(162 days)
In vitro diagnostic reagent for the determination of the activity of coagulation factor V and for the detection of Factor V Leiden in citrated human plasma when used in conjunction with the Dade Behring ProC APC Method.
Coagulation Factor V Deficient Plasma is a lyophilized human plasma with a residual Factor V activity of less than or equal to 1% and contains activities of the remaining coagulation factors of more than 40%.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Coagulation Factor V Deficient Plasma based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from predicate) | Reported Device Performance (Dade Behring Coagulation Factor V Deficient Plasma) |
|---|---|---|
| Sensitivity (for Factor V Leiden detection) | 100% (from Coatest APC Resistance VS assay with V-Def Plasma) | 99% (when used with Dade Behring ProC APC assay) |
| Specificity (for Factor V Leiden detection) | 99% (from Coatest APC Resistance VS assay with V-Def Plasma) | 100% (when used with Dade Behring ProC APC assay) |
| Reproducibility (Precision) - Normal Sample | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | 2.3% CV |
| Reproducibility (Precision) - Pathological Sample | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | 4.9% CV |
| Residual Factor V activity | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | ≤ 1% |
| Activities of remaining coagulation factors | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | > 40% |
Note: The acceptance criteria for sensitivity and specificity are inferred from the performance of the predicate device (Coatest APC Resistance VS assay with V-Def Plasma) as reported in the comparative analysis. The other criteria are inherent properties of the device or evaluated against general precision expectations for such assays, aiming for substantial equivalence to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 300 patient samples
- 88 samples from individuals with Factor V Leiden
- 212 samples from healthy blood donors
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective, as it uses "patient samples" that imply they were collected prior to the study for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text does not describe how the Factor V Leiden status or healthy status of the 300 patient samples was definitively established.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
This information is not applicable and not provided. The device is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a diagnostic reagent, which inherently functions "stand-alone" in its chemical application, but its results are interpreted by human users within a clinical context. The "standalone" concept as typically applied to AI algorithms (algorithm-only performance) does not directly apply here. The study did evaluate the reagent's performance in detecting Factor V Leiden without human influence on the detection itself, but in conjunction with an "appropriate APC Resistance assay" (Dade Behring ProC APC assay).
7. The Type of Ground Truth Used
The ground truth for the test set appears to be clinical diagnosis or confirmed genetic status for Factor V Leiden and confirmed healthy status for the control group. The text mentions "88 Factor V Leiden samples" and "212 healthy blood donors," implying a pre-established "true" status for these samples, likely determined by a definitive genetic test for Factor V Leiden mutation or a clear health assessment.
8. The Sample Size for the Training Set
This information is not provided. The document describes a "comparative analysis" and a "reproducibility study," which are essentially validation or performance studies, not training. For an in vitro diagnostic reagent, the concept of a "training set" for an algorithm is generally not applicable in the same way it is for AI/machine learning. The reagent itself is formulated based on scientific principles, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an in vitro diagnostic reagent. The reagent's properties and composition (e.g., "residual Factor V activity of less than or equal to 1%" and "activities of the remaining coagulation factors of more than 40%") are established through manufacturing and quality control processes based on biochemical standards, not through a data-driven training process.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).