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While the Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system, it can be:

1. For the measurement of cerebral artery blood velocities to determine the presence of hemo-dynamically significant deviations from normal values;
2. To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and internal carotid artery via the eye. The robotic probe headband facilitates monitoring use by its ability to track the Doppler signal.
   While the Transcranial Doppler Ultrasound System to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The system provides a noninyasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The noninvasive blood pressure waveform is measured on the subject's finger.
   Using the blood pressure calibration module, the system can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
   The system is intended for use during:
3. Diagnostic exams;
4. Surgical interventions.
   The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
   The EMS-9D EXP and EMS-9D PRO is intended to be used for subjects above 18 years of age. The MS-9D EXP and EMS-9D PRO is intended for use in hospitals, clinics and research centers.

EMS-9D PRO and EMS-9D EXP are Transcranial Doppler (TCD) ultrasound system, which is developed based on the EMS-9D, it inherits all the EMS-9D's hardware and mechanical structure design. EMS-9D PRO and EMS-9D EXP are not only a Transcranial Doppler ultrasound system which used non-invasive technique to obtain the information of blood flow velocities throughout the body, but also a blood pressure monitor. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain, and continuously measuring blood pressure.
TCD is useful for evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. TCD is also extremely valuable for intraoperative monitoring to help detect sudden changes in blood flow.
The EMS-9D PRO and EMS-9D EXP integrate main unit, TCD probes, Nano Core module, upper arm blood pressure module and analog output module (EMS-9D EXP only), dedicated software, remote control, headframe, upper arm cuff, finger cuff and optional probes.
EMS-9D EXP/EMS-9D PRO should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

The provided text describes a Transcranial Doppler Ultrasound System (EMS-9D EXP/PRO) and references several non-clinical tests to assert its substantial equivalence to predicate devices, particularly regarding its Transcranial Doppler Ultrasound part, Nano Core part (Finger Arterial Blood Pressure), and Upper Arm Cuff Measurement part.

However, the document is a 510(k) Summary for regulatory submission, not a detailed clinical study report. It focuses on demonstrating equivalence to previously cleared devices rather than presenting novel clinical efficacy data with defined acceptance criteria and study results in the typical sense of a diagnostic performance study.

Therefore, many of the requested details about acceptance criteria, specific study design (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for new clinical performance evaluation are not explicitly present or applicable in this regulatory summary. The document primarily relies on engineering performance specifications and comparison to predicate device specifications.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly substantial equivalence to the predicate devices and adherence to relevant safety and performance standards. The "reported device performance" refers to the specifications of the proposed device, which are shown to be equivalent to the predicate.

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

• Transcranial Doppler Ultrasound System: This document does not specify a sample size for a clinical test set or details on data provenance (e.g., country of origin, retrospective/prospective). The performance data cited are technical specifications compared to a predicate device.
• Nano Core Module & Upper Arm Cuff: Similarly, no specific sample sizes for clinical test sets or data provenance are mentioned for these components, as they are being compared to cleared predicate devices.

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

• Not applicable/Not provided. This document demonstrates technical equivalence and adherence to standards rather than a clinical performance study requiring expert ground truth establishment for a diagnostic output.

4. Adjudication method for the test set

• Not applicable/Not provided, as this is not a study focused on diagnostic accuracy requiring adjudication.

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

• Not applicable. The described device is a Transcranial Doppler Ultrasound System, not an AI-assisted diagnostic tool for image interpretation that would typically be evaluated with MRMC studies.

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

• Not applicable, as this device is not an algorithm for standalone diagnostic interpretation. It is a diagnostic ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the technical specifications, the "ground truth" is derived from engineering measurements, adherence to recognized standards (e.g., IEC 60601 series, NEMA UD 2-2004), and comparison against the specifications of the predicate devices. Clinical ground truth like pathology or outcomes data is not mentioned in this summary.

8. The sample size for the training set

• Not applicable. This document does not describe a machine learning or AI algorithm that requires a training set.

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

• Not applicable, as there is no mention of a training set for an AI algorithm.

Summary of Study Type:

The document describes a 510(k) premarket notification, which is a process to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The "study" referenced in the document is primarily non-clinical testing to ensure safety, electrical performance, acoustic output, and electromagnetic compatibility according to recognized international and national standards (IEC 60601-1, IEC 60601-2-37, IEC 80601-2-30, IEC 60601-1-2, NEMA UD 2-2004). The clinical performance is inferred through the substantial equivalence claim based on identical intended use and equivalent technical specifications to predicate devices. The modifications (addition of NIBP module, higher input power) are addressed by stating they do not impact safety and effectiveness or by referencing compliance with additional relevant standards for those components.

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