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HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy. For in vitro diagnostic use.

HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

The HemosIL Liquid Antithrombin XL device is a modified version of the HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes. The modification does not alter the fundamental scientific technology or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma. It is intended as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.

1. Table of acceptance criteria and the reported device performance:

The provided document describes performance metrics related to precision and method comparison but does not explicitly state pre-defined acceptance criteria (e.g., "CV must be Y%"). Instead, it presents the results of these studies. For the method comparison, the results are presented in a highly obfuscated and unreadable table due to OCR errors.

However, based on standard laboratory practice for diagnostic assays, the reported precision (CV%) values demonstrate acceptable performance for an Antithrombin assay, especially given the range of AT levels tested. The predicate device (HemosIL Antithrombin K980499) serves as the benchmark for substantial equivalence.

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

• Precision Studies:
  • For Normal, Low Abnormal, and High Abnormal control levels, the sample size (n) for each level was 60.
  • Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based performance evaluations, likely retrospective as they involve control plasmas rather than patient samples for the precision part.
• Method Comparison Study:
  • The sample size for the method comparison study is not explicitly stated in the readable portion of the provided text. The table intended to present this data is corrupted.
  • Data provenance: Not explicitly stated.

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 in the document. For an in vitro diagnostic device like this, "ground truth" often refers to reference methods or clinically established values for the analytes in the control or patient samples. The document focuses on comparing the new device to a predicate device and evaluating its precision, not on new clinical diagnoses established by experts.

4. Adjudication method for the test set:

This information is not applicable to this type of study for an in vitro diagnostic device where the "truth" is typically laboratory-derived values or predicate device results, not expert consensus on interpretations.

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:

This is not applicable. The HemosIL Liquid Antithrombin XL is an automated chromogenic assay, not an imaging device or AI-driven diagnostic tool that relies on human readers or interpretations. Therefore, an MRMC study and AI assistance are not relevant to its evaluation.

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

The device itself is an automated laboratory assay, which by its nature operates in a "standalone" fashion (algorithm/reagent/instrument only) to produce a quantitative result. The performance data provided, specifically precision and method comparison, represent this standalone performance. There isn't a "human-in-the-loop" component in the sense of a human interpreting the primary output of the assay.

7. The type of ground truth used:

• Precision Studies: The "ground truth" for precision is the mean Antithrombin (% AT) value established for each control level (Normal, Low Abnormal, High Abnormal). This is typically determined through repeated measurements and confirmation with established methods.
• Method Comparison Study: The "ground truth" for the modified device (HemosIL Liquid Antithrombin XL) was the results obtained from the legally marketed predicate device (HemosIL Antithrombin K980499). The study aimed to show substantial equivalence to this predicate.

8. The sample size for the training set:

For an in vitro diagnostic assay like this, there isn't typically a "training set" in the machine learning sense. The assay is based on chemical reactions and photometric detection. The development and optimization of the reagent volumes and assay parameters would involve extensive experimentation and optimization, but not a distinct "training set" of data in the way an AI algorithm is trained. The reported values for precision are from performance studies, not "training."

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

As indicated above, the concept of a "training set" and associated "ground truth" in the machine learning context does not directly apply to the development and validation of this chemical assay. The "ground truth" for optimizing the assay parameters would be the known concentrations of Antithrombin in reference materials and controls, used to ensure accuracy and precision.

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Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).

Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).

Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.

Here's a breakdown of the acceptance criteria and study details for the Coamatic® LR Antithrombin device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state pre-defined numerical "acceptance criteria" for the slope, intercept, r-value, or CV%. Instead, it presents the results from which the FDA made a substantial equivalence determination based on the overall performance compared to the predicate device. The values presented here are the "reported device performance."

Study Details

2. Sample Size and Data Provenance

• Sample Size for Test Set: 61 citrated plasma samples.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable (N/A): This type of information is usually relevant for medical imaging or AI diagnostic devices where human experts interpret data. For an in vitro diagnostic (IVD) assay like this, the "ground truth" is typically established by a reference method or validated analytical procedure rather than human expert consensus. The comparison is made against the predicate device.

4. Adjudication Method for Test Set

• Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for this type of IVD device study. The comparison is objective, based on analytical measurement.

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

• No, an MRMC study was not done. This type of study is primarily for medical imaging devices where different human readers evaluate cases with and without AI assistance. This device is an automated IVD assay.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The "Method Comparison" section directly assesses the performance of the Coamatic® LR Antithrombin assay on the ACL Futura against the predicate device (IL Test™ Liquid AT) on the ACL 9000. This is a direct measurement of the device's performance as an algorithm/test system. The "Precision" study also assesses the standalone analytical performance of the device on the ACL Futura.

7. Type of Ground Truth Used

• Predicate Device/Reference Method: The "ground truth" or reference for comparison was the IL Test™ Liquid Antithrombin on the ACL 9000, which is the legally marketed predicate device. This implies that the predicate device is considered the established method for determining Antithrombin levels in this context.

8. Sample Size for Training Set

• Not Applicable (N/A): The document describes a traditional analytical validation for an IVD assay, not a machine learning or AI-driven device that requires a training set. The device itself is a reagent kit and instrument system.

9. How Ground Truth for Training Set Was Established

• Not Applicable (N/A): As there is no training set mentioned or implied for a machine learning algorithm, this question is not relevant.

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