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510(k) Data Aggregation
(38 days)
The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.
Here's an analysis of the provided text regarding the FibroTek FIB device, including the requested information:
Acceptance Criteria and Device Performance for FibroTek FIB
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical performance criteria. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the requirement for the new device to demonstrate comparable performance. The study described is a comparison study against the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (FibroTek FIB) |
|---|---|
| Correlation with predicate device (Fibrinogen Assay Set) on various plasma types. | Correlation Coefficients: - Photo-optical instrument: r² = 0.969, slope = 0.859 - Mechanical instrument: r² = 0.958, slope = 0.848 (Tested on normal and abnormal patient plasma, and plasma samples from patients undergoing heparin therapy) |
| Within-run precision (CV) comparable to predicate (reported < 6%). | Within-run Precision: CV's of less than 8% were obtained. |
| Between-run precision (CV) comparable to predicate (reported < 6%). | Between-run Precision: CV's of less than 8% were obtained. |
| Identical intended use. | Identical Intended Use: Both the predicate and proposed product are formulated to determine fibrinogen levels in plasma. (Quantitative determination of fibrinogen in citrated human plasma, for general patient population and patients with possible fibrinogen disorders). |
| Similar technological characteristics. | Similar Technological Characteristics: The summary states "similar technological characteristics," implying the underlying method of fibrinogen determination is comparable to the predicate. (Further details are not provided in this summary, but typically refer to the reagent composition and reaction principles). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact number of samples used. It mentions "normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy" were tested.
- Data Provenance: The document does not specify the country of origin of the data. The study involved testing at "two sites and on two different instrument types," which suggests a multi-site evaluation. The data is presented as a prospective comparison study against the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (fibrinogen test kit) does not typically rely on "expert ground truth" in the same way an imaging or diagnostic AI model would. The "ground truth" for the test set is established by the measurement obtained from the predicate device. The performance of the FibroTek FIB is then compared to these measurements.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for comparison is the measurement from the predicate device itself, not a consensus interpretation by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists, pathologists) and would assess the impact of AI assistance on their performance. The FibroTek FIB is an in-vitro diagnostic (IVD) test kit, where the result is generated by the instrument/reagent, not human interpretation of complex data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance evaluation of the FibroTek FIB represents a standalone (algorithm/device-only) performance. The results (fibrinogen levels) are generated directly by the kit and associated laboratory instruments, without human interpretive input as part of the core measurement. The "human-in-the-loop" here refers to qualified laboratory professionals performing the test and interpreting the numerical output, not subjectively assessing raw data to reach a diagnosis.
7. The Type of Ground Truth Used
The ground truth used for this study was the measurements obtained from the predicate device (Fibrinogen Assay Set). The new device's performance was evaluated by its correlation and precision relative to an already legally marketed and established method.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable in the context of this traditional IVD kit submission. The FibroTek FIB is a chemical reagent kit, not an AI/ML algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for a chemical reagent kit. The development of such kits involves chemical formulation, optimization, and rigorous manufacturing controls, rather than data-driven machine learning training.
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