(71 days)
Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.
The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered solution or supplemented with purified fibrinogen and stabilized.
The provided text describes a 510(k) notification for the Dade Behring Inc. Fibrinogen Calibrator Kit. This document focuses on the intended use and substantial equivalence of the device to a legally marketed predicate device (Dade Behring Fibrinogen Standards K925988), rather than a study proving performance against specific acceptance criteria for a new clinical diagnostic or imaging device.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to the information provided in this 510(k) summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: The submission is for a calibrator kit, not a diagnostic device with specific performance metrics like sensitivity, specificity, or AUC against a ground truth. The acceptance criteria for a calibrator kit typically relate to its ability to establish a stable and accurate reference curve for a known assay, ensuring that the assay measurements are reliable. While the device is "substantially equivalent" to a predicate, specific quantitative performance data for the calibrator itself against predefined acceptance criteria (e.g., precision, stability, lot-to-lot consistency) are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This information is not part of the 510(k) summary provided. The nature of a calibrator kit means that "sample size" in the context of diagnostic performance studies is not relevant. The human plasma used to prepare the calibrators is stated to be from "selected, healthy donors," but no further details on sample size or provenance for testing the calibrator's performance are given.
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: Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for a calibrator would be its own assigned fibrinogen concentration, which is established through a different validation process (e.g., using reference methods and materials), not by expert consensus on patient cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: Adjudication methods are used in studies involving subjective interpretation of diagnostic results (e.g., imaging). This is not relevant for a calibrator kit.
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: This is a calibrator kit for an in vitro diagnostic assay, not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: As mentioned above, ground truth in the context of patient diagnosis is not relevant for a calibrator kit. The "truth" for the calibrator itself would be its characterized concentration values, established through metrological traceability.
8. The sample size for the training set
- Not Applicable/Not Provided: This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: This is not an AI/machine learning device.
§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.