(225 days)
Automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (VWF:Ag) in human citrated plasma on IL Coagulation Systems.
The VWF:Ag kit is a latex particle enhanced immunoturbidimetric assay to quantify VWF:Ag in plasma. When a plasma containing VWF:Ag is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of VWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.
The provided document is a 510(k) Summary for the HemosIL von Willebrand Factor Antigen device. It describes a Special 510(k) submission rather than a traditional premarket notification that would typically include substantial new performance data. The core of this submission is a modification to a limitation/interference claim regarding Rheumatoid Factor (RF) rather than a broader study proving overall device performance against new acceptance criteria.
Therefore, the requested information, particularly regarding a comprehensive study with a test set, expert adjudication, MRMC studies, and standalone performance for an AI/algorithm-based device, is not present in this document. This submission pertains to an in-vitro diagnostic (IVD) assay that measures a biological marker, not an AI-powered diagnostic device.
However, I can extract the relevant information from the document regarding the acceptance criteria related to the modified claim and the "study" (which in this context refers to the basis for the change, here being a literature reference and internal design control activities rather than a new clinical trial).
Here's an attempt to answer based on the provided document, while clarifying what information is missing due to the nature of this particular 510(k) submission:
Acceptance Criteria and Device Performance for HemosIL von Willebrand Factor Antigen (K200033) - Modifed Rheumatoid Factor Interference Claim
This 510(k) submission is a Special 510(k), indicating a minor change to an already cleared device. The "acceptance criteria" and "study" are specifically focused on the modified claim regarding Rheumatoid Factor interference, rather than a broad re-evaluation of the device's overall performance. No new clinical study was conducted for this specific submission to prove general device performance. Instead, the modification is based on internal design control activities and a literature reference.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for this specific modification is the non-interference within a certain concentration range of Rheumatoid Factor (RF). The "reported device performance" reflects a change in the claimed non-interference level.
| Acceptance Criterion (for RF interference) | Reported Device Performance (Modified Claim) |
|---|---|
| Previous Claim: | New Claim: |
| VWF:Ag results on ACL Family Systems not affected by RF up to 750 IU/mL. (Note: Original document states "may produce an overestimation" for ACL Family, but for ACL TOP it says "not affected up to 750 IU/mL"). | VWF:Ag results on ACL Family Systems are not affected by Rheumatoid Factor up to 50 IU/mL. |
| VWF:Ag results on ACL TOP Family and ACL TOP Family 50 Series not affected by RF up to 750 IU/mL. | VWF:Ag results on ACL TOP Family and ACL TOP Family 50 Series are not affected by Rheumatoid Factor up to 50 IU/mL. |
| Interpretation: The new claim reduces the stated non-interference level for RF on all listed systems to 50 IU/mL. This implies that the previous claim of 750 IU/mL for ACL TOP systems was either incorrect or no longer supported, and for ACL Family systems, the previous "overestimation" warning is being replaced with a non-interference claim up to 50 IU/mL. |
Note on "Acceptance Criteria" for a Special 510(k): For this type of submission, the primary acceptance criterion is that the modified device remains substantially equivalent to the predicate device and that the change does not introduce new questions of safety or effectiveness. For the specific change (RF interference), the acceptance is based on the rationale provided (literature reference). No specific quantitative performance metric (e.g., accuracy, sensitivity, specificity) for the RF non-interference claim is explicitly stated, other than the new 50 IU/mL threshold being deemed acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The document explicitly states: "Performance data are unnecessary since the current Rheumatoid Factor claim in the HemosIL von Willebrand Factor Antigen insert is being replaced with a limitation and a supporting literature reference." This indicates that a dedicated new test set for this specific change was not used for performance validation.
- Data Provenance: Not explicitly stated as new data was not generated. The basis for the change is a "supporting literature reference."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. There was no new test set requiring expert ground truth establishment for this specific change.
4. Adjudication Method for the Test Set
- Not applicable. No new test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only)
- Not applicable. This device is an in-vitro diagnostic assay. The concept of "standalone performance" typically applies to AI algorithms operating independently of human interpretation.
7. Type of Ground Truth Used
- For the modified RF interference claim: The "ground truth" for the new claim (non-interference up to 50 IU/mL) is based on a "supporting literature reference" combined with internal design control activities and possibly previous knowledge/studies that led to the revised understanding of RF interference. No new direct "ground truth" (e.g., from pathology, clinical outcomes, or expert consensus on new data) was established for this specific special 510(k).
8. Sample Size for the Training Set
- Not applicable. This is an IVD assay, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
Summary of Key Takeaway from the Document:
This 510(k) submission (K200033) is a Special 510(k) for the HemosIL von Willebrand Factor Antigen. The purpose is to modify the product insert's "Limitations/Interfering substances" section concerning Rheumatoid Factor interference. The submission states that no new performance data was generated or deemed necessary for this change because it relies on existing knowledge and a literature reference. Therefore, the detailed requirements for a study proving device performance (especially for an AI/algorithm) are not met by this particular regulatory filing, as it pertains to a different type of device and a very specific, limited modification.
§ 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).