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Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculoskeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), Intra-cardiac. Intra-luminal and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, OLED or LCD display monitor (alternatives) and optional image storage and printing devices. It includes 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 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 adapter) connection.

This document describes the FDA's 510(k) clearance for the GE Medical Systems Ultrasound and Primary Care Diagnostics' Vivid E80/E90/E95 ultrasound system. It outlines the regulatory process and provides a summary of the device's characteristics and equivalence to predicate devices. However, it explicitly states that no clinical studies were required to support substantial equivalence for this premarket submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study was not described or conducted as part of this particular FDA submission for the Vivid E80/E90/E95 ultrasound system. The clearance was based on demonstrating substantial equivalence to already legally marketed predicate devices through non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).

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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.

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The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac maging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculosketal Conventional, Musculoskeletal Superficial, Transesophageal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Vivid T8/Vivid T9 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid T8/Vivid T9 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, and dual array including dedicated CW 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.

This document describes the 510(k) Pre-market Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid T8/T9 ultrasound system, primarily focusing on its substantial equivalence to predicate devices rather than the performance of a novel AI-driven feature with detailed acceptance criteria and a specific study proving those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (specifically for an AI/ML component) is not extensively described in this document. The document mentions the addition of several AI-based features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) that were previously cleared on the Vivid S70N (K200497). The submission states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This implies that the performance of these AI features was established and cleared in the previous submission (K200497) for the Vivid S70N, and no new clinical studies were conducted for the Vivid T8/T9 to demonstrate their performance against new acceptance criteria.

Based on the provided text, I cannot reconstruct a detailed table of acceptance criteria and reported device performance for the AI features or the specific study proving the device meets these criteria for the Vivid T8/T9 itself. The document implicitly relies on the prior clearance of these AI features on a different device to demonstrate substantial equivalence.

However, I can extract the information that is present regarding the AI features and the overall submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in this document directly for the Vivid T8/T9. The document states that the AI features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) are the "same feature as cleared on Vivid S70N (K200497)." This implies that their performance was assessed and accepted during the clearance of K200497, but the specific acceptance criteria and detailed performance data from that prior submission are not included here.

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

• Not specified in this document. Since no new clinical studies were conducted for the Vivid T8/T9 specifically for these AI features, details about the test set for the AI components are presumed to be part of the K200497 submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not specified in this document. This information would likely be found in the K200497 submission for the Vivid S70N, where these AI features were originally cleared.

4. Adjudication Method for the Test Set:

• Not specified in this document. Again, this would pertain to the information from the K200497 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size:

• Not specified in this document. There is no mention of MRMC studies or human reader improvement with AI assistance for the Vivid T8/T9. Any such studies would have been part of the original K200497 submission for the Vivid S70N.

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

• Not specified in this document. Details on standalone performance for the AI features would be in the K200497 submission.

7. The Type of Ground Truth Used:

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

8. The Sample Size for the Training Set:

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

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

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

Summary based on the provided document:

The 510(k) submission for the Vivid T8/T9 leverages the substantial equivalence pathway, specifically by stating that new "AI Auto Measure" and "AFI" features are "same feature as cleared on Vivid S70N (K200497)." This means that the device's adherence to acceptance criteria for these AI features was established during the clearance of the Vivid S70N, and that information is not detailed in this specific document. The submission explicitly states, "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This indicates that the performance data for the AI features was carried over from the prior clearance.

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