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The Vivid ig is a high-performance compact ultrasound for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatal Cephalic, Adult Cephalic, Adult Cephalic, Cardiac, Penpheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal, Transcranial, Transvectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. It offers an innovative ergonomic design, superb image quality, advanced connectivity, productivity tools and advanced technology. Compatibility with the Vivid product family offers flexibility in lab configuration and upgrade opportunities.

The provided document is a 510(k) Premarket Notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq diagnostic ultrasound system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or defining specific performance acceptance criteria for new algorithms.

Therefore, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study designed to prove the device meets such criteria in the context of an AI/algorithm. Instead, it demonstrates substantial equivalence to existing devices for its intended use.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) summary for a diagnostic ultrasound system, not an AI/algorithm-specific submission with performance acceptance criteria. The claim is substantial equivalence to predicate devices, not performance against specific metrics for a novel algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No separate test set for an algorithm is described. The document indicates that no clinical studies were required to support substantial equivalence (page 30). The "Indications for Use" tables list where indications are "new" (N) or "previously cleared" (P), which refers to the clearance of the transducer/system for that application, not performance evaluation of an AI algorithm on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described, as no efficacy study for an AI/algorithm is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication is described.

5. 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. No MRMC study is mentioned. This document is for a diagnostic ultrasound system, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance study is indicated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described in the context of an algorithm's performance evaluation.

8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.

9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.

Summary of Device and Evidence Presented:

The GE Vivid iq is a high-performance compact ultrasound system intended for cardiovascular and shared services applications.

Predicate Devices:

• Primary Predicate Device: Vivid i and Vivid q (K121062)
• Secondary Predicate Devices: Vivid E95 (K150087), Voluson S10 (K160184), LOGIQ F8 Expert (K160277), K140318 by Biosense Webster, Inc.

Substantial Equivalence Claim:
The Vivid iq system is substantially equivalent to its predicate devices in terms of intended use, imaging capabilities, technological characteristics, and safety and effectiveness.

Non-Clinical Tests:
The device underwent non-clinical evaluations for:

• Acoustic output (compliance with NEMA UD 3, NEMA UD 2)
• Biocompatibility (compliance with ISO10993-1)
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety (compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO14971)

Clinical Tests:
No clinical studies were required to support the substantial equivalence claim (page 30).

Technology:
The Vivid iq employs the same fundamental scientific technology as its predicate devices. Changes noted include:

• Addition of tissue biopsy indication, previously cleared in LOGIQ F8 Expert (K160277).
• Addition of Real Time 3D mode, previously cleared in Vivid E95 (K150087).
• Addition of several new transducers (M5Sc-RS, E8Cs-RS, L8-18i-RS, ML6-15-RS, C1-5-RS, 6VT-D, SOUNDSTAR eco 8F (G version)) which were previously cleared on other GE systems or by Biosense Webster, Inc.
• The embedded operating system is Windows 7, similar to LOGIQ F8 Expert (K160277).

Conclusion:
GE Healthcare states that the Vivid iq is as safe, as effective, and its performance is substantially equivalent to the predicate device(s).

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