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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.

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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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.

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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The Quantra® System is composed of the Quantra Hemostasis Analyzer, OPlus 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 sem-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, 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 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 and lysis in trauma, surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), single-use disposable cartridges, (OPlus and OStat cartridges) and Quantra Quality Controls (external Quality Control materials).

This document describes a Special 510(k) submission for the HemoSonics Quantra Hemostasis Analyzer. The purpose of the submission is to implement a new operating system (Microsoft Windows 10 IoT Enterprise LTSC 2019) in the device. The FDA determined that this change does not affect the device's intended use or alter its fundamental scientific technology. Therefore, the information provided focuses on the substantial equivalence to the predicate devices (Quantra System cleared under K213917 and K223433), rather than a detailed clinical study demonstrating device performance against new acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a software update (operating system change) that does not alter the fundamental scientific technology or intended use, traditional performance acceptance criteria in terms of clinical accuracy or diagnostic efficacy are not presented in this document. The "acceptance criteria" here refer to demonstrating that the new software version maintains the performance of the predicate device.

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

This submission is for a software update (operating system change) and does not involve a new clinical study with a test set of patient data as would be typical for a de novo device or a significant change in intended use/technology. The document does not specify a "test set" in the context of clinical data. It relies on the performance data from its predicate devices (K213917 and K223433) for which clinical data would have been submitted.

Therefore:

• Sample size for test set: Not applicable (no new clinical test set for this specific software update).
• Data provenance: Not applicable for a new clinical test set. The predicate devices' data would have included (presumably) prospective or retrospective clinical data, but its details are not in this document.

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

Not applicable for this software update submission. No new clinical ground truth establishment described here.

4. Adjudication Method for the Test Set

Not applicable for this software update submission. No new clinical adjudication described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as this submission pertains to a software (operating system) update, not a change requiring a new clinical evaluation of human reader performance with or without AI assistance. The Quantra System is a diagnostic instrument that measures viscoelastic properties of whole blood; it is not an AI-assisted diagnostic tool for imaging interpretation.

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

This is not applicable in the context of a software update for an in vitro diagnostic device like the Quantra System. The device performs automated measurements. Its performance is inherent to the algorithm and instrument design, which are not changing beyond the operating system.

7. The type of ground truth used

Not applicable for this software update submission. The "ground truth" for the original device clearance (K213917, K223433) would have been established through correlation with established clinical methods for assessing coagulation status (e.g., standard coagulation assays, clinical outcomes, expert clinical judgment), but details are not provided in this document.

8. The Sample Size for the Training Set

Not applicable. This submission is about updating the operating system of an already cleared device, not about training a new algorithm with a specific training set.

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

Not applicable, as no new algorithm training or associated ground truth establishment is described in this submission.

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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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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 (CT), 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.

For prescription use only.

The Quantra OPlus System is an in vitro diagnostic device designed to assess a patient's coagulation status by measuring the shear modulus of a blood sample during clot formation in perioperative settings in the point of care (POC) or clinical laboratory settings. The system consists of the Quantra Hemostasis Analyzer (instrument), QPlus Cartridge (singleuse disposable cartridge), Quantra Controls Level 2 (external quality control materials), and the Quantra Cleaning Cartridge.

The Quantra Hemostasis Analyzer is a fully integrated and automated in vitro diagnostic device designed to assess a patient's coagulation status by measuring the viscoelastic properties of a blood sample during clot formation. The analyzer consists of a base instrument with a software component. The instrument and the software are a closed system, using only Quantra assay cartridges.

The QPlus Cartridge is a single-use four-channel plastic cartridge which has a sample port on one end to draw the blood sample into the cartridge without requiring any sample pipetting. Lyophilized reagents are embedded into the four channels within the cartridge. The four channels enable four independent reactions/tests to be run simultaneously.

The cartridge comes sealed in a foil pouch. After a OPlus Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A venous 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 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 in three different views: dial display screen, stiffness curves, and trend data. The dial display screen is the primary viewing screen and has a dial for each of the six 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 trend data display provides numeric results of tests run during the past 48 hours for a specific patient. In the trend data view, multiple samples from the same patient are displayed.

