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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 Vasculo-sketal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW 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 is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vivid E80/Vivid E90/Vivid E95 ultrasound systems. It does not contain detailed information about a study proving the device meets specific acceptance criteria for AI-related features.

The document states:

• "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence."
• "Summary of Non-Clinical Tests: Vivid E80 / Vivid E90 / Vivid E95 were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards."

While new AI features are mentioned (AI Auto Measure - 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA, 4D Auto TVQ), the document primarily focuses on demonstrating substantial equivalence to predicate devices based on safety, technological characteristics, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for these AI features.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and adjudication methods for a study proving AI device performance is not available in the provided text.

The only performance metric mentioned related to an AI feature is for "AI Auto Measure - 2D": "This saves time compared to manual measurements, due to elimination of user interactions (clicks) by 79% (4 vs. 19)." However, this is a statement of performance, not an acceptance criterion, and the methodology of that specific evaluation is not detailed.

Without a detailed clinical or performance study presented in the document, it is not possible to fill out the table and answer most of the questions.

However, based on the limited information provided, I can infer the following about what kind of information would be relevant if such a study were present:

Hypothetical Example of Desired Information (Not Found in Document):

If a study were present for the AI Auto Measure - 2D feature, here's what the requested information might look like:

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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

• Hypothetical: Test Set: 500 cardiac ultrasound studies (images/clips).
• Hypothetical: Data Provenance: Multi-center retrospective study from hospitals in the US, Europe, and Asia.

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

• Hypothetical: 3 board-certified cardiologists with 10+ years of experience in echocardiography.

4. Adjudication method for the test set:

• Hypothetical: 2+1 (two experts independently reviewed cases, and a third expert adjudicated disagreements).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Hypothetical: Yes, an MRMC study was performed comparing human performance with and without AI assistance for tasks involving cardiac structure measurements (e.g., LVEDD, LVESV, EF).
• Hypothetical Effect Size: Human readers demonstrated a 15% improvement in efficiency (time to read) and a 10% reduction in inter-reader variability when assisted by the AI Auto Measure - 2D feature, primarily due to automated initialization of measurements and reduced manual interactions. The diagnostic accuracy (e.g., agreement with consensus ground truth on disease severity) remained equivalent or showed a slight (e.g., 2%) non-significant improvement with AI assistance.

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

• Hypothetical: Yes, standalone algorithm performance was evaluated against the consensus expert ground truth for relevant measurements, achieving a mean absolute error of X for LVEDD and Y for EF.

7. The type of ground truth used:

• Hypothetical: Expert consensus measurements by highly experienced cardiologists on the ultrasound images/clips.

8. The sample size for the training set:

• Hypothetical: 10,000 cardiac ultrasound studies (images/clips) for AI Auto Measure - 2D.

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

• Hypothetical: Initial ground truth was established by automated scripts based on existing clinical reports and validated by a team of trained sonographers under the supervision of cardiologists. A subset of the training data (e.g., 10%) was manually annotated and verified by a smaller group of expert cardiologists for quality control and refinement.

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Vivid S60N/Vivid S70N 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, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Dopler, 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 S60N / Vivid S70N 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 S60N / Vivid S70N consists of a mobile console with a height-adjustable 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 or dual array format, including dedicated CW transducers and real time 3D transducer. System also can be used with compatible ICE transducers. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vivid S60N and Vivid S70N ultrasound systems. It primarily describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical tests to assure safety and compliance with standards.

Specifically, it states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence." This means that no new clinical study was conducted or provided to demonstrate the device's performance against specific acceptance criteria. The claim of substantial equivalence is based on the device's similarity to existing, legally marketed predicate devices and compliance with relevant safety and performance standards for non-clinical aspects.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is explicitly stated as not required and thus not present in the provided text for this specific submission.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The GE Vivid-i and Vivid-q Diagnostic Ultrasound System is a compact and portable diagnostic ultrasound system.

Here's an analysis of the provided information, addressing your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a premarket notification, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the modified device (GE Vivid-i and Vivid-q BT10) is as safe and effective as the previously cleared version (GE Vivid-i and Vivid-q BT09) and other cleared GE Ultrasound systems, and also to clear new transducers for specific indications. As such, it does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) that were met by the device itself in a typical clinical study, nor does it report numerical device performance against such criteria.

