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Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 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 and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler is intended for use during: 1) Diagnostic exams; 2) 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. This device is intended for use by qualified and appropriately trained healthcare professionals. It can be used in hospitals or medical clinics. Mode of Operation is Pulsed Wave (PW) Doppler mode

The EMS-9M1 and EMS-9M2 Transcranial Doppler Ultrasound System is a Transcranial Doppler (TCD) system using non-invasive technique to obtain the information of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. 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. Both the EMS-9Ml and EMS-9M2 are Track 1 devices. EMS-9M1 and EMS-9M2 should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

The provided document is a 510(k) Premarket Notification from the FDA for a Transcranial Doppler Ultrasound System (models EMS-9M1/EMS-9M2). It focuses on demonstrating substantial equivalence to a predicate device (K173801).

Crucially, the document explicitly states "No clinical study is included in this submission" (Page 5, Section 7). This means that the information requested about acceptance criteria and a study proving the device meets them (clinical performance) is not provided in this document. The submission relies solely on non-clinical tests to show that the proposed device meets design specifications and is substantially equivalent to the predicate device.

Therefore, I cannot provide details about:

• A table of acceptance criteria and reported device performance based on clinical data.
• Sample size used for a clinical test set or its provenance (retrospective/prospective, country).
• Number of experts, their qualifications, or adjudication methods for clinical ground truth.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Stand-alone (algorithm-only) performance studies.
• Type of ground truth used for clinical validation.
• Sample size for a training set or how ground truth was established for it, as no clinical studies were performed.

However, based on the document, I can infer the "acceptance criteria" and "proof" in the context of this 510(k) submission as follows:

Acceptance Criteria (as implied by a 510(k) submission aiming for Substantial Equivalence):

The primary acceptance criteria for a 510(k) cleared device, particularly when no clinical studies are performed, are that the device:

1. Has the same intended use as the predicate device.
2. Has the same technological characteristics as the predicate device, or if there are differences, these differences do not raise new questions of safety or effectiveness.
3. Meets recognized consensus standards for safety and performance.

The Study Proving the Device Meets These Acceptance Criteria (Non-Clinical):

The "study" proving the device meets these criteria is the non-clinical testing performed by the manufacturer, as detailed in Section 6 and 8 of the document.

1. Table of Acceptance Criteria (Implied for Non-Clinical Equivalence) and Reported Device Performance:

Since no clinical study was performed, the "performance" is largely demonstrated by meeting and adhering to established safety and performance standards.

• IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (General medical electrical equipment safety)
• IEC 60601-2-37:2015 (Specific to ultrasonic medical diagnostic equipment)
• IEC 60601-1-2: 2014 (EMC)
• NEMA UD 2-2004 (R2009) Revision 3 (Acoustic Output) (Page 5, Section 6) |

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

• Not applicable for clinical data: As stated, "No clinical study is included in this submission."
• For non-clinical testing: The "test set" would refer to the physical devices and testing environments (e.g., test setups for electrical safety, EMC, acoustic measurements). The document implies that these tests were performed on the proposed device models (EMS-9M1/EMS-9M2). Data provenance would be from internal lab testing by the manufacturer (Shenzhen Delica Medical Equipment Co., Ltd., China). This is standard for pre-market submissions based on non-clinical data.

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

• Not applicable for clinical data: No clinical study was performed.
• For non-clinical testing: The "ground truth" for non-clinical testing is established by recognized standards and their accompanying test methodologies. The "experts" would be the engineers and technicians involved in performing these tests, following the procedures outlined in the standards. Their qualifications would be expertise in medical device testing, particularly in electrical safety, EMC, and ultrasound performance measurements according to the cited IEC and NEMA standards.

4. Adjudication Method for the Test Set:

• Not applicable for clinical data: No clinical study was performed.
• For non-clinical testing: Adjudication is not typically performed in the same way as in clinical studies. Test results from the non-clinical studies are compared directly against predefined acceptance limits specified by the recognized consensus standards. Any deviations would lead to failure and require re-design or re-testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable: The device is a Transcranial Doppler Ultrasound System, not an AI-powered image analysis tool for human readers. No MRMC study was conducted as no clinical study was included.

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

• Not applicable: This is a hardware diagnostic device that measures blood flow velocities; it is not an algorithm for standalone diagnostic interpretation.

7. The type of ground truth used:

• Not applicable for clinical data: No clinical study was performed to establish a clinical ground truth (e.g., expert consensus, pathology, or outcomes data).
• For non-clinical testing: The "ground truth" is based on the specifications and limits defined within recognized national and international consensus standards (IEC 60601 series, NEMA UD 2). For example, the accuracy of velocity measurement (±15%) is compared against physical phantoms or established reference measurements rather than clinical patient outcomes.

8. The sample size for the training set:

• Not applicable: No clinical study was performed, and the device does not involve machine learning algorithms that would require a "training set" in the traditional sense of AI/ML development.

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

• Not applicable: See #8.

In summary, the document details a 510(k) submission based purely on substantial equivalence through non-clinical performance data and adherence to recognized standards, not on a clinical study demonstrating efficacy or specific performance metrics in a patient population.

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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.

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Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 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 intracranial internal carotid artery via the eye. The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. Transcranial Doppler is intended for use during: 1) Diagnostic exams; 2) 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/EMS-9F Transcranial Doppler Ultrasound System is a Transcranial Doppler (TCD) system using non-invasive technique to obtain the information of blood flow velocities throughout the body. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain. 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. EMS-9D/EMS-9F should be used in hospitals or healthcare facilities by doctors or trained healthcare professionals.

This document is a 510(k) Summary for the Shenzhen Delica Medical Equipment Co., Ltd.'s Transcranial Doppler Ultrasound System (models EMS-9D and EMS-9F). The document aims to demonstrate substantial equivalence to a predicate device (K122710).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device (K122710). The reported device performance for the proposed device (EMS-9D and EMS-9F) is compared against these values. It's noted that the "performance of proposed device is fully better than that of predicate device - the proposed device has longer measurement depth, larger speed range and less error."

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

The document does not explicitly state the "sample size used for the test set" in terms of patient data or clinical cases. The non-clinical tests mentioned are related to engineering standards (IEC, NEMA) and device performance specifications. It also does not explicitly state the "country of origin of the data" or if the data was "retrospective or prospective". The testing appears to be primarily laboratory-based non-clinical verification.

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

This information is not provided in the document. The testing described is non-clinical performance verification against engineering standards rather than diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication Method

This information is not provided as it is not relevant to the non-clinical performance verification described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on non-clinical performance testing and substantial equivalence based on technical specifications and adherence to standards.

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

The device is a Transcranial Doppler Ultrasound System, which is a diagnostic tool that provides data for human interpretation. The concept of "standalone performance" for an algorithm without human-in-the-loop is not directly applicable in the AI/algorithm sense to this type of medical device as described in the document. The document describes the technical performance specifications of the ultrasound system itself.

7. The Type of Ground Truth Used

For the non-clinical performance tests mentioned (depth, speed range, maximum error, acoustic output), the ground truth would be based on physical phantom measurements and engineering standards/calibrations. For example, a calibrated flow phantom would be used to measure speed range and error, and specialized equipment would measure acoustic output.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The Transcranial Doppler Ultrasound System is a hardware diagnostic device, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

This information is not provided and is not applicable, as there is no "training set" for an AI/machine learning algorithm mentioned for this device.

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