(142 days)
The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
Device: Sigma Diagnostics Fibrinogen Determination Kit (Procedure No. 886/887)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Target) | Reported Device Performance (Result) |
|---|---|---|
| Correlation with Predicate Device | Substantial equivalence to Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881. | Correlation coefficient of 0.96 with a regression equation of y = 0.91x + 28.3 when compared to Procedure No. 880/881. |
| Precision (Within-Run) | Coefficient of Variation (CV) less than 5% | Within-run CV of less than 5% |
| Precision (Total) | Total precision of 6% or less | Total precision of 6% or less |
| Linearity | Not explicitly stated as a numerical target, but implied requirement for general clinical assay. | Determined to be linear to 1000 mg/dL |
| Range of Measurement | Not explicitly stated as a numerical target, but implied for clinical utility. | Tested with samples having fibrinogen concentrations ranging from 95 to 764 mg/dL. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 102 samples
- Data Provenance: Not explicitly stated, but the reference to "samples having fibrinogen concentrations ranging from 95 to 764 mg/dL" implies clinical samples. No information on country of origin or whether they were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study is a comparison of two diagnostic kits, where one (Procedure No. 880/881) serves as the "established reagent" or reference method for the ground truth. There's no indication of human expert adjudication for individual sample results.
4. Adjudication method for the test set:
- Not applicable. The ground truth was established by another "established reagent" (Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881), not through expert adjudication.
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. This is not an AI-assisted device. It's an in-vitro diagnostic kit for fibrinogen determination.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. This device is a manual or semi-automated laboratory kit. The "standalone" performance is assessed by its direct measurements and comparison to a predicate device.
7. The type of ground truth used:
- Comparative Ground Truth: The ground truth for this study was established using an "established reagent", specifically the Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881. This means the new device (Procedure No. 886/887) was compared to an already accepted and marketed device.
8. The sample size for the training set:
- No specific "training set" is mentioned as this device is not based on machine learning or AI. The study describes a verification and validation process against an existing method.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the performance evaluation was the results obtained from the predicate device (Procedure No. 880/881).
§ 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.