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510(k) Data Aggregation
(111 days)
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 or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The QStat Cartridge is intended for in vitro diagnostic use 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 (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL).
The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma, liver transplantation, and peripartum obstetric procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing 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. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.
The analyzer displays the test results (n=5) in three different views: dial display screen, stiffness curves data, and trend screen. The dial display screen is the primary viewing screen and has a dial for each of the five output parameters. Each dial shows the reference range, assay measurement range, parameter abbreviation, and the numerical result for the corresponding parameter. The stiffness curves are a graphical display of shear modulus measurements over time that enable the user to view the development of clot stiffness over time. The trends screen displays results from a patient for up to six time points.
There are two levels of external QStat Controls (QSL1 and QSL2) that are supplied separately (required but not provided materials) for testing on the Quantra System when changing cartridge lots, changing control lots, or after significant changes are made to the Quantra instrument (e.g., software update).
The FDA 510(k) clearance letter for the Quantra QStat Cartridge describes its intended use for evaluating blood coagulation and clot lysis, specifically extending its indication to peripartum obstetric patients. The submission refers to non-clinical and clinical tests to demonstrate the device meets acceptance criteria.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it describes acceptable performance in relation to interference and clinical agreement.
| Acceptance Criteria (Implied from Study Description) | Reported Device Performance |
|---|---|
| No significant interference from common obstetric medications (hemabate, methergine, misoprostol, oxytocin) | The highest concentration of each substance tested showed no significant interference in whole blood samples collected in 3.2% sodium citrate anticoagulant collection tubes. |
| Clinical agreement between QStat CSL and ROTEM delta EXTEM ML for identifying fibrinolytic samples. | Overall agreement of patient sample assignments into lysis-positive and lysis-negative based on data for QStat CSL and ROTEM delta EXTEM ML was 92%. |
| Correlation between QStat FCS and fibrinogen levels. | Passing-Bablok regression analysis showed good agreement between the methods (slope = 1, r = 0.815), albeit with a constant bias. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 322 subjects
- Data Provenance: Prospective observational study, conducted across seven clinical sites in the US. The study involved parturients (women in labor) aged 18 years or older with concerns for coagulopathy.
- Sample Size (Interference Study): Not explicitly stated with a specific number for the test set, but it mentioned "normal and hypercoagulable whole blood specimens" and that the "number of replicates at each level of a screening study was targeted to provide a 95% confidence interval (2-sided), per CLSI EP07-A2 Guideline."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. Instead, ground truth for some parameters appears to be established by comparison to other legally marketed and established devices (ROTEM delta, TEG 5000) and conventional coagulation testing (aPTT, PT/INR, fibrinogen level, platelet count).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for establishing ground truth. The comparison is made against existing, accepted methods and devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an in vitro diagnostic (IVD) device that measures coagulation parameters, not an AI-assisted diagnostic imaging or interpretation tool.
6. Standalone (Algorithm Only) Performance Study
Yes, the studies described are standalone performance studies. The clinical and analytical specificity studies evaluate the performance of the QStat Cartridge and Quantra Hemostasis Analyzer directly, not in conjunction with human interpretation for the primary measurement. The comparisons are to other standalone diagnostic methods (ROTEM delta, TEG 5000, conventional coagulation tests).
7. Type of Ground Truth Used
The ground truth used for the clinical performance evaluation was based on:
- Comparison to legally marketed viscoelastic testing devices: ROTEM delta or TEG 5000.
- Comparison to conventional coagulation testing: aPTT, PT/INR, fibrinogen level, platelet count.
- The "concern for coagulopathy" as a trigger for testing suggests clinical suspicion as an initial selection criterion, with the aforementioned tests serving as the gold/reference standard for comparison.
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The studies described appear to be focused on performance validation.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
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(82 days)
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 or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The OStat Cartridge is intended for in vitro diagnostic use 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 (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL).
The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing 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. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.
The provided text is a 510(k) Premarket Notification from the FDA regarding the HemoSonics QStat Cartridge. The purpose of this submission is to expand the approved sample matrices to include arterial whole blood, in addition to the previously cleared venous whole blood.
