(29 days)
Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)
Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological ranqe.
The Dade Behring Inc. Control Plasma P is a lyophilized control prepared from pooled human plasma, intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological range.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability (Reconstituted) | Recovering within the assigned values for: | Met acceptance criteria (details below) |
| - 4 hours at +15 to +25°C | Recovered within assigned values | |
| - 4 weeks at -20°C | Recovered within assigned values | |
| - 2 hours after thawing at +15 to +25°C (after 4 weeks storage at -20 to -30°C) | Recovered within assigned values |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states "In duplicate determinations," which indicates that the stability tests were performed at least twice for each condition. However, a specific numerical sample size (e.g., number of vials, number of lots) beyond "duplicate determinations" is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is a submission for a 510(k) modification, implying that the data was generated specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this type of device and study. The "ground truth" for a control plasma in this context refers to the assigned values or defined factor concentrations of the control and the expected performance within a specified range. These are established through manufacturing processes, analytical methods, and internal quality control, not by expert consensus readings of an outcome.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., imaging studies) where there might be disagreement in expert opinions. For a quantitative test like a control plasma, the determination of whether the device "recovers within the assigned values" is an objective, analytical measurement.
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:
- This information is not applicable. The Control Plasma P is an in-vitro diagnostic (IVD) control material, not an AI-powered diagnostic tool, nor does it involve human readers in the context of interpretation. Therefore, an MRMC study or assessment of AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable for this device. The Control Plasma P is a reagent (control material), not an algorithm or an automated diagnostic system that performs a standalone analysis. Its "performance" is its stability and its ability to consistently yield specific assay values when tested on laboratory instruments.
7. The type of ground truth used:
- The ground truth used for this device is based on assigned values/defined factor concentrations of the control plasma. The document states it is "adjusted to defined factor concentrations" and the performance criteria involve "recovering within the assigned values." This refers to the pre-established, analytically determined target values for the various coagulation and fibrinolysis parameters. These values are typically derived through extensive characterization during product development and manufacturing.
8. The sample size for the training set:
- This information is not applicable as the Control Plasma P is not an AI/machine learning model that requires a training set. Its "development" involves chemical and biological formulation, stabilization, and analytical characterization rather than algorithmic training.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reasons as #8.
§ 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.