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For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker in the evaluation of several disease states including disseminated intravascular coagulation, liver disease, inflammatory diseases and malignancy. High levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also found during pregnancy and oral contraceptive use, while reduced levels are found during thrombolytic therapy.

The HemosIL Fibrinogen-C kit and HemosIL Fibrinogen-C XL kit use an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of fibrinogen concentration.

This document, an FDA 510(k) clearance letter for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary clearly states:

• Reason for Submission: "This Special 510(k) is being submitted to remove the reconstituted reagent frozen stability claim of 1 month at -20°C in the original vial for HemosIL Fibrinogen-C and HemosIL Fibrinogen-C XL."
• Data Requirement: "No new performance data are needed to remove the reconstituted reagent frozen stability claim."
• No new performance claims: "Changes to labeled performance claims, except to remove the reconstituted reagent frozen stability claim from the Instructions for Use and add 'Do not freeze reconstituted reagent.'"

Therefore, the document explicitly states that no new performance data or studies were required or submitted for this particular 510(k) clearance. The clearance is based on a minor labeling change related to reagent stability, not on new performance validation.

To provide the information you requested (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc.), you would need a different type of submission document, such as an original 510(k) application or a PMA, where initial and comprehensive performance validation studies are typically included.

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HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems. For in vitro diagnostic use.

The Fibrinogen-C kit uses an excess of thrombin to convert fibrinogen to fibrin in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of the fibrinogen concentration.

Here's a breakdown of the acceptance criteria and study information for the HemosIL Fibrinogen-C device, based on the provided text:

Acceptance Criteria and Device Performance for HemosIL Fibrinogen-C

The submission details modifications to the HemosIL Fibrinogen-C test parameters on the ACL TOP system. The study aims to demonstrate that these modified parameters are substantially equivalent to the previously marketed device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate set of pass/fail thresholds. Instead, it presents the performance of both the "Current Parameters" (predicate device) and the "Modified Parameters" (new device) for comparison, implying that similar or improved performance for the modified parameters constitutes acceptance.

Note on FDP Interference: For FDP, the acceptance criteria are not to maintain "no interference" but rather to accurately characterize and communicate any newly identified interference. The modified parameters identified interference at FDP levels where the current parameters showed none (up to 100 µg/mL), leading to an update in the product insert.

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

The document does not specify the exact sample sizes used for the test sets contributing to the performance data (interference, precision, and linearity).

The document does not explicitly state the data provenance (e.g., country of origin of the data, retrospective or prospective). However, given that this is a 510(k) submission for a medical device in the US, it is implied that the studies were conducted under appropriate regulatory guidelines, likely in the US, and typically involve prospective testing for performance characteristics.

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

This type of in vitro diagnostic (IVD) device (fibrinogen determination) does not typically involve "experts establishing ground truth" in the same way imaging or clinical diagnostic devices might. Instead, the "ground truth" for performance studies of IVD assays is established by:

• Reference Methods: For accuracy and linearity, the "ground truth" would be established by comparing the device's measurements to a known, highly accurate reference method or gravimetric/volumetric preparation of analytes.
• Known Concentrations: For precision studies, specific control levels (Normal, Low Fibrinogen) with known target concentrations are used.
• Spiked Samples: For interference studies, potentially interfering substances are added to samples at known concentrations.

Therefore, no information on the number or qualifications of "experts" for ground truth establishment is provided, as it's not applicable in the traditional sense for this kind of device.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments, such as interpreting medical images or clinical outcomes, where human expert consensus is needed. For an IVD device like HemosIL Fibrinogen-C, which provides quantitative measurements, formal adjudication by experts is not applicable. The measurements are objective and evaluated against established analytical performance metrics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of devices (often imaging-based AI) when interpreted by multiple human readers, often comparing performance with and without AI assistance. This device is an in vitro diagnostic assay that produces a quantitative result, not an interpretation requiring human readers in the MRMC sense.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance assessment was effectively done. The performance data presented (interference, precision, linearity) directly reflects the capabilities of the HemosIL Fibrinogen-C reagent and the ACL TOP system's analytical process, independent of human interpretation or intervention beyond standard laboratory procedures for operating the instrument and running the assay. The "algorithm" here refers to the optimized test parameters, incubation time, and math model.

