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The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.

The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.

The provided 510(k) summary for the INRatio/INRatio2 Test Strips focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical performance testing. It explicitly states that no clinical data was presented or performed for this submission. Therefore, the information requested in the prompt regarding acceptance criteria, clinical study details, sample sizes for test/training sets, expert involvement, and ground truth establishment primarily relates to clinical studies, which are absent in this submission.

However, based on the provided text, I can extract information about the non-clinical performance testing and the basis for the substantial equivalence determination.

Here's the breakdown of what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance:

Since no clinical data is presented, there are no specific clinical acceptance criteria or reported clinical performance metrics in this document. The document refers to non-clinical performance testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided in the document. The document only mentions "Performance testing" without specifying sample sizes for the non-clinical tests or their provenance.

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/Not provided. This question pertains to clinical studies and expert review for ground truth, which were not part of this submission by explicit statement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. This question pertains to clinical studies and ground truth establishment, which were not part of this submission.

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 a Prothrombin Time (PT) monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.

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

Not applicable. This question typically applies to AI algorithms. This device is a PT monitoring system (monitor + test strips), which measures PT directly. Its performance is inherent in the device itself, not an algorithm's interpretation of human-generated data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not provided for non-clinical testing. For the non-clinical performance, the "ground truth" would be established by reference methods or validated laboratory techniques for precision, accuracy, sensitivity, etc., but the specific methodologies are not detailed in this summary.

8. The sample size for the training set:

Not applicable/Not provided. This refers to machine learning algorithms, which are not explicitly mentioned or the focus of this submission. "Training set" typically refers to data used to train an AI model.

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

Not applicable/Not provided. As with point 8, this refers to machine learning algorithms.

Summary of Study (Based on Provided Text):

The study was a non-clinical performance comparison of the modified INRatio/INRatio2 Test Strips against the previously cleared INRatio Test Strips (predicate device, K072727).

• Objective: To verify that the modified INRatio2 Test Strips have equivalent or better performance compared to the predicate device.
• Methodology: Performance testing was conducted to evaluate "within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents."
• Results: The testing "verified that the modified INRatio2 Test Strips have equivalent or better performance" across all assessed parameters.
• Conclusion: Based on this non-clinical data, the INRatio2 Test Strips were deemed substantially equivalent to the predicate device.
• Clinical Data: No clinical validation testing was performed for this submission, as explicitly stated and as per discussions with the reviewer. This implies the substantial equivalence was primarily based on the non-clinical performance data demonstrating that the modifications did not alter the fundamental performance characteristics beyond what was previously cleared.

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The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic assay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.

This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The One Step EDDP (Methadone Metabolite) Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of anti-EDDP antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region. This confirms sufficient specimen volume, adequate membrane wicking and correct

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical targets. Instead, the "Accuracy" and "Analytical Sensitivity" sections describe the performance that was evaluated and found acceptable. The "Overall Agreement with GC/MS Analysis" of 98% is the primary performance metric for accuracy.

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

• Sample Size for Accuracy Study (Clinical Study): 549 specimens across three clinical sites (183 specimens per site).
• Sample Size for Analytical Sensitivity Study (Spiked Samples): 630 tests (90 tests at each of 7 different EDDP concentrations).
• Data Provenance: The text does not specify the country of origin of the data. The clinical study was performed at "three external clinical study sites," suggesting prospective collection for the purpose of this evaluation. The analytical sensitivity study used "drug-free urine pool[s] spiked with EDDP," indicating laboratory-controlled, prospective data generation.

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

• Number of Experts: The document states that the testing for the accuracy study was performed by "3 different employees performing the testing" at the clinical sites for the One Step EDDP Test Strip. However, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the "experts" in this context would be the technicians or analysts operating the GC/MS.
• Qualifications of Experts: The document does not specify the qualifications of the personnel operating the GC/MS.

