(42 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/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).
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 primarily a 510(k) Pre-Market Notification from the FDA regarding the GE Vivid S60N and Vivid S70N ultrasound systems. It does not contain an acceptance criteria table or a study description proving the device meets specific performance criteria in detail, as it is a regulatory clearance document rather than a clinical trial report.
However, based on the information provided, here's what can be inferred or stated about the device's acceptance criteria and the study that "proves" it meets them in the context of this FDA clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the GE Vivid S60N / Vivid S70N complies with various voluntary safety and performance standards. These standards implicitly serve as "acceptance criteria" for the device's technical and safety aspects. The "reported device performance" is the statement of compliance with these standards and the assertion of substantial equivalence to predicate devices for its intended uses and technological characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI ES60601-1 (Medical Electrical Equipment Safety) | Complies |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Complies |
| Compliance with IEC 60601-2-37 (Basic Safety and Essential Performance of Ultrasonic Medical Equipment) | Complies |
| Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices) | Transducer materials and other patient contact materials are biocompatible. |
| Compliance with IEC 62359 (Ultrasonics Field characterization for thermal/mechanical indices) | Complies |
| Compliance with ISO 14971 (Application of risk management to medical devices) | Complies |
| Compliance with NEMA PS3.1-3.20 (DICOM Set) | Complies |
| Performance for listed clinical applications and modes of operation (e.g., Fetal/Obstetrics, Cardiac, etc.) | The device is substantially equivalent to predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. The "P" (previously cleared) and "N" (new) indications for various transducers (across 24 pages of indications for use) define the intended performance envelope. |
| Software Development Quality Assurance (Risk Analysis, Usability Analysis, Requirements/Design Reviews, Testing) | Quality assurance measures were applied, including Risk Analysis, Usability Analysis, Requirements Reviews, Design Reviews, Unit-level Testing, Integration Testing, Performance Testing, and Safety Testing. Successful results and compliance of non-clinical tests ensure safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence."
Therefore, there is no clinical test set described in this document for the evaluation of the device's diagnostic performance against specific acceptance criteria. The clearance is based on a demonstration of substantial equivalence to previously cleared predicate devices and non-clinical engineering and safety testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical studies were performed for this submission. The "ground truth" for demonstrating substantial equivalence would be implied by the regulatory clearance of the predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical studies were performed for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or described in this document. The device did not require clinical studies.
6. Standalone Performance Study:
No standalone diagnostic performance study (algorithm only, without human-in-the-loop) was performed or described in this document, as no clinical studies were required. The closest to "standalone" performance testing mentioned are internal verification and validation of software functionalities and system performance against engineering specifications and industry standards.
7. Type of Ground Truth Used:
Not applicable for a clinical performance study since none was conducted. The basis for clearance is substantial equivalence to predicate devices. This means that the technological characteristics and indications for use are similar to legally marketed devices, and any differences do not raise new questions of safety or effectiveness. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.
8. Sample Size for the Training Set:
Not applicable. This document pertains to the regulatory clearance of an ultrasound system, not an AI/algorithm-based diagnostic device that requires explicit training data. The "training" for such a system would involve engineering development, calibration, and internal testing, but not in the context of a "training set" of patient data for an algorithm as understood in AI/ML performance studies.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for an AI/ML algorithm is described or relevant to this 510(k) submission.
§ 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.