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Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

This document is a 510(k) premarket notification for a quality control device, the Liquichek™ Anti-Sm Control, Positive. It's important to understand that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving direct clinical performance or effectiveness against a disease state in the way a pharmaceutical trial might.

Therefore, many of the typical acceptance criteria and study designs associated with direct diagnostic or therapeutic devices, such as multi-reader multi-case studies, effect sizes of AI assistance, or standalone algorithm performance, are not applicable here. This document focuses on the stability and characteristics of the control material itself.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are related to its stability and its ability to function as an unassayed quality control material, demonstrating substantial equivalence to a previously cleared predicate device.

Study Details

1. Sample Size used for the test set and the data provenance:

   • The document does not explicitly state a "test set" in the context of diagnostic accuracy. The studies performed were stability studies.
   • Data Provenance: Not specified, but the studies were conducted internally by Bio-Rad Laboratories. The data is retained "on file at Bio-Rad Laboratories." This implies internal, retrospective testing of the control material itself rather than patient-derived data from any specific country.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This device is a quality control material, not a diagnostic test that generates ground truth about patient conditions. The "ground truth" here is the established stability of the control material based on internal lab testing.

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

   • Not applicable. As above, this is not a diagnostic device requiring expert adjudication of results.

4. 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 is a quality control material, not an AI-powered diagnostic device. An MRMC study is completely irrelevant.

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

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

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

   • The "ground truth" for the stability studies would be the measured concentration/reactivity of the Anti-Sm analyte within the control over time, under specified storage conditions, compared to initial measurements. These measurements are performed using laboratory assays, not expert consensus or pathology on patient samples.

7. The sample size for the training set:

   • Not applicable. This device does not use a "training set" in the context of an algorithm or machine learning. Its manufacturing and testing follow established quality control procedures.

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

   • Not applicable. As above, there is no "training set" for this type of device.

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