(63 days)
HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor VII Deficient Plasma is human plasma immunodepleted of Factor VII and intended for the in vitro diagnostic quantitative determination of Factor VII 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 VII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the Factor VII in the patient plasma, interpolated from a calibration curve.
Here's a breakdown of the acceptance criteria and study information for the HemosIL Factor VII Deficient Plasma device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates substantial equivalence rather than meeting explicit acceptance criteria in the traditional sense of pre-defined thresholds. The performance is compared directly to predicate devices.
| Performance Metric | Acceptance Criteria (Implicit - Substantial Equivalence to Predicate) | Reported Device Performance | Comments |
|---|---|---|---|
| Method Comparison | |||
| Slope (vs. Hemoliance on ELECTRA E1400C) | Close to 1.0 (indicating good agreement) | 0.9683 | This value is very close to 1.0, suggesting strong agreement with the predicate on the ELECTRA system. |
| Correlation (r) (vs. Hemoliance on ELECTRA E1400C) | Close to 1.0 (indicating strong linear correlation) | 0.9967 | This high correlation coefficient (r) indicates a very strong linear relationship between the new device and the predicate. |
| Slope (vs. IL Test on ACL 300) | Close to 1.0 | 1.0045 | Excellent agreement. |
| Correlation (r) (vs. IL Test on ACL 300) | Close to 1.0 | 0.9994 | Very strong correlation. |
| Slope (vs. IL Test on ACL 6000) | Close to 1.0 | 0.9646 | Strong agreement. |
| Correlation (r) (vs. IL Test on ACL 6000) | Close to 1.0 | 0.9989 | Very strong correlation. |
| Slope (vs. IL Test on ACL 9000) | Close to 1.0 | 0.9778 | Strong agreement. |
| Correlation (r) (vs. IL Test on ACL 9000) | Close to 1.0 | 0.9996 | Very strong correlation. |
| Slope (vs. IL Test on ACL Futura) | Close to 1.0 | 0.9678 | Strong agreement. |
| Correlation (r) (vs. IL Test on ACL Futura) | Close to 1.0 | 0.9943 | Very strong correlation. |
| Within Run Precision | Not explicitly stated as acceptance criteria, but generally low CV% values are desirable. | The CV% values demonstrate good precision across various instruments and control levels. The ACL Advance shows slightly higher CV%s for both within-run and total precision compared to other instruments. | |
| Normal Control Mean % Factor VII | Not explicitly stated, but expected to be around the nominal value. | 79.4 - 100.5% | Values are within expected ranges for normal controls. |
| Normal Control Within Run CV% | Not explicitly stated, but low CV% is desirable. | 0.8 - 4.7% | Generally low, with ACL Advance showing the highest (4.7%). |
| Normal Control Total CV% | Not explicitly stated, but low CV% is desirable. | 1.9 - 5.7% | Generally low, with ACL Advance showing the highest (5.7%). |
| Low Abnormal Control Mean % Factor VII | Not explicitly stated. | 37.8 - 50.9% | Values are within expected ranges for low abnormal controls. |
| Low Abnormal Control Within Run CV% | Not explicitly stated, but low CV% is desirable. | 1.2 - 4.6% | Generally low, with ACL Advance showing the highest (4.6%). |
| Low Abnormal Control Total CV% | Not explicitly stated, but low CV% is desirable. | 2.5 - 5.9% | Generally low, with ACL Advance showing the highest (5.9%). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison: 60 citrated plasma samples (30 normal / 30 abnormal)
- Sample Size for Precision: The text states "multiple runs (n=80)" using two levels of control. This means 80 measurements were taken for each control level on each instrument for the precision study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective measurements of samples (either previously collected or prepared for the study), as opposed to prospective collection specifically for this study. The phrasing "evaluating 60 citrated plasma samples" and "using two levels of control" suggests existing or prepared samples within a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and study. The device is for quantitative determination (measuring Factor VII activity), not for diagnostic interpretation by human experts. The "ground truth" for method comparison and precision studies typically relies on the established accuracy and precision of the predicate device and the known concentrations of control materials.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study, as there is no human interpretation or subjective assessment that would require 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
This information is not applicable. This device is an in vitro diagnostic reagent, not an AI-powered diagnostic imaging or interpretive tool. There are no human readers involved in the direct determination of Factor VII activity using this reagent.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the same way it would be for an AI algorithm. However, the performance data presented (method comparison and precision) is essentially "standalone" in the sense that it measures the performance of the device (reagent and instrument system) independently, without human interpretive input affecting the quantitative result. The device itself performs the measurement.
7. The Type of Ground Truth Used
- For Method Comparison: The measurements from the predicate devices (Hemoliance Factor VII Deficient Plasma and IL Test Factor VII Deficient Plasma) served as the comparative "ground truth" to establish substantial equivalence.
- For Precision: The known, established concentrations or expected values of the control materials (Normal Control and Low Abnormal Control) served as the ground truth against which precision (variability) was assessed.
8. The Sample Size for the Training Set
This information is not applicable. This is an in vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The development of such reagents involves chemical and biological formulation and optimization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 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).