(27 days)
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems. For in vitro diagnostic use.
HemosIL PT-Fibrinogen HS PLUS is a very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy in human citrated plasma on the IL Coagulation Systems.
Here's an analysis of the provided text regarding the HemosIL PT-Fibrinogen HS PLUS device, broken down by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Assay | System | Acceptance Criteria (Range - units) | Reported Device Performance (Range - units) |
|---|---|---|---|
| PT | ACL Futura/ACL Advance | Not explicitly stated as "acceptance criteria," but implied as the target normal range update for the device. | 11.1 - 14.5 (seconds) |
| Fibrinogen | ACL Futura/ACL Advance | Not explicitly stated as "acceptance criteria," but implied as the target normal range update for the device. | 262 - 433 (mg/dL) |
Note: The document presents the "new expected values data" as the outcome of the study, rather than pre-defined acceptance criteria. The purpose of this submission was to update these expected values based on new data, implying that the study's success was determined by the derivation of these new ranges.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 119
- Data Provenance: Not explicitly stated within the document for country of origin. The study was conducted to establish "new normal range study," implying it was a prospective study to determine reference ranges from a healthy population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of "experts" for establishing ground truth in the context of interpreting the results. The "ground truth" here is the measured PT and Fibrinogen values from the healthy individuals in the normal range study. The device itself performs the measurement.
4. Adjudication Method for the Test Set
Not applicable. The study is establishing reference ranges for a quantitative diagnostic test, not interpreting complex medical images or information requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a normal range study for a quantitative diagnostic assay, not a comparative effectiveness study involving human readers.
6. Standalone Performance Study
Yes, in a sense. The data presented are from the device (HemosIL PT-Fibrinogen HS PLUS on ACL Futura/ACL Advance systems) measuring PT and Fibrinogen in human plasma. This is a standalone performance of the algorithm/reagent system as it's designed to operate for in vitro diagnostic use. The study focuses on the values obtained by the device itself.
7. Type of Ground Truth Used
The "ground truth" in this context is the measured Prothrombin Time and Fibrinogen values obtained from a population of apparently healthy individuals. It's essentially the observed data from the device itself when run on a specific population to define normal ranges.
8. Sample Size for the Training Set
Not mentioned. This document describes a study to establish reference ranges for the device, not a machine learning model that would require a separate training set. The normal range study sample of 119 individuals could be considered the "data" from which the expected values were derived.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a typical machine learning "training set" as described in the prompt. For the normal range study, the "ground truth" (the observed PT and Fibrinogen values) was established by running the HemosIL PT-Fibrinogen HS PLUS on the ACL Futura/ACL Advance systems with human citrated plasma from the 119 individuals in the study. The definition of a "normal" range is statistical, based on the distribution of these measured values within that population.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).