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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) |
|:-----------------------------|:-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| 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 T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

The Vivid T9 / Vivid T8 is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid T9 / Vivid T8 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

The document is a 510(k) Premarket Notification Submission for the GE Vivid T8 and Vivid T9 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through new clinical studies.

Based on the provided text, there are no specific acceptance criteria or a study detailed that directly proves the device meets such criteria in terms of diagnostic accuracy or effectiveness. Instead, the submission focuses on comparing the new device to predicate devices to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, particularly in relation to the questions asked, even if direct answers for "acceptance criteria" and "study proving it" are not present:

1. Table of Acceptance Criteria and Reported Device Performance:
   Not applicable in the direct sense of a new study with explicit performance metrics against acceptance criteria. The document claims "performance is substantially equivalent to the predicate device(s)" based on similar technology, intended use, imaging capabilities, and safety/effectiveness. The performance comparison is implicitly tied to the cleared performance of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." Therefore, no test set sample size, data provenance, or study type (retrospective/prospective) is provided for a new clinical performance study.

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):
   Since no new clinical studies were conducted to establish performance against ground truth, this information is not available in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new clinical performance study was conducted.

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. This is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no new clinical performance study was required. The "ground truth" for substantial equivalence is based on the previously established safety and effectiveness of the predicate devices.

8. The sample size for the training set:
   Not applicable for a clinical training set, as no new clinical studies were conducted. The device's "training" refers to its design and evaluation based on engineering principles and comparison to existing, cleared technologies.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of what the document focuses on instead:

The submission relies on demonstrating Substantial Equivalence to legally marketed predicate devices, primarily the Vivid T8 (K160078), Vivid E95 (K170823), Vivid iq (K161706), and Vscan Extend (K180995), along with other LOGIQ systems for specific transducer applications.

The key points for establishing substantial equivalence are:

• Intended Use: The Vivid T9 / Vivid T8 shares the same intended use as predicate devices: ultrasound imaging, measurement, and analysis of the human body for multiple clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult/Neonatal Cephalic, Musculoskeletal Superficial/Conventional, Transcranial, Transrectal, Transvaginal, Transesophageal, Intraoperative, and Tissue Biopsy).
• Technological Characteristics: The device employs the same fundamental scientific technology as its predicate devices.
• Imaging Modes: Identical imaging modes to the predicate Vivid T8 (K160078).
• Transducers: Similar transducers, with new additions (C1-5-RS and E8Cs-RS for Vivid T9) and expanded applications for existing transducers (e.g., Intraoperative for L8-18i-RS, and various clinical applications for 4C-RS, 8C-RS, 3Sc-RS, 6S-RS, 12S-RS, 9T-RS, L8-18i-RS, C1-5-RS, E8Cs-RS) that were cleared on other predicate systems.
• New Features: New features like Virtual convex, QuickApps, Cardiac AutoDoppler, Virtual Apex, Strain and Strain Rate, and Pediatric Z-score (expanded data) were cleared in predicate Vivid E95 (K170823). Tricefy Uplink was cleared with predicate Vscan Extend (K180995). Improvements were made to AFI and Auto EF, which were cleared on predicate Vivid T8 (K160078).
• Safety and Performance: The systems are manufactured with safe materials, have acoustic power levels below FDA limits, and comply with approved electrical and physical safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM). Quality assurance measures (Risk Analysis, Requirements/Design Reviews, various levels of testing) are applied.

Conclusion: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This means that the acceptance criteria are largely met by demonstrating that the device is as safe and effective as existing, legally marketed ultrasound systems, based on an engineering and feature-by-feature comparison rather than a new clinical trial with specific performance metrics.

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