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510(k) Data Aggregation
(75 days)
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
Acceptance Criteria and Study for HemosIL Calibration Plasma
This device, HemosIL Calibration Plasma, is a calibrator for coagulation assays. The performance data presented focuses on its precision in various coagulation analytes. Due to the nature of a calibrator, the acceptance criteria are implicitly tied to the precision requirements for each analyte as demonstrated by the predicate devices or established laboratory practice for calibration quality.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. However, typical acceptance criteria for calibrators revolve around established precision limits (e.g., %CV) that ensure the calibrator is stable and reliable for its intended use. The reported "Within Run %CV" values would be compared against these unstated, but generally understood, acceptable precision ranges for each analyte.
| Analyte | Reagent | Reported Mean | Reported Within Run %CV | Implicit Acceptance Criteria (Example) |
|---|---|---|---|---|
| APTT (Seconds) | HemosIL APTT-SP | 30.5 | 1.15 | e.g., < 5% CV |
| Antithrombin (%) | HemosIL Liquid Antithrombin | 104 | 2.04 | e.g., < 5% CV |
| Factor V (%) | HemosIL FV Deficient Plasma | 117 | 2.09 | e.g., < 5% CV |
| Factor VIII (%) | HemosIL FVIII Deficient Plasma | 83.2 | 4.28 | e.g., < 10% CV |
| Fibrinogen - Clauss (mg/dL) | HemosIL Fibrinogen-C | 295 | 2.30 | e.g., < 5% CV |
| Fibrinogen - PT-Based (mg/dL) | HemosIL PT-Fib Recombinant | 288 | 5.12 | e.g., < 10% CV |
| Plasmin Inhibitor (%) | HemosIL Plasmin Inhibitor | 97.7 | 2.02 | e.g., < 5% CV |
| Plasminogen (%) | HemosIL Plasminogen | 84.6 | 1.59 | e.g., < 5% CV |
| Protein C (%) | HemosIL ProClot | 96.8 | 4.73 | e.g., < 10% CV |
| Protein S (%) | HemosIL Protein S | 70.9 | 3.39 | e.g., < 5% CV |
| PT (Seconds) | HemosIL PT-Fib Recombinant | 11.0 | 1.45 | e.g., < 5% CV |
| Thrombin Time (Seconds) | HemosIL Thrombin Time (2 mL) | 7.59 | 1.84 | e.g., < 5% CV |
| Thrombin Time (Seconds) | HemosIL Thrombin Time (5 mL) | 16.9 | 2.13 | e.g., < 5% CV |
| Thrombin Time (Seconds) | HemosIL Thrombin Time (8 mL) | 24.5 | 1.27 | e.g., < 5% CV |
| von Willebrand Factor (%) | HemosIL VWF Antigen | 104 | 1.13 | e.g., < 5% CV |
Note: The "Implicit Acceptance Criteria (Example)" column contains typical precision thresholds for similar analytes in laboratory settings, as the document does not explicitly state acceptance criteria. The reported performance shows all %CV values are well within typically accepted ranges for laboratory calibrators, indicating the device meets the implicit precision requirements.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The precision testing involved running the HemosIL Calibration plasma in replicates of eight (n=8) for each analyte. This was performed across four ACL 9000 coagulation analyzers, resulting in a total of N=32 data points for each analyte (8 replicates * 4 analyzers).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given the context of a 510(k) submission to the FDA (USA) by a US-based company (Instrumentation Laboratory Company, Lexington, MA), it is highly probable that the study was conducted in the United States and was prospectively designed for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to this device. As a laboratory calibrator, its "ground truth" is not established by human expert consensus or interpretation of images/data. Instead, the "ground truth" for a calibrator refers to its assigned target values and the demonstration of its precision and consistency around those values. These values are determined through rigorous analytical methods and reference to primary standards or established methodologies, not expert opinions.
4. Adjudication Method for the Test Set
This section is not applicable to this device for the same reasons stated in point 3. Adjudication methods like 2+1 or 3+1 are used when human interpretation is involved and there's a need to resolve discrepancies. For a calibrator, the performance is assessed objectively through quantitative measurements of precision and accuracy against established analytical methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assesses the impact of AI assistance on human performance. The HemosIL Calibration Plasma is a laboratory calibrator, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is implicitly analogous to standalone performance of the calibrator itself. The precision testing directly measures the performance of the calibrator (and the reagents/analyzers it calibrates) without human interpretation affecting the result. The study shows the inherent performance characteristics of the calibrator and its interaction with the coagulation systems and reagents.
7. The Type of Ground Truth Used
The "ground truth" for the HemosIL Calibration plasma is established through:
- Analytical measurement: The reported "Mean" values for each analyte represent the established concentration or activity of that analyte in the calibrator plasma. These values are determined using highly accurate and precise laboratory methods.
- Reference to established standards: While not explicitly detailed, calibrators like HemosIL are typically traceable to international reference materials or highly characterized primary standards to ensure accuracy and comparability across different laboratories.
- Consistency and precision: The "Within Run %CV" demonstrates the calibrator's ability to consistently produce the same result when measured repeatedly, which is a critical aspect of its "truthfulness" as a calibrator.
- Plasma source: The text mentions it's "prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool," which defines its biological "ground truth" as a normal human plasma matrix.
8. The Sample Size for the Training Set
This section is not applicable to this device. The HemosIL Calibration plasma is a biological product used for calibration; it is not an algorithm or AI model that requires a "training set" in the computational sense. Its "development" involves formulation, characterization, and value assignment, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons explained in point 8.
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