(51 days)
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
HemosIL Factor VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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 VIII. Correction of the clotting time of the deficient plasma is proportional to the concentration (% activity) of the factor VIII in the patient plasma, interpolated from a calibration curve.
The provided text describes the 510(k) summary for the HemosIL Factor VIII Deficient Plasma device, which is an in vitro diagnostic intended for quantitative determination of factor VIII activity. The study presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific clinical acceptance criteria in the way an AI/ML device would.
However, I can extract the performance data provided and frame it in a table, even if explicit "acceptance criteria" are not stated as pass/fail thresholds in the document. The study's aim was to show comparable performance to predicate devices.
1. A table of acceptance criteria and the reported device performance
For a diagnostic device like this, "acceptance criteria" are typically met by demonstrating performance (like correlation and precision) that is comparable to or better than a legally marketed predicate device. The document states that the device is "substantially equivalent... in performance, intended use and safety and effectiveness."
| Performance Metric | Acceptance Criteria (Implicit for Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison vs. Hemoliance Factor VIII Deficient Plasma (ELECTRA System) | Similar slope and correlation coefficient to predicate | E1400C: Slope = 0.9518, r = 0.9873 |
| Method Comparison vs. IL Test Factor VIII Deficient Plasma (ACL Family) | Similar slope and correlation coefficient to predicate | ACL 300: Slope = 0.9391, r = 0.9942 |
| ACL Advance: Slope = 1.0073, r = 0.9906 | ||
| Within-Run Precision (CV%) | Acceptable precision for clinical use (relative to predicate or industry standard) | ACL 9000: Normal Control (3.1%), Low Abnormal (2.2%) |
| ACL Futura: Normal Control (2.7%), Low Abnormal (3.4%) | ||
| ELECTRA 1600C: Normal Control (4.8%), Low Abnormal (4.1%) | ||
| Between-Run Precision (CV%) | Acceptable precision for clinical use (relative to predicate or industry standard) | ACL 9000: Normal Control (3.1%), Low Abnormal (3.3%) |
| ACL Futura: Normal Control (3.6%), Low Abnormal (4.0%) | ||
| ELECTRA 1600C: Normal Control (6.0%), Low Abnormal (4.6%) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Method Comparison: Approximately 60 citrated plasma samples (30 normal and 30 abnormal) were used for each predicate comparison.
- Within-Run and Between-Run Precision: Not explicitly stated as a number of samples, but assessed over "multiple runs (n=80) on different instruments using a specific lot of APTT reagent and both normal and abnormal samples." This refers to the number of runs, not individual patient samples. Typically, controls are run multiple times.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of in vitro diagnostic device study does not typically involve human expert adjudication for ground truth in the same way an AI image analysis device would. The "ground truth" for method comparison is the result obtained from the predicate device (another established diagnostic test). For precision, the "ground truth" is the expected value of the control sample. Therefore, this section is not applicable.
4. Adjudication method for the test set
Not applicable. As noted above, this study compares the device's measurements to predicate device measurements or established control values, not to adjudicated expert opinions.
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 an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device. The performance data presented (method comparison, precision) reflects the device's intrinsic analytical performance when run on the specified coagulation systems. It's a reagent that works with an instrument to produce a result, without direct human-in-the-loop interpretation of that result in the way an AI would assist.
7. The type of ground truth used
- For Method Comparison: The "ground truth" was the results obtained from the predicate devices (Hemoliance Factor VIII Deficient Plasma and IL Test Factor VIII Deficient Plasma) on their respective analytical systems.
- For Precision: The "ground truth" was the assigned values of normal and low abnormal control plasmas.
8. The sample size for the training set
Not applicable. This is a conventional in vitro diagnostic device, not an AI/ML device that requires a "training set" in that sense. The device's formulation and manufacturing processes are developed to achieve the intended performance characteristics.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm 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).