Search Results

GradiLeiden V is a simple functional clotting test system intended for screening of resistance to Activated Protein C in plasma from individuals with the Factor V (Leiden) defect. It can also be performed on plasma from patients on stabilized oral anticoagulant or heparin therapy.

The GradiLeiden V Test is a lyophilized paired reagent containing 5 vials of whole diluted Agkistrodon contortrix venom and 5 vials of phospholipid rich Russell's Viper Venom time reagent.

Here's a breakdown of the acceptance criteria and study information for the GradiLeiden V Test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Size: 164 individuals (This number includes 35 oral anticoagulated plasmas, 21 heparinized plasmas, and 12 Lupus Anticoagulant positive plasmas, alongside other samples).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Australia, suggesting the data may originate from there or an international collaboration. It describes the comparison as "GradiLeiden V was compared against the predicate device in a series of clotting assays," implying a prospective approach for the comparison study, but the source of the patient samples (retrospective/prospective collection) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The ground truth was established by "DNA analysis," which implies a laboratory-based, molecular diagnostic method rather than expert interpretation of a diagnostic image or clinical presentation.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on DNA analysis, not expert consensus requiring adjudication.

4. 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-based diagnostic device; it's a laboratory clotting test. The comparison was between two laboratory tests (GradiLeiden V and Coatest APC Resistance V) with ground truth established by DNA analysis.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance was done for the GradiLeiden V device. Its performance was evaluated against DNA analysis as the ground truth.

6. The type of ground truth used:

   • DNA analysis (specifically mentioned: "all results confirmed by DNA analysis"). This is a highly accurate, molecular diagnostic method for determining Factor V Leiden status.

7. The sample size for the training set:

   • Not explicitly stated. The document focuses on the test set used for validation. The device's cut-off of 1.57 was "obtained by ROC analysis," which implies a dataset was used to determine this threshold, but whether this constitutes a distinct "training set" in a machine learning sense, or if it was part of the overall validation process, is not detailed.

8. How the ground truth for the training set was established:

   • Assuming the "training set" (or data used for ROC analysis) was drawn from similar sources as the test set, the ground truth would have been established by DNA analysis.

Ask a specific question about this device