(47 days)
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
The provided document is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid S60N / Vivid S70N diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that would define acceptance criteria and prove its fulfillment.
Therefore, the requested information elements related to detailed study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.
The document explicitly states: "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence."
This indicates that clinical studies, which would typically involve the kind of detailed performance metrics, acceptance criteria, and study methodology you're asking about, were not conducted or submitted for this particular premarket notification. The submission relies instead on demonstrating equivalence to legally marketed predicate devices based on technological characteristics and non-clinical testing.
Therefore, I cannot provide a table of acceptance criteria or a study that proves the device meets those criteria based on the provided text.
Here's what information I can extract regarding the device and the nature of the submission:
- Device Name: Vivid S60N / Vivid S70N Diagnostic Ultrasound System
- Regulation Number: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system)
- Regulation Name: Ultrasonic pulsed doppler imaging system
- Regulatory Class: Class II
Elements that cannot be provided from this document:
- Table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not applicable as no clinical study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was conducted.
- Adjudication method for the test set: Not applicable as no clinical study was conducted.
- 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 present. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no standalone algorithm performance study was mentioned.
- The type of ground truth used: Not applicable as no clinical study was conducted.
- The sample size for the training set: Not applicable as no clinical study data for training was mentioned.
- How the ground truth for the training set was established: Not applicable as no clinical study data for training was mentioned.
This 510(k) submission primarily addresses the substantial equivalence of the Vivid S60N / Vivid S70N to its predicate and reference devices by outlining:
- Its intended use and indications for use.
- Its technological characteristics.
- Non-clinical testing for safety and performance (acoustic output, biocompatibility, cleaning, electrical, electromagnetic, mechanical safety, and compliance with various standards like IEC 60601 series, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 DICOM).
- Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing).
§ 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.