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The Quantra® QPlus® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use.

The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer.

The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).

The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.

Results obtained with the Quantra OPlus System should not be the sole basis for patient diagnosis.

The Quantra QPlus System is an in vitro diagnostic device designed to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation in surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), QPlus Cartridge (single-use disposable cartridge) and Quantra Quality Controls (external Quality Control materials).

This document describes a Special 510(k) submission for a software modification to the Quantra QPlus System. The modification involves the implementation of an optional accessory called the Quantra Desktop Remote Viewer (QDRV) software application. The primary purpose of this submission is to demonstrate that the modified device, particularly the QDRV, does not alter the device's intended use or fundamental scientific technology and thus maintains substantial equivalence to the previously cleared Quantra QPlus System (DEN180017).

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of clinical or analytical validation for this specific Special 510(k) submission. This is because the submission is for a software modification (QDRV) that allows for remote viewing of results and doesn't change the core functionality or intended use of the Quantra QPlus System itself.

Therefore, the acceptance criterion for this submission is implicitly the demonstration of substantial equivalence to the predicate device, meaning the new software does not negatively impact the safety or effectiveness of the previously cleared system.

The reported device performance for the new QDRV software is that it allows "remote viewing of real-time (active) and historical test results created by the Quantra Hemostasis Analyzer only by authorized users. Users cannot manipulate the test data that is stored on the Quantra Hemostasis Analyzer and displayed within the QDRV software application. Users cannot input any additional clinical data into the QDRV software application or the Quantra Hemostasis Analyzer from the QDRV." This functionality is compared against the predicate device which "Not Applicable" for this remote viewing feature.

Table 1: Comparison of Modified Device (with QDRV) and Predicate Device

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document focuses on a software modification (QDRV) for remote viewing. Clinical or analytical performance studies with specific sample sizes from test sets are not described or required for this type of Special 510(k) submission, as the core analytical performance parameters of the Quantra QPlus System are not being altered. The submission confirms that the change "does not affect the device's intended use nor alter the device's fundamental scientific technology." Therefore, previous validation data for the predicate device would be referenced, but no new clinical or analytical study data for the QDRV itself are presented here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As described above, this submission is for a software accessory that enables remote viewing of existing analytical results. It does not involve new diagnostic interpretations or ground truth establishment based on expert consensus for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This submission does not involve a test set requiring expert adjudication.

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

Not applicable. The Quantra QPlus System is a coagulation measurement device, not an AI-assisted diagnostic imaging system that would typically use MRMC studies. The QDRV is a viewing tool, not an AI component.

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

This is not applicable in the context of an "algorithm only (standalone)" performance study as commonly understood for AI/ML devices. The Quantra QPlus System measures viscoelastic properties of blood. The QDRV is a software interface for displaying these measurements. The "performance" of the QDRV is its ability to accurately display the data generated by the Quantra Hemostasis Analyzer without allowing manipulation. This is typically verified through software validation and verification, not a standalone clinical performance study like an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The QDRV displays output from an IVD device. The accuracy of the displayed data is verified against the data stored on the Quantra Hemostasis Analyzer using software validation methods, not medical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. The QDRV is a commercial software product and not an AI/ML model that requires a "training set" in the context of machine learning model development.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this software modification.

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