Search Results

Image display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

Standalone software product with Primary Operating Functions:
• Display and editing of GE Ultrasound 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Transrectal, Vascular, Cephalic, Small Parts, Pediatrics, Musko-Skeletal (MSK)
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM®1)
• Adding annotations to acquired image

This document describes the 510(k) premarket notification for GE Medical Systems Ultrasound and Primary Care Diagnostics' 4D View device. The 4D View is a software product intended for image display of GE Ultrasound 3D/4D datasets for diagnostic purposes, including measurements.

The submission claims substantial equivalence to its predicate device, 4D View (K131118), and references Voluson E10 (K172342). As the submission explicitly states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Based on the provided text, the following information can be extracted regarding the device and its assessment for substantial equivalence.

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

Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission are based on demonstrating substantial equivalence to the predicate device in terms of:

The document states that the proposed 4D View adds workflow improvements and improvements to archive and DICOM functionality, implying performance enhancements in these areas compared to the predicate, but no quantitative metrics are given.

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

Not applicable, as no clinical studies with a test set were 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 studies with a test set were conducted.

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

Not applicable, as no clinical studies with a test set were conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The 4D View is described as a standalone software product primarily for displaying and measuring GE Ultrasound 3D/4D datasets. There is no mention of "AI" or a human-in-the-loop component that would require an MRMC study to assess reader improvement with AI assistance.

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

While the device is a "standalone software product," the documentation does not describe a performance study for the algorithm without human-in-the-loop. The substantial equivalence is based on the device's functional and technological similarities to the predicate, not on a standalone performance study against a clinical ground truth.

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

Not applicable, as no clinical studies were conducted that required establishing a clinical ground truth for performance evaluation.

8. The sample size for the training set:

Not applicable, as this device's submission does not describe an AI/machine learning model development process that would involve a training set.

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

Not applicable, as this device's submission does not describe an AI/machine learning model development process.

Summary of Non-Clinical Tests Used for Substantial Equivalence:

The primary evidence for substantial equivalence for the 4D View device came from non-clinical tests and a comparison to its predicate device. These included:

• Compliance with voluntary standards:
  • ISO 14971:2007 (Risk Management)
  • NEMA PS 3.1 -3.20 (DICOM standards)
  • IEC 62304:2006 (Medical device software life cycle process)
• Quality assurance measures applied during development:
  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Performance testing (Verification)

The manufacturer concluded that the proposed 4D View is as safe, as effective, and its performance is substantially equivalent to the predicate devices based on these non-clinical assessments and the functional comparison.

Ask a specific question about this device

Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image.

4D View is a standalone Software product. which can be installed on a Laptop/PC with Microsoft Windows 7, Windows 8 and as virtual machine with Windows 7 on MAC operating systems. Primary Operating Functions are:
• Display and editing of 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics).
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM)
• Adding annotations to acquired image

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's 4D View software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance, or specific clinical studies in the way a medical device validation study typically would.

Therefore, based on the provided text, I cannot provide the detailed information requested in your prompt.

Here's why and what the text does say:

• No Acceptance Criteria or Device Performance Metrics: The document states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." This means it wasn't a submission based on demonstrating specific performance against predefined clinical criteria through a new study. Instead, it relied on demonstrating that its fundamental technology, intended use, and safety/effectiveness are the same as an already cleared device.
• No Clinical Study Details: Since clinical studies were not required for this submission, there is no information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training sets.
• Focus on Substantial Equivalence: The document highlights that the 4D View "employsthe same fundamental scientific technology as its predicate device(s)" and that "The Intended Use and Indications for use have not changed from the unmodified device." The modifications introduced are the "ability for 4D View to work with additional GE Ultrasound features and data."

What the document does provide:

• Predicate Device: K101166 4D View and K122327 GE Voluson E6/E8/E8ExpertE10 Diagnostic Ultrasound System.
• Voluntary Standards Compliance: IEC62304, ISO14971, NEMA DICOM Set.
• Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing, Final Acceptance Testing. These are general software development and quality control processes, not performance metrics for the device itself.
• Intended Use: "Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image."

To answer your prompt directly, an 510(k) summary for a substantial equivalence determination often does not include the detailed performance criteria and study results you are asking for, especially when clinical studies are not deemed necessary. Such details are more common in PMA (Premarket Approval) applications or 510(k)s where novel technology or new indications require new clinical evidence.

Ask a specific question about this device

Image Display of GE Ultrasound 3D/4D data sets for diagnostic purposes including measurements on displayed image.

4D View 9.1 is a standalone Software product, which can be installed only on a PC with Microsoft Windows Vista operating systems: Primary Operating Functions are: · Display and editing of GE Ultrasound 3D/4D data sets · Measurements on displayed image incl. derived calculations which are all based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics). · Data storage (image, measurement and patient data) · Data transfer to and from remote systems (e.g. via DICOM) · Adding annotations to acquired image Same measurements and calculations are available on the predicate devices

Here's a summary of the acceptance criteria and study information for the GE Healthcare 4D-VIEW 9.1 device, based on the provided 510(k) summary:

The 4D-VIEW 9.1 device did not require clinical studies to support substantial equivalence. Therefore, there are no specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study.

