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Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

Uses:

The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.

This device can be used with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

Prescription Use (Per 21 CFR 801.109)

Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

I am sorry, but based on the limited information provided in the input text, I cannot describe the acceptance criteria and the study that proves the device meets them with the level of detail requested. The provided text is a premarket notification letter from the FDA regarding the "Autostat II Anti-tTg IgA ELISA" device, indicating its substantial equivalence to a predicate device.

The document lacks specific details on:

1. Acceptance criteria and reported device performance table: While it mentions the device is "substantially equivalent," it doesn't provide the quantitative or qualitative metrics for this equivalence or what performance targets were set.
2. Sample size and data provenance for the test set: There is no mention of a test set, its size, the country of origin of the data, or whether it was retrospective or prospective.
3. Number and qualifications of experts for ground truth: No information on expert involvement for ground truth establishment is present.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study: No information on such a study or any effect size related to AI assistance. The device is an ELISA, not an AI-assisted diagnostic.
6. Standalone performance study: While the device itself performs a test, the document doesn't detail a standalone study with specific performance metrics (e.g., sensitivity, specificity, accuracy).
7. Type of ground truth used: It states the device aids in diagnosing diseases like Celiac Disease based on anti-tTg antibodies, but it does not describe how the ground truth for studying the device's performance was established (e.g., against biopsy, clinical consensus, pathology).
8. Sample size for the training set: Not mentioned. This would typically be relevant for AI/ML devices, which this ELISA is not.
9. How ground truth for the training set was established: Not mentioned.

The document primarily focuses on the regulatory determination of substantial equivalence. To answer your request comprehensively, information from the actual 510(k) submission, including performance studies and detailed methodologies, would be required.

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