The device outputs four directly measured parameters (Clot Time, Clot Time with Heparinase, Clot Stiffness, and Fibrinogen Contribution to Clot Stiffness) as well as two calculated parameters (Clot Time Ratio and Platelet Contribution to Clot Stiffness).

Acceptance Criteria and Device Performance for The Quantra QPlus System

The Quantra QPlus System's performance was evaluated through various studies to demonstrate its analytical and clinical capabilities. The acceptance criteria largely stemmed from the regulatory requirements outlined in 21 CFR §864.5430(b)(1).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the special controls specified in 21 CFR §864.5430(b)(1). The reported device performance is summarized from the analytical and clinical studies described in the document.

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

• Clinical Performance Study:

  • Total Subjects: 277 eligible subjects (initially 302 consented, 25 did not complete).
  • Patient Categories:
    • 264 patients undergoing cardiac, vascular, or orthopedic surgery
    • 7 patients presented with acute bleeding or suspected hypercoagulation post-cardiac surgery
    • 13 patients with abnormal coagulation profiles
    • 18 normal individuals whose blood was artificially manipulated (contrived) to mimic abnormal coagulation profiles (used to supplement clinical data).
  • Data Provenance: Multi-center, prospective observational study conducted in the United States at four clinical sites (University of Virginia School of Medicine, Duke University Medical Center, Medical University of South Carolina, and University of Maryland School of Medicine).

• Reference Range Study:

  • Total Subjects: 129 eligible subjects (initially 158 healthy male and female volunteers >= 18 years old were enrolled).
  • Data Provenance: Multi-center, prospective, observational study across three external sites in the United States.

• Precision Studies (Whole Blood Repeatability):

  • Whole Blood Specimens: Included normal, abnormal, and contrived samples to cover reportable ranges. Specific 'n' values range from 3 to 20 for different parameters and ranges in the detailed tables.
  • Data Provenance: Conducted at one internal site.

• Interference Study:

  • Whole Blood Samples: Spiked normal and hypocoagulable blood (heparin-treated, abciximab-treated, fibrinogen-depleted plasma).
  • Data Provenance: Not explicitly stated, but typically conducted in a laboratory setting.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for the test set in the same way one might describe a panel of radiologists reviewing images. Instead, the ground truth for the clinical performance study relied on:

• Standard Laboratory Tests (SLTs): These are FDA-cleared and widely accepted methods (e.g., aPTT, ACT, INR, Clauss fibrinogen, platelet count).
• ROTEM delta Thromboelastometry System: An FDA-cleared viscoelastic device (K101533, K083842).

The "Clinical Composite Indices (CCIs)" were developed "based on in-depth review of the clinical literature, clinical guidelines and consideration from multiple physicians." While "multiple physicians" were involved in developing these indices, their specific number and qualifications (e.g., years of experience, specialty) are not detailed for establishing the ground truth of individual cases within the test set.

4. Adjudication Method

No explicit adjudication method (e.g., 2+1, 3+1) is described for resolving disagreements in ground truth for the clinical test set. The ground truth was established by:

• Clinically relevant and validated standard laboratory tests (SLTs): These tests inherently have established methodologies and result interpretations.
• The ROTEM delta Thromboelastometry System: Also an established device with its own interpretation criteria.
• Clinical Composite Indices (CCIs): Criteria for these indices were defined based on literature and physician input, providing objective classification categories ("Low," "Normal/Subclinical," "High").

