Search Results

The TLink™ DMS is an electronic clinical record keeping and reporting system indicated for use in collecting, displaying, storing and managing data from external medical devices. The system facilitates the creation of electronic patient records and enables post-procedural case reviews. Data and records can be viewed on local workstations or transferred to a central computer or hospital network for storage and post-case analysis/reporting.

The TLink™ DMS consists of the TLink™ software and hardware accessories including computers meeting minimum requirements, data entry devices (barcode laser scanner, touch screen stylus, keyboard), mounting trays and brackets, and serial converters. The system can interface with a variety of external medical devices including, but not limited to, heart-lung machines, blood parameter monitoring systems, centrifugal systems, blood gas devices, patient monitors and anesthesia monitors. Case data can be entered manually by the user or collected automatically from independent medical devices. Screen layouts are customizable to meet hospital and user requirements for patient/case records. Physiological data can be graphed at user defined time intervals for event recording. Certain calculations routinely performed by the clinician during surgery can be performed by the TLink™ DMS, e.g., Body Surface Area (based on patient height and weight data) and Fluid Balance (based on fluid input and output data). Case templates and administrative information are developed on a central computer and transferred to the satellite computer(s) connected to the external medical device(s) in the procedure rooms. Case records are then transferred back to the central computer or hospital information system for central storage and post-case analysis/reporting. All transfers between satellite and central computers are via network and/or removable media. A variety of post-procedure reports are available including case report, clinical activity, case checklist, quality assurance, audit summary report, and audit detail report.

Here's a breakdown of the acceptance criteria and study information for the TLink™ Data Management System (DMS) based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided documentation is a summary for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics like sensitivity/specificity for a diagnostic AI system. The acceptance criteria here are functional and validation-based, typical for a software system that manages and displays data.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a "test set" in the context of clinical data for algorithmic performance. The tests described are System & Software Design Verification Testing and System & Software Design Validation Testing. These are engineering and usability tests, not clinical performance studies involving patient data.

• Sample Size for Test Set: Not applicable in the context of clinical data. The tests refer to the comprehensive evaluation of the software and hardware system.
• Data Provenance: Not applicable. The tests are focused on the system's design and functionality, not analysis of patient data from specific origins.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. As noted above, the tests are functional and validation-based, not reliant on expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication (e.g., of expert interpretations) is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is a data management system, not a diagnostic AI system intended to improve human reader performance in interpreting medical images or data.

6. Standalone (Algorithm Only) Performance

Yes, the studies described (System & Software Design Verification Testing and System & Software Design Validation Testing) are essentially "standalone" in the sense that they evaluate the device's functionality and adherence to design specifications and user needs. There is no human-in-the-loop performance described for these specific tests, as the device itself is designed to collect, display, store, and manage data, not to interpret it in a diagnostic manner that would typically involve a "human-in-the-loop" interaction for algorithmic decision-making.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation tests described would be the design inputs and user requirements themselves. For example:

• Design Verification: The ground truth is whether the system's outputs match the specified design requirements.
• Design Validation: The ground truth is whether the system effectively meets the intended user needs under simulated use conditions.

This is not clinical ground truth (like pathology, expert consensus on imaging, or patient outcomes data) because the device's function is data management, not diagnostic interpretation.

8. Sample Size for the Training Set

Not applicable. The TLink™ DMS is a clinical information management system, not an AI or machine learning model that requires a training set of data. Its functionality is based on programmed logic and user configuration.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for such a set.

Ask a specific question about this device