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The device 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 of Fetal/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document is a 510(k) Premarket Notification for the GE Vivid E80/E90/E95 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific study design details, and ground truth establishment is not explicitly available in this document.

However, I can extract the following information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the GE Vivid E80/E90/E95 system is substantially equivalent to its predicate devices concerning indications for use, imaging capabilities, technological characteristics, safety, and effectiveness. This "substantial equivalence" acts as the acceptance criterion. The reported device performance is that it meets this criterion by being comparable to the 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)

The document primarily relies on comparisons to predicate devices and adherence to recognized standards. It explicitly states: "The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence."
Therefore, there is no specific test set or data provenance details relating to clinical performance provided in this document as new clinical studies were not deemed necessary for this 510(k) submission. The evidence is based on demonstrating the new device performs equivalently to existing cleared devices.

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 new clinical studies were not required, there is no information on experts establishing ground truth for a test set. The predicate devices would have undergone their own validation for their initial clearance.

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

Not applicable, as no new clinical test set was required.

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 diagnostic ultrasound system, and the submission is for showing substantial equivalence to predicate ultrasound systems, not for evaluating AI assistance or human reader improvement with AI.

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 functions with a human operator for image acquisition and interpretation.

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

Not applicable, as no new clinical studies requiring external ground truth were conducted for this 510(k). The "ground truth" for demonstrating substantial equivalence is the established performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as this is related to a new clinical study or AI development, neither of which were required for this 510(k) submission.

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

Not applicable, for the same reasons as above. The submission focuses on demonstrating the device's technical and functional equivalence to already cleared devices.

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The GE EchoPAC is indicated for diagnostic review and analysis of ultrasound images acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN) ; Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K131685

The provided document is a 510(k) premarket notification for the GE EchoPAC, a software-only device for diagnostic review and analysis of ultrasound images. Based on the document, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical targets, nor does it present specific "reported device performance" metrics for individual features. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicate and exhibits similar technological characteristics.

The comparison table provided in the document focuses on features and capabilities rather than quantifiable performance metrics.

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

The document explicitly states: "The subject of this premarket submission. GE EchoPAC, did not require clinical studies to support substantial equivalence."

Therefore, there is no information provided regarding a "test set" in the context of clinical performance evaluation (i.e., patient data, images, etc.). The "testing" referred to in the "Summary of Non-Clinical Tests" section pertains to software development and validation processes, not clinical outcome testing.

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

As clinical studies were not required, there is no mention of experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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 conducted or reported in this submission for the GE EchoPAC. The device is for "diagnostic review and analysis" of ultrasound images, and the submission focuses on software functionality and equivalence to predicates, not AI-assisted reader performance improvement.

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

The document does not describe standalone algorithm performance without human-in-the-loop. The device, EchoPAC workstation software, is inherently designed to be used by human operators for review and analysis. The "performance testing" described in the non-clinical tests refers to software verification and validation, not clinical standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the lack of clinical studies, there is no information about the type of clinical ground truth used for performance evaluation. The "ground truth" for the software's functionality would have been defined by the software requirements and design specifications, verified through internal testing against those specifications.

8. The Sample Size for the Training Set

No training set information is provided, as clinical studies involving machine learning or AI model training are not discussed in this 510(k) submission.

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

Not applicable, as no training set information is provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a non-clinical software verification and validation effort to demonstrate the device's adherence to voluntary standards and internal quality assurance measures, as well as a comparison to legally marketed predicate devices to establish substantial equivalence.

The proof the device meets acceptance criteria (which are largely defined by demonstrating substantial equivalence and compliance with engineering standards) comes from:

• Non-Clinical Tests:
  • Compliance with voluntary standards: IEC 62366 (usability), IEC 62304 (software life cycle), NEMA PS 3.1 3.20 (DICOM), ISO 14971 (risk management).
  • Internal quality assurance measures: Risk analysis, requirements reviews, design reviews, unit testing, integration testing, final acceptance testing (validation), performance testing (verification), and safety testing (verification).
• Substantial Equivalence Argument: The core of the submission is the detailed comparison of the proposed GE EchoPAC's indications for use, imaging capabilities, technological characteristics, and safety and effectiveness to those of the predicate devices (K131685 GE EchoPAC and K142323 Vivid S60/S70). The document concludes that the proposed device employs the "same fundamental scientific technology" and is "substantially equivalent" to the predicates.

