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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 ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

The provided text is a 510(k) Summary for a medical device called "HemosIL ReadiPlasTin." This document doesn't describe an AI/ML-based device, but rather an in vitro diagnostic (IVD) reagent used for Prothrombin Time (PT) and Fibrinogen determination. Therefore, many of the requested categories related to AI/ML device testing (e.g., number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance studies for this IVD device.

Here's a breakdown of the requested information, adapted for an IVD reagent:

Device: HemosIL ReadiPlasTin (In vitro diagnostic thromboplastin reagent)
Purpose: Quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma.
Reason for Submission (K213426): Reformulation of the existing HemosIL ReadiPlasTin by adding EDTA as a stabilizer and removing unnecessary fillers.

1. Table of Acceptance Criteria and Reported Device Performance

For this IVD, "acceptance criteria" are typically defined by the method validation standards (e.g., CLSI guidelines) and the equivalence to the predicate device. The performance data presented are the results of meeting these criteria.

• PT: UFH (1.0 IU/mL), LMWH (1.4 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (1000 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (100 µg/mL)
• Fibrinogen: UFH (1.5 IU/mL), LMWH (1.7 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (600 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (200 µg/mL) | New claims for daptomycin and conjugated bilirubin interference were added. The study used 2 clinical sample levels for both PT and Fibrinogen. |
  | Method Comparison | Strong correlation and agreement between the subject device and the predicate device (HemosIL RecombiPlasTin 2G). Slope should be near 1, intercept near 0, and correlation coefficient (r) close to 1. | ACL TOP Family:
• PT (INR): Slope 1.031 (95% CI 1.009, 1.053), Intercept -0.043 (-0.068, -0.018), r 0.997
• Fibrinogen (mg/dL): Slope 0.975 (95% CI 0.963, 0.986), Intercept 7.171 (3.842, 10.50), r 0.995
  ACL TOP Family 50 Series:
• PT (INR): Slope 1.021 (95% CI 0.999, 1.043), Intercept -0.034 (-0.060, -0.009), r 0.996
• Fibrinogen (mg/dL): Slope 1.015 (95% CI 1.003, 1.027), Intercept -0.811 (-4.148, 2.527), r 0.994 | All method comparison results demonstrated excellent correlation and agreement, supporting substantial equivalence. |
  | Open Vial Stability | Maintain performance for 10 days at 2-8°C in closed original vial after preparation. | "The results support the following labeled open vial stability claim: Once prepared for use, 10 days at 2-8℃ in closed original vial" | Tested across 3 lots per CLSI EP25-A. |
  | On-board Instrument Stability | Maintain performance for 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series after preparation. | "The results support the following labeled on-board instrument stability claim: Once prepared for use, 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series" | Tested across 3 lots per CLSI EP25-A. |
  | Real-time Shelf-life Stability | Device maintains stated performance throughout its claimed shelf-life. | "The study will continue to a point past final claim." (Ongoing assessment to support shelf-life). | Tested across 3 lots per CLSI EP25-A. |

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

• Precision:

  • Sample Size: 80 measurements per instrument per lot (n=80/instrument/lot) for PT (controls + 6 native patient samples) and Fibrinogen (controls + 6 fibrinogen sample pools at 3 levels). Tested across 3 lots and representative members of both ACL TOP Family and ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" suggest human biological samples. Typically, these studies are conducted in a controlled laboratory setting (Likely within the manufacturer's R&D facilities or a contract research organization). The document is submitted to the US FDA, implying relevance to the US market. The retrospective/prospective nature is generally prospective for these types of validation studies.

• Interference:

  • Sample Size: Two clinical sample levels each for PT (normal pooled plasma and a high INR clinical sample) and Fibrinogen (normal pooled plasma and a low fibrinogen sample). Specific "n" per concentration/sample type is not given, but refers to CLSI EP07, 3rd Ed and CLSI EP37, 1st Ed which define the study design.
  • Data Provenance: Not explicitly stated, but "clinical sample levels" implies human biological samples.

• Method Comparison:

  • Sample Size:
    • PT (INR): 160 samples (normal and abnormal) for both ACL TOP Family and ACL TOP Family 50 Series.
    • Fibrinogen (mg/dL): 135 samples for ACL TOP Family, 134 samples for ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "normal and abnormal samples" implies human biological samples. The study was "in-house."

