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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.

The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times. Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors.

This document is not structured as a typical study report, but rather as a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification is made to a legally marketed device, and the modification does not affect the device's indications for use or its fundamental scientific technology. In this case, the modification is to the device's labeling (specifically, clarifying heparin interference information) based on updated guidance (CLSI Guideline H60-A).

Therefore, the primary "study" proving the device meets acceptance criteria in this context is the demonstration that the changes are only to the labeling and do not impact the assay's performance compared to the predicate device. This type of submission relies heavily on the predicate's prior clearance and the assertion that the core device technology and performance remain unchanged.

Given this, I will describe the "acceptance criteria" and "device performance" in terms of substantiating that the change in labeling does not alter the device's substantial equivalence to its predicate.

Here's the breakdown of information, addressing your points where applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document describes a Special 510(k) submission. This type of submission is based on the premise that there are no actual changes to the device's performance, but rather to its labeling or minor design aspects.
Therefore, no new "test set" data from patient samples is typically required or provided for a Special 510(k) for a labeling change. The claim of substantial equivalence rests on the device being unchanged and performing as cleared under its predicate (K050221). The "study" here is the comparison demonstrating no change to the device itself.

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)
Not applicable. No new clinical or analytical performance study requiring a ground truth determination from experts on a new test set was conducted for this Special 510(k) submission. The changes are to informational labeling based on a published guideline (CLSI H60-A).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new test set requiring expert adjudication was utilized for this type of submission.

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
Not applicable. This device is an in vitro diagnostic (IVD) reagent for a laboratory test (detection of Lupus Anticoagulants), not an imaging device or an AI-powered diagnostic system designed for human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an IVD reagent, not an algorithm. Its performance is measured directly by clinical laboratory methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable to this Special 510(k) based on a labeling change. The original predicate device (K050221) would have established its performance against appropriate reference methods or clinical outcomes during its initial clearance process. For this submission, the "ground truth" is that the device itself has not changed and therefore its previously established performance holds. The update to the labeling regarding heparin interference aligns with an industry-accepted guideline (CLSI Guideline H60-A).

8. The sample size for the training set
Not applicable. No training set was used for this Special 510(k) submission.

9. How the ground truth for the training set was established
Not applicable. No training set was used for this Special 510(k) submission.

In summary of the "study":

The "study" in this Special 510(k) is a comparison study that demonstrates the "modified device" is identical in all functional aspects to the "predicate device," with the only changes being to the instructional labeling regarding heparin interference. The acceptance criterion is that no functional or performance changes were introduced, and therefore the device remains substantially equivalent to the previously cleared predicate (K050221). The proof is in the documentation confirming no changes to formulation, operating principle, indications for use, stability, specimen requirements, software, or test parameters.

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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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