(433 days)
The EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness The fib-TEM® reagent is always used in conjunction with ex-TEM® reagent. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. The ap-TEM® reagent is always used in conjunction with ex-TEM® reagent. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM®, hep-TEM®, star-TEM®, ex-TEM®, fib-TEM® and ap-TEM®, quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into amplitude with the following definitions applying to the thromboelastogram (TEM): Amplitude of 0 mm means unobstructed oscillation, while amplitude of 100 mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.
Here's a breakdown of the acceptance criteria and study information for the ROTEM® delta Thromboelastometry System, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are primarily focused on the precision of the ROTEM® delta system's assays (EXTEM, FIBTEM, APTEM) and their comparability to the predicate device (TEG® 5000).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Within-run Precision) | Reported Performance (Within-run CV%) | Acceptance Criteria (Between Operator Precision) | Reported Performance (Between Operator CV%) |
|---|---|---|---|---|
| EXTEM | ||||
| CT | 0.8)** between ROTEM® and TEG® for kinetic parameters (CT vs. R, CFT vs. K, Alpha Angle vs. Angle). The reported R_OLS values for all comparisons generally exceed 0.9, indicating strong linear correlation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- EXTEM Method Comparison: CT vs. R (n=100), CFT vs. K (n=91), α vs. Angle (n=100), MCF vs. MA (n=93).
- APTEM Method Comparison: CT vs. R (n=84), CFT vs. K (n=73), α vs. Angle (n=82), MCF vs. MA (n=79).
- FIBTEM Method Comparison: MCF vs. MA (n=88).
- Precision Studies: Conducted with healthy donor blood and ROTROL N control. Specific sample numbers are not provided beyond "5 runs on each of the 4 channels of one instrument" and "5 operators run ROTROL N in duplicates."
- Reference Ranges: Estimated using the CSLI C28-A2 guideline on three clinical US reference sample groups, with results consistent with earlier European studies.
- Data Provenance:
- Method Comparison: Patient samples from 3 US centers. These patients were during surgery and post-surgery in the intensive care unit (ICU). Contrived samples were added to broaden the range of comparison.
- Reference Ranges: US and European reference sample groups.
- Retrospective/Prospective: Not explicitly stated, but the mention of "patient samples during surgery and post surgery at the intensive care unit (ICU)" and "contrived samples were added" for the method comparison, along with "healthy donor blood" for precision, suggests a mix of prospective collections and prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The "ground truth" in this context is the measurement provided by the predicate device, TEG® 5000, which is a legally marketed device. The study seeks to establish substantial equivalence to this predicate.
4. Adjudication Method for the Test Set
Not applicable. The study is a direct comparison of measurements between the investigational device (ROTEM® delta) and the predicate device (TEG® 5000), not an interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance (precision and method comparison) of the device itself against a predicate, not on how human readers' performance changes with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the ROTEM® delta system and its reagents. The device generates quantitative functional parameters (CT, CFT, Alpha, A20/MCF), and the study evaluates the accuracy and precision of these measurements, as well as their correlation to the predicate device. There is no human-in-the-loop component being evaluated for this 510(k) submission.
7. The Type of Ground Truth Used
The primary "ground truth" used for method comparison is the measurements obtained from the predicate device, the TEG® 5000 Thrombelastograph.
For precision studies, the ground truth involves the expected consistency of measurements on controlled samples (healthy donor blood, internal controls like ROTROL N).
For reference ranges, the ground truth is established through analysis of measurements from "clinical US reference sample groups" and consistency with "earlier studies on European reference sample groups."
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development or any machine learning algorithms. The study focuses on the validation of the device's analytical performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned or implied in the provided text. The device's measurement principle is based on physical oscillation detection and established thromboelastometry principles, rather than a learned algorithm needing a separate training phase.
§ 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.