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The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of kappa free light chains in serum using the Binding Site Optilite turbidimetric analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systematosus (SLE) in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the Optilite® Freelite® Kappa Free Kit and Optilite® Freelite® Lambda Free Kit
does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specific study proving the device meets those criteria.

The document is a clearance letter, which confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It typically does not include the detailed study design, data, or acceptance criteria used by the manufacturer to demonstrate performance to the FDA. Such information would usually be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts, qualifications, or adjudication methods for ground truth establishment.
4. Information about MRMC studies or their effect sizes.
5. Information about standalone performance studies.
6. The specific type of ground truth used (beyond implying clinical findings).
7. Sample size for the training set.
8. How ground truth for the training set was established.

The letter focuses on regulatory approval, product codes, and general controls, rather than the specifics of the device's performance validation studies.

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