(29 days)
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:
| Acceptance Criterion (Inferred from goal of demonstrating equivalence) | Reported Device Performance |
|---|---|
| Agreement between arterial and venous whole blood samples for all QPlus Cartridge output parameters (CT, CTH, CS, FCS, PCS, CTR). | The study aimed to demonstrate that the Quantra QPlus System provides comparable results when used with either arterial or venous whole blood samples across all functional parameters (Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution, Platelet Contribution, and Clot Time Ratio). The FDA cleared the device, implying that this equivalence was successfully demonstrated. |
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.
§ 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
(a)
Identification. A coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in perioperative patients, as an aid in the assessment of coagulopathies when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include detailed documentation of, and results from, the following:
(i) A study assessing precision using protocols determined to be acceptable by FDA, to cover the measurement range for each reported parameter (test output). Testing must include native specimens with coagulation profiles representative of the intended use population. In order to cover the measuring range, testing may include a limited number of contrived specimens, not to exceed 10 to 20 percent, or as otherwise deemed appropriate by FDA. The contrived specimens must be prepared to resemble clinical specimens. This testing must evaluate repeatability and reproducibility and provide assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system;
(ii) Studies that demonstrate the performance of each parameter (test output) throughout the claimed measurement range, to include linearity studies or dose-response studies, as applicable to the parameter (test output);
(iii) Potential interferent study that includes evaluation of hemolyzed and lipemic samples as potential interferents; exogenous and endogenous interferents associated with each patient population intended for use with the device, and which might be expected to affect assay performance, must be evaluated; and potential interferents that are specific for, or related to, the technology or methodology of the device. Evaluation of all potential interferents must be performed using a protocol determined to be acceptable to the FDA (
e.g., an FDA-recognized standard) and include both normal and abnormal specimens covering coagulation profiles representative of the intended use population;(iv) A study that evaluates specimen stability under the intended conditions for specimen collection, handling, and storage, using samples that cover the coagulation profiles representative of the intended use population, and using protocols determined to be acceptable by FDA;
(v) A multisite clinical study, determined to be acceptable by FDA, demonstrating performance, relative to clinically relevant and clinically validated laboratory test(s) for each parameter (test output). Further, the study must meet all of the following criteria:
(A) The study must be performed in the intended use population and include representation from all patient populations for whom the device is intended to be used. Potential endogenous and exogenous interferents for each target patient population must be evaluated or known prior to the study;
(B) The study must be conducted at a minimum of three external sites representative of the intended use setting by the intended operators;
(C) Test samples must be collected at time intervals relevant to the device's use in the intended use population;
(D) Clinical specimens, which cover coagulation profiles representative of the intended use population, must be evaluated at each of the three clinical sites in the study;
(E) Analysis of the concordance of clinical interpretation of patient coagulation status made from individual test parameter (test output) results as compared to clinical interpretation of coagulation status from a clinically relevant laboratory test or tests (
e.g., a comparative viscoelastic device or standard laboratory tests) must be conducted; and(F) Expected (reference) values for each parameter (test output) must be demonstrated by testing a statistically appropriate number of samples from apparently healthy normal individuals;
(vi) For a device with a user interface that has information that needs to be interpreted by the user in correctly using the device to achieve the intended test results or a device that does not provide a final output that is a comprehensive interpretation of all parameter (test output) results, a study evaluating the ability of device users to correctly interpret results;
(vii) For any device indicated to guide blood product use, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding blood product use; and
(viii) For any device indicated to guide use of medication, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding use of medication.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A summary of results from the study required by paragraph (b)(1)(i) of this section, including repeatability, reproducibility, and assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system.
(ii) The claimed measurement range of each parameter (test output), as supported by demonstrated performance of the parameter (test output) throughout the claimed measurement range, including studies required by paragraphs (b)(1)(i) through (iii) and (v) of this section, and, if applicable, paragraphs (b)(1)(vii) and (viii) of this section.
(iii) Identification of known interferents, including all endogenous, exogenous, technology-specific, and patient population-specific interferents, specific to each parameter (test output). The information must include the concentration(s) or level(s) at which interference was found to occur and the concentration range or levels at which interference was not found to occur.
(iv) Information regarding the multisite clinical study required by paragraph (b)(1)(v) of this section, including:
(A) Each patient population evaluated;
(B) Each intended use setting and the operators;
(C) A summary of the results, including the concordance analysis to clinically relevant laboratory test(s); and
(D) Demonstrated expected (reference) values for each parameter (test output).
(3) The labeling required under § 809.10 of this chapter must include the following:
(i) A limiting statement that the result(s) from the device is(are) not intended to be used as the sole basis for a patient diagnosis.
(ii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(vii) of this section that specifically validate an indication for the device's use in guiding blood product use, a limiting statement that the device has not been evaluated to guide blood product use.
(iii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(viii) of this section that specifically validate an indication for the device's use in guiding use of medication, a limiting statement that the device has not been evaluated to guide use of medication.