(69 days)
Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
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The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (IVD) called "Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators." This type of device is a reagent system used in laboratory settings to measure C-Reactive Protein (CRP) in human serum and plasma.
The request asks for information about acceptance criteria, device performance, and study details typically associated with AI/ML-driven medical devices, especially those interpreting images or signals. However, this document describes a chemical reagent and not an AI/ML or image analysis device. Therefore, most of the requested information (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of IVD and will not be found in the provided text.
The document discusses the regulatory clearance process for a common laboratory test kit, where "performance" relates to its analytical accuracy and precision in measuring a biomarker, not interpretive accuracy of AI.
I will address the applicable parts of your request based on the provided text, and explicitly state when information is not available or not relevant for this type of device.
1. A table of acceptance criteria and the reported device performance
The provided document (an FDA clearance letter) does not explicitly state the specific acceptance criteria or detailed performance data (like sensitivity, specificity, accuracy, precision, linearity ranges) for the Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators. Such data would typically be found in the 510(k) submission itself, which is not provided here, or in the device's labeling/instructions for use.
The letter merely states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is based on the data presented in the 510(k) submission, confirming the device performs as intended and is as safe and effective as a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document is an FDA clearance letter for a chemical reagent. It does not contain information about sample sizes for test sets, data provenance, or study design (retrospective/prospective) for performance evaluation. These details would be in the full 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. This information is relevant for devices that require human interpretation or expert labeling (e.g., imaging devices). For a CRP reagent, the "ground truth" would be established by reference methods or validated laboratory measurements of CRP, not by expert consensus in the typical sense for image or signal interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically used for establishing ground truth in expert-based assessments (e.g., image interpretation). This is not relevant for a chemical reagent's performance evaluation.
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 / Not provided. MRMC studies are used for evaluating diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with AI assistance. This device is a chemical reagent, not an AI-driven image analysis or diagnostic interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This relates to AI algorithms. The Olympus CRP device is a reagent system, not an algorithm. Its performance is inherent to the chemical reactions and measurement principles.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided in detail. For a chemical reagent like this, the "ground truth" for evaluating its performance (e.g., accuracy, precision) would typically be reference methods or highly validated laboratory measurements of CRP in clinical samples. The document does not specify the exact methods used for establishing this ground truth.
8. The sample size for the training set
- Not applicable / Not provided. The concept of a "training set" doesn't apply to a chemical reagent device in the way it does for AI/ML algorithms.
9. How the ground truth for the training set was established
- Not applicable / Not provided. See explanation for #8.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).