(78 days)
The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices.
The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/ PWD, B/Color/PWD, B/Power/PWD.
Vivid T9/Vivid T8 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 T9/Vivid T8 consists of a mobile console with 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, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alphanumeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
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.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new, innovative device.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment for performance claims cannot be found in this document.
The document primarily states that the device is "substantially equivalent" to predicate devices, and relies on non-clinical tests (safety, electrical, etc.) and design similarities to justify this claim. It explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence."
Below is a table summarizing the information that could be extracted from the provided text, and noted where information is explicitly not available or not applicable based on the content.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Performance | Not applicable per document; no clinical studies were required to support substantial equivalence. The device is considered substantially equivalent to its predicate. |
| Acoustic Output Conformity | Device has been evaluated for acoustic output and found to conform with applicable medical device safety standards. |
| Biocompatibility | Device has been evaluated for biocompatibility and found to conform with applicable medical device safety standards. Transducer materials and other patient contact materials are biocompatible. |
| Cleaning and Disinfection Effectiveness | Device has been evaluated for cleaning and disinfection effectiveness and found to conform with applicable medical device safety standards. |
| Thermal Safety | Device has been evaluated for thermal safety and found to conform with applicable medical device safety standards. |
| Electrical Safety | Device has been evaluated for electrical safety and found to conform with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37). |
| Electromagnetic Safety | Device has been evaluated for electromagnetic safety and found to conform with applicable medical device safety standards (e.g., IEC 60601-1-2). |
| Mechanical Safety | Device has been evaluated for mechanical safety and found to conform with applicable medical device safety standards. |
| Risk Management | Application of risk management to medical devices (ISO 14971) is applied. |
| Quality Assurance | Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification & Validation), Safety testing (Verification) are applied to development. |
| DICOM Conformity | Conforms to NEMA PS 3.1 - 3.20. Digital Imaging and Communications in Medicine (DICOM) Set (Radiology), 2022d. DICOM Encapsulated PDF reports feature allows transfer through DICOM data flows. |
| Ultrasonics Field Characterization | Conforms to IEC 62359. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017. |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence." Therefore, no "test set" in the context of clinical performance evaluation is described. The non-clinical tests (acoustic, electrical, thermal, etc.) inherently involve testing of the device itself rather than patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for substantial equivalence.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was performed.
- 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. This document pertains to a general-purpose ultrasound system without specific mention of AI features that would necessitate an MRMC study for improved human reader performance. The "Clarity +" feature is described as "real-time image processing/filtering technique," not an AI-driven diagnostic aid that would directly impact human reader performance in a quantifiable way for this type of submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not a standalone algorithm. Its "Clarity +" feature is an image processing technique integrated into the system, not a separate diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance evaluation, as no clinical studies were deemed necessary. For the non-clinical tests (e.g., safety, electrical, acoustic), the "ground truth" is adherence to recognized performance standards and internal quality assurance measures.
- The sample size for the training set: Not applicable. As this device did not require clinical studies, there is no mention of a "training set" for algorithm development related to diagnostic performance.
- How the ground truth for the training set was established: Not applicable, as no training set for diagnostic algorithm development is mentioned or required in this 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.