(49 days)
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.
Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.
ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.
Here's a breakdown of the acceptance criteria and the study details for the ACTICLOT® Protein S Quantitative Factor Deficiency Test, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes performance in relation to a predicate device and precision. While explicit, pre-defined acceptance criteria (e.g., "R-value must be greater than X") are not directly stated in the summary, the performance data implicitly serves as the basis for demonstrating substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (ACTICLOT Protein S) |
|---|---|---|
| Method Comparison | ||
| Linear Regression (Lot 1) | Positive correlation with predicate device | Y = 0.91X + 17.2, R = 0.868 |
| Linear Regression (Lot 2) | Positive correlation with predicate device | Y = 1.06X - 7.5, R = 0.916 |
| Precision | ||
| Intra-Assay CV% (Normal Control) | Low variability (implicitly acceptable) | 3.0% |
| Inter-Assay CV% (Normal Control) | Low variability (implicitly acceptable) | 5.9% |
| Intra-Assay CV% (Abnormal Control) | Low variability (implicitly acceptable) | 2.3% |
| Inter-Assay CV% (Abnormal Control) | Low variability (implicitly acceptable) | 5.1% |
Study Details
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Sample size used for the test set and the data provenance:
- Method Comparison:
- Lot 1: n = 78 samples
- Lot 2: n = 37 samples
- Precision: n = 80 per control sample (4 replicates over 20 runs for each of the two control levels)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the samples are "human plasma."
- Method Comparison:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative determination of protein S activity. The performance is assessed against a predicate device and through precision measurements, not against expert human interpretation.
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Adjudication method for the test set: Not applicable. See point 2.
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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 is not an AI-assisted diagnostic imaging or interpretation device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The studies described are for the device (ACTICLOT Protein S) performing as an assay. This is inherently a "standalone" performance evaluation in the context of an in vitro diagnostic test, as it quantitatively determines protein S activity directly.
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The type of ground truth used:
- For the method comparison, the "ground truth" is the results obtained from the predicate device (BIOCLOT Protein S-300 ACT). The ACTICLOT device's performance is compared to this established method to demonstrate substantial equivalence.
- For precision studies, the ground truth is implicitly the known concentration of the control samples.
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The sample size for the training set: Not applicable. As an in vitro diagnostic assay, this device does not rely on a "training set" in the machine learning sense. Its performance is based on its chemical and biological principles and optimization of the assay reagents and protocol.
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How the ground truth for the training set was established: Not applicable. See point 7.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).