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The Vivid ig 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 in clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), Thoracic/Pleural, Intraoperative (Vascular), Intracardiac and Intraluminal.

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, 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 ig 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, color LCD Touch Panel that includes an on-screen alphanumeric keyboard. The system also has standard height-adjustable new ergonomic mobile cart for comfortable standing and sitting positions. The Charge Box in the Mobile Cart provides Vivid iq up to 4 hours scanning time without power supply.

There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE 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.

The provided text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq. It details the device's characteristics and its comparison to predicate devices, but it explicitly states that no clinical studies were required to support substantial equivalence for this particular submission. Therefore, it is not possible to provide acceptance criteria or a study that proves the device meets those criteria, as such studies were not conducted or submitted for this 510(k).

The document is primarily focused on demonstrating substantial equivalence to a predicate device (Vivid iq K221148) through design similarities, conformance to recognized performance standards, and non-clinical performance testing.

Here's what can be extracted based on the provided text, while acknowledging the absence of clinical study data for this submission:

Summary of Non-Clinical Tests (from the document):

The document does list the non-clinical tests conducted and the standards to which the device conforms:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic and mechanical safety

Voluntary Standards Complied With:

• AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005/A2:2021
• AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
• IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020
• IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
• ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within Risk Management Process, Fifth edition, 2018
• ISO 14971, Application of risk management to medical devices. 2019
• NEMA PS 3.1 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2022d
• 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

Quality Assurance Measures:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification & Validation)
• Safety testing (Verification)

In conclusion, for this specific 510(k) submission (K243620), "Vivid iq," the device met acceptance criteria by demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than through clinical studies with specific performance metrics.

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The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by 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), 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, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, 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 ig 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, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.

There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of 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.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the performance of the AI algorithms, "Easy Auto EF" and "Easy AFI LV," which are components of the Vivid iq system. The primary acceptance criterion appears to be the accuracy of the AI algorithm in terms of its Dice score.

Note: The document only provides performance metrics for the AI algorithms specifically, not for the entire Vivid iq system's overall clinical performance beyond safety and equivalence to predicates for its general ultrasound functions.

Study Details for AI Algorithms (Easy Auto EF and Easy AFI LV)

2. Sample size used for the test set and the data provenance:

• Number of images: 135 images.
• Number of exams: 45 exams.
• Assumed number of patients: 45 patients (exact number unknown due to anonymization).
• Provenance: Retrospective data collected from different countries, including Europe, Asia, and the US. The document states that the testing dataset came from different clinical sites than the training data to ensure independence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Initial Experts: Two certified cardiologists.
• Adjudication Panel: An unspecified "panel of experienced experts" for cases where the initial two cardiologists did not agree. Specific qualifications for the panel are not provided beyond "experienced experts."

4. Adjudication method for the test set:

• Primary Method: Consensus reading between two certified cardiologists. They performed manual delineation and then reviewed each other's annotations. They discussed and agreed upon annotations.
• Secondary Method: For annotations where the two cardiologists could not agree, a "panel of experienced experts" further reviewed and established a consensus ground truth. This suggests a 2+1 (or 2+N) approach for disagreements.

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:

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The evaluation focuses solely on the standalone performance of the AI algorithm against expert-established ground truth.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance evaluation of the AI algorithm was conducted. The reported Dice scores (91-92% or higher) reflect the algorithm's accuracy in autonomously delineating structures.

7. The type of ground truth used:

• Expert consensus was used as the ground truth. This was derived from manual delineations by two certified cardiologists, with a panel of experienced experts resolving disagreements.

8. The sample size for the training set:

• The sample size for the training set is not specified in the provided document. It only mentions that datasets from different clinical sites were used for training compared to the test set.

9. How the ground truth for the training set was established:

• The document does not explicitly describe how the ground truth for the training set was established. However, given the description for the test set, it is highly probable that a similar expert-driven delineation and consensus process was used.

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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.

Ask a specific question about this device

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, 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.

This FDA 510(k) summary for the GE Vivid iq ultrasound system (K181727) focuses on establishing substantial equivalence to predicate devices, rather than performing a de novo study with specific acceptance criteria related to disease detection performance.

