(26 days)
Coatest Factor VIII was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma. For in vitro diagnostic use.
Coatest Factor VIII (K833892) was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma.
The Coatest Factor VIII (Modified) device is intended for the photometric determination of Factor VIII activity in citrated plasma. The modification involved substituting natural porcine phospholipids with synthetic phospholipids in the Phospholipid reagent. The study aimed to demonstrate substantial equivalence to the predicate device (Coatest Factor VIII, K833892).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Coatest Factor VIII (Modified)) |
|---|---|---|
| Precision | CV% should be within acceptable clinical limits (not explicitly stated but inferred from typical assay performance for factor VIII). | |
| Within-run CV (Low range) | 1.5% | |
| Between-run CV (Low range) | 2.3% | |
| Within-run CV (High range) | 1.4% | |
| Between-run CV (High range) | 2.4% | |
| Method Comparison | High correlation and agreement with the predicate device (Coatest Factor VIII). Implicitly, the slope should be close to 1 and the intercept close to 0. | Slope = 1.002, Intercept = 0.365 |
Note: The acceptance criteria are not explicitly defined in the provided text. They are inferred based on the performance data presented and the claim of substantial equivalence to a predicate device. For precision, typical clinical laboratory standards would dictate acceptable CVs.
2. Sample size used for the test set and the data provenance:
- Precision Test Set:
- Low Range: 90 samples
- High Range: 89 samples
- Provenance: Not specified, but likely from a controlled laboratory setting (e.g., control plasma samples). It is not specified if it's retrospective or prospective.
- Method Comparison Test Set: The sample size for the method comparison study is not explicitly stated in numerical form. However, the table for method comparison has a column labeled "N" with "1. 20 Special..." which might indicate 20 samples were used. The sample range is given as "Californial . 47 % EVET 1...". This phrasing seems incomplete or garbled, and does not clearly specify the sample provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The study focuses on evaluating the analytical performance of the modified device (precision and method comparison), not on diagnostic accuracy against a clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable or not provided. This type of adjudication is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), where disagreements among experts need to be resolved to establish ground truth. This study focuses on an in-vitro diagnostic device's analytical performance.
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:
No MRMC comparative effectiveness study was done. This study is for an in-vitro diagnostic device (Factor VIII assay) and does not involve human readers interpreting cases or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was done for the device. The precision and method comparison studies evaluate the device's analytical capabilities independent of human interpretation or intervention beyond standard laboratory procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For precision studies, the "ground truth" is the expected concentration or true value of the control materials used, which are typically established through rigorous characterization and standardization by the manufacturer.
For method comparison, the reference method (predicate device Coatest Factor VIII) served as the comparator, with its measurements being the "gold standard" against which the modified device's measurements were compared.
8. The sample size for the training set:
Not applicable. This device is an in-vitro diagnostic assay, not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
§ 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).