(71 days)
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.
The provided text describes the "Control Plasma LMW Heparin" device and a precision study conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" with defined thresholds. However, it presents the results of a precision study. For the purpose of this analysis, we can infer that the reported precision values (CV%) are the performance metrics against which the device's acceptability would be judged, likely in comparison to the predicate device or established industry standards, although these are not detailed.
| Description | Performance Metric | Reported Device Performance |
|---|---|---|
| Low Level | Within Run %CV | 3.81 |
| Low Level | Between Run %CV | 1.70 |
| Low Level | Total CV% | 4.65 |
| High Level | Within Run %CV | 2.26 |
| High Level | Between Run %CV | 0.71 |
| High Level | Total CV% | 3.34 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The precision study was performed over multiple days with multiple runs, totaling n=60. This total "n" likely refers to the number of individual measurements or test runs.
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, it describes a study performed using specific lots of IL reagents on IL instrumentation, suggesting it was a controlled, likely prospective, study conducted by the manufacturer, Instrumentation Laboratory Company, which is based in Massachusetts, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described is a precision study for a quality control material where the "ground truth" for heparin levels would be established by the manufacturing process itself and validated by internal analytical methods, not by expert interpretation.
4. Adjudication method for the test set:
This information is not applicable and not provided. The study is a quantitative precision study for a quality control material, not a study requiring expert adjudication of a diagnostic finding.
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 and not provided. The device is an in vitro diagnostic quality control material, not an AI-assisted diagnostic tool that would be evaluated in an MRMC study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. The device is a quality control material, not an algorithm. The reported performance is the "standalone" analytical performance of the quality control material itself when tested on laboratory instrumentation.
7. The type of ground truth used:
The "ground truth" for a quality control material like Control Plasma LMW Heparin is its manufactured concentration of Low Molecular Weight Heparin (LMW Heparin). The mean values reported (0.42 IU/mL for low level and 0.75 IU/mL for high level) represent the expected values, which would be established and verified during the manufacturing and characterization process of the control material. This is based on analytical methods/measurements rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not applicable and not provided. The device is a quality control material validated through performance studies (like precision), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reason as point 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.