• Open Vial and On-board Instrument Stability:

  • Sample Size: For PT, controls and four native (unadulterated) patient samples were tested in eight replicates at each time interval. For Fibrinogen, controls and six fibrinogen sample pools at three levels were tested in eight replicates at each time interval.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" imply human biological samples.

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

This is not applicable for this type of IVD device. The ground truth for chemical assays like PT and Fibrinogen is established through precise measurement methods and reference materials, not through expert consensus of visual or diagnostic interpretations. The "truth" is the quantitative value derived from the reference method or calibrator.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD reagent and not an AI/ML-based diagnostic system requiring human interpretation or 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, as this is an IVD reagent and not an AI/ML-based diagnostic system involving human interpretation.

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

Not applicable, as this is an IVD reagent. Its performance is inherent to the chemical reaction and the analytical instrument it is used with.

7. The Type of Ground Truth Used

The "ground truth" for this IVD is established by:

• Reference Methods/Materials: For PT and Fibrinogen, this would rely on internationally recognized standards and calibrators, and the values obtained from a validated reference method (or the predicate device in method comparison studies).
• Known Concentrations: For linearity and interference studies, samples are often spiked with known concentrations of analytes or interfering substances.
• Validated Predicate Device: In the method comparison study, the predicate device (HemosIL RecombiPlasTin 2G) serves as the comparator for verifying the new formulation's performance.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not an AI/ML model that requires a "training set." The development of the reagent involves chemical formulation and optimization, not data-driven machine learning.

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

Not applicable, as there is no "training set" for an IVD reagent.

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The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.

The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The performance of this device has not been established in neonate and pediatric patient populations.

Diazyme Fibrinogen Assay System consists of the following items:

• 1. The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide.
• 2. Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide
• 3. Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide.

The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals.

The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths.

After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-point calibration curve.

This document describes the Diazyme Fibrinogen Assay and compares its performance characteristics to a predicate device, the Kamiya K-Assay Fibrinogen (K993482), to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of values that the device met. Instead, it presents performance characteristics and then concludes "Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Diazyme Fibrinogen Assay and offers users an in vitro diagnostic device system to measure fibrinogen in human plasma," implicitly suggesting these performance levels are acceptable for substantial equivalence.

Here's a comparison of the Diazyme Fibrinogen Assay's performance against the predicate:

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

• Precision (Sample Repeatability): 6 citrated plasma samples. Tested over 10 days, 2 runs/day, 2 replicates/run = 240 measurements per sample type.
• Precision (Calibrator Repeatability): 3 levels of calibrators. Tested over 10 days, 2 runs/day, 2 replicates/run = 360 measurements per calibrator level.
• Precision (Control Repeatability): 2 levels of controls. Tested over 20 days, 2 runs/day, 2 replicates/run = 160 measurements per control level.
• Reproducibility (Multi-site precision): 6 citrated plasma samples, 3 calibrator levels, 2 control levels. Plasma: 60 measurements per sample (implies 3 sites, but not explicitly stated how many measurements per site). Calibrator/Control: 120 measurements per level.
• Linearity: An eleven-level linearity set prepared by mixing a pooled fibrinogen spiked plasma sample and saline at different proportions.
• Method Comparison: A total of 176 human plasma samples.
• Interference: Not specified as a specific "test set" size, but various interferents were tested at specified concentrations.

Data Provenance:
The document does not explicitly state the country of origin of the samples. For precision, linearity, and interference, it implies in-house testing by Diazyme Laboratories. For method comparison, it states "Human plasma samples" from "3 clinical sites," but the location of these sites and whether the data is retrospective or prospective is not specified.

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

This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for method comparison is typically established by results from the predicate device itself, or in some cases, a well-established reference method. There is no mention of experts establishing a ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. For analytical performance studies of quantitative IVD assays, an adjudication method (like 2+1 expert consensus) is typically not used in the same way it would be for qualitative image-based diagnostic systems. The reference method (predicate device) provides the comparative "truth."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. The Diazyme Fibrinogen Assay is an in vitro diagnostic assay run on an automated analyzer (Roche Modular P), not a system designed for human interpretation.

