(84 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses:
The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Here's an analysis of the provided text regarding the AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA device, focusing on acceptance criteria and study data:
Acceptance Criteria and Device Performance
The provided document is a 510(k) clearance letter from the FDA, which primarily confirms substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics (e.g., actual sensitivity and specificity percentages) from internal validation studies.
The "Indications For Use" section describes the intended use of the device, which implicitly defines the performance characteristics it must demonstrate to be deemed safe and effective.
Here's a breakdown of what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from "Indications for Use") | Reported Device Performance (Not explicitly detailed in this document) |
|---|---|
| Aid in the diagnosis of Coeliac Disease. | The FDA deemed the device substantially equivalent to a legally marketed predicate, implying its performance meets acceptable standards for its intended use. |
| Semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum. | The device performs this function. |
| Validation for use with the HYCOR HY.TEC automated EIA instrument. | This validation was successfully completed. |
| For in vitro diagnostic use only. | The device is intended for in vitro diagnostic use. |
Important Note: The FDA's 510(k) clearance process focuses on substantial equivalence. Detailed performance data, including specific sensitivity, specificity, accuracy, and precision with corresponding statistical analysis, would have been submitted by the manufacturer in their 510(k) application. This document is the outcome of that review, not the detailed performance report itself. Therefore, the specific numerical performance metrics are not available in this particular FDA letter.
2. Sample size used for the test set and the data provenance:
- Not specified in this document. The FDA letter does not include details on the sample size used for validation studies.
- Data Provenance: Not specified in this document. The country of origin for the data or whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in this document. The FDA letter does not detail the methodologies for establishing ground truth in the manufacturer's studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in this document. The document does not provide details on how discrepancies in ground truth establishment were resolved.
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 device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is a laboratory test, not an imaging device or AI-assisted diagnostic tool that would involve human "readers" or "interpreters" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but not explicitly detailed as "standalone AI performance." As an ELISA, the device's performance is inherently "standalone" in the sense that the test results are generated by the assay itself without real-time human interpretation in the way an imaging AI works. The document states it's validated for use with an automated EIA instrument, suggesting it operates without direct human intervention once initiated. However, the exact performance metrics of this "standalone" (algorithm-only) aspect are not provided in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in this document. For a diagnostic test like this, ground truth for Coeliac Disease diagnosis would typically involve a combination of clinical assessment, endoscopy with duodenal biopsy showing characteristic pathology, and resolution of symptoms on a gluten-free diet. The specific methods used in the manufacturer's studies are not detailed here.
8. The sample size for the training set:
- Not applicable/Not specified. ELISA devices are not "trained" in the same way machine learning models are. They are biochemical assays developed and optimized based on chemical principles and validation studies, rather than using a "training set" to learn patterns.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, the concept of a "training set" and associated ground truth establishment for AI/ML purposes does not directly apply to the development of an ELISA assay. The development involves optimization of reagents, reaction conditions, and calibration, which are different processes.
In summary: The provided FDA 510(k) clearance letter confirms the device's substantial equivalence and intended use. However, it does not contain the detailed technical specifications or study results (like sample sizes, expert qualifications, specific performance metrics, or ground truth methodologies) that would typically be found in the manufacturer's full 510(k) submission or a peer-reviewed publication.
§ 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).