(57 days)
HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor V Deficient Plasma is human plasma immunodepleted of factor V and intended for the in vitro diagnostic quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Abnormalities of the extrinsic pathway factors are determined by performing a modified prothrombin time (PT) test. Patient plasma is diluted and added to a plasma deficient in factor V. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor V in the patient plasma, interpolated from a calibration curve.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HemosIL Factor V Deficient Plasma device:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in terms of pre-defined thresholds for slope, correlation, or CV%. Instead, the implied acceptance criteria for substantial equivalence are based on demonstrating comparable performance to the predicate devices. The study data presented serves as the evidence that these implicit criteria (i.e., performance similar to predicate devices) are met.
| Performance Metric | Implied Acceptance Criteria (Demonstrate equivalence to predicate) | Reported Device Performance (HemosIL Factor V Deficient Plasma) |
|---|---|---|
| Method Comparison vs. Hemoliance F-V Deficient Plasma (ELECTRA E1400C) | Slope and 'r' comparable to predicate | Slope: 1.0161, r: 0.9877 |
| Method Comparison vs. IL Test F-V Deficient Plasma (ACL 300) | Slope and 'r' comparable to predicate | Slope: 1.0005, r: 0.9932 |
| Method Comparison vs. IL Test F-V Deficient Plasma (ACL 6000) | Slope and 'r' comparable to predicate | Slope: 0.9771, r: 0.9940 |
| Method Comparison vs. IL Test F-V Deficient Plasma (ACL 9000) | Slope and 'r' comparable to predicate | Slope: 0.9746, r: 0.9945 |
| Method Comparison vs. IL Test F-V Deficient Plasma (ACL Futura) | Slope and 'r' comparable to predicate | Slope: 1.1331, r: 0.9814 |
| Within Run Precision (ACL 300 - Normal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 110.6, Within run CV%: 1.0, Total CV%: 3.1 |
| Within Run Precision (ACL 300 - Low Abnormal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 30.1, Within run CV%: 1.8, Total CV%: 3.5 |
| Within Run Precision (ACL 6000 - Normal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 115.1, Within run CV%: 1.5, Total CV%: 3.0 |
| Within Run Precision (ACL 6000 - Low Abnormal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 31.5, Within run CV%: 1.9, Total CV%: 2.8 |
| Within Run Precision (ACL 9000 - Normal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 113.7, Within run CV%: 1.2, Total CV%: 1.7 |
| Within Run Precision (ACL 9000 - Low Abnormal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 29.0, Within run CV%: 4.0, Total CV%: 5.6 |
| Within Run Precision (ACL Advance - Normal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 132.4, Within run CV%: 6.0, Total CV%: 7.6 |
| Within Run Precision (ACL Advance - Low Abnormal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 27.1, Within run CV%: 4.1, Total CV%: 5.7 |
| Within Run Precision (ELECTRA 1400C - Normal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 101.0, Within run CV%: 2.1, Total CV%: 3.5 |
| Within Run Precision (ELECTRA 1400C - Low Abnormal Control) | CV% comparable to expected diagnostic precision for this assay type | Mean % Factor V: 24.0, Within run CV%: 1.5, Total CV%: 2.6 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal).
- Sample Size for Precision: Controls run over multiple runs (n=80) for each instrument.
- Data Provenance: The document does not specify the country of origin or whether the samples were retrospective or prospective. It only states "citrated plasma samples."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in vitro diagnostic reagent. The "ground truth" for Factor V activity would typically be established by the reference method (the predicate device, in this case) or a validated laboratory method using established controls.
- The concept of "experts" in the sense of clinical reviewers (e.g., radiologists) and their qualifications is not applicable to this type of device and study. The ground truth is the measured laboratory value.
4. Adjudication method for the test set:
- Not applicable. This is a comparison of quantitative laboratory measurements, not a qualitative assessment requiring adjudication.
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:
- Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data. It's an in vitro diagnostic reagent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic reagent. Its performance is evaluated intrinsically through comparison to predicate devices and precision studies, without human interpretation as part of the primary diagnostic result.
7. The type of ground truth used:
- The ground truth for the method comparison study is implicitly the results obtained from the predicate devices (Hemoliance Factor V Deficient Plasma and IL Test Factor V Deficient Plasma) on their respective analyzer systems, using a common PT reagent (HemosIL RecombiPlasTin).
- For the precision studies, the ground truth for the "normal" and "low abnormal" controls would be their assigned target values (or range) based on their manufacturing and calibration processes.
8. The sample size for the training set:
- This device is a reagent and not a machine learning or AI model, so there is no "training set" in that context. The development of the reagent itself would involve formulation, characterization, and quality control, but not in the sense of a data-driven training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an algorithm.
§ 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).