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The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. 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), 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, Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, 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 T9/Vivid T8 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 T9/Vivid T8 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 user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alphanumeric keyboard.

The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.

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.

Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.

The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.

The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new, innovative device.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment for performance claims cannot be found in this document.

The document primarily states that the device is "substantially equivalent" to predicate devices, and relies on non-clinical tests (safety, electrical, etc.) and design similarities to justify this claim. It explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence."

Below is a table summarizing the information that could be extracted from the provided text, and noted where information is explicitly not available or not applicable based on the content.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence." Therefore, no "test set" in the context of clinical performance evaluation is described. The non-clinical tests (acoustic, electrical, thermal, etc.) inherently involve testing of the device itself rather than patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for substantial equivalence.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was performed.
4. 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 document pertains to a general-purpose ultrasound system without specific mention of AI features that would necessitate an MRMC study for improved human reader performance. The "Clarity +" feature is described as "real-time image processing/filtering technique," not an AI-driven diagnostic aid that would directly impact human reader performance in a quantifiable way for this type of submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not a standalone algorithm. Its "Clarity +" feature is an image processing technique integrated into the system, not a separate diagnostic algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance evaluation, as no clinical studies were deemed necessary. For the non-clinical tests (e.g., safety, electrical, acoustic), the "ground truth" is adherence to recognized performance standards and internal quality assurance measures.
7. The sample size for the training set: Not applicable. As this device did not require clinical studies, there is no mention of a "training set" for algorithm development related to diagnostic performance.
8. How the ground truth for the training set was established: Not applicable, as no training set for diagnostic algorithm development is mentioned or required in this submission.

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The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. 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), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Vivid T9/Vivid T8 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 T9/Vivid T8 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, and dual array including dedicated CW transducers.

The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.

The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.

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.

Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.

The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.

The GE Vivid T8/Vivid T9 ultrasound system includes AI algorithms named Easy Auto EF and Easy AFI LV. The acceptance criteria and the study proving the device meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of Individual Patients' Images: 135 images
• Number of Exams: 45 exams (assumed 45 patients, exact number of patients unknown due to anonymization)
• Data Provenance:
  • Country of Origin: Europe, Asia, US
  • Retrospective/Prospective: Not explicitly stated, but implies retrospective collection from various clinical sites.

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

• Initial Ground Truth Establishment: Two certified cardiologists.
• Adjudication Panel: A panel of experienced experts. Specific number and years of experience not provided, beyond "experienced experts."

4. Adjudication Method for the Test Set

The adjudication method appears to be a 2 + 1 method (or similar consensus-based approach):

1. Two certified cardiologists performed manual delineation and reviewed each other's annotations.
2. A consensus reading was conducted where the two cardiologists discussed their agreement.
3. For annotations where the two cardiologists could not agree, a panel of experienced experts further reviewed and established the consensus.
4. The final ground truth comprised annotations agreed upon by the two cardiologists, and the consensus annotations from the expert panel review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. The document focuses on the standalone performance of the AI algorithm.

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, specifically measuring the accuracy (Dice score) of the AI algorithm(s) against an established ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus. It was established through a multi-step process involving initial independent delineation by two certified cardiologists, their consensus discussions, and further review by a panel of experienced experts for disagreements.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It only states that the testing dataset was independent of the training data.

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. It only mentions that the testing dataset was ensured to be independent from the training data by using datasets from "different clinical sites for testing as compared to the clinical sites for training."

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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 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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The Vivid T8 is a multipurpose cardiovascular ultrasound system intended for diagnostic ultrasound imaging and fluid flow analysis. The system supports the following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular. Adult Cephalic. Neonatal Cephalic. Musculoskeletal Superficial/ Conventional, Transcranial, Transrectal, Transvaginal and Transesophageal.

The Vivid T8 is the full featured cardiovascular diagnostic ultrasound system designed for cardiac and shared service imaging which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel

This is a premarket notification for the GE Vivid T8 ultrasound system. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Here's a breakdown of the information that is present in relation to your request, and what is not:

1. A table of acceptance criteria and the reported device performance

• This document does not contain a table of acceptance criteria for diagnostic performance or specific device performance metrics in relation to clinical efficacy.
• The tables provided (pages 5-16) describe "Indications for Use" for different transducers with various clinical applications and modes of operation. These tables indicate whether an indication is "new" (N) or "previously cleared" (P, P1, P2) with predicate devices. This represents the scope of intended use rather than performance criteria.
• The "Summary of Non-Clinical Tests" (page 19-20) lists compliance with various medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, ISO14971, NEMA DICOM). These are safety and engineering standards, not diagnostic performance acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document explicitly states on page 20, "The subject of this premarket submission, Vivid T8, did not require clinical studies to support substantial equivalence."
• Therefore, there is no information on a test set, sample size, or data provenance related to clinical diagnostic performance.

