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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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An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with ß2-glycoprotein I (ß2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The IgG Anti-AtherOx Test Kit is an indirect ELISA detecting IgG anti-oxLDL/B2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL-ß2GPI complex. Incubation allows the IgG anti-oxLDL-B2GPI antibody present in the samples to react with the immobilized antigen complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added forming complexes with the bound IgG anti-oxLDL-B2GPI antibody. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-B2GPI antibody. Results are obtained by reading the OD (optical density or absorbance) of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-B2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean ODs. Controls and patient results are determined from the calibration curve.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets those criteria:

The document provided does not contain explicit "acceptance criteria" for clinical performance in the typical sense of metrics like sensitivity, specificity, or agreement thresholds against an established reference standard. Instead, the clinical testing section focuses on demonstrating agreement with a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit) across various patient populations. Therefore, the "acceptance criteria" are implied by the observed agreement rates with the predicate, rather than set a-priori.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (demonstrating substantial equivalence to a predicate device), the primary "acceptance criterion" appears to be sufficient agreement with the predicate device across different patient populations.

Study Information:

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

   • Test Set Sample Size: A total of 448 serum samples were tested:
     • 205 from healthy control patients.
     • 99 from patients with rheumatoid arthritis.
     • 143 from patients with systemic lupus erythematosus (SLE).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it uses "serum samples from" patients, implying they were collected prior to the study for testing.

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

   • The document does not state that experts were used to establish a "ground truth" for the test set. Instead, the device's performance is compared to a legally marketed predicate device (REAADS IgG Anti-Cardiolipin Test Kit). The predicate device itself serves as the reference for comparison, not an independent expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • There is no mention of an adjudication method in the context of expert review or ground truth establishment. The comparison is directly between the new device and the predicate device.

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:

   • This is an in vitro diagnostic (IVD) device (ELISA test kit) for detecting antibodies in serum. It is not an AI-powered diagnostic imaging device or a device involving human readers/interpreters in the presented study. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable to this submission.

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

   • This is an IVD test kit. The "standalone" performance is essentially what is presented in the study: the direct comparison of the assay's results against the predicate device. There is no human-in-the-loop component in the interpretation of the test results described here beyond the laboratory technician performing the assay and reading the ODs.

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

   • The "ground truth" (or reference standard for comparison) in this 510(k) submission is the performance of the REAADS IgG Anti-Cardiolipin Test Kit, a legally marketed predicate device. The clinical diagnoses of the patients (healthy controls, RA, SLE, APS) serve as classification for the samples, but the direct comparison is test-vs-test.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" for the purpose of machine learning or algorithm development. This is a traditional ELISA assay kit. The provided clinical study data (448 samples) represent the "test set" for performance evaluation, not a training set. Development and optimization of the assay would typically involve internal validation, but those details are not part of this summary in terms of a "training set" as understood in AI/ML contexts.

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

   • As there's no mention of a "training set" in the context of algorithm development, this question is not applicable. The development of the assay itself would have involved establishing specific assay parameters, but the mechanism for doing so isn't detailed as "ground truth establishment" for a training set.

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