Instead, the acceptance criteria are implicitly related to:

• Safety and Effectiveness: The device being "substantially equivalent" to predicate devices in terms of safety and effectiveness.
• Conformance to Standards: Adherence to applicable medical device safety standards.
• Intended Uses: The modified device performing its stated indications for use reliably.

The document asserts that these criteria have been met through non-clinical tests and a comparison with the predicate.

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

No specific test set or clinical data (sample size, data provenance) is mentioned for evaluating the performance of the GE Vivid-i and Vivid-q BT10 system itself beyond the non-clinical tests. The submission states "Clinical Tests: None required."

For the new transducers (8C-RS, 4C-RS, SoundStar 3D 10F, AcuNav™ 8F), the document lists new indications for use that are "N = new indication (previously cleared by FDA...)" on other existing and cleared devices (GE LOGIQ Book K032477, Vivid 7 K051449, stand-alone devices K070242 by Biosense Webster, Inc., and K071234 by Siemens Medical Solutions). This implies that the safety and effectiveness for these indications with these transducers have been established in previous clearance processes and are being leveraged for this new comprehensive system. However, specific test set sizes or data provenance for these previous clearances are not detailed in this document.

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

Not applicable, as no dedicated clinical test set with ground truth establishment is described for this submission. The "Clinical Tests: None required" statement implies that existing knowledge and previous clearances were sufficient.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence and "Clinical Tests: None required."

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The device is a diagnostic ultrasound system, not an algorithm-only device. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device's performance is intrinsically linked to its use by a qualified physician.

7. Type of Ground Truth Used

Not explicitly stated for this particular submission, as "Clinical Tests: None required." For the previously cleared devices supporting the new indications for the transducers, ground truth would have been established through standard medical practices (e.g., expert clinical diagnosis, other imaging modalities, pathology, or surgical findings).

8. Sample Size for the Training Set

Not applicable. This document pertains to the clearance of a medical device (ultrasound system) and not the submission of an AI/ML algorithm that would typically involve a separate training set. The device's functionality is based on established ultrasound physics and signal processing, not a trained AI model in the modern sense.

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

Not applicable, as there is no mention of an AI/ML training set.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.

The provided document K092079 is a 510(k) Premarket Notification for the GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System. This submission focuses on establishing substantial equivalence to a predicate device and introducing new transducers and extended indications for use.

Crucially, the document states "Clinical Tests: None required." (Section b) 2. of Attachment B). This indicates that a study proving the device meets specific acceptance criteria, in the traditional sense of a clinical trial with performance metrics and statistical analysis, was not performed. Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985), and other previously cleared GE ultrasound systems/transducers for the new indications.

Therefore, the following information cannot be extracted from this document: acceptance criteria with reported device performance (beyond established safety standards), sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set details.

The acceptance criteria for this submission are fundamentally satisfied by demonstrating that the modifications (new transducers and expanded indications for use) do not raise new questions of safety or effectiveness and perform as well as or better than legally marketed predicate devices.

Here's a breakdown of the available information relevant to "acceptance criteria" and how they were met in the context of a 510(k) submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The study that proves the device meets the acceptance criteria is the 510(k) submission itself, where GE Healthcare argues for substantial equivalence based on the points above.

Missing Information (as per the document):

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical tests were required or performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. The "ground truth" here is the regulatory precedent of previously cleared devices and transducers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the new indications is the precedent of prior FDA clearance for similar technologies and applications on other GE ultrasound systems, signifying recognized safety and effectiveness.
8. The sample size for the training set: Not applicable, as no clinical tests or algorithm training were explicitly mentioned as part of this 510(k) submission for new device clearance. The device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.

The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Here's an analysis of the provided text regarding the GE Vivid-i and Vivid-q Diagnostic Ultrasound System.

Acceptance Criteria and Study for GE Vivid-i and Vivid-q Diagnostic Ultrasound System (K082374)

Based on the provided document, the GE Vivid-i and Vivid-q Diagnostic Ultrasound System's acceptance criteria and proof of their being met are primarily based on substantial equivalence to a predicate device and compliance with recognized safety and quality standards, rather than a clinical performance study with specific quantitative acceptance criteria or statistical measures of device performance.

