(82 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 physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
Vivid S60N / Vivid S70N is a Track 3 diagnostic ultrasound system, 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. 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.
This document is a 510(k) Premarket Notification submission for the GE Vivid S60N and Vivid S70N Diagnostic Ultrasound Systems, specifically outlining their indications for use and a summary of non-clinical tests. It states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity for diagnostic tasks.
The document focuses on demonstrating substantial equivalence to predicate devices for its intended uses and assuring safety through engineering and quality assurance tests.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for any specific clinical application. Instead, it lists various standard compliance points for safety and an overall claim of "substantially equivalent" performance to predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no clinical performance study for diagnostic criteria is described. The document states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical performance study for diagnostic criteria is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study for diagnostic criteria is described.
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
Not applicable. The document states that clinical studies were not required. The product is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations. While it mentions new features like "4D Auto MVO" and "4D Auto AVQ" and "Cardiac AutoDoppler" as "functionality" or "workflow improvements" migrated from other predicate devices, it does not detail any comparative effectiveness study for these features.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system that requires a human operator and physician for image acquisition and interpretation, respectively. There is no mention of a standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study for diagnostic criteria is described.
8. The sample size for the training set
Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission. The mention of "new functionality" being "migrated" suggests these may have been developed and tested previously as part of other predicate device submissions or internal development, but details are not provided here.
9. How the ground truth for the training set was established
Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission.
Summary from the document:
The GE Vivid S60N and Vivid S70N are general-purpose ultrasound systems. The submission demonstrates substantial equivalence to previously cleared predicate devices (Vivid S60/S70, Vivid E80/E90/E95, Vivid iq, LOGIQ E9, TomTec Arena TTA2) based on:
- Intended Use: Similar to predicate devices, specialized for cardiac imaging but also covers vascular and general radiology. The document expands on previously cleared indications for use by adding specific applications from other predicate devices (e.g., Intra-cardiac, Intra-luminal, Transvaginal, Transrectal, Musculo-skeletal Superficial).
- Technological Characteristics: Employs the same fundamental scientific technology. New features ("4D Auto MVO," "4D Auto AVQ," "Cardiac AutoDoppler," "FlexiViews," "QuickApps," "Virtual Convex," "View-X") are presented as alternative implementations, new functionalities, workflow improvements, or migrated techniques from other cleared devices.
- Safety and Effectiveness: Compliance with numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety (e.g., ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). Quality assurance measures were applied, including risk analysis, usability analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).
The key takeaway is that this 510(k) submission relies on demonstrating substantial equivalence to existing, cleared devices through non-clinical testing and shared technology, rather than presenting novel clinical performance data for new diagnostic accuracy claims.
§ 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.