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Adults, Hospital, Cardiology, Internal medicine

TEBCO-W is indicated for noninvasive, continuous assessment and monitoring of the left-ventricular performance and global blood flow (Stroke Index, SI and Cardiac Index, CI) in adults, where use of invasive catheters is contraindicated. The device may be used only on the order of a physician and is "By prescription only." The intended use is physician's office and cardiovascular physiology laboratory.

TEBCO-W is the substantially equivalent wireless version of the existing tethered predicate device TEBCO (Thoracic Electrical Bioimpedance Cardiac Output, K962128). Both the TEBCO and TEBCO-W are a hardware component of a system for noninvasive measurement of Cardiac Output and other cardiodynamic parameters. The system comprises of TEBCO (or TEBCO-W) and a PC, which acts as a host system. TEBCO (or TEBCO-W) acquire the TEB and data via a patient cable attached to 8 electrodes placed on a patient's thorax. 4 out of 8 electrodes are also used to detect a patient's ECG signal, which is utilized by both devices as a system clock. They sample the instantaneous TEB values @ 5 msec sample rate, and send continuously the binary values of digital samples in packets every 20 msec via a serial communication link to a host system (a PC), where the TEB signals are reconstructed and displayed. Both TEBCO and TEBCO-W also measure the magnitude and timing of the TEB signal in reference to Q-time of the QRS complex, from which the Heart Rate and Stroke Index are calculated, calculate then the value of Cardiac Output and sent the digital values of these parameters via the same serial link once every heartbeat to the host system, where they are displayed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: TEBCO-W
Predicate Device: TEBCO

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative "acceptance criteria" for the device's performance in terms of its primary function (measuring cardiac output/stroke index). Instead, it focuses on demonstrating that the new device (TEBCO-W) is as safe and effective (substantially equivalent) as its predicate device (TEBCO) despite technological changes, primarily concerning wireless communication and power source. The "performance" being evaluated implicitly is the reliability of data transmission and lack of interference.

Clinical Test Conclusion 2: "The ICU setting - the most interference-rich environment - did not produce any observable interference with the TEBCO-W operation."

Overall Conclusion: TEBCO-W is "as safe and effective (therefore substantially equivalent) as the predicate device TEBCO." |
| Patient Mobility Improvement | Allowed by wireless communication, "limited by the capability of the WiFi connection." |
| Patient Safety (Electrical) Improvement | Departure from AC power source using externally rechargeable batteries "improves a patient's safety." |

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

• Nonclinical (Bench) Test:
  • Sample Size: One person ("a person representing a patient").
  • Data Provenance: Retrospective (implied, as the test was conducted in their lab after device development). Country of origin is the US (BoMed Inc., Hawaii).
• Clinical Test:
  • Sample Size: One person ("Our subject, monitored by TEBCO-W").
  • Data Provenance: Prospective, conducted at North Hawaii Community Hospital, in its Intensive Care Unit. Country of origin is the US.

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

No explicit experts are mentioned for establishing "ground truth" in the typical sense for diagnostic accuracy. The studies were focused on interference and reliable data transmission.

• Nonclinical Test: The "operator of each of the network computers and the operator of the TEBCO-W host system looked for presence of any disruption in service." Their qualifications are not specified, beyond being operators familiar with the system.
• Clinical Test: No specific experts are mentioned for establishing a ground truth. The observation was whether "any observable interference either on the ICU patient monitor (that would indicate TEBCO-W as a source of interference) or on the TEBCO-W host system (which would indicate a TEBCO-W susceptibility to noise emitted by the ICU equipment)." This implies observation by clinical staff and/or the study team.

4. Adjudication Method for the Test Set

Not applicable. There was no formal adjudication method described, as the evaluation was based on direct observation of signal integrity and patient monitor behavior. It was directly observed by the operators/study team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, this type of study was not performed. The device is not an AI-assisted diagnostic tool that requires human interpretation of outputs to improve diagnostic accuracy. It's a physiological monitoring device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The entire evaluation of the TEBCO-W focused on its ability to acquire and transmit physiological data reliably (its "algorithm" via the device's hardware and software sending packets) without human intervention needed for primary data generation or transmission. The "human-in-the-loop" was in observing the output and the lack of interference. The device itself, when functioning, is standalone in its data acquisition and transmission.

7. The Type of Ground Truth Used

The "ground truth" was the absence of observed interference (electrical or signal disruption) and the continuity/integrity of the transmitted physiological signal. This is based on direct observation of:

• Signal waveform consistency on the host system.
• Lack of disruption on other network computers.
• Lack of disruption on ICU patient monitors.

It's not traditional "expert consensus," "pathology," or "outcomes data" in the diagnostic accuracy sense, but rather a verification of operational integrity in various environments.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. Its underlying algorithms are based on established physiological principles and signal processing, mirroring its predicate device. The "training" here would be the engineering design and development validated against physics and electrical engineering principles.

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

As noted above, a "training set" and associated "ground truth" are not applicable here. The device's functionality (measuring cardiac output parameters via impedance cardiography) is based on established medical and engineering principles, inherited from its predicate device. The studies described were for verification and validation of the new technological changes (wireless and battery power) rather than training a machine learning model.

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