(48 days)
HemosIL High Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA™ Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
Values for all analytes are in the high abnormal range.
Available as an assayed high abnormal control (HemosIL High Abnormal Control) or unassayed high abnormal control (HemosIL High Abnormal Control 3), the product is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRATM Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to simulate an abnormal coagulation sample.
Here's an analysis of the provided text regarding the HemosIL High Abnormal Control, focusing on acceptance criteria and the supporting study:
The provided document describes a quality control device (HemosIL High Abnormal Control) for coagulation assays. As such, the "acceptance criteria" and "device performance" are focused on the device's precision in measuring known analytes, rather than diagnostic accuracy against a ground truth for individual patient samples.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds for the precision study results. Instead, it presents the results of a precision study. For a quality control device, the reported "Within-Run %CV" values inherently represent the device's performance against an implicit expectation of low variability for accurate quality control. I will present the reported performance as the observed precision.
| Analyte | Reported Within-Run %CV | (Implicit Acceptance: Low CV for Quality Control) |
|---|---|---|
| Activated Partial Thromboplastin (APTT) | 2.62% | Lower CV indicates better precision |
| Antithrombin | 9.90% | Lower CV indicates better precision |
| Protein C | 6.11% | Lower CV indicates better precision |
| Protein S | 2.75% | Lower CV indicates better precision |
| Prothrombin Time (PT) | 1.61% | Lower CV indicates better precision |
Note: The document only provides within-run CVs. A full precision study typically includes total CV (inter-run, inter-day, inter-lot, etc.). However, only "Within-Run %CV" is reported here.
2. Sample Size Used for the Test Set and Data Provenance
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Test Set Sample Size (n):
- Activated Partial Thromboplastin (APTT): N = 80
- Antithrombin: N = 80
- Protein C: N = 80
- Protein S: N = 40
- Prothrombin Time (PT): N = 80
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Data Provenance: The document states the study was performed "over multiple days with multiple runs using specific lots of reagents and control." The device itself is "prepared using human citrated plasma from healthy donors." The study details do not specify the country of origin. The study is prospective in nature, as it describes a controlled experiment to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this device and study. The HemosIL High Abnormal Control is a quality control material, not a diagnostic device that interprets patient samples or images. Its "ground truth" is its own formulated "target values" for the analytes it controls. The study evaluates the precision of the device in consistently measuring these internal known values, not its accuracy against an external "ground truth" established by experts.
4. Adjudication Method for the Test Set
This question is not applicable as there is no expert interpretation or diagnostic decision being made that would require adjudication. The study is a quantitative measurement of precision.
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 question is not applicable. This is not an AI/imaging device, nor is it a device that involves human readers or interpretation of cases. It is a laboratory quality control material.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm-based device. It's a laboratory reagent. The performance reported (precision) is inherent to the control material and the analytical system it's used with, which can be seen as "standalone" in the sense that the results are quantitative measures from the system.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is its intended (manufactured) analyte concentration/activity values. The HemosIL High Abnormal Control is designed to simulate an abnormal coagulation sample with specific, known levels of APTT, Antithrombin, Protein C, Protein S, and PT. The study's "Mean" values (e.g., 64.4 seconds for APTT) represent the experimentally determined average for those manufactured values, and the "Within-Run %CV" indicates how consistently the device and system measure these known values.
8. The Sample Size for the Training Set
This question is not applicable. This device is a quality control material, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as #8. No training set is involved.
§ 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.