4. Adjudication Method for the Test Set

• The document implies a direct comparison of the One Step EDDP Test Strip results to the GC/MS results. There is no mention of an "adjudication method" involving multiple human readers for either the test device results or the GC/MS results. The GC/MS is presented as the reference method ("preferred confirmatory method"), suggesting its results were considered definitive for ground truth.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a diagnostic test strip, not an AI-assisted diagnostic tool for interpretation by human readers.

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

• Yes, the performance data presented is for the "One Step EDDP (Methadone Metabolite) Test Strip" itself, without human interpretation influencing the reported accuracy against GC/MS. The test is designed to provide a "visual, qualitative result," which is then compared to the GC/MS. While a human reads the test strip, the reported accuracy reflects the strip's ability to correctly indicate the presence or absence of EDDP at the cutoff, rather than a human's ability to interpret complex images or data. The "Analytical Sensitivity" section, especially with spiked samples, is a clear standalone performance evaluation.

7. The Type of Ground Truth Used

• The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is described as the "preferred confirmatory method" and the "reference method" against which the device's accuracy was compared.

8. The Sample Size for the Training Set

• The document does not provide details on a separate "training set" or its sample size. This type of immunoassay device typically does not involve a machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on the chemical and immunological properties built into the strip. The studies described are for validation/testing.

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

• As there's no mention of a traditional "training set" for a machine learning algorithm, this question is not applicable. The device's performance is inherently linked to its design and manufacturing specifications.

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The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.

This submission describes Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set, which are assayed quality control materials used to monitor the performance of specific Triage® tests (Troponin I, BNP, Cardio2 Panel, Cardio3 Panel) and the Triage® Meter. The device is being compared to a predicate device, the Triage® Total 5 Controls and Calibration Verification Set.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the new device. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "performance testing." The key performance characteristic mentioned is "value assignment and stability."

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

The document does not provide specific details on the sample size used for the performance testing. It generally refers to "bench performance testing."

It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given that it's a Triage® product, the test is likely performed in clinical laboratories, which could be in the US or other regions where Triage® products are used. The testing described appears to be laboratory-based ("bench performance testing") rather than patient-based.

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

Given that this device is a quality control material, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologists interpreting images) is not applicable. The "ground truth" in this context would be the accurately determined concentrations of the analytes (CKMB, cardiac troponin I, and BNP) within the control materials. These values are established through rigorous analytical methods and reference standards, not human expert consensus. The document does not specify the number or qualifications of experts involved in this process, as it falls under standard quality control manufacturing practices.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for quality control materials is established through analytical validation and reference methods, not human adjudication.

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

No. This is a quality control material for in vitro diagnostic tests, not an AI or imaging device that would involve human readers. Therefore, an MRMC study is not relevant.

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

Yes. The performance testing described (value assignment and stability) represents standalone performance of the control materials in conjunction with the Triage® meter/assays, without direct human intervention in the "performance" aspect itself beyond standard laboratory procedures for running controls. The device's function is to objectively monitor the performance of other diagnostic tests.

7. Type of Ground Truth Used

The "ground truth" for this type of device would be the analytically determined concentrations of the target analytes (CKMB, cardiac troponin I, and BNP) within the control materials, established through validated reference methods and traceable standards. The document doesn't explicitly detail the methodology for establishing these values but implies they are part of the "value assignment" process.

8. Sample Size for the Training Set

Not applicable. This device is a quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device involves the manufacturing process and analytical validation.

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

Not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the target values) for such quality control materials are established during their development and manufacturing through precise analytical methods.

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The Triage® CardioProfilER® Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage® Profiler S.O.B.TM (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peotide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

The Triage CardioProfilER Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are builtin control features that ensure that the test was performed properly and the reagents were functionally active.

The Triage Profiler S.O.B. Panel is a single-use device containing murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myodlobin, murine monoclonal and qoat polyclonal antibodies against troponin I, murine monoclonal antibodies against D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that the test was performed properly and the reagents were functionally active.

