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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/Obsterics, 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, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Dopler, 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 for use by qualified and trained healthcare professionals, 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 can also be used with compatible ICE (Intra Cardiac Echocardiography) 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 is a 510(k) summary for the GE Medical System Ultrasound and Primary Care Diagnostics, for the device names Vivid S60N / Vivid S70N.

Based on the provided text, the device itself is an ultrasound system, not an AI/ML-driven device. The document explicitly states:

• "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence." This indicates that a clinical study, including any form of ground truth establishment, expert review, or MRMC study, was not performed for this submission. The substantial equivalence was based on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety compliance with standards).

Therefore, it is not possible to provide the requested information related to acceptance criteria, ground truth, expert adjudication, or clinical study results for an AI/ML device, as this pertains to a conventional ultrasound system and the submission did not rely on such clinical data for its clearance.

The document describes the device, its intended use, and its substantial equivalence to a predicate device, primarily based on the fact that its underlying technology, intended use, and capabilities are similar to already cleared devices, and it meets relevant safety and performance standards.

In summary, none of the requested information (acceptance criteria, test set, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is available in this document because the device is a conventional ultrasound system that did not undergo a clinical study for this 510(k) submission.

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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, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 can also 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 USBadapter) connection.

The provided text focuses on the 510(k) premarket notification for the GE Vivid S60N/S70N ultrasound system. It details device descriptions, intended use, technological characteristics, and non-clinical tests. Crucially, it includes information on the "AI Summary of Testing: Easy Auto EF and Easy AFI LV," which addresses the performance of the AI algorithms incorporated into the device.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Study that Proves Device Meets Acceptance Criteria

The document states that the acceptance criterion for the AI algorithms (Easy Auto EF and Easy AFI LV) is an average dice score of 91% or higher across various testing conditions.

Study Proving Device Meets Acceptance Criteria:

The study involved testing the AI algorithms on datasets from different countries, scanning views, and left ventricle volumes.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The text states "92% or higher" and "91% or higher" for the reported performance, implying the acceptance criterion was at least 91%.

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

• Sample Size: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization). 135 images extracted from the 45 exams.
• Data Provenance:
  • Country of Origin: Europe, Asia, US (mixed data from different countries).
  • Retrospective/Prospective: Not explicitly stated, but the description of "data collection protocol was standardized across all data collection sites" and "During testing of the AI algorithm, we have included images from different countries..." suggests a pre-existing collected dataset, making it likely retrospective.

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

• Number of Experts:
  • Initial Delineation and Review: 2 certified cardiologists.
  • Consensus Review: A panel of experienced experts.
• Qualifications of Experts:
  • "Certified cardiologists" (for initial delineation and review).
  • "Experienced experts" (for the consensus review panel). Specific number of years of experience is not provided, but "certified" and "experienced" imply relevant qualifications.

4. Adjudication Method for the Test Set:

• Method: A multi-stage adjudication process was used:
  1. Two certified cardiologists performed manual delineation.
  2. They then reviewed each other's annotations.
  3. A "consensus reading" was performed where the two cardiologists discussed agreement/disagreement.
  4. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
• The final ground truth relied on annotations that the two cardiologists agreed upon, and the consensus annotations achieved by the expert panel.

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. The information provided focuses on the standalone performance of the AI algorithm (Easy Auto EF and Easy AFI LV) in terms of Dice score accuracy for image segmentation, not on reader performance with or without AI assistance.

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 done. The reported "average dice score" is a metric for the algorithm's performance in automatically segmenting cardiac structures (Left Ventricle volume). The study describes the AI's accuracy in delineating these structures.

7. The Type of Ground Truth Used:

• Expert Consensus. The ground truth was established through manual delineation by certified cardiologists, followed by their mutual review, and a final consensus adjudicated by a panel of experienced experts.

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. The document only mentions that "To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training." This implies a training set existed and was distinct, but its size is not given.

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

• Not explicitly stated in the provided text. While the method for establishing ground truth for the test set is detailed, the process for the training set is not described. It is implied that ground truth was established, as AI models require labeled data for training, but the specific methodology is omitted.

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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, 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 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 S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 can also 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 document is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid S60N / Vivid S70N diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that would define acceptance criteria and prove its fulfillment.

Therefore, the requested information elements related to detailed study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.

The document explicitly states: "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence."

This indicates that clinical studies, which would typically involve the kind of detailed performance metrics, acceptance criteria, and study methodology you're asking about, were not conducted or submitted for this particular premarket notification. The submission relies instead on demonstrating equivalence to legally marketed predicate devices based on technological characteristics and non-clinical testing.

Therefore, I cannot provide a table of acceptance criteria or a study that proves the device meets those criteria based on the provided text.

Here's what information I can extract regarding the device and the nature of the submission:

• Device Name: Vivid S60N / Vivid S70N Diagnostic Ultrasound System
• Regulation Number: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system)
• Regulation Name: Ultrasonic pulsed doppler imaging system
• Regulatory Class: Class II

Elements that cannot be provided from this document:

1. Table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was conducted.
4. Adjudication method for the test set: Not applicable as no clinical 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 present. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no standalone algorithm performance study was mentioned.
7. The type of ground truth used: Not applicable as no clinical study was conducted.
8. The sample size for the training set: Not applicable as no clinical study data for training was mentioned.
9. How the ground truth for the training set was established: Not applicable as no clinical study data for training was mentioned.

