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The Quantra QPlus System is intended for in vitro diagnostic use.

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 QPlus System should not be the sole basis for patient diagnosis.

The Quantra QPlus System consists of an instrument (the Quantra Hemostasis Analyzer), a single-use disposable cartridge (QPlus Cartridge), and external quality control materials (QPlus Controls). The OPlus System is intended for use with patients 18 years or older by professionals in a hospital setting (point of care or laboratory). The measurements are performed in four test channels of the disposable cartridge.

The QPlus Cartridge is a multichannel disposable cartridge which enables four independent measurements to be performed in parallel with different sets of reagents without the need for any reagent preparation or controlled pipetting. The cartridge utilizes a citrated evacuated blood collection tube filled with a patient whole blood sample The proprietary technology SEER Sonorheometry measures the evolution of shear modulus (i.e., clot stiffness) in all four channels as a function of time.

Clot times and clot stiffness values obtained from the measurements performed by the QPlus Cartridge are combined to form parameters that depict the functional status of the patient's coagulation system. Four (4) of the parameters are measured and two (2) are calculated.

Here's an analysis of the Quantra QPlus System's acceptance criteria and the study used to demonstrate its performance, based on the provided FDA 510(k) summary:

The context indicates that this 510(k) submission is a "Special 510(k)" to add arterial whole blood as a permissible sample matrix, expanding upon the previously cleared venous whole blood. Therefore, the study focuses on demonstrating the substantial equivalence of arterial and venous samples.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific submission. However, the core of the study is to demonstrate comparability between arterial and venous whole blood samples. The performance is assessed by showing that the results obtained from both sample types are in agreement.

Here's an inferred representation based on the purpose of the submission:

Important Note: The document is a 510(k) summary, which often condenses detailed study results. The specific statistical metrics (e.g., correlation coefficients, mean differences with confidence intervals, p-values) and the thresholds used for "agreement" are not provided in this summary. These would typically be found in the full 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the sample size for the study demonstrating the comparability of arterial and venous blood samples.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given the nature of a 510(k) for a medical device requiring patient samples, it is highly likely to be prospective clinical data collected for this specific purpose.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For a coagulation system like the Quantra QPlus, the "ground truth" is typically the measured values themselves, compared between different sample types, or against a reference method. It's not typically a subjective interpretation that requires expert consensus for "ground truth" in the same way an imaging device might.

• Ground Truth Establishment: The ground truth for this device's performance is established by the agreement between the measurements from arterial and venous samples themselves. There isn't an external "expert" panel adjudicating the results in this context.
• Qualifications of Experts: Not applicable in the context of establishing ground truth for quantitative measurements.

4. Adjudication Method for the Test Set

Not applicable. This device produces quantitative measurements, and its performance is evaluated by the statistical agreement between measurements from different sample types, not by subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images, and the AI's effect on human performance is being evaluated.
• Effect Size: Not applicable as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study described implicitly or explicitly assesses the standalone performance of the device (algorithm only). The purpose of the study for this 510(k) is to determine if the Quantra QPlus System, when analyzing arterial whole blood, produces results comparable to those from venous whole blood. This is a direct evaluation of the device's measurement capabilities.

7. The Type of Ground Truth Used

The ground truth used is direct quantitative measurement from patient samples. The comparability study would involve:

• Taking paired arterial and venous blood samples from the same patient.
• Analyzing both samples with the Quantra QPlus System.
• Comparing the measured parameters (CT, CTH, CS, FCS, PCS, CTR) between the arterial and venous samples to determine if they are statistically equivalent or within acceptable limits of agreement.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This 510(k) is for an expansion of a previously cleared device. While new data for the arterial sample matrix was collected for validation, the core algorithm for measuring viscoelastic properties would have been developed and trained using a separate dataset prior to the original 510(k) (DEN180017). This summary focuses only on the modification.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. For devices that measure physiological parameters, training often involves:

• Collecting a diverse set of patient samples.
• Running these samples on the device to generate measurements.
• Potentially comparing these measurements against a gold standard or well-established reference method (if one exists for developing the technology) to optimize the algorithm's accuracy and precision during its initial development.

Given that the Quantra QPlus System uses "Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry," the training would involve optimizing the processing of the ultrasound-based signals to accurately derive the shear modulus and coagulation parameters. The "ground truth" during this phase would be the known or derived physical properties of the blood samples used for development and internal validation.

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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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