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• HemosIL LA Positive Control .
  For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Negative Control
  For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Positive Control
  The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• HemosIL LA Negative Control
  The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

The provided text describes a 510(k) summary for the HemosIL LA Positive Control and HemosIL LA Negative Control devices. These devices are quality controls for Lupus Anticoagulant (LA) assays performed on specific IL Coagulation Systems. The study presented aims to demonstrate the precision of these control devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Note: The "Conclusion" section explicitly states: "All results were well within specification for both lots of controls tested." The tables provided show detailed CV% values, all of which are below 6% for both within-run and total precision across various instruments and reagents.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: N=80 (2 replicates per run / 2 runs per day / 20 days) for each of two lots of each control level, with two different LA assays per instrument platform.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective study as it describes a specific experimental protocol for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This study is evaluating the precision of quality control materials for an in-vitro diagnostic device, not an interpretation of images or clinical data by experts. Therefore, the concept of "ground truth established by experts" as typically understood in AI/medical imaging does not directly apply here. The "ground truth" for these controls is their expected value (positive or negative for LA) and their performance characteristics against established quality standards (precision).

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

No adjudication method is described as this is a laboratory assay precision study, not a study involving human interpretation with potential discrepancies.

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

No. This is not an MRMC comparative effectiveness study. It's a precision study for diagnostic controls.

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

Yes, this is a standalone performance study. The devices (quality controls) are tested on automated coagulation systems. There is no human interpretation or "human-in-the-loop" component being evaluated beyond the inherent operation of the lab instruments.

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

The "ground truth" for these controls is their known characteristics:

• HemosIL LA Positive Control: Lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies, confirmed positive for LA according to ISTH Guidelines.
• HemosIL LA Negative Control: Lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma, recommended as a negative control for LA by ISTH Guidelines.

The performance of the controls is then measured against a precision specification (≤ 6% CV).

8. The sample size for the training set

This document does not describe the development of an algorithm or AI. It describes the performance evaluation of quality control materials. Therefore, there is no "training set" in the context of machine learning.

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

As there is no training set for an algorithm, this question is not applicable. The "ground truth" for the controls themselves (their positive or negative status) is established by their formulation and adherence to established guidelines (ISTH).

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HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

Here's a summary of the acceptance criteria and study details for the HemosIL Silica Clotting Time device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document explicitly states that the device "is substantially equivalent to the commercially available predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) in performance and intended use." This implies that the acceptance criteria were based on demonstrating comparable performance to these predicate devices rather than pre-defined absolute thresholds, for the correlation and clinical performance metrics. For precision, the reported %CVs fall within generally acceptable ranges for diagnostic assays.

Study Details

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

   • Method Comparison Study: 210 citrated plasma samples (120 normals/90 abnormals)
   • Clinical Study: 206 citrated plasma samples (121 normals/85 abnormals)
   • Data Provenance: "in-house study" and "clinical study." The document does not specify the country of origin, but given the manufacturer (Lexington, MA, USA) and the 510(k) submission to the FDA, it is highly probable the studies were conducted within the US or followed US regulatory guidelines. The studies appear to be retrospective as they involved analyzing collected plasma samples.

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

   • The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. The ground truth appears to be based on the results from the predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) for comparison. The classification of samples as "normals" and "abnormals" for Lupus Anticoagulants would have been based on established clinical diagnostic criteria, likely involving expert interpretation of multiple tests, but this detail is not provided.

3. Adjudication method for the test set:

   • The document does not describe a specific adjudication method. As the primary comparison is against predicate devices, the "ground truth" for the test set is established by the results of those predicate devices.

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 device is an in-vitro diagnostic (IVD) assay, not an AI-assisted imaging or diagnostic tool that requires human reader interpretation. Therefore, an MRMC study is not applicable.

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

   • Yes. The reported performance metrics (slope, intercept, r, sensitivity, specificity, precision) are for the HemosIL Silica Clotting Time device running on an IL Coagulation System, indicating a standalone (algorithm/device only) performance evaluation. There is no mention of human-in-the-loop performance.

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

   • The ground truth for the test sets (both method comparison and clinical) appears to be established by the results obtained from the predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm). Additionally, for the clinical study, it's mentioned that "All known Lupus Anticoagulant samples (n=48) tested as part of this study gave SCT normalized ratios > 1.24," suggesting that a subset of the abnormal samples had a pre-established clinical diagnosis of Lupus Anticoagulant, likely based on a combination of tests and expert consensus.

7. The sample size for the training set:

   • The document does not specify a separate "training set" in the context of machine learning. This is an IVD device, and the development process would involve formulation, optimization, and characterization rather than AI model training. The "in-house study" and "clinical study" are performance validation studies.

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

   • Not applicable as there is no mention of a separate training set in the context of an AI/ML model for this IVD device. The development of such a device focuses on reagent formulation and instrument calibration, typically using well-characterized samples and reference methods.

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