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The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum.

Olympus Prealbumin Calibrator

The provided text is related to a 510(k) premarket notification for a medical device called "Olympus Prealbumin Calibrator". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with diagnostic AI/imaging devices.

The device in question is a calibrator, which is a substance specifically designed to set or check the accuracy of an instrument. Its performance is typically assessed by ensuring it produces accurate and precise results when used with the associated assay and analyzer, rather than through studies involving human readers or ground truth established by experts interpreting medical images or pathology.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance with human-in-the-loop, training set details) are not applicable to this type of device and its regulatory submission.

However, I can extract the relevant information where available and note where other information is not present or applicable.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report device performance in a table format. A 510(k) submission for a calibrator would typically include performance data demonstrating accuracy, precision, and stability when used with the target assay. This data is usually compared against established benchmarks or the predicate device's performance, but this specific information is not detailed in the provided K letter or "Indications for Use Statement".

2. Sample size used for the test set and the data provenance:

• Not explicitly stated in the provided documents. For a calibrator, the "test set" would typically involve multiple runs/replicates on an analytical instrument, and the data provenance would relate to the laboratory conditions and samples used for validation.

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

• Not applicable. For a calibrator, "ground truth" is typically established by reference methods or validated standards of known concentration, not by expert interpretation.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not relevant for a calibrator.

5. 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:

• Not applicable. An MRMC study is relevant for AI-powered diagnostic tools that assist human readers in interpreting medical images or data. This device is a calibrator.

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

• Not applicable. This device is a physical calibrator used with an analytical instrument, not an algorithm. Its performance is inherent in its chemical composition and stability.

7. The type of ground truth used:

• Likely "Reference Standards" or "Known Concentrations". For a calibrator, the ground truth is established by precisely manufacturing the calibrator with a known concentration of the analyte (Prealbumin in this case), often verified against recognized reference materials or methods. The document does not explicitly state this, but it's standard for calibrators.

8. The sample size for the training set:

• Not applicable. A calibrator does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As above, no training set for a calibrator device.

Summary regarding the device and its assessment:

The Olympus Prealbumin Calibrator is a Class II device (21 CFR 862.1150) intended to "provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum."

The 510(k) process determined it was "substantially equivalent" to legally marketed predicate devices, meaning it performs as safely and effectively as existing devices. This determination is based on a comparison of intended use, technology, and performance data (e.g., precision, accuracy, stability, interfering substances), which would have been submitted in the full 510(k) application but are not detailed in the provided letter or "Indications for Use" statement.

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