(409 days)
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The provided text describes a 510(k) premarket notification for a medical device called "VisuCon-F Low Fibrinogen Control Plasma." This document is a regulatory submission to the FDA (Food and Drug Administration) for a Class II medical device.
The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on the comparison to a predicate device and performance characteristics that support this equivalence, rather than a classical study design with acceptance criteria for a novel AI/imaging device.
Because the request asks for specific details relating to AI/imaging device acceptance criteria and study methodology (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance), it's important to note that the provided document does not contain this type of information. This document is for an in-vitro diagnostic control plasma, not an imaging or AI diagnostic device.
However, I will extract the information that is present in the document and clearly state when the requested information is not available or not applicable based on the document's content.
Here's a breakdown based on the provided text:
Device Description and Intended Use:
- Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma
- Regulation Number: 21 CFR 864.5425
- Regulation Name: Multipurpose system for in vitro coagulation studies
- Regulatory Class: Class II
- Product Code: GGN
- Predicate Device: Cryocheck Low Fibrinogen Control Plasma (Precision Biologic Inc.)
- Device Description: A pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
- Device Intended Use: An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. It may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. Intended for "In Vitro Diagnostic Use" by trained laboratory personnel in clinical laboratories.
Acceptance Criteria and Device Performance (based on comparison to Predicate):
The document details a "technical comparison" to the predicate device to demonstrate substantial equivalence, rather than defining explicit acceptance criteria in the sense of a target performance threshold for a new AI/imaging algorithm. The study proves the device meets the criteria by exhibiting similar characteristics and performance ("precision") to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VisuCon-F Low Fibrinogen Control Plasma) |
|---|---|---|
| Intended Use | Recommended for use as an abnormal control in quantitative fibrinogen assays | An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range |
| Analytes | Fibrinogen | Fibrinogen |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-Vial Stability | 72 hours at 2-8°C | 72 hours at 2-8°C or 8 hours onboard instrument (19-22°C) |
| Precision (% Coefficient of Variation (CV)) | 2.8 - 3.7% (n=36 for predicate) | Within Run = 3.15% |
| Between Day = 0.54% | ||
| Between Run = 0% | ||
| Within Device = 8.44% | ||
| Conclusion | Substantially equivalent (based on similar intended use, matrix, stability, and performance characteristics (precision)) | The VisuCon-F Low Fibrinogen Control plasma is substantially equivalent to its predicate device. |
Note: The "acceptance criteria" here are implied by the characteristics and performance of the chosen predicate device, as the goal is to show equivalence, not superiority or meeting an arbitrary threshold. The "study" described is the "technical comparison" presented in the table.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document reports precision data for the proposed device (VisuCon-F Low Fibrinogen Control Plasma) as: Within Run = 3.15%, Between Day = 0.54%, Between Run = 0%, Within Device = 8.44%. It also states the predicate's precision as 2.8 - 3.7% (n=36). However, the specific sample size (N) for the VisuCon-F device's precision calculations (e.g., number of runs, number of days, number of plasma samples) is not explicitly stated in this summary.
- Data Provenance: Not specified in terms of country of origin or whether it's retrospective/prospective. This is an in vitro diagnostic control, so "data provenance" in the sense of patient data is not applicable. The plasma is "human plasma" but no further detail on its origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in vitro diagnostic control plasma used for quality control of lab assays, not an imaging/AI device requiring expert interpretation or ground truth establishment by medical specialists like radiologists. The "ground truth" for this product would be the established fibrinogen concentration values from the manufacturer's own assay methods and validation, which is common for control plasmas.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, this is an in vitro diagnostic control; expert adjudication methods for imaging or clinical cases are not relevant here.
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 control and does not involve human readers or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an in vitro diagnostic control, not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a control plasma, the "ground truth" (or accepted value) is typically the assigned value from the manufacturer's reference method, established through meticulous testing and calibration. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from the analytical performance of laboratory instruments and reagents.
8. The sample size for the training set:
- Not Applicable. This is a physical biological control product, not a software algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set for this type of medical device.
In summary, the provided document is a 510(k) submission for an in vitro diagnostic control plasma. The "study" described is a comparison to a predicate device to demonstrate substantial equivalence, focusing on analytical performance characteristics like precision and stability. It does not contain the types of information (e.g., expert-based ground truth, MRMC studies, training/test sets for algorithms) that would be relevant for an AI or imaging-based medical device.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.