(106 days)
The SonoScape S50 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatic, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (pediatric and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape S50 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. 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 touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.
The SonoScape S50 Digital Color Doppler Ultrasound System is compared to a predicate device, the SonoScape S30/S40 Digital Color Doppler Ultrasound System (K150045) for substantial equivalence in safety and effectiveness.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with recognized electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output standards. The "reported device performance" is the statement that the S50 Digital Color Doppler Ultrasound System met these specifications and conformed to the applicable medical device standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1:2005+A1:2012 (General Requirements for Basic Safety and Essential Performance) | Device met all design specifications and conformed to applicable standards. |
| EM Compatibility | Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility) | Device met all design specifications and conformed to applicable standards. |
| Ultrasound Specific | Compliance with IEC 60601-2-37:2007 (Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment) | Device met all design specifications and conformed to applicable standards. |
| Biocompatibility | Compliance with ISO 10993-5:2009 (In vitro cytotoxicity) and ISO 10993-10:2010 (Irritation and Skin Sensitization) | Device met all design specifications and conformed to applicable standards. |
| Acoustic Output | Compliance with AIUM/NEMA UD 2:2004 (R2009) (Acoustic Output Measurement Standard) and AIUM/NEMA UD 3:2004 (R2009) (Real-Time Display of Thermal and Mechanical Acoustic Output Indices) | Device met all design specifications and conformed to applicable standards. |
| Technical Equivalence | Similar design, operation controls, display modes, operation modes, measurement items, Cine Loop, operating and storage conditions to predicate device S30/S40 (K150045). Probes have similar performance, frequency, or clinical application. | The basic and key technical features of the Subject Device S50 are the same as the predicate device. Probes are similar to or have minor differences that do not affect safety, effectiveness, and clinical use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set sample size" in terms of number of patients or images. The evaluation primarily relies on non-clinical tests performed on the device itself.
- Data Provenance: The testing was conducted in a laboratory setting to verify design specifications and standard compliance. The document does not specify the country of origin of this testing, but the manufacturer is SonoScape Medical Corp. located in Shenzhen, GuangDong, CHINA. The study is retrospective in the sense that it's based on internal verification against established standards rather than data collected from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned as establishing ground truth for a "test set" in the context of clinical performance. The ground truth for device safety and performance is based on well-established international and national medical device standards (e.g., IEC, ISO, AIUM/NEMA) and internal design specifications verified through laboratory testing. The expertise would be inherent in the engineers and testers who conducted the evaluations against these standards.
4. Adjudication Method for the Test Set
Not applicable. Since no clinical test set requiring expert interpretation or adjudication is described, there is no adjudication method mentioned.
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 mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and compliance with safety regulations, not on comparing reader performance with or without AI assistance. The device is a "Digital Color Doppler Ultrasound System," and there is no indication it includes AI features that would necessitate such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned. As noted above, the device is an ultrasound system, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used in this submission is the compliance with recognized international and national standards for medical electrical equipment, ultrasonic medical diagnostic equipment, biocompatibility, and acoustic output. Additionally, the technical characteristics and intended use of a legally marketed predicate device (SonoScape S30/S40 Digital Color Doppler Ultrasound System K150045) serve as a comparative ground truth for establishing substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a submission for an ultrasound system, not an AI/ML device that would typically involve a separate training set. The "training" in this context refers to the design and testing of the hardware and software to meet specific engineering and performance criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is mentioned. The "ground truth" for the device's development primarily comes from the engineering specifications, design requirements, and the aforementioned medical device standards that the device was designed to meet.
§ 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.