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)

• As clinical studies were not required, there is no information on experts, ground truth establishment, or their qualifications.

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

• As clinical studies were not required, there is no information on an adjudication method.

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 clinical studies were performed. The document mentions "Scan Coach feature" and "Smart Start feature with battery" as additions, stating they are "equivalent to that cleared in the LOGIQ F Series (K133034)" and "equivalent to that cleared in Vivid S5/S6 (K121063)" respectively (page 18). These are features, possibly with AI components, but no MRMC study or effect size of AI assistance is discussed or presented.

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

• No clinical studies or standalone algorithm performance evaluations are discussed.

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

• No ground truth for diagnostic performance is discussed as clinical studies were not performed.

8. The sample size for the training set

• No information about a training set for an AI/algorithm is provided.

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

• No information about ground truth establishment for a training set is provided.

In summary, this FDA 510(k) clearance document for the GE Vivid T8 ultrasound system does not contain the detailed information requested regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, imaging capabilities, technological characteristics, and compliance with safety standards, without requiring new clinical performance studies.

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The Vivid T8/Vivid T8 Pro is Multipurpose Cardiovascular System designed for cardiac and Shared Service Imaging, the system supports following applications: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Musculoskeletal Superficial/Conventional, Adult Cephalic, Neonatal Cephalic, Transcranial, Transrectal, Transvaginal and Transesophageal.

The Vivid T8/Vivid T8 Pro is the full featured general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, color LCD image display and touch panel.

The GE Healthcare Vivid T8/T8 Pro is a diagnostic ultrasound system. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing "substantial equivalence" of the Vivid T8/T8 Pro to predicate devices (K121063 GE Vivid S6/S5 BT12 and K133034 GE LOGIQ F Series). The acceptance criteria are implicitly defined by the safety and performance characteristics of these predicate devices. The study demonstrates that the Vivid T8/T8 Pro meets these implied criteria, meaning it performs comparably to the predicate devices and thus is considered safe and effective.

The provided document does not contain a specific table of quantitative acceptance criteria for image quality or clinical performance that would typically be found for an AI/CADe device. Instead, the "performance" is demonstrated through conformity to relevant medical device safety and performance standards, and comparison of features and intended use with the predicate devices.

Summary of Device Performance (based on provided text):
The Vivid T8/Vivid T8 Pro is reported to be substantially equivalent to the predicate devices regarding:

• Intended Use and Clinical Applications.
• Imaging Capabilities (Image modes: B; M; Color, Power, PW & CW Doppler modes, Color M-mode, Harmonic imaging, Combined modes).
• Technological Characteristics.
• Safety and Effectiveness.

It also conforms to the following voluntary standards:

• AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1 : General Requirements for Safety)
• IEC60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
• IEC60601-2-37 (Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
• NEMA UD 3 (Thermal and Mechanical Acoustic Output Indices)
• ISO10993-1 (Biological Evaluation of Medical Devices)
• NEMA UD 2 (Acoustic Output Measurement Standard)
• ISO14971 (Application of risk management to medical devices)
• NEMA, DICOM Set (Digital Imaging and Communications in Medicine)

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

The submission explicitly states: "The subject of this premarket submission, Vivid T8/Vivid T8 Pro, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set or associated data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical tests and comparison to predicate devices.

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

As no clinical studies were performed, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done, as explicitly stated that no clinical studies were required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The submission is for a diagnostic ultrasound system, which is a medical imaging device operated by a human. It is not an AI algorithm or CADe device, so the concept of standalone algorithm performance is not applicable in this context. The device's performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

Not applicable, as no clinical studies were performed. The "ground truth" for this submission relies on established safety and performance standards for diagnostic ultrasound systems and the performance characteristics of predicate devices.

8. The Sample Size for the Training Set

Not applicable. The Vivid T8/T8 Pro is a traditional ultrasound system, not an AI/Machine Learning model that requires a training set.

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

Not applicable, as no training set was used.

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