GRADILEIDEN V TEST

• K Number: K992456
• Device Name: GRADILEIDEN V TEST
• Manufacturer: GRADIPORE LTD.
• Date Cleared: 1999-12-21 ( 151 days)
• Product Code: GGW
• Regulation Number: 864.7925
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Sensitivity	100%
Specificity	98.8%
Within Run Precision for FVL+ plasma	1.1%
Within Run Precision for normal plasma	1.9%
Within Run Precision at cutoff	0.9%
Total Precision for FVL+ plasma	8.9%
Total Precision for borderline normal plasma	1.6%
Total Precision for normal plasma	5.6%
Identifies Factor V Leiden status correctly	163/164 individuals
Identifies Oral Anticoagulated plasmas	35/36
Identifies heparinized plasmas	21/21
Identifies Lupus Anticoagulant positive plasmas	12/12

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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.

Regulation Number and Section

§ 864.7925 Partial thromboplastin time tests.

(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).