(291 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 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:
- Has the same intended use as the predicate device.
- 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.
- 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.
| Acceptance Criterion (for Substantial Equivalence based on Non-Clinical Data) | Reported Device Performance (from Non-Clinical Tests) |
|---|---|
| Same Intended Use (21 CFR 892.1550/1570) | Met: Proposed device's indications for use are identical to the predicate device, K173801. (Page 4, "Indication for use" table) |
| Same Technological Characteristics, or differences do not raise new safety/effectiveness questions. (Key physical & functional parameters) | Met: Most core technological characteristics (e.g., product code, regulation number, class, intended use, probe type, depth measurement, speed range, maximum error) are identical to the predicate. Minor differences (Connection modes, power supply mode, nominal voltage, internal power supply) were tested and deemed not to affect safety or effectiveness. (Pages 6-8, "Summary of Technological characteristics" tables and "Difference" explanations) |
| Compliance with Recognized Consensus Standards (Electrical safety, EMC, Acoustic Output, Basic Safety & Essential Performance) | Met: Non-clinical tests verified compliance with: |
- 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.
§ 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.