(14 days)
The SonixTouch Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial, Intravascular, Laparoscopic.
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The SonixTouch Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.
The biopsy kits are accessories to the SonixTouch Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.
The provided document is a 510(k) Summary for the SonixTouch Ultrasound Scanner, which primarily focuses on establishing substantial equivalence to predicate devices and detailing general safety considerations for an ultrasound system. It is not a study proving device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled diagnostic devices that generate quantifiable results (e.g., sensitivity, specificity for disease detection).
The document details the device's technical specifications and clinical applications for various transducers. It mentions "Elastography verification data" which points to a verification protocol, but this is described as verifying the algorithm's ability to differentiate different structures with different rigidity, rather than a clinical performance study with acceptance criteria.
Therefore, much of the requested information (like quantitative acceptance criteria, sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) is not present in the provided text, as this type of information is usually associated with studies validating a diagnostic claim or quantitative performance, which is not the primary focus of this 510(k) submission for a general ultrasound imaging system.
However, I can extract information related to the device's safety acceptance criteria and the methods used to demonstrate compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes compliance with specific acoustic output limits as a safety consideration.
| Acceptance Criteria (Acoustic Output Limits) | Reported Device Performance |
|---|---|
| ISPTA(d) |
§ 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.