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510(k) Data Aggregation
(50 days)
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor XI Deficient Plasma is human plasma immunodepleted of Factor XI and intended for the in vitro diagnostic quantitative determination of Factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the intrinsic pathway factors are determined by performing a modified activated partial thromboplastin time (APTT) test. Patient plasma is diluted and added to a plasma deficient in Factor XI. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor XI in the patient plasma, interpolated from a calibration curve.
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Acceptance Criteria and Device Performance Study for HemosIL Factor XI Deficient Plasma
The HemosIL Factor XI Deficient Plasma is intended for the in vitro quantitative determination of Factor XI activity in citrated plasma. The acceptance criteria for this device are established through method comparison with predicate devices and precision studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly derived from the performance of the predicate devices. For quantitative assays like this, key performance indicators are correlation (r) and agreement in slope for method comparison, and reproducibility (CV%) for precision.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance (HemosIL Factor XI Deficient Plasma) |
|---|---|---|
| Method Comparison | ||
| vs. Hemoliance F-XI Def Plasma (ELECTRA 1400C) | High correlation (r ≥ 0.95), Slope ≈ 1.0 | Slope: 1.0063, r: 0.9808 |
| vs. IL Test F-XI D Plasma (ACL 300) | High correlation (r ≥ 0.95), Slope ≈ 1.0 | Slope: 0.9605, r: 0.9886 |
| vs. IL Test F-XI D Plasma (ACL 6000) | High correlation (r ≥ 0.95), Slope ≈ 1.0 | Slope: 1.0093, r: 0.9669 |
| vs. IL Test F-XI D Plasma (ACL 9000) | High correlation (r ≥ 0.95), Slope ≈ 1.0 | Slope: 0.9512, r: 0.9857 |
| vs. IL Test F-XI D Plasma (ACL Futura) | High correlation (r ≥ 0.95), Slope ≈ 1.0 | Slope: 0.9924, r: 0.9722 |
| Within Run Precision (CV%) | ||
| Normal Control (ACL 300) | Expected low CV% | 4.5% |
| Low Abnormal Control (ACL 300) | Expected low CV% | 4.0% |
| Normal Control (ACL 6000) | Expected low CV% | 3.5% |
| Low Abnormal Control (ACL 6000) | Expected low CV% | 5.4% |
| Normal Control (ACL 9000) | Expected low CV% | 4.5% |
| Low Abnormal Control (ACL 9000) | Expected low CV% | 4.8% |
| Normal Control (ACL Advance) | Expected low CV% | 4.6% |
| Low Abnormal Control (ACL Advance) | Expected low CV% | 4.6% |
| Normal Control (ELECTRA 1400C) | Expected low CV% | 2.4% |
| Low Abnormal Control (ELECTRA 1400C) | Expected low CV% | 2.9% |
| Between Run Precision (CV%) | ||
| Normal Control (ACL 300) | Expected low CV% | 4.4% |
| Low Abnormal Control (ACL 300) | Expected low CV% | 5.6% |
| Normal Control (ACL 6000) | Expected low CV% | 4.7% |
| Low Abnormal Control (ACL 6000) | Expected low CV% | 7.4% |
| Normal Control (ACL 9000) | Expected low CV% | 9.7% |
| Low Abnormal Control (ACL 9000) | Expected low CV% | 7.5% |
| Normal Control (ACL Advance) | Expected low CV% | 7.5% |
| Low Abnormal Control (ACL Advance) | Expected low CV% | 5.5% |
| Normal Control (ELECTRA 1400C) | Expected low CV% | 6.8% |
| Low Abnormal Control (ELECTRA 1400C) | Expected low CV% | 6.6% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Approximately 60 citrated plasma samples (30 normal / 30 abnormal) were used for the method comparison studies. For precision studies, specific numbers of runs (n=80) were performed, but the number of unique samples is not explicitly stated beyond "normal and abnormal samples".
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a quantitative assay comparing against established predicate devices, not an interpretive diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the test set is the result obtained from the predicate devices.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically employed for subjective evaluations or when establishing ground truth from multiple human readers. This study involves objective quantitative measurements and comparisons to predicate device results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This is a laboratory diagnostic device, not an imaging or clinical decision support AI tool that would typically involve a multi-reader multi-case comparative effectiveness study to assess human reader improvement with AI assistance. The device operates in a standalone capacity to quantify Factor XI activity.
6. Standalone Performance Study
Yes, a standalone performance study was done. The precision studies (within-run and between-run variability) demonstrate the device's performance characteristics independently of comparison to another device, assessing its inherent reproducibility. The method comparison also implicitly evaluates the standalone performance by showing its agreement with predicate devices whose performance is already established.
7. Type of Ground Truth Used
The ground truth used for the method comparison studies was the results obtained from the legally marketed predicate devices: Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers and IL Test Factor XI Deficient Plasma on ACL Family of Analyzers. For precision, the ground truth is the expected performance (e.g., target values for controls) and statistical measures of variability.
8. Sample Size for the Training Set
N/A. This device is a reagent and an assay system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical and biological principles and optimization, rather than machine learning on a dataset.
9. How the Ground Truth for the Training Set Was Established
N/A. As stated above, this is not an AI/ML device requiring a training set and associated ground truth establishment.
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