(14 days)
The SONOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Pediatric Cardiology, TCD, Cardiac, Small parts, Vascular, Muscularskeletal, Pediatric Abdomen, OB, Gynecology, Urology, Pediatric Cardiac, Adult Cardiac, Pediatric and Appendix applications.
The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode. The SONOACE X8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
The provided document is a 510(k) Summary for the SONOACE X8 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and technical characteristics. Critically, the provided text does not contain any information regarding acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The document states that "The SONOACE X8 Diagnostic Ultrasound System is substantially equivalent to the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911, and the SA8000 Diagnostic Ultrasound System, cleared via K013627." Substantial equivalence is the primary pathway for clearance of medical devices by the FDA, meaning that the new device has the same intended use as a legally marketed predicate device and has similar technological characteristics to the predicate device. If the new device has different technological characteristics than the predicate device, it does not raise different questions of safety and effectiveness.
Therefore, the "studies" mentioned in this document are primarily focused on outlining the technical specifications and clinical applications for which the device and its various transducers are intended to be used, and comparing these to predicate devices. There is no performance study with quantifiable acceptance criteria and results described.
Based on the provided text, the following information can be extracted regarding the lack of specified acceptance criteria and performance study details:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set sample size or data provenance is mentioned as there is no performance study described.
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 ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set or adjudication is described.
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 MRMC comparative effectiveness study was performed or described. This is a diagnostic ultrasound system, not an AI-powered analytical tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a medical imaging device and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no ground truth is mentioned in the context of a performance study. The "ground truth" for this type of device is regulatory compliance and functional equivalence to predicate devices.
8. The sample size for the training set:
Not applicable, as this is a general purpose diagnostic ultrasound system, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set 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.