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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.

The proposed device, Transcranial Doppler (TCD) with Robotic Probe Headband.is intended for obtaining the information of blood flow velocities throughout the body by using non-invasive technique. This method of measurement is particularly useful for examining the major arteries supplying blood to the brain.

Robotic Probe is developed by Delicate for monitoring brain blood application. It was previously cleared in K092164 at May 10, 2010. The system can adjust the angle of probe automatically according to signal intensity when monitoring.

TCD is used to evaluation of numerous neurological vascular diseases such as vasospasm and intracranial stenosis. It is also used for intraoperative monitoring to help detect sudden changes in flow and potential embolic events. Emboli are small particles of foreign matter (air, particulate, thrombin, etc.) within the bloodstream that can potentially cause obstructions in various arteries in the body and the brain. Such obstructions can often lead to stroke.

The provided document is a 510(k) summary for a Transcranial Doppler with Robotic Probe Headband (models EMS9UA and EMS9PB). It describes the device, its intended use, and indicates that non-clinical bench tests were conducted to verify the safety of design changes. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance or clinical accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K092164) through safety standards compliance (IEC 60601-1, IEC 60601-1-2, NEMA UD 2-2004) and clarification of intended uses for various transducers. It also lists the products cleared under the 510(k).

Therefore, I cannot populate the requested tables and sections with specific acceptance criteria and detailed study results from the provided text for diagnostic performance.

Here's what can be inferred and explicitly stated from the document regarding the "study" mentioned, which is primarily focused on safety and equivalence, not diagnostic accuracy:

The "study" refers to non-clinical bench tests conducted to verify that risks associated with a design change were acceptable, ensuring the updated device maintains substantial equivalence to the predicate device in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable or not specified in terms of clinical subjects/data. The "test set" here refers to the physical device and its components undergoing bench testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are "bench tests" performed by the manufacturer, Shenzhen Delicate Electronics Co., Ltd. in China. The data would be prospective, as it's generated from direct testing of the device.

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

• This information is not provided. The "ground truth" for the bench tests would be the established safety and performance standards (e.g., IEC, NEMA). It's unlikely external experts were used to establish these fundamental technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is not applicable for non-clinical bench testing against established engineering standards.

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, an MRMC comparative effectiveness study was not done. This device is a Transcranial Doppler system, not an AI-assisted diagnostic imaging interpretation system. The document does not mention any AI components or human-in-the-loop performance studies.

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

• No, a standalone algorithm-only performance study was not done. The device is a physical ultrasound system, not an algorithm, and the submission focuses on its physical and electrical safety as a medical device.

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

• The "ground truth" for the non-clinical tests was adherence to internationally recognized safety and performance standards (IEC 60601-1, IEC 60601-1-2, NEMA UD 2-2004).

8. The sample size for the training set

• Not applicable. This device is an ultrasound system and there is no mention of a "training set" in the context of AI or machine learning. The "training" for such a device would relate to engineering design and manufacturing processes, not data-driven model training.

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

• Not applicable, as there is no training set mentioned in the context of the device's development as described in the summary.

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The EMS9UA 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 hemodynamically 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. The EMS9UA Transcranial Doppler is intended for use during:

a) Diagnostic exams
b) 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.

Shenzhen Delicate believes that the Model EMS-9UA is substantially equivalent to its EMS OU Transcranial Doppler which was cleared on May 5, 2006 510kH K060112. The EMS-9UA has the same device description except that the head frame used for longer term monitoring has the ability to track the Doppler signal and therefore not lose the signal with patient movement and time. The tracking is accomplished by adding to the EMS9U an additional circuit which detects the ultrasound Doppler return and positions the face of the probe in the headband to maximize the detected ultrasound return. The headband electronics does not change or interfere with the transmitted ultrasound. Except for the servo motor controller added to the circuitry of the EMS9U range and the software added to control it, and the modifications to the INNSO Tange and the servo motor controlled probe, the EMS9U range and the EMS- 9UA are identical internally and functionally. The probes are identical to those cleared in K060112.

Here's a breakdown of the acceptance criteria and study information for the EMS9UA Transcranial Doppler with Robotic Probe Headband, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative performance acceptance criteria (e.g., specific accuracy thresholds) for the EMS9UA device. Instead, the "acceptance criteria" are implied by compliance with safety and industry standards, and the demonstration of safety and effectiveness through performance testing and a clinical trial, showing substantial equivalence to the predicate device.

The reported device performance emphasizes its capabilities as a diagnostic ultrasound fluid flow analysis system for measuring cerebral artery blood velocities and detecting micro embolic signals, with the added functionality of the robotic headband to track the Doppler signal.

Table of Acceptance Criteria and Reported Device Performance:

Study Information

The document describes a clinical trial, though details are limited.

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

   • Sample Size: 100 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is referred to as a "clinical trial," which typically implies prospective data collection, but this is not explicitly confirmed.

2. 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 study compared the EMS9UA with a predicate device, but it doesn't describe who evaluated the outputs or established a ground truth for the comparison.

3. Adjudication Method for the Test Set:

   • This information is not provided in the document.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • Yes, a comparative study was done. A "clinical trial involving 100 patients was conducted comparing the EMS9UA Transcranial Doppler with Robotic Headband with the Spencer Technologies Marc 600 predicate headband."
   • Effect Size: The document states that the device "was found to be safe and effective" in comparison to the predicate, implying non-inferiority or similar performance. However, no specific quantitative effect size or details on how human readers improved with AI vs. without AI assistance are provided. The robotic headband's function is to track the Doppler signal and not lose the signal with patient movement and time, which is a practical improvement in monitoring, rather than an AI-driven interpretive enhancement for human readers. This device's primary improvement is in signal stability and monitoring duration, not necessarily in diagnostic interpretation per se.

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

   • The document implies that the device is a diagnostic ultrasound system intended for use by "trained medical personnel." It is not described as an AI algorithm providing standalone diagnoses. The robotic probe head is an automated feature for signal tracking, which enhances the device's performance, but it's not suggested that it operates entirely without human oversight or interpretation of the ultrasound data. Therefore, a standalone algorithm-only performance study as typically understood for AI diagnostics is not applicable/not described.

6. The Type of Ground Truth Used:

   • This is not explicitly stated. Given that it's a comparative study against a predicate device, the "ground truth" for the comparison would likely be the diagnostic output or clinical utility of the predicate device. However, details on how this was established or if an independent clinical ground truth (e.g., pathology, follow-up outcomes) was used are not provided.

7. The Sample Size for the Training Set:

   • This is not applicable/not provided. The document describes a medical device (Transcranial Doppler with a robotic headband for signal tracking), not a typical AI model that undergoes a separate training phase with a distinct training dataset. The "training" for such a device would involve engineering design, calibration, and internal verification.

8. How the Ground Truth for the Training Set Was Established:

   • This is not applicable/not provided for the reasons stated above.

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