(30 days)
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.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Within-Run Precision | Low CV% to demonstrate consistency within a single run | Normal: 2.5% CV, Low Abnormal: 4.4% CV, High Abnormal: 6.4% CV |
| Between-Run Precision | Low CV% to demonstrate consistency across multiple runs | Normal: 3.4% CV, Low Abnormal: 4.9% CV, High Abnormal: 7.4% CV |
| Method Comparison | Substantial equivalence to the predicate device (K980499) | Data unreadable due to OCR errors. |
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.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).