Search Results

The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only.

The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.

Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.

Here's a breakdown of the acceptance criteria and study information for the Diazyme D-Dimer Assay Kit, Diazyme D-Dimer Assay Calibrator Set, and Diazyme D-Dimer Assay Control Set, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied by comparing the new device's performance to the predicate device and recognized standards like CLSI guidelines. The predicate's correlation coefficient, slope, and intercept were against a different comparator (Asserachrom D-Dimer), so the Diazyme assay provides new comparison values against its chosen predicate (Roche Tina-Quant D-Dimer).

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

The provided document describes the test set as follows:

• Precision (Internal Study):
  • Plasma Samples: 3 levels of pooled citrated plasma (0.60 µg/mL, 2.41 µg/mL, 5.88 µg/mL FEU). Each level had 240 data points (duplicates over 20 days, likely 6 runs per day to get 240, though not explicitly stated as 'runs').
  • Control Samples: 3 levels of D-Dimer controls (0.97, 2.99, 7.47 µg/mL FEU). Each level had 240 data points.
• Precision (External Study):
  • Patient Samples: 4 different patient samples of citrated plasma (0.36, 1.06, 3.53, 7.20 µg/mL FEU).
  • Total Data Points: Not explicitly stated as a single number, but tested in duplicates with 2 runs per day over 5 nonconsecutive working days at three sites, with three lots of reagent, three lots of calibrators, three different operators, and three different instruments. This implies a significant number of data points per sample.
• Method Comparison:
  • Samples: A total of 128 citrated plasma samples (88 unique samples).
  • Range: D-Dimer ranging from 0.17 to 7.95 µg/mL FEU.
  • Provenance: Collected from an "intended target population" (Intensive Care Unit, Obstetrics, Trauma, Post-Operative, and Operating Room). Tested at the manufacturer site and two external clinical laboratories. This suggests a prospective or retrospective collection with prospective testing across multiple sites, with the data coming from diverse patient populations. No specific country of origin is mentioned, but "intended target population" and "external clinical laboratories" suggest it's likely within the US, where the submission is being made.
• Linearity: 11 levels of the D-Dimer linearity set.
• LOB, LOD, LOQ: Specimens with mean measured concentrations ranging from 0.02 to 0.93 were assayed.

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

For this type of in vitro diagnostic device (IVD) for quantitative determination of a biomarker (D-Dimer), the "ground truth" is typically the quantitative value obtained from testing the samples using a well-established, legally marketed reference or predicate method.

• Experts: Not applicable in the traditional sense of clinicians or radiologists reviewing images. The "ground truth" for the method comparison study was established by the Roche Tina-Quant D-Dimer (K062203), which is itself a legally marketed, validated assay.
• Qualifications: The "qualification" of the ground truth in this context relies on the regulatory approval and established performance of the predicate device. The analysis was performed by laboratory personnel following standard laboratory practices, as implied by the CLSI (Clinical and Laboratory Standards Institute) guidelines cited.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of subjective data (e.g., imaging where multiple readers provide independent assessments).

• Adjudication Method: None was explicitly mentioned or implied. For quantitative biomarker assays, adjudication is not typically used. The accuracy of the Diazyme D-Dimer Assay was compared directly to the quantitative results from the predicate device (Roche Tina-Quant D-Dimer K062203) using statistical methods like regression analysis.

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

• MRMC Study: No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
• Reason: This device is an in vitro diagnostic (IVD) assay that quantitatively measures D-Dimer in human plasma. It does not involve human readers interpreting images or data where AI assistance would be relevant. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

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

• Standalone Performance: The study inherently demonstrates standalone performance of the Diazyme D-Dimer Assay. The device is an automated, immunoturbidimetric assay for quantitative determination of D-Dimer. Its performance (precision, linearity, method comparison, LOB/LOD/LOQ, interference) was evaluated as a standalone analytical system, with the instrument calculating concentrations based on the optical measurements and its calibration curve. There is no human-in-the-loop performance described in the context of interpretation or output modification for this type of IVD.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the method comparison study was the quantitative D-Dimer concentration results obtained from the predicate device, Roche Tina-Quant D-Dimer (K062203). This is a common approach for IVD assays, where a new device's performance is gauged against an approved, established method.
  • For other performance metrics like LOB/LOD/LOQ and linearity, the ground truth is established by carefully prepared standards and dilutions, and statistical models applied to the measurements.

