(29 days)
The Vivid T8/Vivid T8 Pro is Multipurpose Cardiovascular System designed for cardiac and Shared Service Imaging, the system supports following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Musculoskeletal Superficial/Conventional, Adult Cephalic, Neonatal Cephalic, Transcranial, Transrectal, Transvaginal and Transesophageal.
The Vivid T8/Vivid T8 Pro is the full featured general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel.
The GE Healthcare Vivid T8/T8 Pro is a diagnostic ultrasound system. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing "substantial equivalence" of the Vivid T8/T8 Pro to predicate devices (K121063 GE Vivid S6/S5 BT12 and K133034 GE LOGIQ F Series). The acceptance criteria are implicitly defined by the safety and performance characteristics of these predicate devices. The study demonstrates that the Vivid T8/T8 Pro meets these implied criteria, meaning it performs comparably to the predicate devices and thus is considered safe and effective.
The provided document does not contain a specific table of quantitative acceptance criteria for image quality or clinical performance that would typically be found for an AI/CADe device. Instead, the "performance" is demonstrated through conformity to relevant medical device safety and performance standards, and comparison of features and intended use with the predicate devices.
Summary of Device Performance (based on provided text):
The Vivid T8/Vivid T8 Pro is reported to be substantially equivalent to the predicate devices regarding:
- Intended Use and Clinical Applications.
- Imaging Capabilities (Image modes: B; M; Color, Power, PW & CW Doppler modes, Color M-mode, Harmonic imaging, Combined modes).
- Technological Characteristics.
- Safety and Effectiveness.
It also conforms to the following voluntary standards:
- AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1 : General Requirements for Safety)
- IEC60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
- IEC60601-2-37 (Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- NEMA UD 3 (Thermal and Mechanical Acoustic Output Indices)
- ISO10993-1 (Biological Evaluation of Medical Devices)
- NEMA UD 2 (Acoustic Output Measurement Standard)
- ISO14971 (Application of risk management to medical devices)
- NEMA, DICOM Set (Digital Imaging and Communications in Medicine)
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "The subject of this premarket submission, Vivid T8/Vivid T8 Pro, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set or associated data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical tests and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no clinical studies were performed, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was done, as explicitly stated that no clinical studies were required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The submission is for a diagnostic ultrasound system, which is a medical imaging device operated by a human. It is not an AI algorithm or CADe device, so the concept of standalone algorithm performance is not applicable in this context. The device's performance is inherently human-in-the-loop.
7. The Type of Ground Truth Used
Not applicable, as no clinical studies were performed. The "ground truth" for this submission relies on established safety and performance standards for diagnostic ultrasound systems and the performance characteristics of predicate devices.
8. The Sample Size for the Training Set
Not applicable. The Vivid T8/T8 Pro is a traditional ultrasound system, not an AI/Machine Learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.