(175 days)
The Vivid is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
The proposed Vivid iq system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, numeric keyboard. There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid iq utilizes a variety of linear, sector, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.
The provided text does not contain information regarding the acceptance criteria of and performance of the device "Vivid iq". It also lacks details about a specific study designed to prove the device meets such criteria, as well as information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
The document is a 510(k) premarket notification for the Vivid iq, which primarily discusses the device's substantial equivalence to existing predicate devices based on technological characteristics and intended use. It lists various features and functions, noting that many are the "same feature as cleared on" other GE Healthcare devices.
However, based on the information provided in the text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. The document states that the Vivid iq uses the "same fundamental scientific technology as its predicate and reference devices" and lists various feature updates (e.g., AI Auto Measure, AFI 3.0, Auto EF 3.0) that are "same feature as cleared on" other GE Healthcare systems. Implicitly, the acceptance criteria for these features would have been met during the clearance of the previous devices, and the performance of the Vivid iq with these features is presumed to be equivalent. However, explicit numerical acceptance criteria and performance metrics for the Vivid iq itself are not detailed in this submission.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The document states, "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." This implies that no new clinical test set was used for this specific submission to prove the performance of the listed features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission. For the features inherited from other devices, the original submissions for those devices would contain this information.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the given text. While some AI-based features are mentioned (e.g., "AI Auto Measure – 2D" and "AI Auto Measure – Spectrum Recognition"), the document does not detail any MRMC study conducted for the Vivid iq or the effect size of AI assistance on human readers. It only states that these are "same feature as cleared on Vivid S70N(K200497)," suggesting that any such studies would have been part of the K200497 submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided in the given text. Given that clinical studies were not required for this submission, standalone performance data for the AI algorithms specifically on the Vivid iq system are not detailed here.
7. The Type of Ground Truth Used
This information is not provided in the given text for the Vivid iq itself. For the features inherited from other devices (e.g., AI Auto Measure components), the ground truth type (e.g., expert consensus, manual measurements, pathology) would have been established during the development and clearance of those original devices.
8. The Sample Size for the Training Set
This information is not provided in the given text. For the AI-based features, the training set size would have been part of the K200497 submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the given text. For the AI-based features, the method for establishing ground truth for the training set would have been part of the K200497 submission.
In summary, the provided document focuses on confirming "substantial equivalence" based on existing technologies and previously cleared features from other devices, rather than presenting new clinical study data with detailed acceptance criteria, test set specifics, or human-in-the-loop performance metrics for the Vivid iq specifically.
§ 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.