which is then interpreted by a laboratory professional. The document describes the kit's performance ("matches Scimedx test kit" on specificity, sensitivity, etc.), which represents its standalone analytical performance. However, there isn't an "algorithm" in the typical AI sense. The "interpretation of fluorescent patterns" mentioned in the MeDiCa kit's advantages implies a human in the loop for reading the final result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For a diagnostic test for Celiac Disease and Dermatitis Herpetiformis, ground truth would typically be established by a definitive clinical diagnosis, often involving biopsy (pathology) for Celiac Disease, and/or other established diagnostic criteria and patient outcomes.
8. The sample size for the training set
The document describes a 510(k) submission for a traditional in vitro diagnostic test kit, not an AI/machine learning device. Therefore, the concept of a "training set" for an algorithm is not applicable in the context of this submission. The performance evaluation was likely conducted on a test set of patient samples to demonstrate equivalence to the predicate device.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" is not applicable to this device.
§ 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).