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The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals from intracranial vessels:

-For the display and measurement of cerebral artery blood flow velocities to determine the presence of hemodynanically significant deviations from normal values.

-For the detection of micro-embolic signals.

TCD-X has the ability to be used as Holter mode on ambulatory patients.

The robotic probe facilitates monitoring use by its ability to track Doppler signal all along recording time. The device is not intended to replace other means of evaluating vital patient physiological processes.

The TCD-X system is a unilateral, non-invasive Transcranial Portable or body-worn Ultrasound Diagnosis Doppler. It is designed to non-invasively measure and display major transcranial vessels blood flow velocities that supply the brain. The system can also provide potential embolic events count.

It is composed by a recorder module, a robotized probe, a hand held probe and associated components (three available sizes for spectacle frames, small carrying bag, SD card, battery charger, USB cable).

TCD-X module needs to be connected to an external computer for its display, processing, archiving records and printing.

All probes are reusable, non invasive and non sterile. TCD-X can be fitted by one probe at a time.

It is fitted with 2MHz PW robotized monitoring probe, and 2MHz PW hand held probe.

The robotized probe has the ability to adjust its angle automatically to search the Doppler signal. When the Doppler signal becomes weaker during its recording, the orientation of the robotized probe can be adjusted automatically to retrieve a good quality signal.

TCD-X can be used in two modes: Holter mode or Desktop TCD mode.

The Holter mode is used on ambulatory patient. During the recording of the transcranial Doppler signal, the TCD-X is placed on the patient in a shoulder bag. The transcranial Doppler signal is recorded on a SD card. The recorded Doppler signal display and processing are made after examination on the computer.

The desktop TCD mode is a common conventional mode used for all TCD ultrasound Doppler. This mode allows the user to display the transcranial Doppler signal in real time. During this mode, the TCD-X remains connected to the PC via an isolated USB, the patient is immobile and the recording is done directly on the PC hard disk. The Doppler signal processing and printing is also possible after the end of real time recording.

The provided documentation describes the TCD-X Transcranial Doppler Ultrasound System. The acceptance criteria and the study proving the device meets them are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: 97 patients were involved in the clinical trial.
• Data Provenance: The document does not explicitly state the country of origin, but the manufacturer is based in France. The study appears to be a prospective clinical trial comparing the new spectacle frame probe holder to the predicate's headband.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document mentions "Clinical trials have been conducted with a prototype of TCD-X and points out that: - Fixing the transducer in place with the spectacle frame resulted in recordings of better . quality, and fewer manual adjustments were required compared with fixation with the standard headband." and "No risk for the users or the patients was reported in this study."
• However, the document does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specialization), nor does it explicitly state how ground truth was established for the performance evaluation in this 97-patient study (e.g., a formal "ground truth" for a diagnosis, or expert evaluation of recording quality/patient comfort).

4. Adjudication method for the test set:

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial results. The findings are reported as observations from the trial.

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:

• This device is a Transcranial Doppler Ultrasound System, which is a diagnostic tool for measuring blood flow velocities and detecting micro-embolic signals. It does not appear to involve "human readers" interpreting images or AI assistance in a way that would fit a typical MRMC study aiming to improve human reader performance. The "robotic probe" automatically tracks the Doppler signal, which is a functional automation, not an AI interpretation aid for a human reader.
• Therefore, an MRMC comparative effectiveness study was not performed in the context of human readers improving with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The document focuses on the hardware and its functional capabilities, including the robotic probe's ability to track the Doppler signal automatically and the Holter mode's ability to record signals for later processing. While these aspects imply automated functions, the evaluation is primarily on the device's ability to acquire good quality Doppler signals and provide measurements, not on a standalone algorithm making diagnostic decisions without human involvement. The indications for use state "The TCD-X is a transcranial Doppler device intended for recording non-invasively Doppler signals... For the display and measurement of cerebral artery blood flow velocities... For the detection of micro-embolic signals." This implies the human operator is still responsible for interpreting the data output by the system.
• The study primarily validates the physical components (probe, frame) and operational modes (Holter).

7. The type of ground truth used:

• The clinical study involving 97 patients primarily assessed the safety and effectiveness of the new spectacle frame probe holder compared to the predicate's headband, focusing on recording quality, need for manual adjustments, patient tolerance, and comfort.
• For the core functional equivalence and performance, the ground truth is implicitly based on comparison to a legally marketed predicate device (EMS-9UA), which itself would have been cleared based on its ability to accurately measure blood flow velocities and detect emboli (likely established through phantom studies and/or correlation with other established diagnostic methods). The TCD-X ensures its measurements are equivalent to the predicate.

8. The sample size for the training set:

• The document does not mention a "training set" in the context of machine learning or AI models. The TCD-X system is described as a medical electrical equipment (ultrasound device) with software (IEC 62304), but not explicitly as an AI/ML powered diagnostic tool that would require a distinct training set for an algorithm.

9. How the ground truth for the training set was established:

• As no "training set" for an AI/ML algorithm is described, this question is not applicable.

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