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This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings

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The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) clearance letter from the FDA for a device called "Human C4 Kit for use on SPAPLUS™," indicating that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• Device Name: Human C4 Kit for use on SPAPLUS™
• Intended Use: For the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. To be used in conjunction with other laboratory and clinical findings.
• Regulatory Information: Regulation Number, Regulation Name, Regulatory Class, Product Code, and 510(k) Number.

However, it does not provide the following information requested in the prompt:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval notice, not a detailed study report describing performance characteristics against acceptance criteria.

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