(113 days)
The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, 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 (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.
The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is an integrated, preprogrammed, color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes and 3D/4D.
The provided document is a 510(k) premarket notification for the Toshiba Medical Systems Corporation Viamo c100 TUS-VC100 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, the document explicitly states, "No clinical testing was required."
However, it does detail non-clinical tests conducted to ensure safety and effectiveness.
Here's a breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since no clinical studies were performed to establish performance metrics against specific acceptance criteria for diagnostic accuracy, a direct table of clinical acceptance criteria and reported device performance cannot be generated.
However, the non-clinical acceptance criteria are based on conformance to established medical device safety standards. The reported performance is that the device was found to conform to these standards.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Electrical Safety: Conformance to IEC 60601-1:2005 | Device found to conform to the standard. |
| Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2:2007 | Device found to conform to the standard. |
| Ultrasonic Medical Diagnostic Equipment Safety: Conformance to IEC 60601-2-37:2007 | Device found to conform to the standard. |
| Acoustic Output Measurement: Conformance to NEMA UD 2-2004 | Device found to conform to the standard. |
| Real-time Display of Thermal and Mechanical Acoustic Output Indices: Conformance to NEMA UD3:2004 | Device found to conform to the standard. |
| Biocompatibility: Conformance to ISO 10993-1:2009 | Device found to conform to the standard. |
| Software Validation: Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" (May 11, 2005) | Successful completion of software validation. |
| Risk Management and Design Controls: Application of established principles (21 CFR § 820 and ISO 13485 Standards) | Application of risk management and design controls. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used. The submission states "No clinical testing was required." The evaluation was based on non-clinical tests demonstrating conformance to safety standards.
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. Since no clinical testing was performed, there was no need for experts to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set was used, therefore no adjudication method was employed.
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. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware-based diagnostic ultrasound system, not an algorithm being tested for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth (for non-clinical tests): The "ground truth" for the non-clinical tests was the established requirements and specifications within the referenced international and national safety standards (IEC, NEMA, ISO). Conformance to these standards served as the "ground truth" for demonstrating the device's safety and fundamental performance characteristics.
8. The sample size for the training set
- Not applicable. This document pertains to regulatory clearance for a diagnostic ultrasound system, not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As no training set was used (see point 8), there was no ground truth to establish for it.
§ 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.