7. Type of Ground Truth Used

The type of ground truth for these studies would be based on:

• Analytical Measurement Standards: For linearity and accuracy, traceable reference materials or highly characterized plasma samples with known fibrinogen concentrations.
• Known Fibrinogen Concentrations: For precision, commercially prepared control materials with assigned target values.
• Spiked Interferent Concentrations: For interference studies, specific concentrations of potentially interfering substances (Heparin, Hemoglobin, Triglycerides, Bilirubin, FDP) added to plasma samples.

The document does not explicitly state the specific reference methods or standards used, but these are standard practices for IVD validation.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. For an IVD like HemosIL Fibrinogen-C, the "training" analogous to an AI model would be the development and optimization of the assay parameters, calibration levels, incubation time, and math model. This ongoing development process happens internally, often involving numerous experiments, but these are generally not characterized as a distinct "training set" in regulatory submissions, which focus on the final validation data.

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

As with the "test set" ground truth, for the optimization/development (analogous to "training") phase of an IVD, the ground truth would be established through a combination of:

• Analytical Chemistry Principles: Ensuring the Clauss method is accurately implemented.
• Reference Materials: Using validated reference materials for calibration and early performance checks.
• Methodology Development: Iteratively testing and refining parameters (e.g., thrombin concentration, reaction time, dilution protocols, mathematical models) to achieve desired analytical performance characteristics (sensitivity, specificity, linearity, precision) against known standards and characterized samples.

The specific details of this internal development process for establishing ground truth are not provided in this 510(k) summary, which focuses on the final validation results.

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For use in the quantitative determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies.

Fibrinogen is a plasma protein which is converted from a soluble protein to an insoluble polymer by the action of thrombin resulting in the formation of a fibrin clot. The thrombin clotting time of dilute plasma is inversely proportional to the fibrinogen concentration of the plasma. Using this principle, Clauss developed a simple quantitative assay for fibrinogen by measuring the clotting time of dilute plasma when excess thrombin is added. The clotting time obtained is then compared with that of a standardized fibrinogen preparation.

Here's a breakdown of the acceptance criteria and study details for the Dade® Thrombin Reagent, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for the Dade® Thrombin Reagent is demonstrated through a method comparison study against the legally marketed predicate device, the Dade® Fibrinogen Determination Reagents kit. The acceptance criteria are implicit in the "Correlation Coefficient" values, indicating a strong correlation between the new device and the predicate.

Study Details

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

   • Sample Size: 80 samples were used for each of the two lots tested (SHP Lot # 502587 and SHP Lot # 502589), for a total of 160 samples in the method comparison study.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

   • Not applicable. This is an in vitro diagnostic device for quantitative determination, not an imaging or qualitative diagnostic device requiring expert interpretation of results for ground truth establishment in the traditional sense. The "ground truth" for comparison is the performance of the legally marketed predicate device.

3. Adjudication Method for the Test Set:

   • Not applicable, for the same reasons as point 2. The comparison is quantitative against a predicate device.

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

   • No, this type of study was not done. MRMC studies are typically used for imaging devices or diagnostics that involve human interpretation, which is not the primary function of this in vitro diagnostic reagent.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

   • Yes, in a sense. The performance presented is for the reagent itself, functioning on an instrument. There is no "human-in-the-loop" component in the direct measurement process of a fibrinogen level using a coagulation assay. The device determines the fibrinogen level directly.

6. The Type of Ground Truth Used:

   • Comparative Ground Truth: The "ground truth" for this device's performance evaluation is established by comparison to a legally marketed predicate device. The predicate device itself (Dade® Fibrinogen Determination Reagents kit) serves as the reference standard. The study aims to show that the new device produces results that are highly correlated and comparable to the established method.

7. The Sample Size for the Training Set:

   • The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For a reagent test, development typically involves analytical validation and optimization rather than a separate training set for a "machine learning" algorithm.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as a discrete "training set" with established ground truth as understood in machine learning is not described or required for this type of in vitro diagnostic reagent. The development of such reagents generally relies on established chemical and biological principles, optimization through analytical testing, and ultimately validation against reference methods or clinical samples.