The Test Cartridges are inserted into the Triage Meter and results for each analyte are measured and displayed on the display screen or printout. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

This 510(k) summary (K080269) describes the Triage CardioProfilER Panel and the Triage Profiler S.O.B. Panel, which are fluorescence immunoassays used with Triage Meters for the quantitative determination of various cardiac and circulatory markers in EDTA whole blood and plasma specimens.

The submission focuses on establishing substantial equivalence to a predicate device, the Biosite Triage BNP Test (K051787), particularly for the use of BNP in risk stratification of heart failure patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the Triage CardioProfilER Panel or the Triage Profiler S.O.B. Panel.

Instead, the submission states that:

• "The devices and test methods described in this Premarket Notification for the Triage CardioProfilER Panel and the Profiler S.O.B. Panel are identical in principle, reagents and procedure to their predecessors."
• "More specifically, the BNP assays included in these panels are identical to the BNP assay used in the Triage BNP Test (K051787)."
• "Therefore, the use of the Triage CardioProfilER and the Profiler S.O.B. Panels as an aid in the risk stratification of patients with heart failure is substantially equivalent to the predicate method."

This indicates that the acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to the previously cleared predicate device (K051787) through comparison of their identical principles, reagents, and procedures, rather than presenting new performance data against specific numerical targets.

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

The document does not specify any sample sizes used for a test set or data provenance for a study proving device performance. The submission relies on the substantial equivalence of the new devices to the predicate.

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

Not applicable. No de novo study featuring a test set with ground truth established by experts is described in the provided document.

4. Adjudication Method for the Test Set

Not applicable. No de novo study featuring a test set with adjudication is described in the provided document.

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

No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The devices are diagnostic assays, not AI-assisted interpretation tools for image analysis.

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

The document does not describe a standalone performance study in the sense of an independent algorithm's performance. The devices are immunoassay panels that produce quantitative measurements. Their performance is indirectly addressed by claiming identity to previously-cleared assays within the predicate device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation of the new devices, as it primarily relies on substantial equivalence. For the predicate device's clearance (K051787), it would have been expected that clinical diagnosis, pathology, or patient outcomes data were used as ground truth for establishing the performance characteristics of the individual assays (CK-MB, myoglobin, troponin I, BNP, D-dimer).

8. The Sample Size for the Training Set

Not applicable. The document does not describe an AI or machine learning model that would require a "training set" in the context of typical AI device submissions. These are immunoassay panels.

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

Not applicable. As above, there is no mention of a training set or its associated ground truth establishment methods for these immunoassay panels.

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The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.

The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at < -20℃. Preservatives and stabilizers are added to maintain product integrity. The quality control materials are not calibrators and are not used to calibrate the Triage Test Devices.

The provided text is a 510(k) summary for Triage Total Controls 5 / Triage Total Calibration Verification 5. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information related to specific acceptance criteria or the details of a study that proves the device meets those criteria.

Instead of presenting quantitative acceptance criteria and detailed study results, the document states:

• "The stability of the Triage Total Controls 5 and the Triage Total Calibration Verification 5 have been validated according to established procedures at the manufacturing site."
• "The performance of the control materials are similar to other products in commercial distribution intended for similar use."
• "The Triage Total Controls 5 and Triage Total Calibration Verification 5 employ similar characteristics to the predicate device including multi-analytes assay control, 5 levels, liquid control, EDTA human plasma matrix and ≤ -20℃ storage condition."
• "The information presented in this Premarket Notification demonstrates the suitability of the device for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution."

Therefore, based solely on the provided text, I cannot fill out the requested table and answer many of the detailed questions about the study design, sample size, ground truth, and expert involvement.

Here's what can be stated based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "established procedures at the manufacturing site," implying internal company testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This device is a quality control material for in vitro diagnostic tests, not an AI/imaging device requiring expert interpretation of results for ground truth. Therefore, this question is not applicable in the context of this 510(k) summary. The ground truth for this type of device would typically be established through analytical methods and certified reference materials or established laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/imaging device 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. This device is a quality control material and not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• While not explicitly stated as "ground truth," the performance of quality control materials is typically verified against:
  • Defined levels: The document states they are "prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels." These defined levels act as the analytical "ground truth."
  • Established analytical methods: Performance would be compared to expected values using reference methods or the target Triage® test systems.

