(237 days)
The Dolphin/IQ and Dolphin/4D are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.
Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.
Note : The Dolphin is to be used only by trained medical personnel.
Dolphin/IQ and Dolphin/4D systems are part of the Dolphin product family of noninvasive peripheral vascular diagnostic systems. The Dolphin/IQ and the Dolphin/4D are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. Both systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes and integrated computer system with hard disk, and touch screen display. The functionality and performance of both systems is identical. Both systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Both support the same accessories: IR wireless remote control, foot switch and monitoring head set.
The provided text describes the Viasonix Ltd. Dolphin/IQ and Dolphin/4D medical devices, which are ultrasonic pulsed Doppler imaging systems. However, it explicitly states that no clinical study was conducted to support the application. Therefore, it is impossible to describe acceptance criteria and a study proving the device meets those criteria from the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to standards.
Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no specific performance-based acceptance criteria related to clinical efficacy or accuracy that can be directly reported for the device’s performance in a clinical setting. The document only provides a "Measurement accuracy" specification of "± 10% accuracy" as a technical characteristic compared to predicate devices (page 10). This is a technical specification, not clinical acceptance criteria derived from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
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
Not applicable, as no clinical study was conducted, and the device is a diagnostic ultrasound system, not explicitly an AI-driven tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical study defining standalone performance was conducted. The device itself is a diagnostic tool operated by trained medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical study was conducted. The "Measurement accuracy" of ± 10% mentioned on page 10 would typically be assessed against a known standard or reference value in a bench test, not against a clinical ground truth.
8. The sample size for the training set
Not applicable, as no clinical study was conducted.
9. How the ground truth for the training set was established
Not applicable, as no clinical study was conducted.
Information from the document related to "acceptance criteria" and "testing" (but not clinical trials):
- Non-Clinical Performance Testing (page 12):
- "The Dolphin/IQ and Dolphin/4D devices have been thoroughly tested through verification of specifications and validation, including software validation."
- "The following performance verification testing were applied to the development of the system: Acoustic output Measurement, temperature rise and velocity accuracy testing."
- Standards Compliance (page 11 & 12): The device meets several IEC and NEMA standards related to medical electrical equipment, electromagnetic disturbances, essential performance of ultrasonic diagnostic equipment, acoustic output measurement, and real-time display of thermal and mechanical acoustic output indices. These standards define the "acceptance criteria" for the safety and technical performance of the device, rather than its clinical diagnostic accuracy.
In summary, based solely on the provided document, it is not possible to answer most of your questions because the submission explicitly states: "No clinical study was conducted to support this application." The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and technical standards.
§ 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.