This 510(k) submission primarily addresses the substantial equivalence of the Vivid S60N / Vivid S70N to its predicate and reference devices by outlining:

• Its intended use and indications for use.
• Its technological characteristics.
• Non-clinical testing for safety and performance (acoustic output, biocompatibility, cleaning, electrical, electromagnetic, mechanical safety, and compliance with various standards like IEC 60601 series, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 DICOM).
• Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing).

Ask a specific question about this device

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.

Ask a specific question about this device

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 physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).

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. 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 is primarily a 510(k) Pre-Market Notification from the FDA regarding the GE Vivid S60N and Vivid S70N ultrasound systems. It does not contain an acceptance criteria table or a study description proving the device meets specific performance criteria in detail, as it is a regulatory clearance document rather than a clinical trial report.

However, based on the information provided, here's what can be inferred or stated about the device's acceptance criteria and the study that "proves" it meets them in the context of this FDA clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the GE Vivid S60N / Vivid S70N complies with various voluntary safety and performance standards. These standards implicitly serve as "acceptance criteria" for the device's technical and safety aspects. The "reported device performance" is the statement of compliance with these standards and the assertion of substantial equivalence to predicate devices for its intended uses and technological characteristics.

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

The document explicitly states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence."

Therefore, there is no clinical test set described in this document for the evaluation of the device's diagnostic performance against specific acceptance criteria. The clearance is based on a demonstration of substantial equivalence to previously cleared predicate devices and non-clinical engineering and safety testing.

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

Not applicable, as no clinical studies were performed for this submission. The "ground truth" for demonstrating substantial equivalence would be implied by the regulatory clearance of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies were performed for this submission.

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

No MRMC study was performed or described in this document. The device did not require clinical studies.

6. Standalone Performance Study:

No standalone diagnostic performance study (algorithm only, without human-in-the-loop) was performed or described in this document, as no clinical studies were required. The closest to "standalone" performance testing mentioned are internal verification and validation of software functionalities and system performance against engineering specifications and industry standards.

7. Type of Ground Truth Used:

Not applicable for a clinical performance study since none was conducted. The basis for clearance is substantial equivalence to predicate devices. This means that the technological characteristics and indications for use are similar to legally marketed devices, and any differences do not raise new questions of safety or effectiveness. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This document pertains to the regulatory clearance of an ultrasound system, not an AI/algorithm-based diagnostic device that requires explicit training data. The "training" for such a system would involve engineering development, calibration, and internal testing, but not in the context of a "training set" of patient data for an algorithm as understood in AI/ML performance studies.

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

Not applicable, as no training set for an AI/ML algorithm is described or relevant to this 510(k) submission.

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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 physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.

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. 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 is a 510(k) Premarket Notification submission for the GE Vivid S60N and Vivid S70N Diagnostic Ultrasound Systems, specifically outlining their indications for use and a summary of non-clinical tests. It states that clinical studies were not required to support substantial equivalence. Therefore, the document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, or specificity for diagnostic tasks.

The document focuses on demonstrating substantial equivalence to predicate devices for its intended uses and assuring safety through engineering and quality assurance tests.

Here's the breakdown of the information requested, based on the provided document:

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

The document does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for any specific clinical application. Instead, it lists various standard compliance points for safety and an overall claim of "substantially equivalent" performance to predicate devices.

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

Not applicable, as no clinical performance study for diagnostic criteria is described. The document states: "The subject of this premarket submission, Vivid S60N / Vivid S70N, did not require clinical studies to support substantial equivalence."

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 performance study for diagnostic criteria is described.

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

Not applicable, as no clinical performance study for diagnostic criteria is described.

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. The document states that clinical studies were not required. The product is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations. While it mentions new features like "4D Auto MVO" and "4D Auto AVQ" and "Cardiac AutoDoppler" as "functionality" or "workflow improvements" migrated from other predicate devices, it does not detail any comparative effectiveness study for these features.

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 a human operator and physician for image acquisition and interpretation, respectively. There is no mention of a standalone algorithm performance.

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

Not applicable, as no clinical performance study for diagnostic criteria is described.

8. The sample size for the training set

Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission. The mention of "new functionality" being "migrated" suggests these may have been developed and tested previously as part of other predicate device submissions or internal development, but details are not provided here.

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

Not applicable, as no clinical software training/performance study for diagnostic criteria is described for this submission.

Summary from the document:

The GE Vivid S60N and Vivid S70N are general-purpose ultrasound systems. The submission demonstrates substantial equivalence to previously cleared predicate devices (Vivid S60/S70, Vivid E80/E90/E95, Vivid iq, LOGIQ E9, TomTec Arena TTA2) based on:

• Intended Use: Similar to predicate devices, specialized for cardiac imaging but also covers vascular and general radiology. The document expands on previously cleared indications for use by adding specific applications from other predicate devices (e.g., Intra-cardiac, Intra-luminal, Transvaginal, Transrectal, Musculo-skeletal Superficial).
• Technological Characteristics: Employs the same fundamental scientific technology. New features ("4D Auto MVO," "4D Auto AVQ," "Cardiac AutoDoppler," "FlexiViews," "QuickApps," "Virtual Convex," "View-X") are presented as alternative implementations, new functionalities, workflow improvements, or migrated techniques from other cleared devices.
• Safety and Effectiveness: Compliance with numerous voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety (e.g., ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3 & 2, ISO10993-1, ISO14971, DICOM). Quality assurance measures were applied, including risk analysis, usability analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).

The key takeaway is that this 510(k) submission relies on demonstrating substantial equivalence to existing, cleared devices through non-clinical testing and shared technology, rather than presenting novel clinical performance data for new diagnostic accuracy claims.

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