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Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.

Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants.

This product is for in-vitro diagnostic use only.

Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Frozen Format LA Screen" device does not contain the detailed information necessary to answer your request.

Specifically, the document focuses on the regulatory clearance process and substantial equivalence determination, and it does not include any study data, acceptance criteria, or performance metrics for the device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for the test set.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The 510(k) clearance process generally focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of device characteristics and intended use, rather than a full clinical study with detailed performance metrics and ground truth establishment as you've described for AI/CADe devices. This document is a clearance letter, not a full study report or technical specification.

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Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.

Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants.

This product is for in-vitro diagnostic use only.

Frozen Format LA Confirm is a phospholipid-rich DRVVT reagent for the specific correction of Lupus Anticoagulants.

The provided text is a 510(k) premarket notification summary for a medical device called "Frozen Format LA Confirm." It's a regulatory document from the FDA, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document.

This document primarily indicates that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device for its stated indications for use, thereby allowing DSRV, Inc. to market it. It discusses regulatory compliance and general controls, but not the specific technical performance data or study details required to fill out the requested table and answer the questions.

Ask a specific question about this device