8. The Sample Size for the Training Set

• Training Set: The document does not describe a "training set" in the context of machine learning. This device is a biochemical assay, not an AI/ML-based device that requires a separate training set for algorithm development.
  • However, the calibration curves are established using a 6-point calibration curve (stated in Assay Principle). The Diazyme D-Dimer Calibrator Set consists of 5 calibrators plus saline (Cal 0). These calibrators are used to "train" the instrument to accurately translate turbidity measurements into D-Dimer concentrations for each assay run.

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

• As explained above, there is no "training set" for an AI/ML algorithm.
• For the calibration curve, the "ground truth" concentrations of the calibrator set are established during the manufacturing process of the Diazyme D-Dimer Calibrator Set. This process involves precise formulation and validation of the D-Dimer concentrations in each calibrator level. These assigned values are then used by the instrument to generate the standard curve against which patient samples are measured.

Ask a specific question about this device

Ask a specific question about this device

System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers.

Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.

In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles

The Olympus D-Dimer Test System, consisting of the Olympus D-Dimer Reagent, Calibrator, and Control, is intended for the quantitative determination of D-Dimer in human plasma on Olympus analyzers. It is designed to aid in detecting the presence and degree of intravascular coagulation and fibrinolysis and in monitoring therapy for disseminated intravascular coagulation.

Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary compares the Olympus D-Dimer Test System with the predicate device, Roche Tina-Quant® D-Dimer Test System. The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate, with specific performance characteristics indicating acceptable levels.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size for the test set used in performance evaluations (e.g., precision, method comparison, interfering substances). It refers generically to "samples" for precision and provides a "Range" for method comparison without indicating the number of individual patient samples.
The data provenance (country of origin, retrospective/prospective) is not specified.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement, and its performance is assessed against established analytical methods and reference standards, not against expert human interpretation of images or other diagnostic findings.

4. Adjudication Method for Test Set

Not applicable. Clinical test performance is determined by a quantitative measurement against a comparative method.

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

Not applicable. This is an in vitro diagnostic device for quantitative chemical analysis, not a medical imaging or diagnostic aid that involves human reader interpretation.

6. Standalone (Algorithm Only) Performance

Yes, the performance characteristics (Precision, Assay Range, Analytical Sensitivity, Method Comparison, Interfering Substances, Stability) represent the standalone performance of the Olympus D-Dimer Test System, as measured on Olympus analyzers, without human intervention in the result generation beyond operating the instrument.

7. Type of Ground Truth Used

The ground truth for evaluating the Olympus D-Dimer Test System implicitly relies on:

• A commercially available assay (predicate device, Roche Tina-Quant® D-Dimer) for method comparison. This assay itself would have been validated against a traceable standard.
• In-house Master Calibrator: The Olympus D-Dimer Test System is traceable to an in-house Master Calibrator.
• Defined concentrations/levels: For precision studies, specific "samples" (likely control materials or spiked plasma) are used with known D-Dimer concentrations. For interfering substances, known concentrations of bilirubin, hemoglobin, rheumatoid factor, heparin, and lipids are added to samples.

8. Sample Size for the Training Set

Not applicable. This is an analytical immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI/ML algorithms. The development and optimization of the reagent and assay would involve various experimental and testing phases, but these are not referred to as training sets.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is performed using a 6-point calibration curve, which is described as being traceable to an in-house Master Calibrator and aligned with another commercially available test system. This establishes the analytical accuracy of the measurements.

Ask a specific question about this device

For the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.

The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Latex particles of uniform size are coated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-dimer lead to an increase in the turbidity of the test reactants, which can be determined turbidimetrically. The calibrator is D-Dimer calibrator and the recommended control material is D-dimer Control I/II.

Here's an analysis of the provided text regarding the Tina-Quant D-Dimer Test System, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text describes the results of the studies but does not explicitly state predefined acceptance criteria (e.g., "The device must achieve a sensitivity of at least 95%"). The phrase "excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity" implies that the reported values (99.3%, 99.4%, 0.6% for DVT and 100%, 100%, 0% for PE) met the internal criteria for "high sensitivity."

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

• DVT Exclusion Study:
  • Sample Size: 812 outpatients with suspected DVT.
  • Data Provenance: Multicenter management study. The country of origin is not specified but is likely within regions where such clinical studies are conducted (e.g., North America, Europe) given the 510(k) submission to the FDA. The study is prospective in nature as patients were followed up for 3 months for development of DVT.
• PE Exclusion Study:
  • Sample Size: 168 outpatients with suspected PE.
  • Data Provenance: Management study. The country of origin is not specified. The study is prospective in nature as patients were followed up for 3 months for development of PE.