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

Yes, the performance studies described (Precision, Linearity, Method Comparison, Interference) are all standalone performance evaluations of the Diazyme Fibrinogen Assay device itself, without human-in-the-loop performance measurement. The device runs on an automated analyzer (Roche Modular P), and its performance is assessed against established analytical performance metrics and comparison to a predicate device.

7. The Type of Ground Truth Used

For the method comparison study, the predicate device's results (Kamiya K-Assay Fibrinogen) served as the comparative "ground truth" or reference method. For linearity, it was prepared standards. For precision, the "truth" is the statistical mean of repeated measurements.

8. The Sample Size for the Training Set

This information is not applicable/provided. The Diazyme Fibrinogen Assay is an immunoturbidimetric assay based on chemical reactions and optical measurements, not a machine learning or AI-based device that would typically involve a "training set" in the computational sense. The "training" of the assay involves establishing calibration curves using known calibrator concentrations.

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

This information is not applicable/provided. As above, the device is not an AI/ML system requiring a training set with "ground truth" labels. Calibration curves are established using the "Diazyme Fibrinogen Calibrator Set," which contains purified human fibrinogen antigen at known concentrations. These known concentrations serve as the basis for the instrument to interpret sample results.

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HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

The thromboplastin reagent included in the ReadiPlasTin kit is a liquid liposomal preparation that contains recombinant human tissue factor (RTF) in a synthetic phospholipid blend combined with calcium chloride, buffer and a preservative. In the PT test, the addition of tissue thromboplastin to the patient plasma, in the presence of calcium ions, initiates the activation of the extrinsic pathway. This results in the conversion of fibrinogen to fibrin, with the formation of a solid gel. The fibrinogen is then quantitated by relating the absorbance to a calibrator.

ReadiPlasTin can be used with II's Normal control, Routine controls 1-3, Low abnormal control, high abnormal control, ISI calibrate and INR validate.

Here's a breakdown of the requested information based on the provided text for the HemosIL ReadiPlasTin device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text describes several studies, each with specific sample sizes and implicit provenance:

• Precision/Reproducibility:
  • Sample Size: 3 lots of reagent, 3 instruments (2 ACL TOP 700, 1 ACL TOP 500 CTS), 3 operators. For each control level (Normal, Low Abnormal, High Abnormal for PT; Normal, Low Abnormal, Low Fibrinogen for Fibrinogen), N=80 per instrument per lot (20 days, 2 runs/day, 2 replicates/run), totaling 240 measurements per control level per lot across all instruments.
  • Data Provenance: Implied to be prospective laboratory testing conducted by the manufacturer ("utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family by 3 independent operators"). Country of origin is not explicitly stated but assumed to be where the company is based (Bedford, MA, USA).
• Fibrinogen Linearity:
  • Sample Size: Not explicitly stated how many samples were used, but the study was performed in accordance with CLSI EP6-A.
  • Data Provenance: Implied to be retrospective (prepared linearity samples) or prospective laboratory testing. Country of origin not specified.
• Extrinsic Factor Linearity:
  • Sample Size: Not explicitly stated how many samples were used for factors II, V, VII, and X.
  • Data Provenance: Implied retrospective (prepared factor-deficient plasmas) or prospective laboratory testing. Country of origin not specified.
• Analytical Specificity (Interfering Substances):
  • Sample Size: Not explicitly stated how many samples were tested for each interfering substance, but the study was performed according to CLSI EP7-A.
  • Data Provenance: Implied retrospective (spiked samples) or prospective laboratory testing. Country of origin not specified.
• Method Comparison with Predicate Device:
  • Sample Size:
    • In-house: "100+ samples (Normal & Abnormal)". Specifically, n=230 for PT(sec) on ACL TOP 700, n=65 for PT (INR) on ACL TOP 700, n=241 for Fibrinogen on ACL TOP 700. Similar numbers for ACL TOP 500 CTS (n=238 for PT(sec), n=65 for PT (INR), n=242 for Fibrinogen).
    • US Field Studies: Site 1: 254 for PT(sec), 76 for PT(INR), 237 for Fibrinogen. Site 2: 312 for PT(sec), 89 for PT(INR), 284 for Fibrinogen. Site 3: 135 for PT(sec), 71 for PT(INR), 129 for Fibrinogen.
  • Data Provenance: The "in-house method comparison" is likely prospective or retrospective from internal lab samples. The "US field studies" are prospective patient samples from clinical sites in the US.
• Matrix Comparison (Fresh vs. Frozen):
  • Sample Size: n=245 (140 normal, 105 abnormal patient samples).
  • Data Provenance: Prospective patient samples. Country of origin not specified, but likely associated with the manufacturer or field sites.
• Normal Range Study:
  • Sample Size: n=199 healthy subjects.
  • Data Provenance: Prospective collection from healthy subjects. Country of origin not specified, but likely associated with the manufacturer or field sites.