In essence, for this 510(k), the "acceptance criteria" are implicitly met by demonstrating that the new GE EchoPAC, with its modified/added software features, is as safe, as effective, and performs substantially equivalently to the previously cleared predicate devices, supported by robust software development and testing processes, rather than new clinical performance data.

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6VT-D is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Cardiac anatomy of adults through Transesophageal means of access, having imaging capabilities in 2D as well as in real-time 3D / 4D mode.

The 6VT-D is an ultrasound-imaging device that is attached to a GE ultrasound imaging system and used for diagnostic imaging. 6VT-D does not directly control energy delivered to the patient nor does it contain any software. The 6VT-D is a transducer for imaging cardiac anatomy in adults with transesophageal means of access.

The provided document is a 510(k) summary for the GE Healthcare 6VT-D Diagnostic Ultrasound Transducer. It describes a modification to an existing transducer, specifically the replacement of a patient contact material.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of advanced AI/ML performance metrics (such as sensitivity, specificity, or AUC) as it is a submission for a hardware modification of an ultrasound transducer.

Here's a breakdown of why this information is missing and what is available:

• Type of Device: The 6VT-D is an ultrasound transducer, a hardware component that attaches to an ultrasound imaging system. It "does not directly control energy delivered to the patient nor does it contain any software" (Page 1). This explicitly states it's not a software device with AI/ML capabilities, which would typically undergo performance studies with acceptance criteria based on diagnostic accuracy.
• Nature of the Submission: This 510(k) submission is for an "incremental improvement where one patient contact material of the endoscope is replaced by another" (Page 1). The focus of the submission is on demonstrating "substantial equivalence" to a predicate device, particularly regarding the safety and biocompatibility of the new material.

What the document does provide in relation to "acceptance criteria" and "study" are engineering and safety standards:

• Acceptance Criteria (Safety and Performance Standards): The device's "acceptance criteria" are compliance with various international standards for medical electrical equipment, acoustic output, biocompatibility, and risk management. These are the "general requirements for safety" and "particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment."
  • IEC60601-1 (General Safety)
  • IEC60601-1-2 (EMC)
  • IEC60601-2-37 (Ultrasonic Medical Equipment Safety)
  • NEMA UD 3 (Acoustic Output Display)
  • ISO10993-1 (Biocompatibility Evaluation)
  • NEMA UD 2 (Acoustic Output Measurement)
  • ISO14971 (Risk Management)
• Study/Evaluation (Non-Clinical Tests): The "study" mentioned for these acceptance criteria are "Non-Clinical Tests," which include:
  • Acoustic output evaluation
  • Biocompatibility evaluation
  • Cleaning and disinfection effectiveness
  • Thermal, electrical, electromagnetic, and mechanical safety testing
  • Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing, Integration testing, Performance testing, Safety testing, Final Acceptance testing (Validation).
• Clinical Studies: The document explicitly states: "The subject of this premarket submission, 6VT-D Transducer, did not require clinical studies to support substantial equivalence." (Page 2). This further confirms that no performance study involving human subjects or diagnostic accuracy metrics was conducted or deemed necessary for this specific submission.

Therefore, the requested information elements related to AI/ML performance (sample size for test/training set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are not applicable to and cannot be extracted from this document.

Summary of available information as per your request, framed by the context of this device:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance accuracy test set was used for this hardware modification submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance was established for this hardware modification.
4. Adjudication method 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 an ultrasound transducer, not an AI-enabled software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component.
7. The type of ground truth used: Not applicable. Ground truth for diagnostic performance was not relevant for this hardware modification. For biocompatibility, the ground truth was conformance to ISO10993-1 using laboratory testing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The device may include EchoPliot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate device and functionality cleared on GE EchoPAC K123894.

