(164 days)
Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
- For the measurement of cerebral artery blood velocities to determine the presence of hemo dynamically significant deviations from normal values;
- 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:
- Diagnostic exams;
- 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
| Acceptance Criteria (Inferred from compliance standards) | Reported Device Performance (from document) |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1:2005 Ed3.0 | Bench tests conducted to verify compliance. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2007 Ed3.0 | Bench tests conducted to verify compliance. |
| Acoustic Output: Compliance with NEMA UD 2-2004 (R2009) | Bench tests conducted to verify compliance. |
| Functional Equivalence: The modified device (EMS9UA, EMS9PB) should perform its intended functions (cerebral artery blood velocity measurement, micro embolic signal assessment, Doppler signal tracking) safely and effectively, similar to the predicate device (K092164). | "Determined to be Substantially Equivalent (SE) to the predicate device... in respect of safety and effectiveness." |
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.
§ 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.