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

• No "experts" in the traditional sense (e.g., radiologists interpreting images) are mentioned in this submission. This is a submission for an in vitro diagnostic reagent and system, where the "ground truth" is typically established by reference methods, accuracy against known standards, or comparison with a cleared predicate device.
• The "predicate device" (HemosIL RecombiPlasTin 2G) served as the primary comparator for establishing substantial equivalence, meaning its results were considered the "reference" or "ground truth" for comparison in the method comparison studies. The predicate device itself would have undergone its own rigorous validation.
• For the Normal Range Study, the "ground truth" was simply the biochemical values obtained from a healthy population.

4. Adjudication Method for the Test Set

• No adjudication method is described. This type of IVD submission does not typically involve human adjudication of results in the way image analysis or clinical endpoint studies might. The results are quantitative (PT in seconds/INR, Fibrinogen in mg/dL), and performance is assessed statistically by comparing the device's numerical outputs against predicate device outputs or established reference values.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging interpretation or other scenarios where multiple human readers are tasked with making a subjective assessment, and the AI's impact on their performance is being evaluated. This submission is for an automated in-vitro diagnostic assay.

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

• Yes, the primary performance studies are standalone algorithm/device performance. This device, the HemosIL ReadiPlasTin reagent on the ACL TOP Family analyzers, is an automated system. Its performance (precision, linearity, method comparison, etc.) is measured directly by the instrument, without human intervention in the result generation process itself. Humans operate the instrument and interpret the results, but the analytical performance described is "standalone" in the sense that it reflects the device's inherent capability to produce accurate measurements.

7. The Type of Ground Truth Used

• The "ground truth" for the performance studies primarily used:
  • Predicate Device Data: For the method comparison studies, the results from the HemosIL RecombiPlasTin 2G served as the comparative "truth" to demonstrate substantial equivalence.
  • Reference Standards/Calibrators: Traceability is described against "ISI certified House Standard" which is calibrated against "international reference preparation according to the WHO recommendations" for PT/INR, indicating a form of metrological traceability for quantitative accuracy.
  • Known Reference Samples: Clinical samples (normal and abnormal patient samples) were used to cover the operating range.
  • Statistical Methodology: For precision, linearity, and interference studies, performance metrics were compared against statistical acceptance criteria (e.g., %CV, correlation coefficient r) which are based on established clinical laboratory standards (CLSI guidelines).
  • Healthy Population Values: For the normal range study, the "ground truth" was derived from a statistically significant sample of healthy individuals.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. This is a traditional in-vitro diagnostic device (a reagent) used with an existing analyzer. The device itself is not an AI algorithm that "learns" from data.
• However, the traceability and calibration processes for the reagent involve internal "House Standards" which are themselves developed and validated using extensive data. Each batch of ReadiPlasTin is calibrated against these standards. While not a "training set" in the AI sense, this represents the historical data and standards used to ensure accurate performance of each reagent lot.

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

• As noted above, there isn't a "training set" in an AI/ML context. The calibration and standardization process serves a similar function:
  • House Standards: These internal reference materials are "calibrated against the corresponding international reference preparation according to the WHO recommendations." This means that the ultimate "ground truth" for the device's accuracy is established through international consensus standards and reference measurement procedures, which are the gold standard for many IVD assays.
  • The "consensus values from > 200 laboratories" for INR reference values also indicate a broadly established and verified "ground truth" derived from a large number of expert laboratories.

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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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Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.

The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized.