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

The text does not provide information on the number of experts or their qualifications for establishing the ground truth for the DVT and PE diagnoses. The ground truth (development of DVT or PE) was determined by "further diagnostic testing" (for patients not excluded by D-Dimer and Wells score) and clinical follow-up over 3 months. This typically involves established medical diagnostic procedures and clinical outcomes, implicitly involving medical professionals, but specific details about expert panels are absent.

4. Adjudication Method for the Test Set

The text does not describe an explicit adjudication method (e.g., 2+1, 3+1 for discrepancies) for establishing the ground truth diagnoses of DVT or PE. The studies followed a management strategy:

• Patients with a non-high Wells score and a normal D-Dimer were not subjected to further diagnostic testing but were followed clinically for 3 months.
• Patients who did not meet these exclusion criteria presumably received standard diagnostic workups for DVT/PE which would establish the ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The studies described are management studies evaluating the performance of the Tina-Quant D-Dimer test in conjunction with clinical probability assessment (Wells score) for excluding DVT and PE, rather than comparing human reader performance with and without AI assistance. The device itself is an in vitro diagnostic (IVD) test, not an AI imaging or diagnostic algorithm designed to assist human readers.

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

Yes, in a sense, the performance metrics reported (sensitivity, NPV, failure rate) reflect the standalone diagnostic utility of the D-Dimer test when used in conjunction with a clinical probability assessment. The "algorithm" here is the combined clinical probability assessment (Wells score) + D-Dimer cutoff. The reported outcomes (e.g., "Only one of 176 such patients developed DVT") are based on the result of this combined diagnostic strategy, where a particular result (non-high PTP + normal D-Dimer) leads to no further testing and a subsequent clinical follow-up. While there's a human in the loop for the Wells score assessment, the test itself has a standalone numerical result.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / clinical diagnosis, specifically:

• For patients who were not excluded by the D-Dimer + Wells score, the ground truth for DVT/PE would likely be established by conventional diagnostic imaging (e.g., ultrasound for DVT, CTPA for PE).
• For the patients who were excluded (non-high PTP + normal D-Dimer), the ground truth was established by absence of clinical events (DVT/PE) during a 3-month follow-up period. The "failure rate" indicates how many of these excluded patients did develop the condition. This indicates that a combination of clinical outcomes and potentially further diagnostic testing was used for the entire study cohort.

8. Sample Size for the Training Set

The text does not provide information on a training set sample size. This is an in vitro diagnostic (IVD) device, which typically undergoes analytical validation (precision, accuracy, measuring range, etc.) and then clinical validation (as described here). The clinical studies presented are for validation/testing, not for training a machine learning model.

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

As no training set is described for a machine learning context, this question is not applicable based on the provided text. The device is an immunoturbidimetric assay, not an AI/ML diagnostic.

Ask a specific question about this device

The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens.

The provided document describes the Triage® D-Dimer Test, a fluorescence immunoassay for quantitative determination of D-dimer in blood and plasma. The K042890 submission establishes its substantial equivalence to a predicate device, the Triage® Profiler S.O.B. Panel (K040437).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance thresholds for sensitivity, specificity, accuracy, etc. Instead, it describes a method comparison study to demonstrate "substantial equivalence" to a predicate device, which implies that its performance should be comparable to the established predicate.

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

• Sample Size for Test Set: 180 specimens.
• Data Provenance: Not specified in the provided document. It does not mention the country of origin or whether the data was retrospective or prospective.

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

Not applicable. This device is an in-vitro diagnostic test. The "ground truth" for the method comparison was based on the results from the predicate device, not on expert consensus or adjudication. The document does not mention any human readers or experts used to establish a ground truth for the device's performance in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth was based on a predicate device's results, not on interpretation by experts requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. The study performed was a method comparison study between the new device and a predicate device.

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

Yes, the study described is a standalone performance assessment of the Triage D-Dimer Test. It directly compares the quantitative results of the Triage D-Dimer Test to a predicate method, without involving human interpretation or a human-in-the-loop component for the device being evaluated.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the results obtained from the predicate device. The underlying "ground truth" for D-dimer measurements in general would be the actual concentration of D-dimer in the specimens, as measured by a validated method.

8. The Sample Size for the Training Set

The document does not provide information about a training set. The study described is an analytical performance study (method comparison) using 180 specimens. It is possible that the device underwent internal development and validation with other data, but this is not detailed in the 510(k) summary.

