(33 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 Multifibren™ U.
The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized.
The provided document describes a 510(k) premarket notification for a Fibrinogen Calibrator Kit, which is a device used to calibrate fibrinogen assays. This type of device is an in-vitro diagnostic (IVD) product and its performance evaluation typically focuses on analytical characteristics rather than human-in-the-loop or AI-related metrics. Therefore, several of the requested sections (e.g., MRMC studies, AI improvement, expert ground truth, training set size) are not applicable to this specific device evaluation. The information provided heavily emphasizes the substantial equivalence to a predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Fibrinogen Calibrator Kit K994341) in terms of "intended use and performance." This implies that the performance of the new device is expected to be comparable to or within acceptable variations of the predicate device's established performance. The document doesn't provide specific performance metrics or data in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria in this summary document. | The device is deemed "substantially equivalent in intended use and performance to the Fibrinogen Calibrator Kit (K994341)." This implies its performance is comparable to the predicate device, but specific metrics are not detailed in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide details on the sample size used for any testing or the data provenance (e.g., country of origin, retrospective/prospective). Evaluations for calibrators typically involve testing across a range of concentrations and multiple lots, but this information is absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in-vitro diagnostic calibrator, not an AI or imaging device that requires human expert interpretation for establishing ground truth on a test set. Its "ground truth" relates to the accuracy and precision of its calibration values, which would be determined through analytical methods and reference materials.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical calibrator kit, not an algorithm. However, the performance assessment would effectively be "standalone" in that it directly evaluates the calibrator's characteristics without a human-in-the-loop component in the evaluation itself.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator refers to its assigned values being accurate and traceable to higher-order reference materials or methods. The summary states the calibrators are "prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized." The establishment of the specific calibration values (the "ground truth" for the calibrator levels) would be based on analytical methods and certified reference materials, but the details are not provided in this summary.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.