The provided document describes a 510(k) premarket notification for a Fibrinogen Calibrator Kit, which is a device used to calibrate fibrinogen assays. This type of device is an in-vitro diagnostic (IVD) product and its performance evaluation typically focuses on analytical characteristics rather than human-in-the-loop or AI-related metrics. Therefore, several of the requested sections (e.g., MRMC studies, AI improvement, expert ground truth, training set size) are not applicable to this specific device evaluation. The information provided heavily emphasizes the substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Fibrinogen Calibrator Kit K994341) in terms of "intended use and performance." This implies that the performance of the new device is expected to be comparable to or within acceptable variations of the predicate device's established performance. The document doesn't provide specific performance metrics or data in this summary.

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

The summary does not provide details on the sample size used for any testing or the data provenance (e.g., country of origin, retrospective/prospective). Evaluations for calibrators typically involve testing across a range of concentrations and multiple lots, but this information is absent.

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 calibrator, not an AI or imaging device that requires human expert interpretation for establishing ground truth on a test set. Its "ground truth" relates to the accuracy and precision of its calibration values, which would be determined through analytical methods and reference materials.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical calibrator kit, not an algorithm. However, the performance assessment would effectively be "standalone" in that it directly evaluates the calibrator's characteristics without a human-in-the-loop component in the evaluation itself.

7. The Type of Ground Truth Used

The "ground truth" for a calibrator refers to its assigned values being accurate and traceable to higher-order reference materials or methods. The summary states the calibrators are "prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized." The establishment of the specific calibration values (the "ground truth" for the calibrator levels) would be based on analytical methods and certified reference materials, but the details are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems and Fibrinogen on IL Coagulation Systems only. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibringen to fibrin, with formation of a solid gel. For the IL Coagulation Systems only, the Fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HemosIL RecombiPlasTin 2G device:

It is important to note that this document is a 510(k) Summary, which provides a high-level overview of the device and its performance data. It does not contain a formal table of "acceptance criteria" presented as specific numerical thresholds that must be met for success, but rather presents performance data and states that the device is "not materially different" from the predicate. The "acceptance criteria" are inferred from the reported performance outcomes that demonstrate substantial equivalence to the predicate.

Acceptance Criteria and Reported Device Performance

Inferred Acceptance Criteria: The primary acceptance criterion for this 510(k) appears to be demonstrating substantial equivalence to the predicate device (HemosIL RecombiPlasTin K043184) in terms of precision, method correlation, and expected values. For Daptomycin dose-response testing, specific performance specifications are provided.

Study Details

The provided document describes various analytical performance studies. It does not describe a clinical study in the typical sense for a medical device (e.g., involving human patients, multi-reader multi-case studies, or traditional test set/training set breakdowns for AI algorithms). This device is a reagent for an in vitro diagnostic (IVD) test, and the studies focus on laboratory performance characteristics.

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

   • Precision: Not explicitly stated, but typically involves multiple replicates of control plasmas. "Over multiple runs using three levels of control plasma for PT and two levels of control plasma for fibrinogen" suggests sufficient replicates to calculate CVs.
   • Method Comparison (In-house & Field Site): Not explicitly stated, but typically involves a sufficient number of patient samples (e.g., 50-100+) to establish correlation and agreement.
   • Expected Values (Normal Range):
     • PT: N = 130 per system (ELECTRA, ACL Family, ACL Futura/Advance, ACL TOP).
     • Fibrinogen: N = 129 per system (ACL Family, ACL Futura/Advance, ACL TOP).
   • CUBICIN Dose-Response Testing: Not explicitly stated how many individual "Normal Sample" or "Coumadin Sample" plasma units were used, but multiple concentrations of CUBICIN were tested on each system. Two types of samples (normal and coumadin plasma) were spiked.
   • Data Provenance: Not explicitly stated, but an "in-house" study and "two field site" studies are mentioned, implying a mix of internal lab data and potentially external lab data. Given it's a 510(k) for an IVD, the data would typically be derived from laboratory measurements, likely from the US or international sites where the manufacturer operates. The data is retrospective in the sense that the measurements were likely taken prior to the 510(k) submission as part of development and validation.

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

   • Not applicable. This is an IVD reagent, not an image-based or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these studies is the actual quantitative measurement of PT and Fibrinogen by the predicate device and the new device.

