(247 days)
The VisuCon-F Frozen Coag Screen N plasma is an assayed normal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. The VisuCon-F Frozen Coag Screen N plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
The VisuCon-F Frozen Coag Screen ABN plasma is an assayed abnormal control plasma intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated partial thromboplastin time (APTT), in the mid-level abnormal range. The VisuCon-F Frozen Coag Screen ABN plasma may be used with mechanical and photo-optical coagulation instruments in conjunction with appropriate commercial reagents.
The VisuCon-F Frozen Coag Screen N is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The VisuCon-F Frozen Coag Screen ABN is a pool of normal citrated human plasma collected from a minimum of 20 donors, diluted to defined concentrations, buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The provided text describes two devices, VisuCon-F Frozen Coag Screen N (Normal) and VisuCon-F Frozen Coag Screen ABN (Abnormal), and their substantial equivalence to predicate devices, not a study performing a traditional acceptance criteria evaluation with a test set of data. The document is a 510(k) summary for medical devices, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with a specific set of acceptance criteria and associated results.
Therefore, many of the requested sections (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth) are not applicable to this type of submission.
However, I can extract the "acceptance criteria" in the context of what the device is intended to do and how it compares to its predicate, which serves as the "study" for its claims of substantial equivalence.
Here's the breakdown based on the provided text, focusing on the available information:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device, as the submission aims to demonstrate substantial equivalence. The "reported device performance" is the device's ability to meet these very similar characteristics.
VisuCon-F Frozen Coag Screen N (Normal Control Plasma)
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (VisuCon-F Frozen Coag Screen N) |
|---|---|
| Intended Use: Quality control of coagulation assays in the normal range. | Intended Use: Quality control of quantitative coagulation assays, including PT, APTT, and fibrinogen, in the normal range. |
| Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT), Fibrinogen. | Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT), Fibrinogen. |
| Matrix: Citrated human plasma. | Matrix: Citrated human plasma. |
| Open-Vial Stability: 8 hours at 2-8°C. | Open-Vial Stability: 8 hours at 2-8°C or on-board coagulation instrument (15-22°C). |
| Format: (Predicate is Lyophilized) | Format: Frozen. |
VisuCon-F Frozen Coag Screen ABN (Abnormal Control Plasma)
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (VisuCon-F Frozen Coag Screen ABN) |
|---|---|
| Intended Use: Quality control of coagulation assays in the low abnormal range. | Intended Use: Quality control of quantitative coagulation assays, including PT and APTT, in the mid-level abnormal range. |
| Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT). | Analytes: Prothrombin Time (PT), Activated partial thromboplastin time (APTT). |
| Matrix: Citrated human plasma. | Matrix: Citrated human plasma. |
| Open-Vial Stability: 8 hours at 2-8°C. | Open-Vial Stability: 8 hours at 2-8°C or on-board coagulation instrument (15-22°C). |
| Format: (Predicate is Lyophilized) | Format: Frozen. |
Study Details (As applicable to a 510(k) Substantial Equivalence Submission)
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Sample size used for the test set and the data provenance:
- Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a performance study with a specific test set of cases or data. The device itself is a control plasma used in studies, not a diagnostic device being evaluated on patient samples. The device description mentions that the plasmas are collected from a minimum of 20 donors, but this is for the composition of the device, not a test set for performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "test set" in the context of diagnostic performance evaluation requiring expert ground truth in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set requiring adjudication is described or performed.
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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 device is a quality control plasma for coagulation assays, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a quality control reagent, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for these control plasmas is established by their formulation (e.g., normal vs. abnormal range, specific analytes) and performance against recognized reference methods during their manufacturing and validation. The 510(k) focuses on demonstrating that these formulations and expected performance are substantially equivalent to existing, legally marketed controls.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
§ 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.