The comparison was then made between the Quantra QPlus System's classification and the classification derived from these objective comparators. Therefore, rather than a subjective adjudication process, this relied on agreement with established, objective laboratory and device results.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No explicit MRMC comparative effectiveness study, evaluating how much human readers improve with AI vs. without AI assistance, was conducted or described in this document. The "Reader Study" (Section O) focused solely on the ability of potential Quantra users to correctly interpret results displayed on the Quantra Hemostasis Analyzer's dial display screen, rather than a comparison of diagnostic accuracy with and without AI assistance to human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the primary performance evaluation of the Quantra QPlus System (which includes the analyzer and its embedded software/algorithm) focused on its standalone performance. The analytical performance studies (precision, linearity, interference, stability) and the clinical concordance studies (against SLTs and ROTEM) all evaluated the device's ability to accurately measure and classify coagulation parameters directly, without human interpretation influencing the measurement itself. The "Reader Study" evaluated the user's ability to interpret the device's output, confirming appropriate human-device interaction, but the core measurement and classification performance is standalone.

7. Type of Ground Truth Used

The ground truth used for evaluating the clinical performance of the Quantra QPlus System was a combination of:

• Standard Laboratory Tests (SLTs): These included aPTT, ACT, INR, Clauss fibrinogen, and platelet count. These are widely accepted and routinely used in clinical practice.
• A Comparative Viscoelastic Device (ROTEM delta): This is an FDA-cleared device that provides similar viscoelastic measurements.
• Clinical Composite Indices (CCIs): These were derived from the SLT data and the status of heparin use, developed based on clinical literature, guidelines, and physician input. These effectively codified expert consensus into objective criteria for classifying coagulation states.
• Pathology/Outcomes Data: Not directly mentioned as primary ground truth, but the relevance of coagulation assessment for perioperative patients is linked to patient outcomes (e.g., blood product usage, bleeding/thrombosis risk).

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is typical for a De Novo submission for a diagnostic device like the Quantra QPlus System, which is an in vitro diagnostic (IVD) device. The device's algorithms for calculating parameters (CT, CTH, CS, FCS, PCS, CTR) are based on the physics of SEER Sonorheometry and established coagulation principles, rather than being "trained" on a large dataset of clinical images or physiological waveforms in the way a deep learning AI model would be.

The "functional response studies" (e.g., heparin dose-response, platelet/fibrinogen levels) could be seen as part of the developmental work that informed the algorithm's design and parameter calculation methods, ensuring they reflect known biological responses. These studies involve spiking samples from a smaller number of donors (e.g., 5 normal donors for heparin, 4 donors for platelet count, etc.).

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

As noted above, there isn't a traditional "training set" with ground truth established in the AI/machine learning sense. The device's underlying principles are based on the physics of mechanical properties of clots and their progression. The "ground truth" for developing and validating the functional calculations within the device would have involved:

• Known concentrations/manipulations: For instance, in dose-response studies, blood samples were spiked with known concentrations of heparin or platelet inhibitors, or adjusted to known platelet/fibrinogen levels. The expected outcome (e.g., linear increase in CT with heparin, decrease in CS/PCS with platelet inhibition) serves as the "ground truth" for the algorithm's ability to reflect these changes.
• Reference methods: Fibrinogen levels, for example, were confirmed using the Clauss fibrinogen assay, a standard reference method.

This approach ensures the device accurately measures the intended physical properties and reflects real-world physiological changes in a quantifiable manner.

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The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.

Quantra is a software application used to produce assessments of breast composition and categorize them. A breast consists of fat and fibroglandular tissue. Fibroglandular tissue, also referred to as dense tissue, contains a mixture of fibrous connective tissue (stroma) and glandular tissue (epithelial cells), and usually appears brighter than surrounding tissue on a digital mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.

The Quantra software is designed to estimate breast composition categories by analyzing distribution and texture of parenchymal tissue patterns which can be responsible for the masking effect during mammographic reading.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with specific thresholds for performance metrics. Instead, it presents performance results from a study, effectively demonstrating the device's capabilities. The "Acceptance Criteria" here are inferred from the demonstrated performance in categorizing breast density.

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

• Sample Size: 230 studies.
• Data Provenance: Retrospectively collected images of 4-view screening negative cases. The country of origin is not specified in the provided text.

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

• Number of Experts: 5 radiologists.
• Qualifications of Experts: Not explicitly stated, beyond being "radiologists". It's implied they are qualified to assess BI-RADS® 5th Edition categories.

