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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The AcuNav 8F and 10F Ultrasound Catheter, ACUSON AcuNav™ V 10F Ultrasound Catheter, ACUSON AcuNav™ Volume 12F Ultrasound Catheter, SoundStar™ 8F Ultrasound Catheter, SoundStar™ 10F Ultrasound Catheter, SoundStar™ eco 8F Ultrasound Catheter, and SoundStar™ eco 10F Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode. M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

Additional features for the ACUSON SC2000 v5.1 update includes the Joystick remote control accessory that is intended to be used for interventional procedures with the ACUSON AcuNav Volume ICE catheter where remote control of the cursor is desired. The joystick plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press.

This is a premarket notification (510k) for the ACUSON SC2000 Diagnostic Ultrasound System. The information provided heavily references previous clearances for substantial equivalence rather than presenting new studies with acceptance criteria explicitly defined for the current submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics for this specific 510(k) submission (K181098). Instead, it relies on the substantial equivalence to previously cleared devices. The "Features on SC2000 System" table in Section 6.1 (pages 25-26) implicitly acts as a comparison to the predicate device, showing that the current device either has the same feature (√) or improved features (e.g., "Updated TEQ", "Added Manual Trace", "New" features). The "Frequencies Supported" are identical across the three compared devices for most applications.

The acceptance criteria here are implicit and based on the predicate device's established performance, meaning the new device must perform at least as well as, or be substantially equivalent to, the predicate in all relevant aspects.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "clinical studies were not required to support substantial equivalence" (Part 8, page 29). Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The submission relies on non-clinical tests (acoustic output, biocompatibility, safety standards compliance) and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no clinical studies were performed for this submission, there is no mention of experts or their qualifications for establishing ground truth. The substantial equivalence is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MrMC comparative effectiveness study was done or reported as clinical studies were deemed unnecessary due to substantial equivalence to predicate devices. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

No standalone performance study of an algorithm is described or reported. The device is an ultrasound system with accessories, not an AI/algorithm-only product.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is established through adherence to recognized medical device safety standards (e.g., AAMI / ANSI ES60601-1, IEC series, ISO 10993-1) and comparison of technological characteristics to already cleared predicate devices. Clinical outcomes data or expert consensus for new evaluations were not used for this submission's substantial equivalence determination.

8. Sample Size for the Training Set:

The document does not mention any training set or its sample size, as it does not involve a de novo AI/ML model development requiring such data for this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is discussed, the method for establishing its ground truth is not provided.

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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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