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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 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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