8. The sample size for the training set

• Not applicable. This is a quality control material, not a machine learning model that requires a "training set."

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

• Not applicable. This device does not have a "training set" in the context of machine learning.

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The Triage Protein C Controls are assayed materials to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance.

The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.

The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at < -20°C. The liquid external quality control materials are not calibrators and are not used to calibrate the Triage Protein C Test.

Here's a breakdown of the acceptance criteria and the study details for the Triage Protein C Test controls, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text for the Triage Protein C Test controls does not explicitly state numerical acceptance criteria for precision or accuracy. Instead, it uses qualitative descriptors for performance.

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

• Test Set Sample Size: 240 coded samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "three different sites," which suggests a multi-center study, but it doesn’t specify if these were in the US or other countries. The study appears to be prospective as it describes the evaluation of the controls.

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 quality control materials, the "ground truth" (expected values) is typically established through a rigorous process of assaying the control material using a reference method or multiple validated methods, often involving independent laboratories or highly calibrated instruments. The document refers to "expected values" but doesn't detail how these were established or if experts were involved in setting them.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods are typically relevant for studies where a "true" diagnosis or classification needs to be resolved among multiple interpretations (e.g., by different readers). For a study evaluating controls against "expected values," a formal adjudication method as described (e.g., 2+1, 3+1) is less applicable. The "expected values" themselves serve as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 study is for quality control materials for an instrument, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not relevant to this submission.

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

• No, this is not applicable. The device is a set of control materials used with an assay (the Triage Protein C Test), not an algorithm or an AI system. The study evaluates the performance of these control materials in monitoring the assay's performance.

7. The Type of Ground Truth Used

• The ground truth used was based on "expected values" for protein C concentrations in the control materials. How these "expected values" were precisely determined (e.g., against a reference standard, by a consensus of multiple validated assays, or pathology results) is not explicitly detailed beyond the mention of prepared materials 'at defined levels'. It's implied that these 'defined levels' are the reference.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a control material, not an algorithm or AI model that requires a training set.

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

• This information is not applicable for the same reason as in point 8.

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The Triage® Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active. The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

The provided text describes a 510(k) summary for the Triage® Protein C Test, a rapid, point-of-care fluorescence immunoassay. However, it does not contain specific acceptance criteria (performance targets for sensitivity, specificity, accuracy, etc.) or a detailed study report that proves the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Asserachrom® Protein C Kit) through a method comparison study. It establishes that the new device yields similar results to the predicate.

Given the information, I can extract and infer the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., "The device must achieve >90% sensitivity"). Instead, the fundamental "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device.

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

• Sample Size for Test Set: 225 split patient samples.
• Data Provenance: The samples were collected from patients who presented with suspected or proven infection, evidence of systemic inflammation, and at least one sepsis-induced organ failure. This suggests a prospective collection within specific clinical settings (sepsis patients). The study was conducted at three independent clinical laboratory sites, but their geographical location (country of origin) is not specified.

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

This information is not provided in the document. The "ground truth" in this context is implicitly the measurement from the predicate device. Experts would typically be involved in interpreting patient conditions or establishing true disease states for diagnostic accuracy studies, which is not the primary focus here (it's a method comparison).

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant when establishing a "ground truth" through expert consensus, especially when there's disagreement among reviewers of images or clinical data. In this method comparison study, the "truth" for comparison is the result from the predicate device.

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

• Was it done? No, a MRMC comparative effectiveness study was not done. This study is a method comparison between the new device and a predicate device, focusing on quantitative agreement. It does not involve human readers interpreting results with and without AI assistance to assess improved effectiveness.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was performed.