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

Not applicable, as no training set details are provided in the document.

Ask a specific question about this device

Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.

The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.

This is a 510(k) summary for a D-Dimer test system, which is an in vitro diagnostic device. The provided text does not include the specific acceptance criteria or the study data proving the device meets those criteria. It focuses on the device's description, intended use, and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor the details about the study design, sample sizes, expert involvement, and ground truth for a performance study.

The text does provide information in some of the other requested categories based on the context of a 510(k) submission for an in vitro diagnostic:

1. A table of acceptance criteria and the reported device performance:
* Not Available in the provided text. This information is typically found in the performance studies section of a 510(k) submission, detailing sensitivity, specificity, accuracy, precision, linearity, etc., and statistical results compared to pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not Available in the provided text.

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/Available in the provided text. For an in vitro diagnostic device like a D-Dimer test, "ground truth" for a test set would typically be established by a reference method (e.g., another established D-Dimer assay, or clinical outcome data if demonstrating clinical utility), rather than by human expert consensus in the way a medical imaging device might. The document does not mention details of the reference method used in any performance studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not Applicable/Available in the provided text. Adjudication methods are typically used when human interpretation of data (e.g., images) forms part of the ground truth or comparison, which is not the case for this type of quantitative biochemical assay.

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. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Yes, by nature of the device. The Tina-quant® D-Dimer Test System is an automated immunoturbidimetric assay. Its performance is inherently standalone, as it provides quantitative results directly from a plasma sample without human interpretation of raw data beyond reading the numerical output. The "algorithm" in this context refers to the chemical and optical reactions and the instrument's processing of the turbidity changes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated in the provided text. For an in vitro diagnostic device like this, the "ground truth" in a validation study would typically be established by a well-characterized reference method or by clinical diagnosis/outcomes against which the D-Dimer levels are correlated.

8. The sample size for the training set:
* Not Applicable/Available in the provided text. This is an automated assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" of such an assay involves chemical formulation and calibration, not algorithm training on data.

9. How the ground truth for the training set was established:
* Not Applicable/Available in the provided text due to the nature of the device (see point 8).

Ask a specific question about this device

MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quantitative determination of crosslinked fibrin degradation products containing the D-dimer domain in citrated human plasma. MDA D-Dimer is an assay for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep vein thrombosis (DVT) in outpatients suspected of a first episode of DVT. MDA D-Dimer can also be used as and in the assessment and evaluation of patients suspected of pulmonary embolism (PE). The assay is designed for use on the MDA automated coagulation analyzers.

bioMerieux Inc. MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quatitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citrated human plasma. These latex particles aggregate in the presence of fibrin derivatives containing the D-dimer domain. The rate of latex microparticle aggregation is proportional to the concentration of D-dimer in the sample. D-dimer concentration may be interpolated from a reference curve.

This summary describes the acceptance criteria and the study proving the MDA® D-Dimer device meets these criteria.

Acceptance Criteria and Device Performance

Study Details for Clinical Performance (DVT Exclusion)

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 556 consecutive eligible outpatients.
   • Data Provenance: Multi-center, prospective cohort study conducted at three hospitals. The country of origin is not explicitly stated but is implied to be the USA given the submission to the FDA by a US-based company.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It mentions that an MDA D-Dimer test was performed on presentation without knowledge of the Pre-test Probability Assessment (PTP) results. The "ground truth" for DVT diagnosis in patients with a positive D-Dimer and/or high PTP was established through serial compression ultrasound (CUS). For patients with a negative D-Dimer and low/moderate PTP, they underwent no further diagnostic testing but were "followed up for 3 months for development of DVT," which implies clinical outcomes as part of the ground truth.

3. Adjudication method for the test set:

   • The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the diagnosis of DVT. The ground truth appears to be based on a combination of diagnostic imaging (serial CUS for some) and clinical follow-up for outcomes.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the clinical performance described ("The sensitivity, specificity and negative predictive value of the MDA D-Dimer assay for a clinical cut off of 0.50 µg FEU/n1") represents the standalone performance of the assay when used in conjunction with a clinical PTP model. The assay itself (MDA D-Dimer) generates a quantitative output. The clinical "human-in-the-loop" component is the interpretation of that output in the context of the PTP model, but the assay's performance metrics are standalone for its measurement capabilities.

