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510(k) Data Aggregation
(29 days)
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra 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 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.
The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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 QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
The Quantra® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. 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 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. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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 QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The provided text is a 510(k) summary for a software modification to the Quantra Hemostasis Analyzer. The primary change is extending the QPlus Cartridge maximum assay time for reporting clot stiffness results from 15 minutes to 25 minutes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "Acceptance Criteria" table with specific quantitative thresholds. Instead, the "J. CLINICAL AND NON-CLINICAL STUDIES" section describes the studies conducted and their outcomes, which implicitly serve as the demonstration that the device performs acceptably for the modified function.
| Study Type | Implicit/Explicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Interfering Substance Testing | No specific quantitative acceptance criteria mentioned, but the goal was to evaluate "Not Computable" results. | "As previously observed, rivaroxaban and dabigatran demonstrated a dose response effect of clot time parameter prolongation (starting at 100 ng/mL and at all levels tested, ≥ 25 ng/mL, respectively) and clot stiffness parameter reduction (starting at 200 and 100 ng/mL respectively)." This confirms the device's behavior in the presence of these anticoagulants within the extended time frame. |
| Precision Testing: Whole Blood Repeatability Study | Demonstration of acceptable precision (imprecision). | "Total imprecision, including variability between operators, cartridge lots, instruments, and test replicates ranged from 5.8% to 14.4% CV." This indicates that the repeatability of the device, even with the extended assay time, is within an acceptable range for a diagnostic test. |
| Clinical Performance Testing | Strong correlation with a predicate device (ROTEM delta) for comparative measurements (r > 0.8). | "Linear regression summary results for all comparisons showed r > 0.8 (0.82 to 0.94) for the correlation analysis, demonstrating a strong correlation of QPlus parameters to corresponding ROTEM delta parameters." This confirms the device's accuracy and consistency with an established method, even with the extended assay time. |
2. Sample Size Used for the Test Set and Data Provenance:
- Interfering Substance Testing: "similar protocols, acceptance criteria, and sample sizes were utilized" as a previous submission (DEN180017). The exact sample size for this specific study is not explicitly stated in the provided text.
- Precision Testing (Whole Blood Repeatability): The exact sample size is not explicitly stated. It mentions "contrived whole blood requiring an assay time within the extended maximum assay time."
- Clinical Performance Testing: "Clinical samples were collected from adult cardiac surgery patients undergoing treatment in the intensive care unit at a single medical center." The exact number of samples is not explicitly stated. The data provenance is prospective (samples collected for the study) and from a single medical center (country implied to be USA, given FDA submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document describes a comparative study against a predicate device (ROTEM delta) and evaluations of precision and interference. It does not rely on expert consensus for "ground truth" derived from image interpretation (as would be common for AI/ML in radiology).
- For the clinical performance testing, ground truth is established by the independent measurement from the ROTEM delta, a cleared predicate device.
4. Adjudication Method for the Test Set:
- Since the ground truth is established by comparison to an existing analytical instrument (ROTEM delta) and precision/interference testing, no expert adjudication method (like 2+1 or 3+1 for imaging) is described or relevant for this type of in vitro diagnostic device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) measurement system, not an AI-assisted diagnostic imaging interpretation tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The performance studies described (interference, precision, clinical correlation) evaluate the device's performance as a standalone system in generating the measurements (clot time, clot stiffness, etc.). The device itself is an automated system providing quantitative results. Human intervention is primarily in sample collection, loading, and interpreting the output, but the measurement itself is automated by the device's algorithm.
7. The Type of Ground Truth Used:
- Analytical/Instrumental Ground Truth:
- For Interfering Substance Testing: The ground truth is the known concentration of the interfering substance and the expected effect on coagulation parameters.
- For Precision Testing: The ground truth is the consistency/repeatability of the device's own measurements across repeated tests, aiming for low variability.
- For Clinical Performance Testing: The ground truth is derived from the measurements obtained by the ROTEM delta, which is a widely accepted and cleared predicate device for viscoelastic properties of blood. This is a comparative ground truth against an established method.
8. The Sample Size for the Training Set:
- This is a software modification (extended assay time) for an in vitro diagnostic device. The document does not mention any specific training set in the context of machine learning or AI models. The device's underlying technology (SEER Sonorheometry) is based on physical principles, not on learned patterns from a large training dataset in the way a deep learning algorithm would be. The "training" for this type of device would typically involve calibration and validation during development, but not an "AI training set" as commonly understood.
9. How the Ground Truth for the Training Set Was Established:
- As no AI/ML "training set" is described, this question is not applicable in the context of the provided document. The device's measurements are based on established scientific principles and comparison to a predicate device, rather than a machine learning model that requires a ground-truthed training set.
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