The document does not detail a study proving the device meets acceptance criteria in the manner of an AI/ML device, as it concerns an in vitro diagnostic (IVD) device for measuring blood viscoelastic properties. Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC study, training sets, ground truth establishment for AI/ML) are not applicable or described in this type of submission.
However, based on the information provided, we can infer some aspects relevant to device performance and the expansion of its indications for use.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant in this context:
1. A table of acceptance criteria and the reported device performance
The document defines the device's function and indications for use, but it does not provide a table of quantitative acceptance criteria and reported performance metrics for the device itself (e.g., accuracy, precision) in the context of an AI/ML algorithm evaluation. This is a 510(k) submission for a modification to an existing IVD, primarily focused on expanding the sample type. The "acceptance criteria" here refer to demonstrating substantial equivalence for the new claim (arterial blood).
What is reported is the intent to demonstrate equivalency between arterial and venous whole blood samples.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "HemoSonics is submitting this Special 510(k) to demonstrate the equivalency of arterial and venous whole blood samples analyzed on the Quantra Hemostasis Analyzer with the QStat Cartridge in order to expand the sample matrices accepted on this system."
While it explicitly states the intent to perform a study for equivalency, the sample size and data provenance (country, retrospective/prospective) are not provided in this document. This information would typically be detailed in a separate study report submitted as part of the 510(k) supporting data, which is not included in this high-level summary.
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)
This question is typically relevant for interpretative devices, especially those using AI/ML where human expert interpretation forms the ground truth. For an IVD like the QStat Cartridge, which measures objective viscoelastic properties of blood, the "ground truth" is established by the accuracy and precision of the measurement itself against a reference method or known values, not by expert consensus on image interpretation. Therefore, this concept of "experts" to establish ground truth does not directly apply here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Similar to point 3, adjudication methods are used in AI/ML performance studies where multiple human readers might disagree, and a consensus process is needed to establish ground truth. This is not applicable to a laboratory device that performs quantitative measurements.
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
No, an MRMC study was not done, nor would it be relevant for this type of device. MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation (e.g., radiology for diagnostic accuracy). The QStat Cartridge is an IVD that provides quantitative measurements of blood coagulation; it does not involve human "readers" interpreting cases in the sense of an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also more applicable to AI/ML software. The QStat Cartridge is a physical device that performs measurements. Its performance is evaluated fundamentally in a standalone manner (the device's ability to accurately measure blood properties), but not in the context of an "algorithm only" as understood for AI/ML. The device generates quantitative parameters (Clot Time, Clot Stiffness, etc.). An "algorithm" within the device would process sensor data to yield these parameters, and the evaluation would focus on the accuracy of these output parameters.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For an IVD like the QStat Cartridge, the "ground truth" for its measurements would be established through:
- Reference Methods: Comparison of the QStat Cartridge's measurements (Clot Time, Clot Stiffness, etc.) against established, validated reference methods for measuring blood viscoelastic properties or related coagulation parameters.
- Known Samples: Testing with samples having known or characterized coagulation properties (e.g., calibrated controls, samples spiked with known substances).
- Clinical Correlation: While not a direct "ground truth" for the measurement itself, the clinical utility of the device's outputs is validated by correlating its results with patient clinical status or outcomes.
The document states the device provides "semi-quantitative indications" and its results "should not be the sole basis for patient diagnosis," indicating its role as a supportive diagnostic tool. The specific ground truth used for the arterial vs. venous equivalency study is not detailed here, but it would involve comparing measurements from paired arterial and venous samples from the same patient.
8. The sample size for the training set
This question is applicable to AI/ML models. Since this is an IVD device measuring physiological parameters, the concept of a "training set" for an AI model as typically distinguished from a "test set" does not apply in the same way. The device's measurement principles are based on established biophysical principles (SEER Sonorheometry), not on training a machine learning algorithm on a dataset. Any internal "algorithms" would be deterministic or model-based, not learned from data in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
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