(162 days)
The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac maging. 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, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculosketal Conventional, Musculoskeletal Superficial, Transesophageal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), 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 T8/Vivid T9 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 T8/Vivid T9 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 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 describes the 510(k) Pre-market Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid T8/T9 ultrasound system, primarily focusing on its substantial equivalence to predicate devices rather than the performance of a novel AI-driven feature with detailed acceptance criteria and a specific study proving those criteria.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (specifically for an AI/ML component) is not extensively described in this document. The document mentions the addition of several AI-based features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) that were previously cleared on the Vivid S70N (K200497). The submission states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This implies that the performance of these AI features was established and cleared in the previous submission (K200497) for the Vivid S70N, and no new clinical studies were conducted for the Vivid T8/T9 to demonstrate their performance against new acceptance criteria.
Based on the provided text, I cannot reconstruct a detailed table of acceptance criteria and reported device performance for the AI features or the specific study proving the device meets these criteria for the Vivid T8/T9 itself. The document implicitly relies on the prior clearance of these AI features on a different device to demonstrate substantial equivalence.
However, I can extract the information that is present regarding the AI features and the overall submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided in this document directly for the Vivid T8/T9. The document states that the AI features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) are the "same feature as cleared on Vivid S70N (K200497)." This implies that their performance was assessed and accepted during the clearance of K200497, but the specific acceptance criteria and detailed performance data from that prior submission are not included here.
2. Sample Size Used for the Test Set and Data Provenance:
- Not specified in this document. Since no new clinical studies were conducted for the Vivid T8/T9 specifically for these AI features, details about the test set for the AI components are presumed to be part of the K200497 submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not specified in this document. This information would likely be found in the K200497 submission for the Vivid S70N, where these AI features were originally cleared.
4. Adjudication Method for the Test Set:
- Not specified in this document. Again, this would pertain to the information from the K200497 submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size:
- Not specified in this document. There is no mention of MRMC studies or human reader improvement with AI assistance for the Vivid T8/T9. Any such studies would have been part of the original K200497 submission for the Vivid S70N.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not specified in this document. Details on standalone performance for the AI features would be in the K200497 submission.
7. The Type of Ground Truth Used:
- Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.
8. The Sample Size for the Training Set:
- Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.
9. How the Ground Truth for the Training Set was Established:
- Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.
Summary based on the provided document:
The 510(k) submission for the Vivid T8/T9 leverages the substantial equivalence pathway, specifically by stating that new "AI Auto Measure" and "AFI" features are "same feature as cleared on Vivid S70N (K200497)." This means that the device's adherence to acceptance criteria for these AI features was established during the clearance of the Vivid S70N, and that information is not detailed in this specific document. The submission explicitly states, "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This indicates that the performance data for the AI features was carried over from the prior clearance.
§ 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.