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LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™ is intended for use as an assayed quality control material for analysis.

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This FDA document is a 510(k) clearance letter for the device "LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific information required to answer your questions about acceptance criteria and the study proving the device meets those criteria.

Here's why and what information is missing:

• Substantial Equivalence: A 510(k) clearance is primarily about demonstrating "substantial equivalence" to a predicate device. It usually relies on comparing device features, intended use, and performance data to an already cleared device. It doesn't typically require a detailed, de novo study with explicit acceptance criteria and corresponding performance metrics for this specific device in the way you've outlined for clinical or diagnostic AI systems.
• Device Type: The device described is a "quality control material" for a diagnostic system (hsCRP calibration verifiers). Its performance is typically assessed by its stability, homogeneity, and its ability to consistently calibrate a diagnostic instrument within defined ranges, not by diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI-driven diagnostic tools.

Therefore, I cannot provide the requested information from this document.

To answer your questions, I would need a different type of document, such as:

• A clinical study report for a diagnostic device.
• A validation report for an AI/ML medical device.
• The actual 510(k) submission document itself, which might contain a summary of the performance data, though often in the context of comparison to a predicate rather than against pre-defined acceptance criteria for a novel clinical claim.

If you can provide a document that describes a specific study with acceptance criteria and device performance evaluation, I would be happy to analyze it for you according to your outlined points.

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