(209 days)
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."
| Parameter | Predicate Device (K122710) Acceptance Criteria | Proposed Device (EMS-9D/EMS-9F) Reported Performance |
|---|---|---|
| 1.6MHz PW | ||
| Depth | not less 134 mm | not less 150 mm |
| Speed range | 20cm/s~200cm/s | 10cm/s~300cm/s |
| Maximum Error | ±20% | ±15% |
| 2MHz PW | ||
| Depth | not less 134 mm | not less 150 mm |
| Speed range | 20cm/s~200cm/s | 10cm/s~300cm/s |
| Maximum Error | ±20% | ±15% |
| 4MHz CW | ||
| Depth | not less 50 mm (EMS-9UA) / not less 85 mm (EMS-9PB) | not less 85 mm |
| Speed range | 10cm/s | 10cm/s~300cm/s |
| Maximum Error | ±20% | ±15% |
| 8MHz CW | ||
| Depth | not less 20 mm (EMS-9UA) / not less 35 mm (EMS-9PB) | not less 35 mm |
| Speed range | 10cm/s | 10cm/s~200cm/s |
| Maximum Error | ±20% | ±15% |
| 16MHz PW | N/A (not present in predicate) | Depth: not less 8 mm, Speed range: 10cm/s~120cm/s, Max Error: ±15% |
| All Probes | Compliance with Track 3 Acoustic Output Limit | Acoustic output test demonstrated compliance |
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.