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The Sigma Diagnostics Fibrinogen Kit is a device used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

The method of Clauss measures the rate of fibrin conversion in the presence of excess thrombin and has been shown to be rapid, sensitive and precise. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time, vielding a curvilinear relationship when plotted on loglog paper. A calibration curve prepared from a fibrinogen reference is used to determine the fibrinogen concentration in the test sample.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:

Device: Sigma Diagnostics Fibrinogen Determination Kit (Procedure No. 886/887)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 102 samples
• Data Provenance: Not explicitly stated, but the reference to "samples having fibrinogen concentrations ranging from 95 to 764 mg/dL" implies clinical samples. No information on country of origin or whether they were retrospective or prospective.

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

• Not applicable. The study is a comparison of two diagnostic kits, where one (Procedure No. 880/881) serves as the "established reagent" or reference method for the ground truth. There's no indication of human expert adjudication for individual sample results.

4. Adjudication method for the test set:

• Not applicable. The ground truth was established by another "established reagent" (Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881), not through 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 is not an AI-assisted device. It's an in-vitro diagnostic kit for fibrinogen determination.

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

• Not applicable in the context of an algorithm. This device is a manual or semi-automated laboratory kit. The "standalone" performance is assessed by its direct measurements and comparison to a predicate device.

7. The type of ground truth used:

• Comparative Ground Truth: The ground truth for this study was established using an "established reagent", specifically the Sigma Diagnostics Fibrinogen Determination Kit, Procedure No. 880/881. This means the new device (Procedure No. 886/887) was compared to an already accepted and marketed device.

8. The sample size for the training set:

• No specific "training set" is mentioned as this device is not based on machine learning or AI. The study describes a verification and validation process against an existing method.

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

• Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the performance evaluation was the results obtained from the predicate device (Procedure No. 880/881).

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A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.

The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution. The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.

Here's an analysis of the provided text regarding the FiF™ Test's acceptance criteria and the supporting study:

The document describes a premarket notification for the American Biogenetic Sciences, Inc.'s FiF™ Test, an immunoprecipitation test for the quantitative determination of fibrinogen in human plasma. The primary acceptance criterion for this submission is demonstrating substantial equivalence to a predicate device, the Baxter Dade®, Data-Fi®, Fibrinogen determination kit.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the overall acceptance criterion as demonstrating substantial equivalence to the predicate device. The performance metrics presented below are the data used to support this claim, rather than a predefined "pass/fail" threshold for each metric. The strong correlation (R^2 = 0.83, p=0.0001) is the central piece of evidence for substantial equivalence.

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

• Sample Size: 101 plasma samples.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but given the company's US address (South Bend, IN, and later Boston, MA), it is highly likely the samples were collected in the United States.
  • Retrospective or Prospective: The samples were collected "from patients in the ER, Catherization Laboratory and also healthy volunteers" with "patient consent." This suggests a prospective collection for the purpose of this study, though some could be leftover samples. The phrasing "collected at the same time" for analysis further supports a planned, concurrent study.

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

• Number of Experts: Not applicable.
• Qualifications: Not applicable.

This study does not involve human interpretation or expert evaluation to establish ground truth. Instead, the "ground truth" for comparison is the measurement produced by a predicate device (the Baxter Dade®, Data-Fi® test), which is an established, quantitative laboratory test.

4. Adjudication Method

• Adjudication Method: Not applicable.

As mentioned above, this study compares a new quantitative test to an existing quantitative predicate device, not subjective interpretations requiring adjudication.

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

• MRMC Study Done: No.
• Effect Size: Not applicable.

This Preamarket Notification is for a standalone in vitro diagnostic (IVD) device, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: Yes. The entire study describes the performance of the FiF™ Test (the "algorithm only," in a sense, as it's a fully automated or semi-automated lab test) independent of human interpretation beyond running the test and reading its numerical output. Its performance is compared directly to the predicate device.

7. Type of Ground Truth Used

• Ground Truth Type: A predicate device's measurement. The FiF™ Test's results were compared to the results obtained from the Baxter Dade®, Data-Fi® functional test on the same samples. This serves as the comparative "reference standard" to establish substantial equivalence.

8. Sample Size for the Training Set

• Sample Size: Not applicable.

This is a predicate comparison study for an IVD kit, not a machine learning model requiring a training set. The device is a chemical/immunological assay, not an AI or algorithm that learns from data.

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

• Ground Truth Establishment: Not applicable.

As there is no training set for this type of device, this question is not relevant.

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