4. Adjudication Method for the Test Set

• Adjudication Method: "5 radiologists' consensus assessment of BI-RADS 5th Edition categories" was used to establish the ground truth. This implies a consensus method, but the specific rule (e.g., simple majority, all 5 agree) is not detailed.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study assessing human readers with and without AI assistance was not explicitly mentioned or performed. The study described focuses on the standalone performance of the Quantra software against a consensus ground truth.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance Study: Yes, a standalone performance study of the algorithm without human-in-the-loop was performed. The tables clearly show the Quantra 2.2 software's performance (Quantra 2.2- QDC 2D and Quantra2.2 – QDC Tomo) against the BI-RADS 5th Ed. ground truth.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, it was the "5 radiologists' consensus assessment of BI-RADS 5th Edition categories."

8. The Sample Size for the Training Set

• The provided document does not specify the sample size for the training set. It only discusses the testing against an independent dataset.

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

• The provided document does not specify how the ground truth for the training set was established, as details about the training set itself are absent.

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Quantra™ is a software application intended for use with images acquired using digital breast x-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra also provides area breast density as a ratio of fibroglandular tissue area estimates. Quantra segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra results for each image, breast, and subject, are intended to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.

The Quantra 2.1 software provides volumetric and area assessment on digital x-ray images of the breast. The Quantra software calculates estimates of breast tissue volumes, estimates of breast tissue areas and statistical measures. The Quantra software operates on a Windows server (e.g., Hologic Cenova server) that meets Quantra data input and output requirements and generally is located outside the patient environment. The device does not contact the patient, nor does it control any life-sustaining devices.

Here's an analysis of the acceptance criteria and study information for the Quantra 2.1 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds for device performance. Instead, the "Performance/Bench Testing" section describes the types of evaluations performed and the comparisons made. The conclusion states that the information and data presented were "adequate...to determine substantial equivalence to the predicate device." This implies the device's performance was considered acceptable if it was comparable to or improved upon the predicate.

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

• Test Set Sample Size:
  • For the accuracy of fibroglandular tissue thickness, a "breast phantom" was used. This would be a single or a small set of phantoms, not a large patient sample size.
  • For reproducibility of Vbd, an "image dataset of the same patients" was used. No specific number of patients is provided, but it implies multiple patients.
  • For consistency of density measures across views/breasts, a "large database of images" was used. No specific number is given, but it is explicitly stated to be "large."
  • For correlation with BI-RADS® scores, a database of "images including BI-RADS category scores" was used. No specific number of images or patients is detailed.
• Data Provenance: The document explicitly mentions images from "Hologic (Selenia and Selenia Dimensions), GE (Senographe and Senographe Essential), and Siemens (Mammomat Novation) digital breast x-ray systems." This indicates data from various manufacturers, suggesting it's likely multi-centric. The origin countries are not specified, but these are internationally recognized manufacturers. The studies appear to be retrospective as they use "image data sets" and "a large database of images."

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

• For the study comparing reader BI-RADS® scores to Quantra measures, 15 readers assigned BI-RADS® category scores.
• Qualifications of Experts: The term "readers" is used in the context of assigning BI-RADS® scores, strongly implying these are radiologists. Their specific years of experience or sub-specialization are not provided in the document.

