(54 days)
Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Environment of use: Clinical laboratories
Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use
The provided text describes a medical device, "Factor deficient coagulation plasma - V," and compares it to a predicate device, Helena - K792507 - Factor V. The document does not describe a study involving machine learning or AI. Therefore, I cannot extract information related to AI/ML acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set details.
The document focuses on the intended use, design, materials, and performance testing for a diagnostic reagent. The performance testing section mentions:
Acceptance Criteria and Reported Device Performance (as described for this diagnostic reagent)
| Acceptance Criteria (Performance Testing) | Reported Device Performance (Intended Product) |
|---|---|
| Compare assay to known sample | Yes |
| Negative by FDA approved test for HIV 1/2 and HBsAG | Yes |
| Negative by FDA approved test for HCV and HIV-1ag | Yes |
| Deficiency of relevant factor less than 1% | Yes |
| Negative for HIV and HBsAG | Yes |
| Negative for HCV, HIV-1ag | Yes |
| No inhibitor present | Yes |
Study Details Related to AI/ML: Not applicable. The document describes a traditional in-vitro diagnostic device, not an AI/ML system. There is no information regarding:
- Sample size for test set or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth (beyond "known sample" for assay comparison).
- Sample size for training set.
- How ground truth for training set was established.
§ 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).