6. The type of ground truth used:

   • The ground truth for DVT diagnosis was a combination of:
     • Diagnostic Imaging: Serial compression ultrasound (CUS) for patients with a positive MDA D-Dimer and/or high Pre-test Probability (PTP).
     • Clinical Outcomes Data: 3-month follow-up for development of DVT in patients with a negative MDA D-Dimer test result and a low or moderate PTP.

7. The sample size for the training set:

   • The document does not specify a training set for algorithm development for the MDA D-Dimer assay. As an immunoassay, its "training" pertains more to establishing its analytical performance parameters (linearity, precision, etc.) and defining a clinical cutoff value. It states that a "clinical cut off value of 0.50 ug FEU/ml previously validated in an accuracy study" was used, suggesting prior studies informed this threshold, but no sample size for that "accuracy study" is provided here.

8. How the ground truth for the training set was established:

   • As noted above, a formal "training set" in the AI/machine learning sense is not applicable here for this immunoassay. However, the clinical cutoff value of 0.50 µg FEU/ml was "previously validated in an accuracy study." The mechanism for establishing ground truth within that prior accuracy study is not detailed in this document.

Ask a specific question about this device

Ask a specific question about this device

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.

While the provided text indicates that the Simplify D-dimer device received 510(k) clearance (K993276) from the FDA, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a clearance letter, stating that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use (aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis, and pulmonary embolism). It outlines regulatory responsibilities and contacts, but does not include the technical details of the performance study that would have supported the substantial equivalence claim.

Therefore, I cannot provide the requested information based solely on the provided input. To answer your questions, I would need access to the actual 510(k) submission summary or other detailed performance study reports for the Simplify D-dimer device.

Ask a specific question about this device

OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.

OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.

Here's a breakdown of the acceptance criteria and study information for the Behring Diagnostics Inc. OPUS® D-Dimer device, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in the format of pass/fail thresholds for the device's performance. Instead, it presents performance characteristics determined through several studies. The underlying acceptance is implied by the FDA's "substantial equivalence" determination, meaning the performance is considered comparable and safe/effective relative to the predicate device.

However, we can infer the reported device performance from the "Device Performance Characteristics" section.

Table of Performance Characteristics:

The document doesn't provide a typical "acceptance criteria" table with specific targets. Instead, it reports the resulting performance metrics from the studies conducted.

Study Details

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

• Accuracy by Correlation: 321 human plasma samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the samples were collected retrospectively or prospectively. It refers to "human plasma samples."

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

• This information is not provided in the document. For in vitro diagnostic devices like D-Dimer assays, "ground truth" is typically established by comparing the device's results to a recognized reference method or a legally marketed predicate device. The document uses the "ASSERACHROM® D-Di" as the comparator for accuracy by correlation, implying its results served as the reference. There's no mention of human experts establishing ground truth for the D-Dimer levels in the plasma samples.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The evaluation methods described (precision studies, recovery studies, and correlation with a predicate device) do not involve adjudication by multiple human readers in the way typically seen for medical imaging or clinical decision support AI devices. The comparison is between the new device and a reference method.

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 comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic aids that assist human interpretation (e.g., radiologists reading images). The OPUS D-Dimer is a standalone in vitro diagnostic assay that quantitatively measures a biomarker, not a device that assists human readers in interpreting clinical cases.

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

• Yes, the OPUS D-Dimer is an in vitro diagnostic standalone device. Its performance characteristics (precision, recovery, and correlation with another assay) are reported for the device itself, without human-in-the-loop interpretation being part of the primary performance evaluation. It's an automated fluorometric immunoassay system.

7. The Type of Ground Truth Used

• For the "Accuracy by Correlation" study, the ground truth was effectively the results obtained from the legally marketed predicate device, ASSERACHROM® D-Di, which is a "commercially available D-Dimer assay." For precision and recovery studies, the ground truth was based on pre-defined control materials or spiked samples with known concentrations.

8. The Sample Size for the Training Set

• This document does not mention a "training set" in the context of machine learning or AI models. The OPUS D-Dimer is an immunoassay system. While the system would have undergone internal development, calibration, and validation, the concept of a separate "training set" and "test set" for an AI algorithm is not applicable here. The reported studies describe analytical performance evaluation, not AI model deployment.

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

• As mentioned above, the concept of a "training set" for an AI model is not applicable to this device. For the development and calibration of the immunoassay, ground truth would have been established through highly characterized reference materials and established laboratory methods. The document does not provide details on the specific methods used for establishing these intrinsic reference values during product development.

Ask a specific question about this device