4. Adjudication Method for the Test Set

• The document states that "BI-RADS category scores assigned by 15 readers were used to compare the reader BI-RADS scores to the q abd, O abd. Vbd and Abd measures." It does not specify an adjudication method like 2+1 or 3+1 for establishing a single consensus ground truth from these 15 readers. It appears the individual reader scores were used directly for comparison against the Quantra output, rather than an adjudicated consensus being formed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• The document describes comparing the software's performance with BI-RADS® scores from "15 readers." While this involves multiple readers and multiple cases, the study described is a comparison of the device's output against human ratings, not a "comparative effectiveness study" in the form of 'readers with AI vs. readers without AI assistance'.
• Effect Size: No effect size of human readers improving with AI vs. without AI assistance is reported. The device is explicitly stated to produce "adjunctive information; it is not an interpretive or diagnostic aid." This reinforces that it's not intended for human-in-the-loop performance measurement for diagnostic improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, standalone performance was assessed. The entire "Performance/Bench Testing" section describes evaluations of the Quantra 2.1 algorithm's output independently.
  • Measurement accuracy on phantoms.
  • Reproducibility on patient datasets.
  • Statistical evaluation of density measures across views/breasts.
  • Comparison of Quantra's density measures to expert BI-RADS® category scores.
    The goal was to demonstrate substantial equivalence, focusing on the algorithm's direct output.

7. The Type of Ground Truth Used

• Mixed types of ground truth were used:
  • Known Composition (Phantom): For the measurement accuracy of fibroglandular tissue thickness.
  • Expert Consensus/Categorization (Implied): For comparing Quantra's density measures to BI-RADS® scores, the BI-RADS® scores assigned by the 15 readers serve as an expert-driven "ground truth" for categorization.
  • Clinical Data (Implied): For reproducibility and consistency evaluations, the actual patient images and their characteristics formed the basis for assessment.

8. The Sample Size for the Training Set

• The document states, "Quantra 2.1 includes a new reference population with the more recent Hologic Selenia Dimensions image sets." However, it does not specify the sample size for this new reference population, nor explicitly differentiate it as a "training set." While a "training set" is generally used for machine learning models, the Quantra device performs calculations based on an algorithm, so the term "reference population" might refer to data used for algorithm development, calibration, or internal validation rather than a traditional machine learning training set.

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

• The document does not explicitly describe how ground truth was established for any "training set" or "reference population." It describes the use of the reference population (Hologic Selenia Dimensions image sets) but not the process for labeling or establishing ground truth within that set.

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Quantra™ is a software application intended for use with images acquired using digital breast X-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates; and area breast density as a ratio of fibroglandular tissue area and total breast area estimates. It segregates breast density into BI-RADS-like breast composition categories, which may be useful in the reporting of consistent breast composition values as mandated by certain state regulations. Quantra provides these numerical values for each image, breast, and subject, to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. Quantra runs on a Windows platform.

Quantra is a software application that estimates breast tissue volume and area density. The estimations are made from images acquired using digital breastray systems.

Here's a summary of the acceptance criteria and study details for the Hologic Quantra™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes validation methods and comparisons rather than explicit, stand-alone acceptance criteria with quantitative thresholds. However, it implicitly demonstrates that the device's performance met the expectation of correlating with existing methods and providing similar distributions across diverse equipment.

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

• Sample Size for Density Measures:
  • Vbd/Abd/q_abd compared to BI-RADS: "a large database of cases" (exact number not specified).
  • Vbd compared to MRI: "MRI cases of the same patients" (exact number not specified).
  • Vbd/Abd/q_abd compared across FFDMs: "a large population of cases" from Hologic, GE, and Siemens (exact number not specified).
  • Consistency (CC/MLO, Left/Right): "substantially large number of images" from Hologic, GE, and Siemens (exact number not specified).
• Data Provenance: Not explicitly stated (e.g., country of origin). The data included cases from Hologic (Selenia and Dimensions), GE (Senographe and Essential), and Siemens (Mammomat Novation) FFDMs, implying diversity in equipment. The data was "retrospective" as it was used for validation of an already developed software.

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

• Number of Experts: 15 radiologists.
• Qualifications: "radiologists" - no further specific qualifications (e.g., years of experience, subspecialty) are provided in the document.

4. Adjudication Method for the Test Set

• The text describes comparing Quantra values to the "mode (most common) BI-RADS density rating from 15 radiologists" and the "mean value of the 15 radiologists." This indicates a form of consensus-based ground truth derived from multiple readers, but it doesn't specify a formal adjudication method like "2+1" or "3+1" (where differing opinions are resolved by a tie-breaker). It appears to use statistical aggregations (mode or mean) of expert ratings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, a formal MRMC comparative effectiveness study "with AI vs without AI assistance" to measure the effect size of human readers improving with AI assistance was not explicitly described for this 510(k) submission. The studies detailed focus on validating the standalone performance of the Quantra software against existing clinical practices and predicate devices.