The provided document is a 510(k) Premarket Notification for the GE EchoPAC device. It outlines modifications to an existing device, rather than introducing a new software feature that necessitates a robust clinical study with specific acceptance criteria.

Based on the content of the document, the device did not require clinical studies to support its substantial equivalence. Therefore, there is no information provided regarding acceptance criteria for device performance, nor a study proving the device meets such criteria.

The document states:

• "The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence." (Page 2, "Summary of Clinical Tests" section).
• "GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device." (Page 2, "Conclusion" section).

The focus of this 510(k) submission is on demonstrating "substantial equivalence" of the modified device to a previously cleared predicate device (K123894). The modifications are primarily related to existing features (e.g., 4D Strain, 2D Strain) and the introduction of a new plug-in feature that was "originally cleared in its own right by their OEM manufacturer."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a clinical study as none were conducted or deemed necessary for this specific submission to demonstrate substantial equivalence.

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GE Vivid E9 ultrasound system 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 of Fetal; 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; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document, K131514, is a 510(k) Premarket Notification for the GE Vivid E9 Diagnostic Ultrasound System. This document does not describe a study proving a device meets specific performance acceptance criteria for a new AI or advanced algorithm feature. Instead, it is a submission for a modified ultrasound system, primarily focusing on the addition of new transducers and two optional plug-in features (TomTec 4D MV Assessment and StereoVision) that were previously cleared.

The core of the submission revolves around demonstrating substantial equivalence to predicate devices. This means that GE Healthcare is asserting the modified Vivid E9 is as safe and effective as existing legally marketed devices, and does not raise new questions of safety and effectiveness. This is fundamentally different from a study proving a novel device or AI algorithm meets specific performance acceptance criteria.

The document explicitly states: "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." This indicates that no specific clinical performance study was conducted to establish acceptance criteria for a new feature demonstrating its performance.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document because it outlines a regulatory submission for device modifications based on substantial equivalence, rather than a clinical performance study for a new or significantly modified feature.

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The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate devices.

This GE EchoPAC Review station K123894 510(k) summary states that no clinical studies were required to support substantial equivalence, thus no specific acceptance criteria or performance studies as typically described for a new diagnostic device are provided. The submission focuses on non-clinical tests and conformance to design specifications and industry standards.

Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies that were not conducted.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set or patient data was used as part of this 510(k) submission.

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

Not applicable. No clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

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. No MRMC comparative effectiveness study was done. The device (EchoPAC) is a workstation software for image review, analysis, and reporting, and the submission does not describe it as an AI-assisted diagnostic tool for human readers.

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

Not applicable. The device is software for a workstation, intended for human review and analysis of ultrasound images. It is not a standalone algorithm performing automated diagnoses without human intervention.

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

Not applicable. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

Not applicable. No clinical training set was described or used for this submission.

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

Not applicable. No clinical training set was described or used, and therefore no ground truth for a training set was established.

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GE Vivid E9 ultrasound system 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 of Fetal: 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; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The GE Healthcare Vivid E9 Diagnostic Ultrasound System is a general-purpose ultrasound system specialized for cardiac imaging. The submission describes the device as substantially equivalent to previously cleared predicate devices (Vivid E9 K101149, Vivid i / Vivid q K102388, and 6Tc Transducer K081921).

Acceptance Criteria and Device Performance (Summary)

The documentation provided does not include specific quantitative analytical or clinical performance acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device safety standards. The "device performance" is implicitly considered to be equivalent to the predicate devices and compliant with the listed voluntary standards.

The table below summarizes the types of tests mentioned as being conducted to ensure device safety and effectiveness.

