Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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).

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family ultrasound scanners, primarily for cardiology ultrasound of 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 K101324.

The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. Specifically, it states:

"The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence."

Instead, the document focuses on establishing substantial equivalence to a predicate device (K101324 - GE EchoPAC) based on similar technology and non-clinical tests for conformance to design specifications and industry standards.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert opinions, or comparative effectiveness studies, as this information is not present in the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

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, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.

This document, K072952, describes the GE EchoPAC Ultrasound Workstation, a medical image management device. It's important to note that this is a Special 510(k) Premarket Notification, meaning it leverages a previously cleared device (K060542) and likely involves minor changes. Therefore, the depth of performance data might differ from a standard 510(k).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "evaluation in a clinical setting" but does not provide details on the number of cases or patients used for this evaluation.
• Data Provenance: Not explicitly stated. The "clinical setting" implies real-world data, but the country of origin and whether it was retrospective or prospective data are not mentioned. Given the nature of a Special 510(k) for an updated workstation for existing ultrasound systems, it's possible this involved internal testing or smaller-scale evaluations rather than a large clinical trial.

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

• Not specified. The document does not describe the methodology for establishing ground truth for any test set or the involvement of experts for this purpose.

4. Adjudication Method for the Test Set:

• Not specified. No information about expert adjudication or consensus is provided.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: None required to confirm safety and effectiveness." The evaluation mentioned is for "reliability within the intended network environment," which is not an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• No standalone study was conducted or described in the provided text. The device is an "Image Analysis and Review Workstation," implying interaction with a human user. The performance claims focus on its design, software, compatibility, and safety standards, rather than the standalone diagnostic accuracy of an algorithm.

7. Type of Ground Truth Used:

• Not specified. Since no clinical tests for confirming safety and effectiveness were "required" and no details of an evaluation test set (beyond "reliability within the intended network environment") are provided, the type of ground truth used is not described.

8. Sample Size for the Training Set:

• Not applicable/Not specified. The GE EchoPAC is described as an "Ultrasound image Analysis and Review Workstation." It does not appear to employ AI in the sense of a machine learning algorithm that requires a "training set" to learn to perform a diagnostic task. Its function is image management, processing, and review, not automated diagnosis. Therefore, there's no mention of a training set.

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

• Not applicable/Not specified, as there is no mention of a training set for an AI algorithm.

Ask a specific question about this device