(30 days)
The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).
The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests.
The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).
Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.
The TEG® 6s Hemostasis System (TEG® Hemostasis analyzer and TEG® 6s Assay Cartridges) is intended for in vitro diagnostic use to provide semi-quantitative indications of a blood sample's ability to form and maintain a clot. The TEG® 6s Hemostasis System records the kinetic changes in a sample of whole blood as the sample clots, retracts and/or lyses. The system output consists of a table of numerical values and graphs resulting from the hemostasis process over time. This information can be used by clinicians to aid in determining if a clotting dysfunction or coagulopathy is present.
To perform a test, a disposable TEG® 6s Assay Cartridge is inserted into the TEG® 6s Hemostasis analyzer. The instrument reads the bar code on the cartridge and identifies the type of cartridge for operator confirmation. Blood (collected in a 3.2% sodium citrate tube) or Quality Control (QC) material is added to the entry port on the cartridge and drawn into the cartridge under the TEG® 6s Hemostasis analyzer control. The amount of the sample drawn into the cartridge is determined by the pre-set volume of the blood chambers in the cartridge. Once in the cartridge, the sample is metered into as many as 4 separate analysis channels, depending upon the assays being performed. Reconstitution of reagents dried within the cartridge is accomplished by moving the sample back and forth through reagent chambers, under the control of microfluidic valves and bellows (pumps) within the cartridge. After each sample has been mixed with reagent, it is delivered to a test cell where it is monitored for viscoelastic changes due to coagulation. Excess sample material is moved under microfluidic control into an enclosed waste chamber within the cartridge.
The TEG® 6s technology is based on a disposable cartridge containing up to 4 independent measurement cells. Each cell consists of a short vertically-oriented injection molded tube (ring). Detection of clotting in the TEG® 6s Hemostasis System is performed optically. A piezoelectric actuator vibrates the measurement cell(s) through a motion profile composed of summed sinusoids at different frequencies. The movement of the measurement cells will induce motion in the sample meniscus, which will be detected by a photodiode. The resulting motion of the meniscus is monitored optically and analyzed by the instrument to calculate the resonant frequency and modulus of elasticity (stiffness) of the sample. By performing a Fast Fourier Transform (FFT) on meniscus motion data, the resonant frequencies can be determined. The analyzer monitors the harmonic motion of a hanging drop of blood in response to external vibration. As the sample transitions from a liquid state to a gel-like state during clotting, the modulus of elasticity (stiffness) and therefore resonant frequency increase. The TEG® 6s Hemostasis analyzer measures these variations in resonant frequency during clotting and lysis.
Resonance is the tendency of a material or structure to oscillate with greater amplitude at some frequencies than others. The exact frequencies at which resonance occurs will depend on the stiffness and mass of the sample. Stiffness, in turn, is a function of a material's modulus of elasticity and the boundary conditions to which the material is exposed, such as the geometry and materials of a test cell. By holding these boundary conditions and sample mass constant from sample to sample, the TEG® 6s Hemostasis System allows direct comparison of elasticity between samples. The output measurements are displayed in a table and on a graphical tracing that reflects the hemostasis profile of the clot formation.
In a typical test, blood that has been delivered to the measurement cell will not clot for several minutes. During this time the sample has no inherent stiffness except that provided by surface tension, and since this remains constant the measured resonant frequencies will not change.
Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. During fibrinolysis, the process is reversed, with elastic modulus and resonant frequencies decreasing. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the ring contained in the cartridge and the resonant frequency will rise with increasing firmness of the Clot. The TEC® 6s Hemostasis Analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide semi-quantitative parameters describing the clot.
The TEG® 6s Hemostasis System monitors the interaction of platelets within the fibrin mesh of the clot during clot formation and lysis, all in a whole-blood setting. The TEG® 6s Hemostasis System uses thromboelastography to provide continuous measurement of clot elasticity.
The provided document is a 510(k) Summary for the Haemonetics TEG® 6s Hemostasis System, specifically for the Citrated: K, KH, RT, FF Assay Cartridge. Its primary purpose is to demonstrate substantial equivalence to a predicate device (K150041). As such, it focuses on comparing the proposed device to the predicate rather than detailing a study that establishes novel acceptance criteria or proves performance against new, distinct benchmarks requiring extensive clinical trials with human-in-the-loop or standalone AI performance.
The document states: "There is no change to the technology, design of the device, reported parameters, or mechanics of how the cartridge is run on the TEG® 6s analyzer. No additional product development of the TEG® 6s system was required." The only change mentioned is an expansion of the "Use Location" from "clinical laboratory" to "clinical laboratory or at the point-of-care."
Therefore, the document does not contain the detailed information necessary to answer the prompt's request for:
- A table of acceptance criteria and reported device performance for a new device or significant modification requiring such a study. Instead, it relies on the predicate's established performance.
- Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as these are typically required for demonstrating efficacy or superiority of a new or substantially modified device, especially AI/ML-driven ones.
The document is a submission for substantial equivalence for a minor modification (expanded use location) of an already cleared device, not a submission for a novel device or a device with a new AI/ML component that requires extensive performance validation against a defined ground truth.
Therefore, based solely on the provided text, I cannot extract the information required by your prompt, as the study described is a demonstration of substantial equivalence via comparison to a predicate, not an independent performance study of a novel device against predefined acceptance criteria for its core functionality.
The "study" described is a regulatory comparison. The "acceptance criteria" are effectively that the modified device performs equivalently to the predicate device, especially in the expanded use environment. No specific performance metrics or detailed study results are presented because the core technology and measured parameters are unchanged from the predicate.
§ 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.