(23 days)
The SonoScape S9 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
This SonoScape S9 Portable 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 with a frequency range of 1.0 MHz to 15.0 MHz. This system consists of a portable console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, 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 subject of this submission is the addition of new probes to legally marketed SonoScape S9.
The provided text is a 510(k) Summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. It outlines the device's technical characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. It is for an ultrasound system, not an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to a predicate device (SonoScape S9 Portable Digital Color Doppler Ultrasound System K142710) based on similar intended uses, technical characteristics, and compliance with safety standards for an ultrasound machine and its transducers. It explicitly states: "No clinical testing was required." and "Laboratory tests (including Phantom tests) were conducted to verify that the S9 system met all design specifications and the S9 system conformed to applicable medical device standards." This indicates a traditional medical device clearance pathway, not one typically involving the robust performance validation studies seen with AI/ML devices.
§ 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.