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

• Yes, the primary focus of the performance/bench testing described is on the standalone performance of the Quantra algorithm. It generates volumetric and area breast density estimates and segregates breast density into BI-RADS-like categories without human input during the calculation process. Its output is "adjunctive information" for radiologists, implying it functions independently before a radiologist's assessment.

7. The Type of Ground Truth Used

• Expert Consensus: The "mode" and "mean" BI-RADS density ratings from 15 radiologists served as a form of expert consensus ground truth for comparison.
• Predicate Device Output: Results from the predicate device (Quantra Volumetric Assessment for Vbd, Sectra IDS5 Workstation with expert hand-drawn annotations for Abd) were used as ground truth for correlation.
• Other Imaging Modalities: MRI cases were used as ground truth for Vbd validation.

8. The Sample Size for the Training Set

• The sample size for the training set is not specified. The document mentions a "reference database" of "approximately 1,000 patients" used to create Vbd-score and Vfg-score (reflecting standard deviations from the mean in this database), but it's unclear if this was the training set or a separate reference population.

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

• The document does not explicitly describe how the ground truth for any potential training set was established. The focus of the "Performance/Bench Testing" section is on validation against established references and expert opinions, not on the training process itself. If the "reference database" of 1,000 patients was part of a training set, the method for establishing its ground truth is not detailed in the provided information.

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Quantra™ is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.

Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).

Quantra is a software application that estimates breast tissue volumes. The estimations are made from mammography images produced by full-field digital mammography (FFDM) systems.

Here's an analysis of the provided text regarding the Quantra™ device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for the Quantra™ device's performance. It primarily focuses on the device's intended use, regulatory classification, and substantial equivalence to predicate devices. The "performance of the software" is mentioned as being tested "in accordance with Hologic's SOPs and testing procedures to demonstrate adequate performance," but no specific metrics or thresholds for "adequate performance" are detailed in this summary.

Therefore, a table of acceptance criteria and reported device performance cannot be created from the given information.

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

The document does not provide any information regarding the sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of any study data.

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

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not provide any information about an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

The document does not explicitly detail a standalone performance study. While it describes the software's functionality in "calculating volumetric breast density," it doesn't present data from a study that solely evaluates the algorithm's performance against a ground truth without human interaction.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used for any potential testing or validation.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for a training set.

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

The document does not provide any information on how ground truth for a training set was established.

Summary of what is present in the document versus what is missing regarding a performance study:

The provided 510(k) summary primarily focuses on the regulatory aspects of the Quantra™ device:

• Intended Use: Calculating volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates, to aid radiologists in assessment (adjunctive, not diagnostic).
• Regulatory Classification: Class II, Picture Archiving and Communications System.
• Predicate Devices: Sectra IDS5 Workstation and WorkstationOne™ Breast Imaging Workstation.
• Safety and Effectiveness Concerns: Covered by instructions for use, cautions, warnings, risk analysis, software development, verification, and validation testing.
• Conclusion: Substantial equivalence to predicate devices.

Critical Missing Information for a Performance Study:

The document is notably lacking specific details about any clinical validation or performance study that would typically include:

• Defined acceptance criteria (e.g., accuracy, precision, correlation with a gold standard).
• Details of a test dataset (size, characteristics, provenance).
• Methodology for establishing ground truth.
• Results of any performance metrics.
• Information on reader studies or standalone algorithm performance.

This suggests that for this 510(k) submission, the primary evidence for substantial equivalence was likely based on the technological characteristics and intended use being similar to existing cleared predicate devices, supported by internal Hologic SOPs and testing procedures for software performance, rather than a full-scale clinical performance study with detailed numerical results presented in the summary.

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