(29 days)
The VIAMO Diagnostic Ultrasound System is indicated for the visualization of structures, characteristics and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).
Viamo V4.0 is a Track 3 ultrasound system. It is a full-digital system that utilizes a wide range of probes (flat linear array, convex array and sector array) with a frequency range of approximately 2.5 MHz to 12 MHz. The slim pole-cart allows the system to be easily moved in the medical facility to perform examinations. The main unit, which can be detached from the cart by one-touch operation, is powered by an internal battery.
Here's a summary of the acceptance criteria and the study information based on the provided 510(k) summary:
This device (VIAMO MODEL SSA-640A V4.0) is a diagnostic ultrasound system and is primarily demonstrating substantial equivalence to a predicate device (Viamo SSA-640A v2.0 Ultrasound System, K100067) by showing that its new features do not alter the existing indications for use or raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For the new features (addition of two transducers and "Vascularity Index"), the acceptance criteria and reported performance are implicitly demonstrated through bench testing to ensure they meet established safety and effectiveness standards, rather than defining specific statistical performance metrics.
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Added Transducers (PVT-712BT, PST-50BT) | Safe and effective for their indicated clinical applications (trans-vaginal for PVT-712BT; abdominal, pediatric, neonatal cephalic, adult cephalic, cardiac adult, cardiac pediatric for PST-50BT). Performance equivalent to current cleared transducers where applicable. | B-mode accuracy and Doppler mode velocity accuracy confirmed effectiveness. Electrical, thermal, and acoustic power tests confirmed safety. The new transducers do not change the cleared intended use. |
| Vascularity Index | Accurate display of the area of blood flow in power mode to support diagnostic use. | Accuracy test of the "Vascularity Index" was conducted and confirmed effectiveness. The addition does not change the effectiveness and safety of the device. |
| New Display Format for Dual Images | Functions as intended without compromising image quality or safety. | Implied to be effective through general safety and effectiveness statement; no specific performance tests mentioned for this particular feature beyond general device safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The document refers to "bench tests" and implies that these tests were conducted internally or at the manufacturer's facility to verify the features.
- Data Provenance: Not specified. Given that only bench testing was conducted, the "data" would likely be derived from internal engineering and performance measurements. The manufacturer is Panasonic Healthcare Co., Ltd. in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document states that "Viamo V4.0 did not require clinical studies to support substantial equivalence." Therefore, no ground truth established by clinical experts for a test set is described. The assessment relied on engineering and performance testing against established standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. The submission focuses on substantial equivalence based on technical characteristics and bench testing, not on comparing reader performance with and without AI assistance (as the "Vascularity Index" is an image processing feature, not an AI diagnostic tool in the sense of AI/ML-enabled CAD systems).
6. Standalone Performance Study
Not applicable in the typical sense of an "algorithm only" performance study. The "Vascularity Index" is an integrated feature of the ultrasound system, and its "performance" (accuracy) was confirmed via bench testing as part of the overall device functionality rather than as a standalone algorithm evaluated against a separate ground truth in a clinical context.
7. Type of Ground Truth Used
- For the added transducers and Vascularity Index: The "ground truth" was established based on engineering and physical measurement standards to confirm accuracy (e.g., B-mode accuracy, Doppler mode velocity accuracy, accuracy of Vascularity Index calculation) and compliance with safety standards (electrical, thermal, acoustic power).
8. Sample Size for the Training Set
Not applicable. This device is an ultrasound system with added features (transducers, image display, and a quantitative index), not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for a machine learning algorithm.
§ 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.