(210 days)
- 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
| Acceptance Criteria (Specification) | Device (HemosIL LA Positive Control) Reported Performance | Device (HemosIL LA Negative Control) Reported Performance |
|---|---|---|
| Within run and Total ≤ 6% CV | Achieved (All reported Total CV% values are ≤ 4.2%) | Achieved (All reported Total CV% values are ≤ 3.9%) |
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).
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.