(245 days)
For use in prothrombin time determinations and prothrombin time-based assays.
Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
Here's a breakdown of the acceptance criteria and study information for the Dade® Innovin® device, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Dade® Innovin® vs. Dade® Thromboplastin IS) |
|---|---|
| High correlation in PT seconds | Correlation coefficient: 0.975 |
| PT seconds regression relationship | Regression equation: Y = 1.32X - 8.3 |
| High correlation in INR values | Correlation coefficient: 0.98 |
| INR values regression relationship | Regression equation: Y = 0.99X - 0.09 |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size of the test set in terms of the number of patient specimens. It only states that "specimens were tested."
- The data provenance (e.g., country of origin, retrospective or prospective) is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves a direct comparison of a new in vitro diagnostic (IVD) device against a predicate IVD device, rather than a clinical interpretation by human experts. The "ground truth" here is the measurement provided by the established predicate device.
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Adjudication method for the test set:
- Not applicable for this type of IVD device comparative study. The comparison is quantitative based on direct measurements.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) reagent, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study in the context of an IVD. The device (Dade® Innovin®) was tested independently and its results were compared directly to those of the predicate device (Dade® Thromboplastin IS) without human intervention or interpretation as part of the core measurement.
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The type of ground truth used:
- The "ground truth" for this comparative study was the results obtained from the predicate device, Dade® Thromboplastin IS (K891169). The goal was to demonstrate substantial equivalence to this legally marketed device.
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The sample size for the training set:
- The document does not mention a separate "training set" as this is a traditional IVD device, not a machine learning or AI model. The comparative performance study described serves as the validation of the device's performance against the predicate.
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How the ground truth for the training set was established:
- Not applicable as there is no mention of a "training set" in the context of this traditional IVD product.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).