3. Adjudication method for the test set:

   • Not applicable. As described above, this is an IVD reagent and does not involve human interpretation or adjudication for ground truth.

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. This is not an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant or performed.

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

   • Yes, in a sense. The "device" here is the reagent itself, and its performance is evaluated in a standalone manner on automated coagulation analyzers (IL Coagulation and ELECTRA Systems) without a human "interpretation" in the loop beyond operating the instrument and ensuring quality control. The reported performance refers to the analytical performance of the combined reagent and instrument system.

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

   • The "ground truth" in these studies is the quantitative analytical measurement provided by:
     • The predicate device (HemosIL RecombiPlasTin) for method comparison studies.
     • Reference materials/control plasmas with known target values for precision studies.
     • Healthy plasma samples for establishing normal ranges.
     • Spiked plasma samples (with CUBICIN) for dose-response testing where the known concentration of the drug and the baseline readings serve as the reference.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a distinct "training set" in the context of algorithm development. The development and optimization of the reagent formulation itself would involve extensive R&D, but not a formally defined "training set" for an algorithm.

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

   • Not applicable, as there is no traditional "training set" for an algorithm in this context.

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Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.
Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an in-vitro diagnostic reagent intended for use for the performance of a citrated Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor assays for Factors XII, XI, IX and VIII.
Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa).
Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.

The provided text describes 12 distinct devices from Wortham Laboratories, each with its own acceptance criteria and study findings. Due to the volume, I will provide a detailed breakdown for the first device, Stasis 1 Coagulation Control (Normal), and then summarize the general approach for the others as they follow a similar pattern.

Device: Wortham Laboratories Stasis 1 Coagulation Control (Normal)

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for Wortham Laboratories Stasis 1 Coagulation Control (Normal) are implicitly established by demonstrating comparable or superior performance to the predicate device, Pacific Hemostasis Coagulation Control Level I. The reported device performance is presented in terms of Coefficient of Variation (CV%) for precision.

Note: The acceptance criteria are "performance equal to or better than the predicate" for most quantitative metrics, and "same" for qualitative metrics like intended use and assay factors. The tables above directly compare the new device's performance to the predicate's stated performance, indicating the new device met or exceeded the predicate's precision values.

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

The document mentions "Mechanical assays of Stasis 1 to the predicate normal plasma control" and "Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level 1 Control," along with "The processing of the Fibrinogen levels in both study graphs."

• Sample size: Not explicitly stated as a number of individual samples or runs for the test set. The data is presented as statistical measures (standard deviation, CV%) which are derived from a series of measurements, implying repeated testing.
• Data provenance: Not explicitly stated. The context suggests that the testing was performed by Wortham Laboratories, likely internally. It does not provide information about the country of origin of the data or if it was retrospective or prospective. The source material for the control is "liquid stable citrated plasma obtained from healthy donors," but this refers to the control product itself, not the clinical data.

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

This information is not provided. The "ground truth" for this device appears to be the quantitative measurements obtained from the predicate device (Pacific Hemostasis Coagulation Control Level I) and the established ranges for PT, APTT, and Fibrinogen in normal plasma. The comparison is against established quantitative performance metrics of a legally marketed predicate, not against expert consensus on a clinical outcome.

4. Adjudication method for the test set:

Not applicable. This is a comparison of quantitative laboratory performance metrics of a new control product against an existing predicate control. There is no human adjudication of diagnostic outcomes involved.

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 a medical device for in-vitro diagnostic quality control, not an AI-assisted diagnostic tool interpreted by human readers.

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

Not applicable. This device is a quality control product, not an algorithm. Its performance is measured directly by laboratory instruments (e.g., fibrometer).

7. The type of ground truth used:

The ground truth or reference standard for comparison is the performance characteristics of a legally marketed predicate device (Pacific Hemostasis Coagulation Control Level I). The "Expected Range" values are based on "Mechanical Mean ± 2SD," implying statistically derived ranges from repeated measurements, rather than pathology, expert consensus on images, or true outcomes data for individual patients.

