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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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The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthicare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Vascular Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD. B/Power/PWD or CWD.

The device is intended for use in an indoor hospital environment, in medical offices chilities.

The Versana Active is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The Versana Active is a compact, portable system, the device includes operator control panel, display monitor and transducers. The system provides digital acquisition, processing and display capability. The system can be powered through an electrical wall outlet for long term use or from internal battery for a short time use. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device. The Versana Active design enables the system to be attached to three kinds of optional mobile carts. The variety of transducers include convex, linear, sector and mechanical 4D. The access tvpes include trans- body surface. transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port connection and with the use of optional Video Output Adapter, the system can have a Composite Out port connection and a S-Video Out port connection. An optional spare battery charger allows the system battery to be charged externally. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) summary for the GE Healthcare Versana Active ultrasound system. It indicates that no clinical studies were required to support substantial equivalence. Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.

The information provided focuses on the device's technical specifications, comparison to predicate devices, and a summary of non-clinical tests (acoustic output, biocompatibility, cleaning, electrical safety, etc.) that demonstrate compliance with safety standards.

Since no clinical studies were performed, I cannot provide the requested information about acceptance criteria, device performance, or study details.

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ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.

ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.

ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.

ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.

ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.

ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality.

This FDA 510(k) summary for GE Healthcare's ViewPoint 6 software does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document states that no clinical studies were required to support substantial equivalence (Page 6).

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This information is derived from clinical studies, which were not performed.
2. Sample size used for the test set and the data provenance: No clinical test set was described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth for a test set was established as no clinical test was conducted.
4. Adjudication method for the test set: Not applicable as no test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, the document explicitly states no clinical studies were required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no algorithm performance study was described. ViewPoint 6 is described as an image archiving and reporting software, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Based on the provided document, the ViewPoint 6 device is a Picture Archiving and Communication System (PACS) software tool. The 510(k) submission for ViewPoint 6 relied primarily on non-clinical tests and a comparison to predicate devices, rather than clinical performance studies, to demonstrate substantial equivalence.

The document states:

• "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." (Page 6)
• "GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (Page 6)
• The determination of substantial equivalence was based on "intended use, capabilities, technological characteristics, safety and effectiveness" compared to predicate devices (ViewPoint 6, K173456, and reference devices Voluson E10, K192159 and Versana Balance, K191792). (Page 5)
• The summary focuses on "Non-Clinical Tests" such as compliance with voluntary standards (IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM, ISO 14971, IEC 82304-1) and quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing). (Pages 5-6)

Therefore, the requested information regarding acceptance criteria and performance data from a clinical study cannot be extracted from this document, as no such study was conducted or presented in this 510(k) summary.

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