(41 days)
Indicated use - Factor deficient plasma, Factor - X 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.
Factor deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Factor deficient coagulation plasma - X" device:
It is important to note that the provided documents (K964459) are from 1996, and the regulatory and scientific standards for device studies have significantly evolved since then. The information available in these summaries is quite limited compared to what would be required for a modern submission.
Based on the provided text, the device in question is a "Factor deficient coagulation plasma - X" intended for in vitro diagnostic use in quantitative determination of Factor X levels. The summary primarily focuses on comparing the new device to a predicate device (Sigma - K843310 - Factor X) to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in the way modern device submissions do (e.g., a specific sensitivity or specificity threshold, or an agreement percentage). Instead, acceptance is implied by demonstrating substantial equivalence to a predicate device across various attributes.
Here's an interpretation of the performance-related comparisons, framed as implicit criteria and reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance (vs. Predicate) |
|---|---|
| Use: Indicated for determining coagulation of plasma | Yes (Matches predicate) |
| Use: In vitro diagnostic use | Yes (Matches predicate) |
| Use: Used as a quantitative assay | Yes (Matches predicate) |
| Design: Packaging either frozen or dry/lyophilized | Yes (Matches predicate) |
| Design: Usable with different instruments/reagents | Yes (Matches predicate) |
| Materials: Donor human plasma | Yes (Matches predicate) |
| Materials: Various buffers | Yes (Matches predicate) |
| Performance Testing: Compare assay to known sample | Yes (Matches predicate) |
| Performance Testing: Negative for HIV 1/2 and HBsAG (FDA approved test) | Yes (Matches predicate) |
| Performance Testing: Negative for HCV and HIV-1ag (FDA approved test) | Yes (Differences cited, but claimed for new device) |
| Donor Criteria: Deficiency of relevant factor less than 1% | Yes (Predicate "not known") |
| Donor Criteria: Negative for HIV and HBsAG | Yes (Matches predicate) |
| Donor Criteria: Negative for HCV and HIV-1ag | Yes (Predicate "not known") |
| Donor Criteria: No inhibitor present | Yes (Predicate "not known") |
Key takeaway for Acceptance Criteria: The primary acceptance criterion appears to be "substantially equivalent to the predicate device, Sigma - K843310 - Factor X, for stated attributes, with additional safety features (HCV/HIV-1ag testing) as an improvement."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any test set. It mentions "Performance Testing: Compare assay to known sample" under the attributes, but no details on how many samples, what type of samples, or their origin are provided.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. It can be inferred that samples would be of human origin, related to coagulation testing, but no specific country or whether it was retrospective/prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information about experts or their qualifications for establishing ground truth for any test set.
4. Adjudication Method (for the Test Set)
The document does not specify any adjudication method. Given the nature of a laboratory diagnostic reagent comparison, it's unlikely that a multi-reader adjudication process (like 2+1) would be directly applicable in the same way it is for image-based diagnostic AI. The "ground truth" for a Factor X level would typically be established by a reference method or known concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is specific to AI/CAD devices, especially in imaging, where human interpretation is a key part of the diagnostic process. The "Factor deficient coagulation plasma - X" is a laboratory reagent, not an AI or CAD system, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" for an algorithm is not directly applicable here because the device is a reagent, not an algorithm. The performance of the reagent would be assessed in a laboratory setting when used with instruments and other reagents to perform a coagulation assay. The performance data mentioned (e.g., negative for certain viruses, deficiency of relevant factor) relates to the quality and characteristics of the plasma itself, not an algorithm's output.
However, if we interpret "standalone" as the performance of the reagent itself (before human interpretation of the final assay results), then the performance attributes listed under "Performance Testing" and "Donor Criteria" could be considered an assessment of the reagent's inherent characteristics. The document implies that the device performs in a manner consistent with a factor-deficient plasma, but details on how that performance was measured (e.g., specific quantitative results, precision, accuracy) are absent.
7. The Type of Ground Truth Used
The document does not explicitly define the "ground truth" in detail. However, based on the context of the device:
- For "compare assay to known sample": The ground truth would likely be the known concentration/activity of Factor X in reference samples or spiked samples.
- For "Negative by FDA approved test for HIV 1/2 and HBsAG" etc.: The ground truth would be the results from the FDA-approved reference tests for these viral markers.
- For "Deficiency of relevant factor less than 1%": The ground truth would be established through a specific laboratory assay (presumably a reference method) that quantifies Factor X levels in donor plasma.
Essentially, it relies on established laboratory methodologies and reference materials as ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. This is because the device is a laboratory reagent and not an AI/machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned (as it's not an AI device), this question is not applicable.
§ 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).