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

• Was it done? Yes, this study effectively represents a standalone performance. The Triage Protein C Test is a fully automated immunoassay read by the Triage Meter. Its performance, as compared to the predicate device, is the standalone performance of the device and its associated meter. The study compared the quantitative output of the Triage Protein C Test directly against the predicate method on patient samples.

7. Type of Ground Truth Used:

• The "ground truth" for this method comparison study was the results obtained from the predicate device, Asserachrom® Protein C Kit (K854016). The study aimed to show that the Triage Protein C Test's measurements align with those of the legally marketed predicate device.

8. Sample Size for the Training Set:

This information is not provided. The document describes a study to validate the device's performance, but it does not mention a separate training set. For immunoassay devices, "training" (calibration curve establishment, reagent optimization) is typically part of the manufacturing and development process, rather than a distinct "training set" of patient data as might be seen for machine learning algorithms. The language used ( "manufactured reagents along with patient and quality control samples with measured Protein C values") implies the use of quality control samples which might be analogous to training data but it's not explicitly stated.

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

This information is not provided, as details about a distinct "training set" are absent. For the development and calibration of such an immunoassay, the "ground truth" would be established by reference methods or highly characterized calibrators.

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The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

This appears to be a 510(k) summary for a medical device called "Triage® TOX Drug Screen Controls." This specific document is a premarket notification for a control material, not a diagnostic device or an AI-powered system that requires performance studies with acceptance criteria in the traditional sense described in your request.

The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Biosite Triage® TOX Drug Screen Controls K050037). Therefore, the "study" is a comparison to a legally marketed device rather than a performance study against predefined clinical acceptance criteria.

Here's how to address your questions based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for performance in the way a diagnostic device would (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criterion implicitly is "substantial equivalence" to the predicate device.
   • Reported Device Performance: Instead of performance metrics, the document provides a table comparing characteristics to the predicate device. This comparison serves as the "proof" of substantial equivalence.

   Characteristic	Acceptance Criteria (Implicit: Substantially Equivalent to Predicate)	Reported Device Performance (Proposed Device Characteristics)
   Intended Use	Assayed control for monitoring urine-based drugs of abuse assays	Assayed control for monitoring urine-based drugs of abuse assays
   Matrix	Human Urine	Human Urine
   Form	Liquid	Liquid
   Analytes	Commonly abused drugs	Commonly abused drugs
   Storage	-20 °C or colder	-20 °C or colder

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not applicable. This is not a clinical performance study with patient samples. The "test set" is essentially the characteristics of the proposed control material being compared to the predicate.
   • Data Provenance: Not applicable. The "data" here refers to the specifications and qualitative characteristics of the control materials themselves, not clinical data from patients.

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. There is no "ground truth" in the sense of expert assessment of clinical cases. The ground truth for the control material is its chemical composition and intended function as defined by the manufacturer for monitoring performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This isn't a study involving human readers or interpretation.

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. This is a control material, not a diagnostic device involving human readers or AI.

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

   • No. This is a control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for a control material is its manufactured composition and the established values/ranges determined during its production, ensuring it challenges the assay appropriately. This document implies that the "truth" is that the proposed control is essentially the same as the predicate in its fundamental properties.

8. The sample size for the training set

   • Not applicable. This is a physical control material, not an AI model or a device requiring a training set in that context.

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

   • Not applicable. See point 8.

In summary: This 510(k) pertains to a control material used to monitor the performance of drug screen tests, not a diagnostic device or an AI-powered system that would typically undergo the types of performance studies you've outlined. The "study" here is a qualitative comparison demonstrating the new control material is substantially equivalent in its characteristics and intended use to a previously cleared predicate device.

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The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.

The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added.

