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Liquichek ANA Control, Speckled Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Liquichek ANA Control, Speckled Pattern is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

The provided document is a 510(k) summary for the Bio-Rad Liquichek ANA Control, Speckled Pattern. It describes the device, its intended use, and claims substantial equivalence to another legally marketed device. However, it does not include information about a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for diagnostic devices.

The document focuses on demonstrating substantial equivalence for regulatory approval, rather than detailing a performance study with acceptance criteria and results.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement cannot be extracted from the provided text because such a detailed study is not presented.

Here's what can be extracted and inferred based on the document's content:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here are implicitly tied to demonstrating performance comparable to the predicate device in the characteristics listed in the comparative table.
• Reported Device Performance: The document doesn't provide numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the Liquichek ANA Control. Instead, it compares its characteristics to a predicate device.

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

• Not provided. The document does not describe a "test set" in the context of a clinical performance study with patient samples. The comparisons are based on device characteristics, not an evaluation against a clinical dataset.

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):

• Not applicable/Not provided. No "test set" requiring expert ground truth is described.

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

• Not applicable/Not provided. No "test set" requiring adjudication is described.

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:

• No. This device is a quality control reagent, not an AI or imaging diagnostic device that would be subject to MRMC studies.

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

• No. This device is a quality control reagent, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for a quality control is its known concentration/characteristics. The document implies the product is manufactured to contain specific ANA (Speckled Pattern) reactivity, which serves as its intrinsic "ground truth" for quality control purposes, but doesn't detail external validation studies against clinical ground truth.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI device, so there's no "training set."

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

• Not applicable/Not provided. This is not an AI device.

In summary: The provided document is a regulatory submission for a quality control product, emphasizing its characteristics and substantial equivalence to a predicate device, rather than a clinical performance study with acceptance criteria for a diagnostic algorithm.

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