(421 days)
The TEG 6s System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The TEG 6s System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The TEG 6s System provides specific blood modifiers, in the form of reagents dried-in-place within TEG 6s cartridges.
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 use for the TEG 6s System 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 TEG6s analyzer is a four-channel in vitro diagnostic instrument with an integrated computer module, a display touch screen for operator interaction, and a slot for inserting one TEG 6s cartridge. The TEG 6s analyzer is for use in laboratories and near patient use. It consists of an assembly of controllers, sensors, and displays, all managed and sequenced by a central processor. The embedded programming in the processor provides the necessary information for the automation of hemostasis testing. The program sequences the instrument hardware through the appropriate cycles to perform the test. Using a compressor, pressure and vacuum sensors, and a series of valves, actuators and controls, blood samples are introduced into the microfluidics of a disposable cartridge.
To perform a test, a disposable cartridge is inserted into the instrument. The instrument reads the bar code on the cartridge, identifies the type of cartridge for operator confirmation. Then, the operator adds a blood sample to the entry port on the cartridge and uses the touch screen to issue the command to the instrument to proceed with the test. The sample is then drawn into the cartridge under instrument control. The amount of the sample drawn into the cartridge is automatically determined by the volume of the reagent chambers in the cartridge.
The TEG 6s analyzer firmware provides features for and manages all functions of the instrument, including user interface (via the touch display screen) and external communications for service and installation via Service Maintenance Software (SMS). SMS is run on a separate computer connected to one or more TEG 6s analyzer(s) via the Ethernet port and a router. Its purpose is to allow additional control of analyzer functions by authorized remote users, such as administrative and service personnel.
The TEG Manager 2.0.0 is an optional accessory to Haemonetics TEG 6s Hemostasis System. TEG Manager 2.0.0 is an application that provides remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices. TEG Manager interfaces with the TEG analyzers to obtain clinical data and retrieves patient information from external Hospital Information System (HIS). Users cannot manipulate the data that is stored and displayed within TEG Manager or input any additional clinical data in the software.
The provided document is a 510(k) summary for the Haemonetics TEG® 6s Hemostasis System and TEG Manager 2.0.0. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the TEG 6s Hemostasis System (K140893 and K150041), with the addition of TEG Manager 2.0.0 as an optional accessory.
Here's the breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the TEG Manager 2.0.0. Instead, the acceptance criterion for the software is described in a more general sense:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| TEG Manager 2.0.0 Software Functionality: The software must be thoroughly verified and validated at different levels (unit, system/integration, verification, validation, beta testing). | "The TEG Manager 2.0.0 software was thoroughly verified and validated via test standards. The overall approach to testing was to test the software at different levels, including unit, system/integration, verification, validation and beta testing." |
| Test Case Results: Acceptance criteria for verification and validation testing were identified in individual test cases as expected results. Test cases were comprised of scenarios with multiple steps along with their respective expected results. | "The acceptance criteria for verification and validation testing were identified in the individual test cases as the expected results. Test cases were comprised of scenarios with multiple steps along with their respective expected results. When all the steps were tested and the actual results matched the expected results, the test case result was passed." "Test data demonstrated that the device met all acceptance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device." "The addition of TEG Manager 2.0.0 as an optional accessory to the TEG 6s Analyzer does not render the device non-substantially equivalent because non-clinical testing has demonstrated that the subject device is as safe and effective as the predicate and the results of verification and validation have not raised different questions of safety and effectiveness than the predicate." |
| Substantial Equivalence: The device, with the optional accessory, must be as safe and effective and perform as well as or better than the predicate device, without raising new questions of safety or effectiveness. | "The data and information provided in the submission support a substantial equivalence determination for the TEG 6s Analyzer and the proposed TEG 6s Analyzer with TEG Manager as an optional accessory." The document implies that the TEG Manager, being primarily a remote viewer of existing data from the predicate device, does not introduce new analytical or interpretive data and thus maintains the safety and effectiveness of the system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the TEG Manager 2.0.0 as an AI/ML device. The testing described is primarily software verification and validation (V&V). Therefore, there are no details on clinical sample size or data provenance (country of origin, retrospective/prospective) for a performance study. The focus is on ensuring the software functions as intended and accurately displays data from the TEG 6s Analyzer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since the "test set" refers to software V&V rather than clinical performance data requiring expert adjudication, there is no mention of experts establishing ground truth or their qualifications. Software testing typically relies on predefined requirements and expected outputs rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned because the V&V of the TEG Manager 2.0.0 does not involve clinical interpretation or a "ground truth" that would require expert consensus. The software's function is to accurately display data generated by the TEG 6s Analyzer.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described. The TEG Manager 2.0.0 is an auxiliary viewing and management tool for data already generated by the TEG 6s Analyzer. It does not involve human readers interpreting images or data with and without AI assistance to assess an effect size.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The TEG Manager 2.0.0 is described as an "optional accessory" that provides "remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices." It "does not provide any additional analytical or interpretive data outside of the TEG analyzer capabilities." Therefore, its performance is intrinsically tied to the TEG 6s Analyzer, and it does not operate as a standalone diagnostic algorithm in the way an AI/ML device typically would. Its "performance" would be related to its ability to accurately reflect the analyzer's output and manage devices, which is covered by the software V&V.
7. Type of Ground Truth Used
For the TEG Manager 2.0.0, the "ground truth" for the software validation would be the expected output values and display capabilities based on the data directly produced by the TEG 6s Analyzer and the specified software requirements. It's not clinical ground truth in the sense of pathology, outcomes data, or expert consensus on a diagnosis.
8. Sample Size for the Training Set
The document does not describe any training set as would be relevant for an AI/ML model. The TEG Manager 2.0.0 is a software application for data display and management, not a learning algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, there is no discussion of how ground truth was established for such a set.
§ 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.