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HemosIL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the . semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate plasma and serum on the ACL™ AcuStar as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
. HemosIL AcuStar Anti-Cardiolipin IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the ACL™ AcuStar, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
HemosIL AcuStar Anti-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin . IgG assay performed on the ACL AcuStar.
HemosIL AcuStar Anti-Cardiolipin IgM Controls: For the quality control of the Anti-Cardiolipin . IgM assay performed on the ACL AcuStar.

HemosIL AcuStar Anti-Cardiolipin IgG is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL antiphospholipid antibodies from the sample. After incubation, magnetic separation and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgG antibody is added and may bind with the captured aCL IgG on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgG concentration in the sample.
The ACL AcuStar aCL IgG assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartidge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator tube barcodes.

Hemos L AcuStar Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL antiphospholipid antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgM concentration in the sample.
The ACL AcuStar aCL IgM assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator tube barcodes.

Hemos L AcuStar Anti-Cardiolipin IgG Controls: The Low and High Anti-Cardiolipin IgG Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgG antibodies.
Low Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgG levels.
High Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgG levels.
Hemos L AcuStar Anti-Cardiolipin IgM Controls: The Low and High Anti-Cardiolipin IgM ● Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgM antibodies.
Low Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgM levels.
High Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgM levels.

The provided text describes the performance data for the HemosIL AcuStar Anti-Cardiolipin IgG and IgM assays and their respective controls, which are automated chemiluminescent immunoassays used to aid in the diagnosis of thrombotic disorders related to Antiphospholipid Syndrome (APS).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the clinical performance in a quantifiable manner (e.g., a required minimum sensitivity or specificity). However, it presents performance data for precision, clinical sensitivity, specificity, and agreement with a predicate device. For the purpose of this response, I will list the reported performance metrics.

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

• Sample Size for Clinical Outcome Study: 321 frozen citrated plasma samples.
• Sample Size for Method Comparison Study:
  • HemosIL AcuStar Anti-Cardiolipin IgG: 136 samples (those within the compared methods' test ranges from the clinical performance study).
  • HemosIL AcuStar Anti-Cardiolipin IgM: 267 samples (those within the compared methods' test ranges from the clinical performance study).
• Data Provenance: The text does not explicitly state the country of origin. The samples were "frozen citrated plasmas" from "6 different groups," including patients diagnosed with primary APS (PAPS), secondary APS (SAPS), systemic lupus erythematosus (SLE) with and without APS, cardiovascular disorders, and apparently healthy people. This indicates a retrospective collection of samples.

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

The document does not provide information about the number of experts or their qualifications used to establish the ground truth for the test set. It mentions "individuals diagnosed as primary APS (SAPS), secondary APS (SAPS), systemic lupus erythematosus (SLE) but not APS and SLE-like by standard objective tests." This implies that the diagnosis (ground truth) was established through existing clinical assessments and standard objective tests, but not necessarily through a de novo expert consensus review for the purpose of this study.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies for the test set. The diagnoses were seemingly pre-existing.

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 section is not applicable to this device. The HemosIL AcuStar Anti-Cardiolipin assays are laboratory diagnostic tests (immunoassays) performed on an automated instrument (ACL™ AcuStar) to measure specific antibodies in patient samples. They are not AI-assisted imaging or clinical decision support tools that involve human "readers" or directly improve human "readers" with AI assistance. The results are quantitative measurements.

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

Yes, the performance data presented (precision, clinical sensitivity/specificity, method comparison) reflects the standalone performance of the HemosIL AcuStar assays. These are automated chemiluminescent immunoassays, meaning the algorithm (the assay's chemical reactions and instrument's measurement/calculation) provides a result without direct human intervention in the measurement or interpretation, beyond loading samples and controls and routine instrument operation. The results are then interpreted clinically by healthcare professionals.

7. The Type of Ground Truth Used

The ground truth used for the clinical outcome studies was based on the clinical diagnosis of the patient groups. Specifically, patients were categorized into groups such as Primary APS (PAPS), Secondary APS (SAPS), Systemic Lupus Erythematosus (SLE), SLE-like, cardiovascular disorders, and apparently healthy people. The "cut-off of 20 U/mL" was applied to the assay results to determine positive/negative status relative to these clinical diagnoses.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the development of any algorithm or model. The description of the device (Section "Device Description") indicates that the instrument uses a "4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve," which is "predefined and lot dependent" and stored via a barcode. This suggests that the master curve might be established during manufacturing/development using a set of reference materials, but no specific "training set" of patient samples for algorithm refinement is mentioned in the context of the regulatory submission.

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

As no explicit "training set" is described for an AI/machine learning algorithm based on patient data, this question is not applicable in the context of this document. The "Master Curve" mentioned for calibration is established using calibrators with known concentrations, not a patient-derived training set with clinical ground truth.

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