The document states: "The modified GE Vivid-i is of a comparable type and substantially equivalent to the currently marketed GE Vivid-i. It is a compact and readily portable unit having the same design, construction, and materials; is comparable in key safety and effectiveness features. It has the same intended uses as the predicate device and additional software features are identical to that of other cleared GE Ultrasound systems."

And under "Conclusion": "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid-i and Vivid -d Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."

Furthermore, it explicitly states under "Clinical Tests: None required."

Therefore, the "acceptance criteria" here are framed around demonstrating equivalence to existing, legally marketed devices and adherence to established regulatory and engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no specific quantitative performance metrics from a clinical study are reported, the table reflects the qualitative acceptance criteria related to substantial equivalence and safety/quality standards.

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

• Sample Size for the Test Set: Not applicable. No clinical test set or study validating specific performance metrics (like sensitivity/specificity) was conducted. The clearance is based on substantial equivalence to a predicate device and adherence to manufacturing and safety standards.
• Data Provenance: Not applicable for a performance test set. The predicate device (GE Vivid-i Ultrasound System, K061525) and other cleared GE Ultrasound systems provide the basis for equivalence.

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

• Not applicable. No new clinical trials or studies requiring ground truth establishment by experts for specific diagnostic performance were conducted for this 510(k) submission. The safety and effectiveness are inferred from the predicate device and the known history of diagnostic ultrasound.

4. Adjudication method for the test set

• Not applicable. No performance test set requiring adjudication 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

• No. This submission does not involve AI. The device is a diagnostic ultrasound system.

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

• No. This submission does not involve an algorithm. The device is a diagnostic ultrasound system.

7. The type of ground truth used

• Not applicable. No new clinical performance data requiring ground truth was generated. The approval relies on the established safety and effectiveness of the predicate device and the general class of diagnostic ultrasound systems.

8. The sample size for the training set

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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

• Not applicable. This submission does not involve a machine learning algorithm or AI that would require a training set.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular (PV), Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transvaginal (TV), and Intraoperative (abdominal, thoracic, & vascular).

The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter weight package.

This document describes the Summary of Safety and Effectiveness for the GE Vivid E9 Ultrasound system, prepared in accordance with 21 CFR Part 807.92(c).

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Vivid 7 Diagnostic Ultrasound) rather than establishing specific quantitative acceptance criteria for device performance. The "acceptance criteria" are implied to be adherence to medical device safety standards and comparable performance to the predicate.

The table below summarizes the claimed performance characteristics and indications for use, noting that these are "previously cleared by FDA" (P) or "new indication" (N) for specific transducers. The core acceptance criterion for the device itself is its safety and effective performance, which is stated to be consistent with traditional clinical practice and FDA guidelines.

Study Details:

A formal clinical study to prove the device meets acceptance criteria was not required or performed for this 510(k) submission.

• 1. A table of acceptance criteria and the reported device performance: See table above.

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

  • No clinical test set was used, as clinical tests were stated as "None required."
  • Therefore, no sample size, data provenance, or retrospective/prospective nature of the data is reported.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

  • Not applicable, as no clinical test set was utilized and no ground truth was formally established for direct comparison of the new device's performance against clinical outcomes. The equivalence relies on the established safety and efficacy of diagnostic ultrasound and its predicate.

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

  • Not applicable, as no clinical test set was utilized.

• 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 done. This submission is for an ultrasound imaging system, not an AI-powered diagnostic aid. The device is a diagnostic ultrasound system, and the submission emphasizes its substantial equivalence to a predicate device and adherence to safety standards, not an improvement in human reader performance through AI assistance.

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

  • Not applicable. This device is a diagnostic ultrasound system that requires human operation, not a standalone AI algorithm.

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

  • Not applicable. No new ground truth for performance evaluation was established for this submission, as clinical tests were not required. The "ground truth" for the device's acceptable safety and effectiveness is implied through its adherence to established medical device safety standards and the long history of safe and effective performance of diagnostic ultrasound as a modality.

• 8. The sample size for the training set:

  • Not applicable. This device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.

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

  • Not applicable, as no training set for a machine learning model was used.

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