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Speciality Urine 1,2 is used to monitor miscellaneous specialized urine constituents and bone resorption test procedures.

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This is a 510(k) premarket notification for "Speciality Urine 1,2," which is a quality control material intended to monitor miscellaneous specialized urine constituents and bone resorption test procedures. The provided documents do not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The available documents are administrative in nature, including:

• A summary detailing the submitter's information, classification, intended use, and predicate devices.
• An FDA letter granting substantial equivalence.
• An "Indications For Use" form.

Therefore, I cannot provide the requested information as it is not present in the given text.

If this information were available in a different part of the submission, it would typically include details such as:

1. A table of acceptance criteria and the reported device performance: This would list specific analytes, their target ranges, and the actual performance of the Speciality Urine 1,2 in comparison to those ranges.
2. Sample size used for the test set and the data provenance: This would describe how many samples of Speciality Urine 1,2 were tested, where the data originated (e.g., in-house lab, external lab), and if it was retrospective or prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not usually applicable for a quality control material. Ground truth for QC materials is often established by reference methods or manufacturing specifications.
4. Adjudication method: Not applicable for a quality control material.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a quality control material. This type of study assesses how human readers perform with or without AI assistance, which is irrelevant for a QC solution.
6. Standalone (algorithm only without human-in-the-loop performance) study: This would involve testing the QC material's performance on automated analyzers without human intervention, which is common for IVD devices.
7. The type of ground truth used: For a quality control material, the ground truth would typically be the assigned values (e.g., mean and range) for each analyte, established through rigorous testing against reference methods or extensive batch analysis.
8. The sample size for the training set: Not directly applicable in the same way as for an AI/algorithm-based device. For QC materials, "training" might refer to the extensive testing during manufacturing and value assignment processes.
9. How the ground truth for the training set was established: Again, this would relate to the process of assigning target values and ranges to the QC material constituents, usually involving multiple assays, reference methods, and statistical analysis by the manufacturer.

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