(15 days)
The SONOACE X6 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, Gynecology, Abdomen, OB, Renal, Urology, Vascular, Small Part, Fetal Heart, Breast, Musculoskeletal, Pediatric, Cardiac, TCD, Neonatal applications.
The SONOACE X6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, PW/CW spectral Doppler mode, Harmonic imaging, Freehand 3D imaging mode or as a combination of these modes on the LCD display. The SONOACE X6 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) Pre-Market Notification for the SONOACE X6 Diagnostic Ultrasound System. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone AI performance).
The document focuses on:
- Substantial Equivalence: Comparing the SONOACE X6 to previously cleared ultrasound systems (SA8000 SE, K043455, and SONOACE X8, K063580) based on technological characteristics and intended uses.
- Compliance with Standards: Listing various safety, EMC, and acoustic output standards for medical equipment that the device has been designed to meet.
- Intended Uses: Defining the clinical applications for the system and its associated transducers.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI, is not present in this document. Such information is generally found in more detailed clinical or performance studies for novel devices or specific algorithm clearances, not in a 510(k) for a diagnostic ultrasound system establishing substantial equivalence to existing technology.
However, I can extract the safety and technical standards that serve as performance criteria for the device's design.
Acceptance Criteria and Device Performance (Based on designed compliance with standards):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Designed to Meet) |
|---|---|
| Safety Requirements for Medical Equipment: | |
| UL 60601-1 | Met |
| CSA C22.2 No. 601.1 | Met |
| IEC60601-2-37 (Diagnostic Ultrasound Safety Standards) | Met |
| EN/IEC60601-1 | Met |
| EMC Requirements for Medical Equipment: | |
| EN/IEC60601-1-2 | Met |
| Acoustic Output Standards: | |
| NEMA UD 2-2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) | Met |
| NEMA UD 3-2004 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment) | Met |
| IEC 61157 (Declaration of the acoustic output) | Met |
| Biocompatibility: | |
| ISO10993 | Met |
Since this is a 510(k) submission for a diagnostic ultrasound system based on substantial equivalence, the document does not contain the following information:
- Sample size used for the test set and data provenance: No specific clinical test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No such experts or ground truth establishment process is mentioned.
- Adjudication method for the test set: Not applicable as no specific test set performance study is detailed.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study typically assesses AI impact on human readers, which is beyond the scope of this type of traditional ultrasound 510(k). The document only establishes substantial equivalence to predicate devices, not AI-enhanced performance.
- Standalone (algorithm only without human-in-the loop performance) study: Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm.
- Type of ground truth used: Not applicable. Performance validation against clinical ground truth (pathology, outcomes) is not detailed in this document.
- Sample size for the training set: Not applicable, as this is not an AI/algorithm submission requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.