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen Methadone assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document focuses on the substantial equivalence of the new Methadone assay to a previously cleared device. The primary performance metric presented is the overall agreement with the predicate device and the confirmation by GC/MS for discordant samples.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 102 specimens
• Data Provenance: Obtained from clinical sources (retrospective, collected from patients for whom testing was clinically indicated). The country of origin is not specified, but the submission is to the FDA in the US, suggesting the data is likely from the US.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The primary ground truth for discordant samples was established using Gas Chromatography/Mass Spectroscopy (GC/MS), which is an analytical chemical method and not a human expert consensus.

4. Adjudication Method

• Not applicable / None specified for clinical samples. The comparison relies on the Triage 8 Panel for Drugs of Abuse as a predicate and GC/MS for discrepancy resolution. There's no indication of multiple human readers adjudicating results.

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

• No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) assay designed for qualitative determination of substances, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply in this context.

6. Standalone (Algorithm Only) Performance Study

• Yes, in effect. The study described is a direct comparison of the Triage Methadone assay ("algorithm only") against a predicate device and GC/MS. The device's performance (96.1% overall agreement, 100% agreement with GC/MS for specific enantiomers) is a standalone performance metric. The "Triage MeterPlus" performs the fluorescence immunoassay without human interpretation of the raw signal.

7. Type of Ground Truth Used

• Predicate Device/Clinical Samples and GC/MS Confirmation: For the initial comparison, the "ground truth" was established by the predicate device (Biosite Triage® 8 Panel for Drugs of Abuse). For the discordant samples between the Triage Methadone assay and the predicate, the definitive ground truth was established by GC/MS (Gas Chromatography/Mass Spectroscopy), an objective analytical gold standard for drug confirmation. Specifically, it determined the presence of l-methadone at concentrations greater than 175 ng/mL.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set sample size. This type of IVD device is typically developed and optimized during its creation phase, and the comparison study is a validation of the finalized assay. The "training" would be part of the R&D process, not typically a separate, reported clinical training set like in AI/ML models.

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

• Not explicitly stated/not applicable in the context of a "training set" as understood in AI/ML. For immunoassay development, ground truth for optimization and calibration would typically be established using known concentrations of analytes (e.g., methadone standards) prepared in a suitable matrix (e.g., synthetic urine or stripped urine), often confirmed by methods like GC/MS. The document focuses on the validation against clinical samples and a well-established reference method.

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The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.

The Triage® BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant.

The provided text is a 510(k) summary for the Triage BNP Test for the Beckman Coulter Immunoassay Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than describing a new study with explicit acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not present in the provided document. The document refers to prior 510(k) clearances and "various peer-reviewed publications" without detailing new studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (K033383, K021317, K051787, R021011, R031170) based on identical principles, reagents, and procedures, rather than presenting new performance data against specific acceptance criteria.

2. Sample size used for the test set and the data provenance

This information is not present in the provided document. While it mentions "various peer-reviewed publications" describing the utility of BNP measurements, it does not detail a specific test set or its provenance for this submission.

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

This information is not present in the provided document.

4. Adjudication method for the test set

This information is not present in the provided document.

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

An MRMC study is not mentioned and is not relevant as this is a quantitative immunoassay device, not an imaging or AI-assisted diagnostic device where human reader performance would be a primary focus.

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

This is an in vitro diagnostic immunoassay. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement. The document implies that the device's performance is demonstrated by its substantial equivalence to previously cleared devices, which would have undergone performance validation studies. However, the details of those specific studies are not provided in this document.

7. The type of ground truth used

This information is not explicitly stated for any new study in this document. For previous clearances of similar BNP tests, ground truth for diagnosis/assessment of heart failure would typically involve clinical diagnosis by cardiologists, imaging (e.g., echocardiography), and patient outcomes data regarding hospitalization or death. The document does state: "Higher BNP concentrations or the lack of a decrease in the BNP concentration from hospital admission to discharge indicate an increased risk of hospitalization or death in patients with heart failure," implying clinical outcomes as the ultimate ground truth for risk stratification.

8. The sample size for the training set

This information is not present as this is not an AI/Machine Learning device that would have a "training set" in that context. The device is a chemical immunoassay system.

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

Not applicable (see point 8).

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