Study Information

1. Sample Size used for the test set and the data provenance:
   The submission explicitly states that "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a defined test set of patient data or its provenance for diagnostic performance evaluation, as clinical studies were not conducted for this submission. The product's compliance was primarily based on non-clinical tests and comparison to predicate devices.

2. 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 clinical studies involving test sets and ground truth from experts were not conducted for this premarket submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as clinical studies involving test sets were not conducted for this premarket submission.

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 submission is for an ultrasound system, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This submission is for an ultrasound system and its software features, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as clinical studies requiring ground truth were not conducted. The "ground truth" for the non-clinical tests mentioned would be established by validated test methods and reference standards for the specific safety and performance metrics (e.g., accuracy of measurements against known physical standards, successful completion of software tests).

7. The sample size for the training set:
   Not applicable. The document does not describe a machine learning model requiring a training set. The device is an ultrasound system with enhanced software features, and its development followed a standard quality assurance process.

8. How the ground truth for the training set was established:
   Not applicable, for the same reasons as above.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; 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 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide 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.

The provided document is a 510(k) Premarket Notification for the GE Vivid E9 BT10 Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail specific acceptance criteria or performance studies in the way a clinical trial report for an AI device might. Instead, it relies on established safety and effectiveness for diagnostic ultrasound systems and the equivalence to predicate devices.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance studies, ground truth establishment for training and test sets, and effect sizes of AI assistance are generally not applicable or not provided in this type of regulatory document for an ultrasound system.

However, I can extract the relevant information regarding safety and equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit performance-based acceptance criteria for a new AI feature or image analysis algorithm, nor does it present detailed quantitative performance metrics for the device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and adherence to general safety standards.

The reported device performance is primarily framed as improved performance and productivity compared to the predicate device, especially regarding new transducers and software features comparable to other cleared GE ultrasound systems.

Key statements on performance:

• "This modification offers improved performance and productivity for users." (Section a): Device Description)
• "The GE Vivid E9 BT10 is of a comparable type and substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers..." (Section a): Comparison with Predicate Device)

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

• Not applicable / Not provided. This 510(k) submission does not describe a clinical test set or data provenance for evaluating a new algorithm's performance. The review focuses on the device as a whole and its equivalence to predicate devices.

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

• Not applicable / Not provided. Ground truth establishment for a specific AI algorithm's performance is not part of this type of submission for a general diagnostic ultrasound system.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable / Not provided. This document does not describe an MRMC study or AI assistance. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool in the sense of comparing human readers with and without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable / Not provided. This relates to an AI algorithm's performance, which is not the focus of this submission.

7. The Type of Ground Truth Used:

• Not applicable / Not provided.

8. The Sample Size for the Training Set:

• Not applicable / Not provided.

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

• Not applicable / Not provided.

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" demonstrating the device meets its "acceptance criteria" (which, in this context, means showing substantial equivalence for regulatory clearance) is summarized in Section b: Non-clinical Tests and Clinical Tests.

• Non-clinical Tests:

  • The device was evaluated for:
    • Acoustic output
    • Biocompatibility
    • Cleaning and disinfection effectiveness
    • Electromagnetic compatibility
    • Thermal, electrical, and mechanical safety
  • It was found to conform with applicable and harmonized medical device safety standards.

• Clinical Tests:

  • "None required." This indicates that for this type of device modification and the established predicate, new clinical trials to demonstrate safety and effectiveness were not deemed necessary by the manufacturer or the FDA (as per the clearance letter). The long history of safe and effective performance of diagnostic ultrasound, combined with the substantial equivalence argument, negated the need for new clinical data.

• Conclusion:

  • The manufacturer stated that 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 conforms with 21 CFR 820, ISO 9001:2008, and ISO13485:2003 quality systems.
  • Compliance with applicable medical device safety standards is verified through 3rd party product certifications and regular production monitoring.
  • GE Healthcare's opinion is that the device is substantially equivalent in safety and effectiveness to devices already cleared for market.