Instead, the submission focused on demonstrating substantial equivalence to predicate devices through non-clinical tests and technological similarity. The "acceptance criteria" are effectively that the device functions as intended, complies with voluntary standards, and has undergone appropriate quality assurance measures.

Here's the breakdown based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No specific clinical test set was used for a performance study. The submission states: "The subject of this premarket submission, 4D-View 9.1, did not require clinical studies to support substantial equivalence."
• "Performance testing (Verification)" and "Simulated use testing (Validation)" were conducted as part of quality assurance measures, but details regarding sample size, data provenance, or specific methodologies for these internal tests are not provided in the 510(k) summary. These are typically internal engineering and V&V activities rather than formal clinical studies.

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 studies were required or conducted, there was no independent test set requiring expert ground truth establishment for a performance evaluation.

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 MRMC comparative effectiveness study was done. The device 4D-VIEW 9.1 is a software product for viewing and measuring 3D/4D ultrasound data, not an AI-powered diagnostic tool for interpretation assistance in the context of comparative effectiveness studies against human readers.

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

• Not explicitly described as a standalone performance study in the way this question is usually posed for AI algorithms. The device itself is described as "standalone Software product." Its performance is based on its ability to accurately display and calculate measurements from GE Ultrasound 3D/4D data. These functions are verified through internal performance testing and simulated use, much like any standard software. There isn't an "algorithm only" performance reported in the context of a diagnostic accuracy study.

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

• No clinical ground truth (expert consensus, pathology, outcomes data) was used. The "ground truth" for the device's functions (e.g., measurement calculations, data display fidelity) would have been established internally through engineering specifications, known mathematical formulas, and comparison to outputs from the predicate devices or validated internal references during verification and validation testing.

8. The sample size for the training set

• Not applicable. This device is a viewing and measurement software. It is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "knowledge" is embedded in its programming logic and algorithms derived from medical literature and engineering principles, rather than learned from a dataset.

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

• Not applicable. As there is no training set, there is no ground truth establishment for a training set. The accuracy of its core functions (measurements, display) would be validated against established mathematical principles and reference standards during development and testing.

Ask a specific question about this device

When used by a qualified physician, this device is intended for displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations.

This device is not intended for diagnosis of lossy compressed images.

The USWP-100A is a software package that may be applied to an existing workstation that is capable of receiving volume data sets via DICOM from Toshiba Ultrasound systems that are configured for 4D imaging. This nofitware consists of measurement packages that were cleared on the predicate device, SSA-790A, AplioXG Diagnostic Ultrasound System.

This 510(k) premarket notification for the Toshiba America Medical Systems, Inc. USWP-100A, 4D Viewer Radiological device does not include information about specific acceptance criteria or an analytical study with performance metrics.

The submission is focused on demonstrating substantial equivalence to a predicate device (Toshiba Aplio XG; SSA-790A V2.2 [K081065]) rather than presenting a detailed performance study with defined acceptance criteria. The core argument is that the new device offers similar functionality and safety as the already cleared predicate device.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be provided based on the provided text.

However, I can extract the following relevant information:

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

• Acceptance Criteria: Not explicitly stated in the document. The document's premise is showing substantial equivalence to a predicate device, implying that its performance should be "similar" to or "no worse than" the predicate device for its intended use.
• Reported Device Performance: Not explicitly reported in terms of specific metrics (e.g., sensitivity, specificity, accuracy). The device is described as "displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations." The document states it offers "measurement packages that were cleared on the predicate device."

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

• This information is not provided in the document. No specific test set or data provenance is mentioned.

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

• This information is not provided in the document. No ground truth establishment using experts is described for a test set.

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

• This information is not provided in the document.

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 is mentioned. This device is a "4D Viewer" for displaying and analyzing images, not an AI-assisted diagnostic tool.

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

• This information is not provided. The device is described as software for displaying and analyzing images, implying human interaction is central to its intended use. There is no mention of a standalone algorithmic performance evaluation.

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

• This information is not provided.

8. The sample size for the training set

• This information is not provided in the document. The device is a "software package" and does not explicitly state the use of machine learning models requiring training data in the context provided.

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

• This information is not provided in the document.

Summary of the document's approach:

The manufacturer, Toshiba America Medical Systems, Inc., pursued a 510(k) premarket notification for the USWP-100A, 4D Viewer radiological device. The primary method for demonstrating safety and effectiveness was by establishing substantial equivalence to a previously cleared predicate device, the Toshiba Aplio XG; SSA-790A V2.2 [K081065].

The rationale for substantial equivalence is based on:

• The device being a "software package" with "measurement packages that were cleared on the predicate device."
• Displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations, which are "identical to those included with the predicate device."
• "No new indications for use that are not already available in devices already marketed in the U.S."
• The device provides "information to the user that is similar to that which is provided by the predicate device" and is "obtained in a manner that is similar to the predicate device."

Therefore, the submission relies on the prior clearance of the predicate device and the assertion that the new device does not introduce new safety or effectiveness concerns, indications, or functions. It does not present a de novo performance study with specific acceptance criteria and performance metrics.

Ask a specific question about this device