Therefore, the document does not report specific acceptance criteria or performance metrics for detecting or diagnosing conditions, as it is a clearance based on the device's technological characteristics and intended use being equivalent to already cleared devices.

Here's a breakdown of the information that is available based on your request, with the understanding that specific diagnostic performance metrics are not provided:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable for this type of submission):

| Criterion Type | Acceptance Criteria (Internal/Regulatory Compliance) | Reported Device Performance (Demonstrated Compliance) |
|:-----------------------------|:-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness | Compliance with all relevant medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2, NEMA DICOM Set). | The Vivid iq has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety and was found to comply with all applicable standards. Non-clinical verification testing covered system-level requirements and risk control measures. Non-clinical validation testing covered intended use, commercial claims, and usability with representative intended users. |
| Technological Equivalence| The device employs the same fundamental scientific technology as its predicate devices. Imaging capabilities, modes, and transducers are similar or identical to predicate devices. New features are cleared on other predicate devices. | The Vivid iq employs the same fundamental scientific technology as its predicate devices. It has identical imaging modes and transducers to its primary predicate (Vivid iq K161706). New features like 4D Markers, Tricefy Uplink, Qview, QuickApps, View-X, FlexiViews, Mitral Valve Quantification (MVQ), 4D AVQ, AFI, Auto EF, Cardiac AutoDoppler improvements, and Pediatric Z-score functionality are equivalent to those cleared in predicate devices such as Vivid E95 (K170823, K160078), Venue (K180599), and Vscan Extend (K161588). Transducer clinical application expansions are based on clearances from LOGIQ e (K151028), Vivid T8 (K160078), and LOGIQ P9/P7 (K163596). The system has similar capabilities in measurements, digital image capture, reviewing, and reporting. Materials are safe, and acoustic power levels are below FDA limits. |
| Intended Use Equivalence | The intended use of the Vivid iq system must be substantially equivalent to that of predicate devices. | The Vivid iq is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body for cardiovascular and shared services applications, including Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal. This intended use is stated to be substantially equivalent to the predicate devices. |

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated as this was a 510(k) submission based on substantial equivalence, not a clinical trial proving diagnostic accuracy from scratch. The submission indicates "Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users." This implies testing was done, but details on the size and nature of the "test set" for performance are not provided.
• Data Provenance: The document does not specify the country of origin for any non-clinical testing data. The submission relies heavily on demonstrating equivalence to predicate devices, which would mean leveraging the accepted performance of those existing devices. The testing mentioned (acoustic output, biocompatibility, etc.) would typically be performed by the manufacturer, GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Wauwatosa, WI, USA, or their global affiliates. The context implies newly conducted non-clinical verification and validation, but not on a specific "dataset" from patients for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. The submission focuses on technical and safety equivalence. Ground truth for diagnostic performance is not established or reported as part of this 510(k) summary, as it relies on the predicate devices having already demonstated acceptable performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication methods are typically relevant for clinical studies establishing diagnostic performance where human readers interpret outputs. This submission is for device clearance based on equivalence, not a clinical diagnostic performance study.

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:

• No MRMC comparative effectiveness study was described or performed. The document explicitly states: "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." This means no studies comparing human reader performance with or without AI assistance were conducted or reported in this submission. The new features mentioned are enhancements or integrations, not AI-driven diagnostic tools requiring such studies for this clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not done. This device is an ultrasound system with various imaging modes and features. It's not a standalone AI algorithm for automated diagnosis or detection. The features mentioned, like "QuickApps," "4D Markers," etc., are productivity tools or display enhancements, not algorithms that act independently for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not provided in the context of diagnostic performance. For the safety and effectiveness evaluations, the "ground truth" would be the established safety standards and regulatory requirements. For functional testing of new features, it would be the expected technical behavior and output of the features.

8. The sample size for the training set:

• Not applicable/Not provided. This submission does not describe the development or training of an AI algorithm in the traditional sense that would require a dedicated training set of medical images for diagnostic tasks. The new features detailed are mostly related to image processing, workflow, and connectivity, not machine learning models trained on vast datasets.

9. How the ground truth for the training set was established:

• Not applicable/Not provided, for the same reasons as point 8.

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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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