The FDA's decision letter (starting on page 3 of the document) confirms that they reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. This means the FDA agreed with GE Healthcare's assessment that the non-clinical tests and the comparison to predicate devices were sufficient to support clearance without a new clinical study.

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The GE EchoPAC BT10 workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the post acquisition image management and reporting functions of the scanner. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.

This document, K101324, describes a 510(k) Premarket Notification for the GE EchoPAC BT10 Review station. It's important to note that this is a submission for a review station software and not a diagnostic AI device in the modern sense. Therefore, many of the performance metrics and study designs typically associated with AI/ML diagnostic tools (like sensitivity, specificity, MRMC studies, training set details) are not applicable here. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and verification of design specifications.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance:

Since this is not a diagnostic AI device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, they are focused on design specifications, compliance with standards, and functional equivalence to predicate devices.

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

• Not applicable / Not explicitly stated. This submission focuses on non-clinical testing and verification. There is no mention of a "test set" in the context of clinical data or patient samples being analyzed for performance metrics. The testing would have involved software validation and verification against functional requirements, not clinical diagnostic accuracy.

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

• Not applicable. As there was no clinical "test set" in the diagnostic sense, there was no need for experts to establish ground truth for such a set.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. An MRMC study was not conducted. This device is a review station, not an AI-powered diagnostic tool, and its purpose is not to assist human readers in a diagnostic capacity that would be measured by an MRMC study.

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

• Not applicable. The GE EchoPAC BT10 is workstation software for image review, analysis, and reporting, which by its nature is a human-in-the-loop system. It is not an algorithm that operates standalone to produce diagnostic outputs.

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

• Not applicable / System Functionality, Compliance, and Equivalence. For this type of device, "ground truth" would relate to the correct functioning of the software, its adherence to design specifications, and its ability to process and display images as intended, consistent with DICOM standards and the functionality of predicate devices. There wouldn't be a clinical "ground truth" in the sense of a disease state.

8. The sample size for the training set:

• Not applicable. As the GE EchoPAC BT10 is not an AI/ML device that requires a "training set" in the machine learning context, this information is not relevant.

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

• Not applicable. There was no training set for a machine learning model.

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The GE Vscan is indicated for ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.

The GE Vscan is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. It has an overall size approximately 73 mm wide, 135 mm deep and 28 mm high in transport configuration, and provides digital acquisition, processing and display capability. The user interface includes an intuitive layout of specialized controls and a color LCD display.

The GE Vscan - Compact Diagnostic Ultrasound System (K092756) is a diagnostic ultrasound system.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated based on its substantial equivalence to predicate devices, rather than a quantifiable performance metric against a specific threshold. The "acceptance criteria" here are essentially meeting established safety standards and having comparable performance to existing, legally marketed ultrasound systems.

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

• Test Set Sample Size: No specific test set sample size is mentioned for a performance study.
• Data Provenance: Not applicable. The submission asserts substantial equivalence based on technical characteristics, established standards, and the known safety and effectiveness history of diagnostic ultrasound, rather than specific performance data from a clinical test set.

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

• Not applicable. No ground truth establishment by experts for a specific test set is described. The basis for approval is substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

• Not applicable. There was no specific test set requiring adjudication.

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 is a compact 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. This is a standalone diagnostic imaging device, but its "performance" is assessed through substantial equivalence and compliance with safety standards, not a standalone algorithm performance measurement.

7. The Type of Ground Truth Used

• Not explicitly defined as "ground truth" in the context of a clinical study. The "ground truth" implicitly references:
  • Established safety standards: Applicable medical device safety standards.
  • Predicate device characteristics: The known performance and safety profiles of the GE Vivid-e, GE Venue 40, and Acuson P10 ultrasound systems.
  • Historical evidence: The "long history of safe and effective performance" of diagnostic ultrasound in general.

8. The Sample Size for the Training Set

• Not applicable. There is no mention of a training set as this is not an AI/machine learning device undergoing model training.

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

• Not applicable, as there was no training set.

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