(154 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures 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 typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic capture of ultrasound images.
Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).
The provided text, primarily a 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System, does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-driven medical device.
This document focuses on establishing substantial equivalence of a new version (VC11/v6.1) of an existing ultrasound system to its predicate device (VC10/v6.0) and an earlier clearance (K171766) for the syngo® TrueFusion software feature. The key modification described is an update to the syngo® TrueFusion software from version 1.0 to 2.0 to support "Live Image Overlay."
The document states:
- "The SC2000 software update to VC11 (v6.1) does not involve any hardware modifications." (Page 11)
- "The VC11A (v6.1) software update and the SC2000 System software has undergone component, integration and system level verification testing. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria consistent with Siemens Product Lifecycle Procedure (PLP) and has passed." (Page 11)
- "Since the ACUSON SC2000 VC11 (v6.1) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000, VC10 (v6.0) K202683, clinical studies were not required to support substantial equivalence. The SC2000 VC11A (v6.1) software was fully validated on phantoms by clinical personal with training in Ultrasound technology and has passed." (Page 12)
- "In summary, based on the successful verification and validation testing to the software acceptance criteria, the update for the TrueFusion 2.0 feature does not introduce any new potential safety risks." (Page 12)
This indicates that the modifications were considered minor enough that extensive clinical studies to prove new acceptance criteria were not deemed necessary for the 510(k) clearance, as the device was shown to be substantially equivalent to an already cleared device. The "acceptance criteria" mentioned are likely related to internal software verification and validation, such as functional testing and regression testing, rather than performance metrics for an AI/ML model for clinical diagnosis.
Therefore, I cannot provide the requested information from this document. The document doesn't detail:
- A specific table of acceptance criteria and reported device performance for an AI/ML component.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods related to an AI/ML performance study.
- MRMC study details or standalone performance of an AI/ML algorithm.
The syngo® TrueFusion feature is described as integrating ultrasound with X-Ray Fluoroscopy for "Live Image Overlay" (page 6). While this involves data processing and fusion, the document does not present it as a new AI/ML diagnostic algorithm requiring a specific performance study with clinical endpoints or detailed AI validation metrics. It's more about system integration and data presentation.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.