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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.

Uses:

The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

The assay may be used on the Hycor Hy. Tec Automated EIA instrument.

For in vitro diagnostic use only.

Not Found

The provided text is a 510(k) clearance letter for the "Autostat II Rheumatoid Factor IgA ELISA" device, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This document primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data that proved the device met those criteria.

Therefore, most of the requested information cannot be extracted from the given text. The relevant sections from the prompt that can be addressed from the text are the device name and its intended use.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. The letter states the device is "substantially equivalent" to a predicate device, but it does not specify the performance acceptance criteria or report the actual performance metrics of the Autostat II Rheumatoid Factor IgA ELISA.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. The document does not describe the test set size or its provenance.

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)

• Cannot be answered from the provided text. This information would typically be in a study report, not a regulatory clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. This detail is not present.

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

• Cannot be answered from the provided text. This device is an ELISA (Enzyme-linked immunosorbent assay), a laboratory diagnostic test, not an image-based device that would typically involve human readers or AI assistance in the way described for MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially addressed indirectly. As an ELISA test, its performance is typically "standalone" in that it produces a result without direct human interpretation in the same way an imaging AI might. However, the document doesn't explicitly state whether a standalone performance study was conducted or its results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be answered from the provided text. While the device aids in the diagnosis of rheumatoid arthritis, the method used to establish the ground truth in any underlying studies is not disclosed.

8. The sample size for the training set

• Cannot be answered from the provided text. This information is not included.

9. How the ground truth for the training set was established

• Cannot be answered from the provided text. This information is not included.

Based on the provided text, here's what can be stated:

• Device Name: Autostat II Rheumatoid Factor IgA ELISA (also referred to as Autostat Rheumatoid Factor IgA ELISA)
• Indications for Use: Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA rheumatoid factor (RF) antibodies in human serum.
• Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor Hy. Tec Automated EIA instrument. For in vitro diagnostic use only.
• Regulatory Status: Cleared by FDA on March 3, 2000, under K993557, as substantially equivalent to a legally marketed predicate device.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance metrics, one would typically need to refer to the full 510(k) submission summary or a separate study report, which is not included here.

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