8. The sample size for the training set:

Not applicable. This device is a quality control product, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary for other devices (Stasis 2, Stasis 3, Serathan-B PT Reagent, Serathan-A PT Reagent, Intrin-EA APTT Reagent, Intrin-SI APTT Reagent, Fibrinogen Control Plasma (Low), Fibrinogen Control Plasma (Normal), Thrombin Reagent, Fibrinogen Assay Set, Heparin Control Plasma Level 1, Heparin Control Plasma Level 2, Calcium Chloride Solution 0.02 M, Fibrinogen Buffer):

All other devices described in the document (Stasis 2, Stasis 3, Serathan-B, Serathan-A, Intrin-EA, Intrin-SI, Fibrinogen Controls, Thrombin Reagent, Fibrinogen Assay Set, Heparin Controls, Calcium Chloride Solution, Fibrinogen Buffer) follow a very similar pattern to Stasis 1 Coagulation Control.

• Acceptance Criteria and Reported Device Performance: This is consistently established by comparing the new device's performance metrics (primarily Coefficient of Variation (CV%) and standard deviation (SD) for precision, and expected ranges) directly against a specific predicate device's reported performance. The new device consistently demonstrates comparable or improved precision compared to its respective predicate.
• Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Size, and Training Set Ground Truth:
  • Sample Size: Not explicitly stated as the number of individual tests or samples; reported as statistical measures (SD, CV%) derived from repeated measurements.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied internal testing by Wortham Laboratories.
  • Experts/Adjudication/MRMC/Standalone: Not applicable to these types of in-vitro diagnostic quality control and reagent products, as they are evaluated based on quantitative laboratory performance against chemical/biological standards or predicate product performance, not human diagnostic interpretation.
  • Ground Truth Type: For all these devices, the ground truth for evaluation is the established performance characteristics of the legally marketed predicate device, as well as the expected physiological/clinical ranges for the assays they control or participate in (e.g., normal/abnormal PT/APTT/Fibrinogen values).
  • Training Set: Not applicable, as these are not AI/ML algorithms.

The overall conclusion for all devices is a claim of "substantial equivalence" to their respective predicates based on comparable intended use, technological characteristics, and performance data consistently showing competitive or superior precision and expected ranges.

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HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems. For in vitro diagnostic use.

HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.

Here's an analysis of the provided text regarding the HemosIL PT-Fibrinogen HS PLUS device, broken down by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents the "new expected values data" as the outcome of the study, rather than pre-defined acceptance criteria. The purpose of this submission was to update these expected values based on new data, implying that the study's success was determined by the derivation of these new ranges.

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

• Test Set Sample Size: 119
• Data Provenance: Not explicitly stated within the document for country of origin. The study was conducted to establish "new normal range study," implying it was a prospective study to determine reference ranges from a healthy population.

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

This document does not describe the use of "experts" for establishing ground truth in the context of interpreting the results. The "ground truth" here is the measured PT and Fibrinogen values from the healthy individuals in the normal range study. The device itself performs the measurement.

4. Adjudication Method for the Test Set

Not applicable. The study is establishing reference ranges for a quantitative diagnostic test, not interpreting complex medical images or information requiring adjudication.

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

No. This document describes a normal range study for a quantitative diagnostic assay, not a comparative effectiveness study involving human readers.

6. Standalone Performance Study

Yes, in a sense. The data presented are from the device (HemosIL PT-Fibrinogen HS PLUS on ACL Futura/ACL Advance systems) measuring PT and Fibrinogen in human plasma. This is a standalone performance of the algorithm/reagent system as it's designed to operate for in vitro diagnostic use. The study focuses on the values obtained by the device itself.

7. Type of Ground Truth Used

The "ground truth" in this context is the measured Prothrombin Time and Fibrinogen values obtained from a population of apparently healthy individuals. It's essentially the observed data from the device itself when run on a specific population to define normal ranges.

8. Sample Size for the Training Set

Not mentioned. This document describes a study to establish reference ranges for the device, not a machine learning model that would require a separate training set. The normal range study sample of 119 individuals could be considered the "data" from which the expected values were derived.

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

Not applicable for a typical machine learning "training set" as described in the prompt. For the normal range study, the "ground truth" (the observed PT and Fibrinogen values) was established by running the HemosIL PT-Fibrinogen HS PLUS on the ACL Futura/ACL Advance systems with human citrated plasma from the 119 individuals in the study. The definition of a "normal" range is statistical, based on the distribution of these measured values within that population.

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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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